From Birth Control to Menstrual ControlThe Launch of the Extended Oral Contraceptive, «Seasonale»

7/27/2019 From Birth Control to Menstrual ControlThe Launch of the Extended Oral Contraceptive, Seasonale

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From Birth Control toMenstrual Control

The Launch of the Extended OralContraceptive, Seasonale

HELEN LOSHNY

Cet article relate une discussion surquelques implications et probl0mes dela sante reproductrice des femmes etleurbien-etrequiontsuivilediscours tle d'veloppement et le lancement en2003 du contraceptif ral: SeasonaleIn September 2003, in amove muchdebated and discussed in the NorthAmerican media, Barr Laboratoriesreceived U.S. FD A approval to re-lease Seasonaleon to the prescriptiondrug market. Seasonale is arepackaging of low-dose birth con-trol pills' in an extended regimenconsisting of 84 straight days of useinstead of the previously prescribed21 days, followed by a seven day pill-free interval. Its release gave formalmedical approval to the practice oflong-term menstrual suppressionachieved through continuous birthcontrol pill use-much longer than84 days in some cases-which hasbeen quietly carried ou t by thou-sands of women, for a variety ofreasons, for at least the last two dec-ades. Some of the public discoursesurrounding this event has beenfuelled by the publication of a bookin 1999 by Brazilian gynecologist,Dr. Elsimar Coutinho and popula-tion scientist, Dr. Sheldon Segal,entitled Is Menstruation Obsolete?Coutinho and Segal's main thesis isthat menstruation isuseless and harm-ful to women, their families, and tosociety. He argues that menstruation

is an evolutionary anomaly, whichhas become an inconvenience and ahassle for women and suggests thatthose who do no t agree with him aremisguided and out of date.Th e extent of the discussion anddebate that has accompanied theseevents is no t a novel aspect of thehormonal contraception issue-thereisan abundant body of iterature andcommentary on what has come to beknown as the "Pill" (Marks). How-ever there is a sense, which comesthrough in the discourse surround-ing these recent events that the em-phasis has shifted from a concernwith birth control to one of men-strual control. Made explicit inCoutinho and Segal's book, this shiftis also alluded to on the Seasonalewebsite in the trademark slogan,"Fewer Periods. More Possi-bilities.TM" This can be read as aseemingly unintended ironic play onthe promise of the Pill, marketed tomillions of women on the impliedassurance of "fewer possibilities" ofpregnancy. And the issue of men-strual control forms the basis of alively and intimately detailed discus-sion thread on the Museum of Men-struation website, which, since itstarted in December 2000, has re-ceived contributions from hundredsofwomen throughoutNorthAmericaand Europe, responding to museumcurator, Harry Finley's question,"Would you stop menstruating if

you could?"There isa significant body of femi-nist scholarship which explores theconnection between the creation anddevelopment of reproductive tech-nologies-of which Seasonaleisoneof many-and age-old beliefs andassumptions about "woman's nature"(Martin, Wajcman, Corea). Such

beliefs and assumptions have beenanalyzed and deconstructed and femi-nist theorists and activists alike(Bordo) have exposed and delineatedthe social, political, and economicimpact on women ofthe most centralof these-the idea that women areinferior or less worthy as a result oftheir reproductive functions and ca-pabilities. Cross-culturally and sinceancient times, say these feminists, theso-called evidence for women's sec-ondary status, manifest in their outof control, substance-exuding, form-changing bodies and their subservi-ent sexual and familial roles, has beensummoned up to deny, subjugate,and oppress them (Duden).However, as part of her contribu-tion to a series of articles on contra-ception, which ran in the nationalCanadian newspaper, the Globe andMail, columnist Margaret Wente putforward the argument that such con-ditions no longer exist for mostwomen in contemporary Anglo-American and Western Europeansociety. This, she claims, is due inlarge part to the so-called sexual revo-

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lution brought on by the introduc-tion of the Pill in the early 1960s.Wente is obviously not alone in thisanalysis (see Tone). There is broadand popular acceptance of the ideathat the introduction of the Pill hashad a dramatic impact on these soci-eties and on the lives of women inparticular, as a result of the fact thatthe Pill, in all its various mutations,has provided them with the histori-

like the Pill itself, not something thathas gained universal acceptance. Is-sues of morality, ideology, and fam-ily values, as well as immediate andlong-term health effects that are bothdirectly and indirectly related to Pilluse, are, as the Seasonale story dem-onstrates, still very much matters ofdebate (Gordon and Gordon). Andwhile, as a result of changing socialvalues and technological advances,

The pharmaceutical industry is moving into thebusiness of disease-creation, a role historicallydominated by physicians, which involves framingnormal bodily experiences less as diseasesthemselves, but as causes of future diseases.

cally unprecedented ability to moreor less effectively and safely controltheir fertility. In her recent book, Dr.Penny Le Couteur comments that inthe last 40 years, in countries wherethe Pill and other similar hormo-nally-based contraceptives have be-come widely available,

the birth rate has dropped, andwomen have gained more edu-cation and have entered theworkforce in unprecedentednumbers: in politics, in businessand in trade, women are nolonger an exception. (Le Couteurand Burreson 221)Le Couteur goes on to concludethat the Pill was more than just a

fertility-controlling medication andthat its introduction signaled a changein awareness. This was not just onissues of fertility and contraception,but also with regard to women's fa-milial and sexual roles, allowing in-creasing numbers of them to speakout about and take significant stepsto address the issues of broad-basedgender inequality, violence, and pov-erty underpinning centuries ofwom-en's oppression.

This being said, the idea that thePill has wrought only changes for thebetter, while popularly accepted, is,

the parameters of the debate havealtered, it is interesting to considerthat the concerns being raised bythose involved in it have some oftheir sources in the conditions andcircumstances surrounding the crea-tion and marketing of the Pill some50 years ago.For instance, what is perhaps thecentral element of the current con-troversy-the issue of continuoususe-has its origins in the particularcharacteristics of the developmentand testing phase of the initial ver-sions of the Pill undertaken in theU.S. in the late '50s and early '60's(Oudshoorn). These were a conse-quence of the attempt to maneuverthe prototype Pill through the con-servative social climate and the ob-stacles raised by the leadership of theCatholic Church regarding the arti-ficial, and therefore unacceptable,method of birth control presented bythe Pill. Initially deriving from hor-monal drugs and therapies that werecreated to treat fertility and men-strual problems through a programof short- to medium-term continu-ous use-this could be a interlude ofa number of months to a number ofyears depending on the need and theproblem-the version of the Pill thatits main creator, the devoutly Catho-lic obstetrician, John Rock, intro-

duced on to the market was specifi-cally formulated to mask these ori-gins. Such a formulation was theoutcome of the need for Rock andthe Pill's co-creator, Gregory Pincus,to produce what Margaret Sanger-champion of he birth control move-ment in America (see Tone)-de-scribed as a safe, cheap, reliable,"magic pill" (208) that could be swal-lowed like an aspirin, and that wouldmeet the demands of he Church andits social conservative allies for abirthcontrol method that was "natural"and "God-given." Rock and Pincus,believing they could promote the Pillto the Church leadership on the basisof it being a method similar to theChurch-approved "Rhythm Method,"which simply uses and incorporatesthe "natural" hormonal cycling ofthe body to regulate the possibility ofconception, "decided to cut the hor-mones offafter three weeks and trig-ger a menstrual period" (Gladwell4). This strategy of creating the im-pression of "business as usual" inwomen's bodies was also aimed at theprospective users, the women them-selves, who Rock and Pincus feltwould be reassured by a continuationof their monthly bleeding.

However, many women, as well asthe Church leadership were to seethrough this ploy. Since the release ofits 1968 encyclical outlawing the useof all forms of artificial birth controlby its members, the Roman CatholicChurch continues to maintain itsban on the use of the Pill, a positionthat is also supported by other con-temporary religious and neo-con-servative movements. As for thewomen, increasing numbers ofthem-80 per cent of Americanwomen born since 1945 have usedoral contraceptives (Tone)-haverejected the edicts of traditional reli-gious and conservative ideology andtaken control oftheirfertilitythroughthe Pill. And as for Rock's and Pincus'sattempt to give women the assuranceof regular menstrual cycles while onthe Pill, there are a numerous refer-ences in the literature to the so-called"honeymoon trick" (Rabin), whereby

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women plan continuous pill takingaround a special event, suggestingthat the practice of continuous usewas adopted by women no t long afterthe Pill's introduction and has con-tinued to grow since then.

Recendy, attention has focused onthe extent to which this latter prac-tice is connected with the "market-ing" and commercialization of dis-ease prevention and control and howthis relates to the use of the precur-sors of the Pill in the treatment ofreproductive and menstrual disor-ders (Lippman). These disorders in-clude a whole range of conditionsfrom mild menstrual discomfort todysmenorrhea, which involves severepain and excessive bleeding. Possiblythe most widespread contemporaryuse of the Pill in this area is in thetreatment of a condition that hasbeen described as one of the mostcommon diseases on the face of theearth, endometriosis (see the Endo-center website). This statement,which isbased on the contention thatendometriosis afflicts over 80 mil-lion women world-wide is unfortu-nately not supported with referencesto any research data. Interestinglyenough, a lack of supportive refer-ences and citations is far from theexception in this area of the litera-ture. There is no supportive datacited for the other main therapeuticuse of the Pill, the prevention of ova-rian and endometrial cancer, whichMalcolm Gladwell, for instance,claims are reduced in Pill users by 70and 60 per cent respectively ( 7).While acknowledging the docu-mented beneficial effects of the Pilland other hormonal compounds inthe treatment of reproductive systempathologies, I would like to suggestthat this issue of unsubstantiatedclaims, which are widely quoted inthe popular literature, is one amonga number of issues that are part of agrowing trend to promote drugs andtherapies, including the Pill, for theirpreventive benefits. Women's healthactivist and McGill University Pro-fessor Abby Lippman has discussedthis trend, coining the term "neo-

medicalization" to describe what sheclaims are two new variations, deriv-ing from contemporary economicforces, on the historic and cross-cul-tural practice of medicalizing wom-en's lives, in particular their repro-ductive lives. In the first place, sheargues, the pharmaceutical industryis moving into the business of dis-ease-creation, a role historically domi-nated by physicians. Lippman de-

hormonal deficiency or imbalanceand was also labeled as the cause ofother conditions such as heart diseaseand osteoporosis. She suggests thatthis framing ofmenopause as a causeof subsequent problems meant thateven when the disease label fell ou t offavour, the treatment of menopausein the form of Estrogen ReplacementTherapy (ERT) and combinedEstrogen and Progesterone Replace-

Menstruation is being cast in the same wayas menopause, as a problem of pathology thatneeds to be "fixed" or "eliminated" for notjust its immediate undesirable effects but alsobecause of its disease-causing potential.scribes an interrelated development,which involves the framing of nor-mal bodily experiences less as dis-eases themselves, bu t as causes offuture diseases. She claims that thephenomenon of neo-medicalization

fits seamlessly in the consumer-oriented society of NorthAmerica today and to currentviews of disease-if no t "pre-disease"-as a "market oppor-tunity!" For example, this latestmedicalization comes packagedas individual "choice" with theoffer of multiple "options" towomen. Thus, both neo-medicalization and consumer-ism construct health as a com-modity, a resource needed foreconomic growth, and both em-phasize increasing women'schoices (via the creation of tests,screening exams, etc.). Further,by framing life experiences as"causes" of disease, neo-medi-calization thereby generates awhole industry to create "pillsfor prevention. ( 9)To illustrate this argument,

Lippman looks at how the transi-tional state in women's lives knownas menopause came to be understoodand treated as a disease caused by

ment Therapy (HRT) continued tobe recommended by the medical com-munity because it was now seen as ameasure preventing the onset of thediseases brought on by menopause.The negative consequences to wom-en's health ofsuch an approach have,argues Lippman, been recently re-vealed in the outcomes of the Wom-en's Health Initiative (WHI) in whichthe two arms ofa longitudinal, large-scale study looking at the effects ofER T and HRT on over 16,000 post-menopausal women in the U.S. werestopped three years earlier than theplanned end date. Th e reasons givenfor the premature cancellation of hebiggest trial of this type in drug trialhistory are outlined on the NationalInstitutes of Health (NIH) websiteand include findings of an increasedrisk of invasive breast cancer as well asevidence that the overall health risks,in the form of increased susceptibil-ity to heart attack and stroke, ex-ceeded any benefits for the trial par-ticipants.

Menstruation is, Lippman sug-gests, being cast in the same way asmenopause, as a problem of pathol-ogy that needs to be "fixed" or "elimi-nated" for not just its immediateundesirable and unwanted effects butalso because of its disease-causingpotential. The proponents of this


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message include the persuasive-be-cause difficult to refute-evolution-ary arguments ofCoutinho and Segal,who make a similar claim to BeverlyStrassman, aU.S. anthropologistwhohas researched the link between breastcancer and m enstruation. Strassmansuggests that the much lower rate ofpregnancy and postpartum amen-horrea in women in post-industrialsociety has given rise to a menstrualcycle rate that is300 per cent greaterthan that of their pre-industrialforemothers (Strassman). This inces-sant ovulation in the form of anaverage of 400 menstrual cycles addsup to more than half of a life time'sworth of monthly discomfort anddistress for women of child-bearingage. In addition, there is he increasedrisk of developing some particularlyaggressive types of cancers and agreater susceptibility to anemia,which, Coutinho and Segal argue, isone of the most serious health prob-lems in the world.Other proponents of this argu-ment such as American MD, PatriciaSulak, demonstrate study evidenceto support this theory about the ill-health effects ofmenstruation (Sulaket al.), and use it, as does Dr. LeslieMiller, the creator of the NoPeriodwebsite, to make their case for theelimination of menstruation. Theirmessage, which is framed in the lan-guage of choice and empowermentand aimed at all women of child-bearing age, emphasizes the benefitsof no t only minimizing the disease-causing potential of menstruation butofgetting rid of he hassle and incon-venience of the monthly period. Andthis is where the Pill comes in. Firstwith the years-old practice of off-label continuous use of the short-cycle oral contraceptives, which in-volves skipping the seven-day por-tion of placebos and continuous useof he 21 active pills in a Pill prescrip-tion. Then with the medically-ap-proved version of this practice in theform of the extended cycle oral con-traceptive, Seasonale, a package of 84active pills and seven placebos, offi-cially launched by the manufactur-

ers, Barr Laboratories at the end of2003, and which is set for release inCanada within the next few months.And in the future, with the smallerdose, longer-use versions that are inthe development pipelines of Barrand some ofthe other major pharma-ceutical companies. With a potentialtarget market of half the populationcombined with the high profit mar-gin on birth control pills (Tone), aswell as the greatly shortened researchand development phase required forthis incarnation of the Pill, it is nothard to see why the pharmaceuticalcompanies seem to be staking outmore space in an already lucrativemarket. Just as ERT and HRT wasand is to menopause, so the Pill is andcan be to menstruation, taking upcenter-stage with its dual roles in theprocesses of birth control and men-strual control.

Lippman's perspective is shared byother women's health advocates whobelieve that outcomes such as thosethat have come out of the Women'sHealth Initiative study should serveas a strong warning about the poten-tial consequences of the neo-medicalization of menstruation.These include the members of theSociety for Menstrual Cycle Research(SMCR), which is an organizationcomprised of reproductive healthprofessionals, researchers, and activ-ists from across North America, aswell as Brazil and Australia. SMCRhas, over the course of its 30-yearhistory, been influential in raisingquestions about the risks to women'sreproductive health of some of themainstream approaches in this area.In a statement on the Society's websitethey have referenced findings fromongoingstudies which were presentedat the most recent SMCR conferencein Pittsburgh in 2003 in order toarticulate their concerns on the issueof menstrual suppression. Amongthese findings were ones that emergedfrom Alex Hoyt and Linda Andrist's2003 study showing that women'snegative attitudes toward the men-strual cycle were a better predictor ofwomen's interest in menstrual sup-

pression than women's menstrualsymptoms, suggesting the importanceof psychosocial factors in women'sdecision-making about altering theirmenstruation. Th e possible source ofsome of these psychosocial factorswas alluded to by Ingrid Johnston-Robledo and Jessica Barnack, whosestudy demonstrated a distinct bias inprint-media coverage of menstrualsuppression, whereby regular men-struation was portrayed as bother-some and even unhealthy and morespace was given to the proponents ofmenstrual suppression and its ben-efits. Furthermore, a review of stud-ies on extended cycle oral contracep-tive use by Christine Hitchcock andJerilynn Prior concluded that, as aresult of a lack of well-designed, pla-cebo-controlled, randomized trials,which examine women's experience,bone health and risks for blood clotsand strokes, and which look at theparticular risks faced by adolescents,there is no t yet enough evidence tosuggest that menstrual suppression ientirely safe and reversible. All thisleads the SMCR membership to con-clude that, as with many other healthissues, women are not getting accu-rate, balanced information thus ren-dering an informed decision aboutthis healthcare option difficult if notimpossible.

Yet while there are potentiallearnings from the menopause andWHI study (see Lippman) there arealso different concerns. Some oftheseare centered on the Pill's history as asafe and effective form of birth con-trol and a harbinger of reproductiveand sexual freedom for a generationofwomen as well as the role this wilplay in influencing w omen's responseto, and acceptance of, the promotionof menstrual suppression. It is prob-ably safe to say that the pharmaceuti-cal companies are counting on thisbeing an important factor in pavingthe way for the potential adoption ofthis practice amongwomen who havethe resources and ability to take ad-vantage of it. Barr laboratories re-ported strong acceptance of men-strual suppression in results from their

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clinical trials of Seasonale, in whichover 1,400 women participated for aperiod of 12 months (Anderson andHait). The strength of these resultshas since been called into question ascloser analysis of the Barr data showsthat of the 456 women who were inthe Seasonale subgroup, 185 or 40per cent, left before the end of thestudy with the majority of them cit-ing the problem of break through ormid-cycle bleeding as the reason forquitting the trial prematurely (Rabin).However, in a press release issued inMa y 2004, Barr stated that initialsales of Seasonale had far exceededtheir expectations and they were tak-ing steps to triple their sales andsupport staff in order to keep up withdemand (Hardy). An in-depth ex-amination of these results and re-ports will be among the many tasksrequired in order to fully chart andanalyze the Pill's makeover into atool of menstrual control.Helen Loshny is a Ph.D. student atSimon FraserUniversity,Burnaby, BC,whereher researchfocuss on reproduc-tive technologies and bioethics. HerMA thesis, completed in 2004, lookedat the conceptualization ofself in theorigins and development of the pre-menstrualsyndrome discourse. HelenworksasresearchassistantinheHealthResearch Methodology TrainingLabat Simon FraserUniversity and n theResource Office ofthe Societyfor Cana-dian Women in Science and Technol-ogy-SCWIST, locatedin Vancouver.SCWISTis a non-profitorganizationestablished in 1981 to promote andsupport women in scienceand echnol-ogy. Helen is married o Gregand themother offive year-oldEmma.'Active ingredients are 0.15mg ofLevonorgestrel and 0.03mgofEthinylEstradiol.References

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Coutinho, E. M. and S. J. Segal. IsMenstruationObsolete?New York:Oxford University Press, 1999.Duden B. Disembodying Women:Perspectives on Pregnancy and theUnborn. Cambridge,Mass.: Har-vard University Press, 1993.

Endometriosis Endocentre. Online:www.Endocenter.org DateAccessed: April 2004Gladwell, M. "Annals of Medicine:John Rock's Error." Online:www. gladwell.com/2000/2000_03_10_a_rock.htm: 1-15.Date accessed: August 2004

Gordon, L., and L. Gordon. TheMoralProperty fWomen:A HistoryofBirth ControlPolitics nAmerica(3rd ed.). Urbana: University ofIllinois Press, 2002.

Hardy, K. "Use of EVMS contra-ceptive soars." The VirginianPilotMay 15, 2004.

Hitchcock, C. and J. Prior."Experiments and Opinions onMenstrual Suppression from theScientific Literature." Society forMenstrual Cycle Research 2003ConferenceProceedings. Pittsburgh,June 2003.Hoyt, A. and L. Andrist. "Women'sAttitudes and Beliefs aboutMenstrual Suppression." SocietyforMenstrual Cycle Research 2003Conference Proceeding. 2003.Johnston-Robledo, I. and Barnack,J. Menstrual Suppression in thePopular Press. SocietyforMenstrualCycle Research 2003 ConferenceProceedings.Pittsburgh, June 2003.

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Sulak, P., T. J. Kuehl, M. Oritz andB.L.Shull. "Acceptance ofAlteringthe Standard 21-Day/7-Day OralContraceptive Regimen to DelayMenses and Reduce HormoneWithdrawal Symptoms."AmericanJournal fObstetricsandGynecology186 (6) (2002): 1142-9.Tone, A. DevicesandDesires:AHistoryofContraceptives in America. NewYork: Hill and Wang, 2001.Wajcman, J. Feminism ConfrontsTechnology. Philadelphia: Pennsyl-vania State University Press, 1991.

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TITLE: From Birth Control to Menstrual Control: The Launch of

the Extended Oral Contraceptive, Seasonale

SOURCE: Can Woman Stud 24 no1 Fall 2004

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