Official publication of the American Medical Writers Association Pacific Southwest Chapter

AMWAPacificSouthwestChapter

March2016

Postscripts

Volume VI Issue 41March 201 6

POSTSCRIPTS

IN THIS ISSUE:

• Powdered Booze

• Numbers & Percentages

• Updates from FDA

POSTSCRIPTS

AIMS AND SCOPEPostscripts is the official publication of American MedicalWriters Association (AMWA) Pacific Southwest chapter. I tpubl ishes news, notices, job postings, and articles of interest inal l areas of medical and scientific writing and communications.The scope covers cl inical and regulatory writing, scientificwriting, publication planning, continuing medical education(CME) and physician/patient education, social media, currentregulations, ethical issues, medical writing training andcertification, and good writing techniques.

MISSION STATEMENTThe mission of Postscripts is to facil itate the professionaldevelopment of medical writers and serve as a tool to advancenetworking and mentoring opportunities among all members.Towards this mission, Postscripts publishes significantadvances in issues, regulations and practice of medical writingand communications; ski l ls and language; summaries andreports of meetings and symposia; and, book and journalsummaries. Additional ly, to promote career and networkingneeds of the members, Postscripts includes news and eventnotices covering AMWA Pacific Southwest Chapter activities.

SUBSCRIPTION : Postscripts is published monthly except inJanuary and July. The magazine is available as open accesspublication and is currently distributed online only.

INSTRUCTION FOR CONTRIBUTORS: We consider articleson any topic of interest to our membership. I t is helpful to lookat the past December issues for year-end table of contents, andbrowse past issues for style and type of articles published. Wewelcome contributions from AMWAmembers. Non-membercontributions are general ly by invitation by the Editor or anymember of the Chapter's Board. Detailed instructions areprovided in the December 201 5 issue, Postscripts201 5;5(39):204.

ADVERTISING : Postscripts is an advertising-free magazine.However, articles describing products and services relevant tomedical writers, editors and communicators may be consideredor solicited. As a service to our members, they may submitadvertisements for their services or products for free. Pleasecontact the Editor.

WEBSITES:Chapter website: http: // www.amwa-pacsw.orgAMWA website: http: //www.amwa.orgPostscripts: http: //issuu.com/postscripts

Copyright 2011 -201 6, American Medical Writers Association PacificSouthwest Chapter, San Diego, CA. All rights reserved. (Authorsretain copyright to their articles. Please contact authors directly forpermission to use or display their work in any form or medium.)Design by Ajay Malik.

EDITORAjay K Malik, PhDajay@amwa-pacsw.org

EDITOR-AT-LARGESusan Vinti l la-Friedman, MWCpresident@amwa-pacsw.org

AMWA Pacific Southwest ChapterLeadership —

PresidentSusan Vinti l la-Friedman, MWCpresident@amwa-pacsw.org

Immediate Past PresidentDonna Simcoe, MS, MS, MBA, CMPPpast-president@amwa-pacsw.org

TreasurerElise Sudbeck, PhDtreasurer@amwa-pacsw.org

SecretaryBrea Midthune, PhDsecretary@amwa-pacsw.org

Arizona LiaisonAmy Van Gels, DVMAZliaison@amwa-pacsw.org

Membership CoordinatorGail Flores, PhDmembership-coordinator@amwa-pacsw.org

Employment CoordinatorSharyn Batey, PhDemployment-coordinator@amwa-pacsw.org

Outreach CoordinatorAsoka Banno, PhDoutreach-coordinator@amwa-pacsw.org

Website CoordinatorLaura J Cobb, PhDwebsite-coordinator@amwa-pacsw.org

Newsletter EditorAjay K Malik, PhDajay@amwa-pacsw.org

AMWA Pacific Southwest Conference ChairsJacqueline A Dyck-Jones, PhD, MScJennifer Grodberg, PhD, RAC

Ban

ner

Photo

ArtbyChip

Reu

ben

,www.photoartw

indows.co

m/Red

phonebooth.ByPetr

Krato

chvil,

publicd

omain

pictu

res.net

© Chip Reuben 2008

26 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

POSTSCRIPTSMarch 201 6 | Volume 6, No.41

COVER:

Joshua Tree in Lost Horse Valley.Source: Fl ickr photostream: Joshua Tree National Park.https://www.fl ickr.com/photos/joshuatreenp/22895354884/in/photostream/

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 27

• From the President's Desk — Susan Vintilla-Friedman, MWC . . . . . . . . . . . .• Editor's Desk: Medical Writing in The Shadow of Uber — Ajay KMalik, PhD . .

Clinical Research, Regulatory Science

• Powdered Booze — Rebecca J. Anderson, PhD . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• News and Updates from the FDA— Kokil Tandon, MBBS, MBA . . . . . . . . . . . . .

Medical Communications

• AMA-zing Style — the AMA Manual of Style Column:— Dikran Toroser, PhD, CMPP . . . . . . . . . .

Meeting Report

• AMWA Happy Hour in Orange County . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Career

• Medical Writing Open Positions — Sharyn Batey, PharmD, MSPH . . . . . . . . . . . .

Departments

• What's Happening at AMWA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Chapter Upcoming Events' Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .• Backpage: MoMA's Free Digital Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

© Chip Reuben 2008In this issue. . .

2829

3134

32

37

39

363841

From the President's Desk

Hi everyone – Spring is almost here, and hopefully our part of thecountry will be getting a little more needed rain before we move onto our typical glorious weather. Also coming very soon is theAMWA Pacific Coast Conference, planned by the NorthernCalifornia chapter as a one-day event at the Park Central Hotel inSan Francisco (in the vibrant South ofMarket district) on April 1 6.Agenda and registration information are available athttp://www.amwancal.org/events/index.html. The programincludes two credit workshops and five open sessions, and topicsinclude regulatory publishing, the Public Library of Science(PLOS), data transparency, LinkedIn, and Investigational NewDrug (IND) Applications. The IND presentation is a creditworkshop by one of our past presidents, Jenny Grodberg. Hope tosee you there!

We have good news about our email services – our replacementsystem seems to be working without a hitch, and hopefully all ourmembers are now receiving all messages. If you have any reasonto believe you are not receiving any messages please do let usknow right away at membership-coordinator@amwa-pacsw.org.

If you’ve heard about powdered alcohol products, but wondered ifthey were for real, Rebecca Anderson’s article in this issue explainshow they work and presents the saga of their approval formarketing (but only in some states). Dikran Toroser’s article onguidelines for writing numbers and percentages will help youpresent data clearly, and Kokil Tandon provides her recurringcolumn on FDA news and updates.

In response to interest from our members our chapter isconsidering developing a mentorship program, and we would bedelighted to hear your thoughts about what would be useful to you.Please contact me at president@amwa-pacsw.org if you have anysuggestions, or would be interested in participating either as amentor or mentee.

Finally, we are looking for an outreach coordinator for theThousand Oaks area, so if you or anyone you know is interestedplease contact me at the email address shown above.

Susan

Susan Vintilla-Friedman, MWCPresident, AMWA Pacific Southwest Chapter

BackgroundimagebySandrinjaviamorguefi les.ImageURI:http://m

rg.bz/qe6UMN

28 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

EDITOR'S desk

Medical Writing in TheShadow of Uber

“Is US healthcare ripe for disruption by amedical Uber?” asked health policy experts inthe recent issue of New England Journal ofMedicine. 1 The answer appears to be yes.

In spite of improved healthcare access with thepassage of Affordable Care Act four years agothis month, the cost of healthcare remains highand the risk of under-insured coveragethreatening personal finances exist keeping thehealthcare industry in the crosshairs of policywonks, economists, and political debates. Thissituation is also attracting innovators to come inwith technology-driven solutions that may likelydisrupt the current model of healthcare delivery,and that wil l potential ly bring change also to thedrug development industry and us, the medicalwriters.

The rise of Uber and the disruption of the taxiand l imousine industry al l over the world providean instructive model for how and why anindustry l ike healthcare is vulnerable todisruption. For decades, Yellow Cabs operatedas regulated monopolies with l ittle competitionin most jurisdictions, not incentivized toinnovate, often providing poor or unrel iableservice, and costing too much to theconsumers. Writing for the March 3, 201 6, issueof NEJM, Allan Detsky and Alan Garber (fromthe University of Toronto and Harvard University,respectively) said: "Unrel iable service,inconvenience, uncomfortable surroundings,and high prices make customers unhappy, andgiven the opportunity they wil l go elsewhere."—People were given the choice and theyembraced Uber over Yellow cabs.

In spite of the taxi industry's tremendouspolitical clout, pol iticians are relenting to vocalpublic pressure, regulatory hurdles are beingremoved and Uber is prevail ing providingpeople with a cheaper rel iable alternative.

Detsky and Garber posit that similar disruptionis already happening at the margins of thehealthcare industry. 1 For example, 23 and Me, acompany based in Mountain View, California, isproviding direct to consumer genetic screeningservices making genetics departments with in-house laboratories obsolete. 23 and Me wasnamed the invention of the year by the Timemagazine in 2008. Another pioneer is Theranos,based in Palo Alto, California, whose laboratorydiagnosis service with transparent (and cheap)pricing and tests requiring few drops of bloodfrom a finger stick rather than vials of blood isgiving a pause to the traditional laboratories andphysicians who held tight grip on test lab results.

The doctor’s office is also not immune tochange—IBM’s Watson is already being testedfor cl inical decision making abil ities incol laboration with Columbia, Cleveland Clinicand other organizations. Similarly, healthcaresupport services, including how the insurancebusiness is conducted and transparency inhealthcare pricing are also ripe targets.

The butterfly effect of shifts in healthcareindustry is slowly tugging the rank and fi lebiotech and pharma industry. In addition, thedrug development industry has to navigate thecomplexity of global and country-specificrequirements, reporting mandates and laws.2

Thus, medical writers and regulatoryprofessionals are increasingly seekingtechnological solutions for increasing efficiency.

PICT

URE:

Seat

tle

Dail

yTi

mes

news

edit

orqu

arte

rs-

1900

.Vi

aWi

kipe

dia

(htt

p://

en.w

ikip

edia

.org

/wik

i/Ed

itin

g#me

diav

iewe

r/Fi

le:S

eatt

le_D

aily

_Tim

es_n

ews_

edit

or_q

uart

ers_

-_19

00.j

pg)

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 29

1. Detsky AS, Garber AM. Uber’ s message for health care. N Engl J Med 2016; 374: 806-809.www.nejm.org/doi/full/10. 1056/NEJMp1512206

2. Malik AK. Regulatory intelligence. Postscripts 2015 Sep; 5(37) : 148-149

3. Lang T. Just who are we and what are we doing, anyway? Needed research in medicalwriting. AMWA J 2009; 24 (3) : 106-112

4. Ciobanu M. Hone your craft: Newsroom training advice from FT and NPR. 19 Jan 2016.www. journalism.co.uk/news/-hone-your-craft-newsroom-training-advice-from-ft-and-npr/s2/a603068/

30 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

Last week at the TIPPA 201 6 meeting in SanDiego, several companies showcased cloud-based software solutions for documentmanagement, assisting regulatory compliance,auditing, reporting and publication requirementsand mandates. “Artificial intel l igence-assistedmedical writing” entered the jargon whenSynchrogenix with offices in San Diego acquiredan artificial intel l igence-assisted medical writingservice, ClinGenuity, based in Cincinnati , Ohio,last year.

Medical writing is a value-added professiondesigned to handle complex tasks.2,3 RebeccaAnderson’s article on Powdered Booze in thismonth’s issue of Postscripts (see page 31 ) is anextreme (and unusual!) example of one productrequiring approval from multiple agencies withina single country. Though, more likely scenariowould be dealing with regulatory authoritiesacross the world with nuanced regulations3; thiswil l sti l l require human decision-making andtargeted writing while being assisted bytechnology assimilating the Ubers and sti l lmaintaining our relevance: The journalists arealready doing that.

Journalists are already knee deep in thistransition from old (print) to the online delivery,and companies are preparing journalists to thenew media.4 Lisa Pollack, head of new projectsat Financial Times (FT) told journalism.co.ukthat FT focuses on 3 types of trainings:

1 . Practical trainings focused on a variety oftopics, including productivity tools,spreadsheets, numbers, graphing, role ofFT’s API , etc

2. Bootcamps lasting 2-3 days on selectedtopics

3. Attending conferences and events with agoal to learn what rest of the industry doesdifferent and what FT does well and canimprove upon

The result of this training effort at FT is a“newsroom unicorn” —ie, a journalist withcoding skil ls or a technologist with an interest instorytel l ing.4

Similarly, to survive the future of medical writing,we wil l need to become unicorns open tochange and embrace Ubers knocking onmedical writing doors and assimilate them intoour portfol io.3 As Albert Einstein once said,“Strive not to be a success, but rather to be ofvalue.”

In the coming months, we plan to organize achapter event/symposium discussing varioustechnological solutions of interest to medicalwriters, so please stay tuned.

Powdered BoozeBy Rebecca J. Anderson, PhD, AMWA Pacific Southwest Chapter Member

With l ittle fanfare but considerable controversy, anew product hit the market last year: powderedbooze. According to the advertisements, al l youneed to do is pour the powder out of its l ittle packet,add water, and voilà, the perfect cocktai l . Well ,perhaps not as perfect as one crafted by your localbartender, but certainly, it’s handy, portable, andready whenever and wherever the urge strikes you.

I get it. We live in an increasingly instant world. Ourfriends reach us instantly on (uh-hem) Instagram.We get blasted with breaking news on our smartphones. So, instant booze was inevitable. A logicalsuccessor to powdered milk, instant tea, freeze-driedcoffee, Tang, and Kool-Aid.

Ok, you say, but how can there be such a thing aspowdered booze? Unlike milk and coffee, whichcontain dissolved solids, grain alcohol is a singlemolecule. And there’s not much water in it. (I fyou’ve ever chugged neat lab ethanol, you knowthere is nothing drier than that!) Even so, when youdo pull out the water, you sti l l have a liquid. So whatgives?

Actual ly, there is a technique, and it isn’t new.Enterprising chemists discovered a long time agothat alcohol can be absorbed by short chainpolymers of sugar (i .e. , dextrins or cyclodextrins),creating a dry powder formulation.

The recently approved product, Palcohol, is 50%alcohol by weight and if mixed according to packageinstructions, it yields a l iquid that is 1 0% alcohol byvolume. But who’s going to mix Palcohol with waterwhen you can spike your favorite l iquor or beerwithout affecting the volume? Adventuresome folksmight even try snorting the stuff. But snortingpowdered sugar? You might need an insul in chaser.

The makers of Palcohol promote its convenience.The one-ounce packets fit easily in a pocket, idealfor “activities where weight and bulk is a factor, l ikehiking or backpacking.” (Actual ly, if I have to choosewhat to put in a one-ounce packet to get high, I canthink of much better “powders.”)

True, nobody wants to lug a case of Stol i up MountEverest when you can mix a handful of snow with apacket of powdered booze. But let’s get real. Whysprinkle it on Frosted Flakes by the campfire whenyou can sneak it into a Roll ing Stones concert?There’s an important regulatory lesson with thisproduct and here it is: Palcohol’s market approvalfel l through the federal cracks between FDA andATF.

FDA reviewed the excipients (essential ly sugar) andfound them compliant. But the drug regulators

claimed no legal authority over the “active”ingredient, alcohol. For that, they punted to abureau in the Treasury Department cal led theAlcohol & Tobacco Tax & Trade Bureau (TTB).

TTB officials reviewed Palcohol’s label, packaging,and formulation, but they are only concernedwhether alcohol products comply with tax law—notissues l ike consumer health and intel lectual propertyrights.

TTB approved Palcohol in Apri l 201 4. Then, just twoweeks later (and perhaps anticipating a backlashfrom people who said the product blatantly invitesabuse), TTB backpedaled and said the approval was“issued in error.” Haggling over the label lasted for ayear. Final ly, in March 201 5, TTB said the “issueshave been resolved” and they approved fourvarieties/flavors of Palcohol (margarita,cosmopolitan, rum, and vodka).

So, here we have a product whose individualcomponents were evaluated by FDA and TTB, butnobody assessed the final product, Palcohol, forconsumer safety. The Feds simply tossed it over thewall to the states—each state also has authority toregulate alcohol products through legislation and/orits l iquor control board.

Currently, the makers of Palcohol are fighting formarketing state-by-state, and so far, the states arewinning. State authorities have thrown uproadblocks, concerned that Palcohol wil l faci l itateunderage drinking in public venues. (I guess thoselawmakers really do remember the '60s and theweed they smuggled into Roll ing Stones concerts.)

But bless their hearts, the Palcohol execs haveresponded by touting Palcohol’s virtues in othersettings, including medicine, the mil itary, andaviation. Every mother knows cough syrup alreadycontains enough alcohol to put your fussy kidasleep. And while GI Joe and Jane may appreciatethe packets on their long deployments, I don’t wantmy Delta pilot anywhere near the stuff.

REBECCA J ANDERSON, PhD, is a freelancemedical writer and the author of two books,Nevirapine and the Quest to End Pediatric AIDS

and Career Opportunities in Clinical Drug

Research. Prior to medical writing, Dr. Andersonmanaged research and development projects fortwenty-five years in the pharmaceutical/biotech industry. Sheholds a Ph.D. in pharmacology from Georgetown University.She lives in Southern California, and when she is not writing,she absorbs the sights and sounds of the West Coast’s richculture and heritage. She can be reached atrebeccanderson@msn.com.

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 31

AMA-zing Style — the AMA Manual of Style ColumnBy Dikran Toroser, PhD, CMPP, Amgen Inc. , Thousand Oaks, Calif.

Why are numbers so difficult for so many? In tryingto answer this question, many have made analogiesto dyslexia. I t appears that the answer is complex,and an appreciation of numbers is not a “natural”phenomenon. The AMA manual of style offers someadvice on required numerical discipl ine in scientificarticles that may offer some consistency and clarityto the reader.

Numbers written as numerals emphasize quantitymore strongly than numbers spelled out aswords—hence, they are general ly preferable intechnical writing. However, common sense andeditorial judgment should always be used.

Use of Numerals. Although in scientific writingnumerals are used to express numbers in mostcircumstances, there are exceptions; eg, numbersare not used to begin a sentence, title, subtitle, orheading.

Numbers of 4 or More Digits Around the DecimalPoint. Commas are not used in large numbers. Ahalf-space or thin space is used to separate every 3digits starting from the right-most integer.

Our analytical sample was based on 32 294 81 0elderly persons in the United States.

Mixed Fractions. For less precise measurements,mixed fractions may be used instead of decimals.

The surgery lasted 3½ hours.

Time. Measures of time usually are expressed asnumerals. For dates, use numerals for day and year;spell out the month (February 25, 1 961 )

At 5:45 AM, October 1 5, 1 994, the researcherscompleted the final experiment.

Temperature. Use the degree symbol with Celsiusor Fahrenheit.

The plates were cultured at 1 7°C, 3°C lower thanusual.

Currency. Use the appropriate symbol (eg, $, €, £).

His charge for the medication was $55.60 plus$0.95 for shipping.

Spelling Out Numbers. Spell out at the beginningof a sentence, title, subtitle, or heading. However, it

may be better to reword the sentence so that it doesnot begin with a number.

Three hundred twenty-eight men and 1 26 womenwere included in the study.Better: The study population comprised 328 menand 1 26 women.

Common Fractions. Common fractions areexpressed with hyphenated words, whether thefraction is used as an adjective or a noun.

Of those attending, nearly three-fourths weremembers of the association.

One Used as a Pronoun . The word one should bespelled out when used as a pronoun or noun.

These differences may be concealed if one looksonly at the total group.

Ordinals. Ordinal numbers general ly express orderor rank. Ordinals first through ninth are usuallyspelled out.

I t has become second nature.

Rounded Large Numbers. Rounded large numbersshould be expressed with numerals and words.

The disease affects 5 mil l ion to 6 mil l ion people.[repeat million to avoid ambiguity. ]

Consecutive Numerical Expressions. When2 numbers appear consecutively, reword thesentence or spell out 1 of the numbers.

Study participants were provided twenty 5-mLsyringes.Avoid: In the cohort of 1 500, 690 were men.Better: In the cohort, 690 of the 1 500 individualswere men.

Hyphens. Hyphens may be used in text when ayear span is used as the identifying characteristic ofa study (eg, the 1 982-1 984 NHANES survey).

The students participated in the study during the1 994-1 995 academic year.

Use of to also may introduce ambiguity. However, insome circumstances, such as life span, historicalperiods, fiscal or academic year, page numbers intext, or age ranges, to may be used.

Numbers and Percentages

32 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

The participants ranged in age from 23 to56 years.

In other circumstances through may be clearer.

We looked at 3 periods: 1 964 through 1 967, 1 968through 1 978, and 1 979 through 1 992.

Bullets. Bul lets without enumeration may be usedfor emphasis and clarity when the specific order ofthe items is not important. I f the items are completesentences, begin each item with a capital letter andend it with a period.

The current labeling provides the fol lowinginstructions:• Use should be limited to physiciansexperienced in emergency treatment ofanaphylaxis.

• Initial dosage should be based on skin testing.

I f the bulleted items are not complete sentences, noend punctuation is needed

Anorexia nervosa includes the fol lowing:• Low body weight with refusal to maintain ahealthy weight

• Fear of being overweight despite having anextremely low body weight

Number. May be abbreviated No. in the body oftables and line art or in the text when used as aspecific designator. Do not use the number sign (#).The word number should always be spelled outwhen it is used as a proper noun (eg, "SocialSecurity number").

When referring to numbers of individuals in astudy—in tables, figures, and withinparentheses—the abbreviation N is used whenreferring to the entire sample; n refers to asubsample.

Patients were enrol led at each study site (N =2758) and randomized to intervention (n = 1 378)or placebo (n = 1 380).

Forms of Numbers

Decimals. The decimal form should be used toreflect the precision of the measurement (eg, 38.0 kgshould not be rounded to 38 kg if the scale wasaccurate to tenths of a kilogram).

The patient was receiving gentamicin sulfate, 3.5mg/kg, every 8 hours.

Because they appear frequently, el iminating the zerocan save substantial space in tables and text; eg,P=.16

Percentages. The term percent and the symbol %should be used with specific numbers. Percentage isa more general term for any number or amount thatcan be stated as a percent. Percentile is defined asthe value on a scale of 1 00 that indicates thepercentage of the distribution that is equal to orbelow it.

Ten percent of the work remained to be done.Heart disease was present in a small percentageof the participants.Her body mass index placed her in the 95th

percenti le of the study group.

Any discrepancy in the sum of percentages (eg, dueto rounding numbers) should be explained in thetext, footnote, or legend.

Reporting Proportions and Percentages.Whenever possible, proportions and percentagesshould be accompanied by the actual numerator (n)and denominator (d). The numerator anddenominator should be expressed as "n of d, " not bythe virgule construction "n/d, " which could imply thatthe numbers were computed in an arithmeticoperation.

Death occurred in 6 of 200 patients. (Not: Deathoccurred in 6/200 patients.)

See pages 821 to 833 in the AMA Manual of Style1 0th edition for additional information.

DIKRAN TOROSER, PhD, CMPP, a memberof the AMWA Pacific Southwest chapter, is aregular contributor to the Postscripts

magazine since 201 2. He developed themonthly AMAzing Style column which coverstopics from the AMA Manual of Style, andhas also written on publication-related topicsin these pages. Dikran is currently a Senior Medical WritingManager at Amgen Inc. in Thousand Oaks, California. Heearned his PhD in Biochemistry from Newcastle University(UK), and did his post-doctoral training in biochemical geneticsat the John Innes Center of the Cambridge Laboratory(Norwich, UK) and in molecular biology with the USDA. Prior toAmgen, Dikran was on the faculty (research) at the School ofPharmacy at the University of Southern California. He can bereached at dtoroser@amgen.com.

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 33

News and Updates from the FDAKokil Tandon, MBBS, MBA

Member, AMWA Pacific Southwest Chapter

The last month was relatively quiet at the agency. A noteworthy development was the approval of a type ofchemotherapy that can increase the survival time of l iposarcoma patients. Liposarcoma is a specific type ofsoft tissue sarcoma (STS), that occurs in fat cel ls. STS is a disease in which cancer cells form in the softtissues of the body. While it can develop anywhere in the body, STS is most common in in the head, neck,arms, legs, trunk and abdomen. In late January, the FDA approved the first drug that improved overal l survivalof l iposarcoma patients by approximately seven months. Halaven (Eisai) is indicated for the treatment ofunresectable or advanced liposarcoma patients, who received prior chemotherapy containing an anthracyclinedrug. The Halaven application was granted priority review status, meant to facil itate and expedite thedevelopment of drugs that can potential ly benefit patients suffering from serious or l ife-threatening conditions.Halaven also received the orphan drug designation which assists and encourages the development of drugsfor rare diseases.

Voluntary recalls were issued by Baxter International Inc. , Lucy's Weight Loss System of Arl ington, TX andPharmakon Pharmaceuticals.

A few advisory committee meetings, as well as other events have been scheduled for March, as detai ledbelow

Selected FDA Announcements

AnnouncementDate

Baxter International Inc. , issued a voluntary nationwide recall of four lots of the fol lowingintravenous solutions: 0.9% Sodium Chloride Injection, USP, 1 00mL in Mini-Bag Plus Container;Metronidazole Injection, USP 500mg/1 00mL and Clinimix E 5/1 5 (5% AA w/Electrolytes in 1 5%Dextrose w/Calcium). These were recalled due to the potential for leaking containers andparticulate matter. Leaking containers may result in contamination of the solution which can causeserious adverse health consequences such as bloodstream infection. Injection of a productcontaining particulate matter, may cause allergic reactions or even block blood vessels resulting instroke, heart attack, organ damage and death. 1

01 -26-1 6

Lucy's Weight Loss System of Arl ington, TX, issued a voluntary nationwide recall of al l lots of PinkBikini and Shorts on The Beach dietary supplements. The recall included all colors, 30 count(750MG per capsule) to the consumer lever. FDA analysis found these products to containundeclared active ingredients Sibutramine, Phenolphthalein, and/or Diclofenac, which havediverse and serious health effects.2

01 -28-1 6

Regulatory Intelligence

FDA leaders announced a plan to re-examine the agency’s opioid related policies, as part ofefforts to combat the opioid abuse epidemic, while sti l l providing effective rel ief to patients in pain.This renewed effort is part of a major initiative led by the Department of Health and HumanServices (HHS) to address opioid abuse, dependence, and overdose. The HHS initiative isfocused on three aspects: apprising opioid prescribing practices, increasing naloxone use, andusing medication-assisted treatment for opioid addiction. The FDA’s announcement also supportsthe work being done by the Centers for Disease Control and Prevention’s on guidel ines for opioidprescription for treatment of chronic pain outside of end of l ife care. A significant part of the FDA’splan is to collaborate with external experts in the fields of pain management and drug abuse, suchas the National Academies of Sciences, Engineering, and Medicine. The agency plans to shareprogress related updates on a regular basis.3

02-04-1 6

The FDA alerted healthcare professionals to a voluntary recall issued by PharmakonPharmaceuticals, of Morphine Sulfate 0.5 mg/mL preservative free in 0.9% Sodium Chloride, 1 mLsyringe, CI I , for intravenous use. The recalled product was made on February 3, 201 6, with anexpiration date of March 1 9, 201 6, and labeled with lot E5241 8EV11 C and NDC 451 83-0322-78. I twas distributed to one medical facil ity in Indiana and one in I l l inois. This product was found to besuper-potent and can cause respiratory depression, coma, and death, on injection.4

02-1 6-1 6

Baxter International Inc. , issued a voluntary nationwide recall of one lot of 0.9% Sodium ChlorideIrrigation, USP, 500 mL Plastic Pour Bottle solution, due to presence of particulate matter,identified as an insect. The recalled lot was distributed to customers and distributors in the UnitedStates between November 1 2, 201 5 and January 11 , 201 6.Using this solution could potential lycause a series of complications such as inflammatory reaction, foreign body reaction, and l ife-threatening infection.5

02-1 7-1 6

34 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

March 201 6 Advisory Committee Meetings

CommitteeDate

Science Board to the FDA Meeting Announcement – Discussion of (1 ) the role of opioids in painmanagement (2) scientific challenges in development of pain medications (3) scientificchallenges in the real-world use of opioids for pain, including the impact of opioids withpotential ly less risk for abuse (4) FDA’s role in providing appropriate pain treatment whilereducing opioid abuse (5) postmarket surveil lance activities related to opioids. The ScienceBoard wil l also receive a final report from the Centers of Excellence in Regulatory Science andInnovation Program Evaluation Subcommittee.8

03/1 /1 6

Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement –Discussion of the specific risk-benefit profi le for NDA 20731 8, submitted by AcadiaPharmaceuticals Inc,1 0

03/29/1 6

Selected FDA Approvals

IndicationDrug

Chronic hepatitis C virus genotypes 1 and 4 infections inadult patients6

ZepatierTM

Company

Merck & Co. Inc.

Add-on treatment for partial onset seizures in epilepticpatients aged 1 6 years and older7

Briviact® UCB, Inc.

WEBLINKS

• For additional information on approvals, including labeling revisions, tentative approvals, efficacy supplements withsupporting cl inical data, manufacturing changes or additions, or chemistry; new strength, seehttp: //www.fda.gov/NewsEvents/Newsroom/default.htm

• For additional information on recalls, market withdrawals, and safety alerts, seehttp: //www.fda.gov/Safety/Recalls/default.htm

• For information on current drug shortages, see http: //www.accessdata.fda.gov/scripts/drugshortages/default.cfm• For information on drugs to be discontinued, see http: //www.accessdata.fda.gov/scripts/drugshortages/default.cfm• For Orange Book drug product l ist additions or deletions, seehttp: //www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm

March 201 6 Conferences, Workshops and Public Meetings

Primary Sclerosing Cholangitis Workshop with the FDA, AASLD, ACG, AGA and NASPGHAN.1103/3-4/1 6

TitleDate

1 http: //www.fda.gov/Safety/Recalls/ucm4831 47.htm2http: //www.fda.gov/Safety/Recalls/ucm483928.htm3http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm484765.htm4http: //www.fda.gov/Safety/Recalls/ucm486450.htm5http: //www.fda.gov/Safety/Recalls/ucm486687.htm6http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm483828.htm7http: //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm486827.htm8http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm487034.htm9http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm486092.htm1 0http: //www.fda.gov/AdvisoryCommittees/Calendar/ucm4841 21 .htm11http: //www.fda.gov/Drugs/NewsEvents/ucm481 994.htm1 2http: //www.fda.gov/Drugs/NewsEvents/ucm475626.htm1 3http: //www.fda.gov/Drugs/NewsEvents/ucm479224.htm

KOKIL TANDON, MBBS, MBA, is a physicianMBA, initiating her journey into the arena ofMedical Writing. Previously she worked as ahealthcare consultant where she focussed onprojects involving healthcare delivery systemsand processes. She is an active volunteer inher local community. She can be reached atkokiltandon@gmail .com.

201 6 DILI Conference XVI : How Should Liver Injury and Dysfunction Caused by Drugs BeMeasured, Evaluated, and Acted Upon in Clinical Trials?1 3

03/23-24/1 6

Pharmacy Compounding Advisory Committee Meeting Announcement – (1 ) Discussion of sixbulk drug substances (quinacrine hydrochloride, boswell ia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine) nominated for inclusion on the section 503Abulk drug substances list. (2) Discussion of two categories of drug products (metered doseinhalers and dry powder inhalers) nominated for the l ist of drug products that presentdemonstrable difficulties for compounding.9

1 03/8-9/1 6

Second Annual Neonatal Scientific Workshop.1 203/8-9/1 6

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 35

What's Happening at AMWABy Susan Vintilla-Friedman, MWC

President, AMWA Pacific Southwest Chapter

AMWA 201 6 Medical Writing & Communication Conference – Call for Proposals opennow.

• Roundtable discussion leaders needed! This is a great way to develop skil ls as apresenter and participate in the conference as a content leader.

• Session proposals due by February 1 9. Visit: http: //www.amwa.org/conference

AMWA Online Learning – Visit www.amwa.org/onl ine_learning and check out member’s onlyresources, archived webinars for on demand viewing, and interactive learning activities.

• Ten Characteristics of Effective Tables and Graphs – first state of the art onl inelearning activity, engaging and self-directed, great refresher or intro into the subject,complements but does not replace the Workbook.

• Harness the Power of EndNote: Manage Your Library's Data - Learn from EndNote®super user Stephen Palmer, PhD, ELS as he shares tips and tricks for the intermediateEndNote user. Practice your new skil ls with the interactive quizzes in this activity.

Find these activities and more in AMWA Online Learning at www.amwa.org/onl ine_learning.

Chapter Conferences – promote and attend regional events

• The Mid-Atlantic, Southwest, and Delaware Valley chapter conferences are open forregistration.

MWC – Upcoming Exam Dates and Locations:

Apri l 1 5, 201 6AMWA Delaware Valley Chapter 20th Annual Princeton Conference, Princeton, NJ.Application Deadline: February 1 2, 201 6• Application information at: http: //www.amwa.org/mwc_apply

Essential Skills package – Purchase all 7 Self-Study Workbooks and earn the AMWAEssential Skil ls certificate at your own pace. Enrol lment is included.

Package sale price: $950 member/$1 ,250 nonmemberES Express Package offers over 25% in savings!

Overarching Mission, Vision, Values and Strategic Goals for AMWA

MissionAMWA's mission is to promote excellence in medical communication and to provideeducational resources in support of that goal.

Vision StatementCreating clear medical communications that lead to better health and well-being

Core Values• Professionalism• Expertise• Continuous learning• Connection

Strategic Goals• Enhance resources and educational opportunities for medical communicators acrosssettings and career levels

• Connect and engage with more medical communicators• Increase awareness of AMWA as a valuable resource for medical communicators

36 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

About 1 0 chapter members based in Orange County got together recently ln Tustin fora l ittle camaraderie, networking and a drink.

Date: Tuesday, February 9, 201 6Location : El Torito in Tustin, 1 7420 East 1 7th Street, Tustin, CA 92780

AMWA Happy Hour in Orange County

From front to back: (on left) Kristen F, Heather O and Eileen L; (on right)Clarice C, Carolyn B and Kathy T. Picture by Susan Vinti l la-Friedman.

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 37

Chapter Upcoming Events Calendar

AMWA Pacific Southwest Chapter lunch (monthly) teleconference

Occurs First Friday of the month, 1 2-1 pm Pacific time

Dial in number: 706-91 3-11 55

Participant code: 02041 57# (or from your iPhone: 706-91 3-11 55,02041 57#)

While at TIPPA meeting, join for a happy hour hosted by our chapter on Monday,

February 29th from 6 pm to 7:30 pm at The Cays Lounge in Loews Coronado

Bay Resort. (Pay for your own drinks). Al l are welcome. Address: 4000 Coronado

Bay Road, San Diego, California, 9211 8. Phone: 61 9-424-4000

https://www. loewshotels.com/coronado-bay-resort/dining/lounge

March 1 2, 201 6 – AMWA presentation at CareFusion. Mari lyn All ison wil l speak

on Career Transitions.

April 1 6,201 6 – AMWA Pacific Coast Conference

Where: Park Central San Francisco, A Starwood Hotel, 50 Third Street, San

Francisco, CA 941 03. Visit http: //amwancal.org/ for more information.

April 29, 201 6 (tentative) – Webinar presentation by Thomas Purcell on Project

Management for Medical Writers.

38 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

Medical Writer, Senior ManagerAvanir Pharmaceuticals, Inc, Aliso Viejo, CAhttp://chm.tbe.taleo.net/chm04/ats/careers/requisition. jsp?org=AVANIR3&cws=1 &rid=81 4&source=indeed.com

Medical Writer - Promotional ActivitiesArbor Scientia, Carlsbad, CAhttp://jobview.monster.com/Medical-Writer-Promotional-Activities-Job-Carlsbad-CA-US-1 6224841 3.aspx?mescoid=2700440001 001 &jobPosition=4

Medical WriterMedtronic Inc. , Goleta, CAhttp://job-openings.monster.com/monster/5938cbbe-2032-4b6f-9e2e-0d6fd1 4ce02e?mescoid=2700440001 001 &jobPosition=7#

Medical Writer- PharmaceuticalBrandkarma, Irvine, CAhttp://careers.brandkarma.org/medical-writer.html

Senior Publication SpecialistRecruiting for Undisclosed Company in Irvine, CAAlexandra Heller at Real Life Sciencesa.hel ler@realstaffing.com

Medical WriterRecruiting for Undisclosed CompanyALKU - Los Angeles, CAhttp://job-openings.monster.com/monster/41 bdacc2-d985-4dde-bf7c-23947a91 7e1 0?mescoid=2700440001 001 &jobPosition=9#

Medical WriterAtara Biotherapeutics, Los Angeles, CAhttp://hire. jobvite.com/CompanyJobs/Careers.aspx?k=Job&c=qk0aVfw9&j=o7CS1 fwm&s=Indeed

Senior Medical Writer (Medical Communications)Recruiting for Undisclosed Company in San Diego AreaLiberty Jobs, San Diego, CAhttp://job-openings.monster.com/monster/1 2bcfad0-d23b-4b0e-b3d9-5a0bb79b2c20?mescoid=2700440001 001 &jobPosition=2

Medical Communications Writer II (temporary position)Recruiting for Undisclosed Managed Healthcare in Thousand Oak, CAKelly Serviceshttps://kel ly.secure.force.com/CandidateExperience/CandExpJobDetails?id=a7V800000003HJI&source=Monster&utm_source=Monster&utm_medium=cpc&utm_campaign=Monster&rx_job=58282448&rx_source=Monster&rx_campaign=Monster20&rx_medium=cpc

Medical Communications ManagerRecruiting for position at Amgen (2 year contract)Hart Employment Services, Thousand Oak, CAhttp://hartjobs.com/careers/?cjobid=HS938238527&rpid=1 6202

Medical Writing Open PositionsCompiled By: Sharyn Batey, PharmD, MSPH

Employment Coordinator, AMWA Pacific Southwest Chapter

Career Corner

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 39

Medical Writing ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/6236808/medical-writing-mgr-thousand-oaks-ca/

Regulatory Writing Senior ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/61 89343/regulatory-writing-sr-mgr-thousand-oaks-ca/

Scientific Communications ManagerAmgen, Thousand Oak, CAhttp://careers.amgen.com/job-en/6284671 /scientific-communications-manager-thousand-oaks-ca/

Technical Writer (Device)Boston Scientific, Valencia, CAhttps://career4.successfactors.com/career?career_ns=job_listing&company=BScientific&navBarLevel=JOB_SEARCH&rcm_site_locale=en_US&career_job_req_id=1 95053&jobPipel ine=Indeed

Report Writer (Preclinical Studies)Charles River Laboratories, Reno Nevadahttp: //job-openings.monster.com/monster/df563d01 -0ee6-4ee3-a531 -2095c665676e?mescoid=1 5001 44001 001 &jobPosition=9

***I f you want to share job leads with the members of the Pacific Southwest Chapter, please

contact Sharyn at employment-coordinator@amwa-pacsw.org.

40 POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6

Backpage

MoMA's Free Digital Archive

POSTSCRIPTS | VOL 6, NO. 41 | MARCH 201 6 41

The best things in l ife are free or just about free for us to enjoy. We love Free!

Postscripts is free. Our National and State Parks are just about free: with a reasonablefee, you get unspoiled playgrounds to get out, and enjoy the gifts of nature. And if youhave a 4th grader in your house, yes, al l National Parks are free unti l the school yearends (http: //www.nationalparks.org/ook/every-kid-in-a-park).

I f you enjoy nature, chances are that you also might enjoy art, and you might want tovisit MoMA from the comfort of your home. Did you know that MoMA's digital archiveis also free and truly open access? While you are at moma.org, enjoy the nature oncanvas, learn how artists over the generations have viewed our world through theirbrushes, colors, lens and imaginations; and do not hesitate to use those images onyour blog, in your articles, newsletter, or just to share with friends -- Share the art andshare the love of nature.

MoMA's Digital Archive is available at http: //www.metmuseum.org/art/col lection.

Source: http: //www.artofcounting.com/201 4/05/20/metropolitan-museum-of-art-announces-free-access-to-400000-digital-images/. Accessed: 1 3 Feb 201 6.

—Editor

Heart of the Andes. By Frederic Edwin Church (American, Hartford, Connecticut 1 826–1 900 New York);1 859. Medium: Oil on canvas. http: //www.metmuseum.org/art/col lection/search/1 0481