Contracepção - ManicaDanielaTonelli

IFICHA CAT.-\LDGR.3FIC.\ E1.-KBORADA PEIA
BIBIJDTECA D-D IFCH - LTNICAMIP
Bibliot-eciria: Cecilia Maria Jorge Ni:-olau CRB a .1-337
Llanica, Daniela Tonell

BB1-I-I: Cnnlzracepgio, natureza e cultnra: unbates e sealtius ua
etangraa e ulna trajetria ." Daniela Tnueli 1\Ianira.
- -Canqrinaa, SP: [a. u.], ZD09.
Orientador: Maria Sibel; Kaine.

T-ese - U||i\'ersi.dade Estaual ll: Canlziuas,
Iustiluto do Filnaoa e Ciindas Humanas.
1. Coutiuhu, Elaiuulr LL - Biograa. 1. Couiracepgiu.

3. Giuaro. 4. Natureza. 5. Culhlra. 6. Emograra. Lliocfea,
Maria Sud)". 11. Uuinrsidae Eztarhal de Campinas. [astuln do
Fnsua eindas Humans. ]I[.Ti1u]o.
Tihn eminglis: nature and cultune: clashes and senses in lb:

ethnography" ofa tr:\iedoa1r
Palan-as chares em inglis (kegwmra) : Cnnipun

Cenzr
Nature
Culture
Ermsrlnllr
Alli. e Cumcenbagiu: Anhnpnlogia Social
Tihagio: Doufor em Antmpnlogia Sada]
Bun mniudnrw Maria Sud-y Kofes, M...-51, Conia, Lrpnert Garcia doa
Santos, Fahinla Rohden, Llarllla Raulir-Cilrzz
Data da dzfasa: 10-ll-I009
Program: e P65-Graduagin: Antrupologia Social

Daniela Tonelli Manica
" Natureza e Clt

Contracepgao, u ura:
embates e sentidos na etnografia de uma trajetoria
Tese apresentada ao Departamento de

Antropologia do lnstituto de Filosofia e Cincias
Humanas da Universidade Estadual de Campinas,
para obtengao do grau de Doutor em Antropologia
Social sob orientago da Profa. Dra. Maria Suely
Kofes.
Este exemplar corresponde a
redago final da Tese defendida e
aprovada peia Comissao Julgadora
em 10I11!2009.
Comissao Julgadora
Profa. Dra. a a \g|%\}<f te)
I
-|. P /"|
'y\,\JQ_/[
Profa. Dra. Mariza Corra (IFCH-Unicamp)
Prof. Dr. Layme s Santos (IFCH-Unicamp)
*j
. O'<.. 5.1.,M \
Profa.5ra. Fabiola Rohden (IMS-UERJ)
~_)
-3
sf?
_ , &_
Profa. D . Martha Celia Ramirez-Gal ez (DCS -UEL
Suglentes:
Prof. DI. Guilherme Jos da Silva e S (DA-UNB)

Prof. Dr. Pedro Peixoto Ferreira (DCH-UFA)
Profa. Dra. Heloisa Andr Pontes (IFCH-Unicamp)
Campinas
novembro 2009
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O cientista
baiano Elsimar
Coutinho acha
que sua
equipe estava
preparada para
realizax a
mesma
experincia
com sucesso
mas lembra
que no
momento
existem outros
projetos
prioritrios na
area da
reproduqao
humana.
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colocagio de lmplames
utilizados para uma que
vio em mulheres
tratamento do endometriose,
Z climinuigio do libido. Tambm sic usados
\suprimir a menstruagio e como anticoncepcionais.
,
Em homens a reposigio de testosterona indicada no
hipogonadismo, andropausa ou simplesmente quando ha
hipoandrogenismo.
Os implantes sio segmentos de tubo microporoso do
silstico contendo em seu interior uma substncia pura que pode ser estradiol, um progestinico ou testosterona e
que aplicado no paciente mediante receirurio mdico de acordo com o tratamemo indicado. O hormnio
conticlo no cpsula vai sendo liberado gradualmeme ao longo de 6 meses ou l ano. A colocagio feita com aiuda
de umitrocter por uma enfermeira, em consultrio. O procedimento nio dura mois que l0'vminutos.
O tratarnento com implantes hormonais apresenm rnuitas vantagens em relagio aos outros mtodos, tais como o
Fato de durar 1 ano, ao contrrio do adrninistragio oral diria que acarreta muitas vezes o esquecimento e o abandono
da terapia Outra vantagem a substncia ser liberada diretamente na corrente sanguinea evitando o metabolismo
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E L.
O Fato em
Mr" i
1 Fvw 0 ulgugiry

_ Cl Odinhu, Elsimar E Gabrielli com 0 scnndur Anlnio Carlos Magalhes

Planejamento familiar
; \/isando ampliar u seu galhes, documemo expendO
projcm dc planejamcnlu fami- as atjvidades do [nsljtulo Pla- 9'+$&!"7"$
!1D!2@"+"&" "
l liar (cm Salvador jd lei mu- nejar na Bahia. Ele quer um
1 nicipal), 0 vcreador Pedro audincia com 0 presidenI ow ! "' 6"@"!6""!' !"(!$"+$$
i Godinho. CO!Tl[)lI.hil(lD do Femando Henrique Cardoso
professor Elsimar C0u\inh0 c para mosuar 0 resullado jzi &"#" -"! !" "%"&"$@"!"
s du depulado federal Gcrson obtido pelo lnstitulo. que po-
Gubriclli. enlregou 10 presi- deria servir dc modelo A cria-
"" $"%$6-
denlc do Congresso Nuciun;\l_ Q50 de um progmma nacional
scnadur Anlfmiu Carlos Ma- dc planejamenlo dz famia.

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$%'##!"@&" 4#&"#!""!6"'# * @#A'
($#" "+ ' ',-" M# !" !" ! $*!" " "%# !
$E# " (#$. "!6" &" "' A' (" *!" # $*!" " # ! ;U "@ #
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N" $"%$6-".

"A0 Vereador Pedro Godi-
nho 0 meu agradecimento
pela extraordinaria luta de-
senvo/vida na Cmara dos
Vereadores da cidade do
Salvador, em favor do
Planejamento Familiar."

- Elsimar Coutinho -
Salvador, hoje, a terceira mais populosa cidade do pais.

O seu crescimento vem acontecendo de forma desordenada, sem qual-
quer planejamento. Por conta disso, a cidade vem pagando um prego mui-
to alto. Sao mais de 500 mil criangas e adolecentes no mais absolute es-
tado de pobreza. E a proliferagao de favelas e a ocupagao desordenada
dos espaoos. principalmente as encostas. E a falta de saneamento basi-
co, de sadde, de educago e um aumento assustador nos indices de vio-
lncia.
Todo esse quadro sempre foi uma das grandes preocupagoes do vera-
ador Pedro Godinho e tema central de sua atuago na Camara Municipal.
Para ele, o planejamento familiar 0 ponlo de partida para que Salvador
($ "!"%!"$5 &!"!6" possa repensar 0 seu futuro.
E de Pedro Godinho o Projeto, transformado em lei; que garante a po-
$,-"*!"@D!. pulagao. principalmente as camadas mais pobres . recursos educacionais
e cientificos para que possa ter direito ao planejamento familiar,
Pedro Godinho conta com 0 seu voto para continuar a sua luta na ca-
mara dos Vereadores por uma cidade melhor. mais humana e mais digna
M92551; VEREADOII yr
P E D R O

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;

CONTENTS
v
WITNESSES
TUESDAY, Ava. 8, 1978

Talc
Opening statement by Mr. Scheuer ________________________________ _ _ 1
Dr. Fred T. Sai former Assistant Secretary General, International Planned
Parenthood Pederation_ _ _. ____________________________________ _ _ 4
' V Dr. Robert A. Hatcher Associate Professor of Gynecology and Obstetrics,
' Emory University Sol-Jol of Medicine, Atlanta, Ga__________________ __ 8
' Dr. D. Malcolm Potts, r ecutive Director ,International Fertility Re-
search Progam _______________________________________________ _ _ 15
Dr. William . Hubbard Jr., President, The Upjohn Co_____________ ,_ 26
Dr. Donald Kennedy, Commissioner, Food and Drug Administration,
Public Health Service, Department of Health, Education, and Welfare_- 31
Ms. Rebecca J. Cook, former head, Law Program, International Planned
Parenthood Federation_________________________________________ __ 48
- Wannnsnn, Auo. 9, 1978
Drs. Ridgely Bennett, Victor Berliner and Bernard St. Raymond, Food
and Drug Administration_______________________________________ __ 58
Dr. Elsimar Coutinho, Professor of Obstetrics and Gynecology, Federal
University of Bahia, Brazil ___________ ______ ____________________ __ 75
Dr. Mokhtar Toppozada, Professor of Ob_ __tet-nos,
___~,'_ _ andnaynecology,
~A.lex-rr-re '*r-"' """"'~
,_,_s_,_s_a.mdr-ia-Universrty;=Egyi:>1TliIi._'_.*i. -.' ."- ;'- _L _ _ ____________________ - _ 83; "1
Dr Samuel Shapiro, Drug Epidemiology Unit, Boston University Medical
enter- - - _ . __________________________________________________ __ 87
Dr. Ronald Henry Gray, World Health Organiza.tion_______ _________ __ 92
Mr. Tieng Pardthaisong, Assistant Professor, Department of Preventive
and Social Medicine, hiang Mai University______________________ __ 99
Dr. Juan Zanartu, Professor of Obstetrics and Gynecology, Faculty of
Medicine Universityof Chile, Santiago ___________________________ .__ 112
Dr. Allan Roseneld, Professor of Obstetrics and Gynecology, Columbia
University_____________________________________________________ __ 116
THURSDAY, Ana. 10, 1978
Mr. Sander Levin, Assistant Administrator for Development Support,
Agency for International Development, accompanied by Dr. Stephen
Joseph, Deputy Assistant Administrator for Human Resources Develop-
ment_________________________________________________________ __ 129
Dr. Philip Corfman, Director, Center for Population Research, National
Institute for Child Health and Human Development_______________ -_ 144
Drs. Giuseppe Benagiano and Ronald Gray, Medical Ofcers, Special Pro-
gram for Research, Development, and Research Training in Human
Drs. Giuseppe Benagiano and Ronald Graly, Medical Oicers, Special
Program for Research, Develo ment, and csearch Training in Human
Reproduction, World Health 6r1g_anization ________________________ __ 148
Dr. S. Bruce Schearer, Associate, he Population Council_______--_____ 163
Ms. Alice Nichols, consumer ________________________ _-________ _____ I77
Ms. Anita Johnson, Environmental Defense Fund ___________________ __ 181
(III)
.-'
ea-~
F

75
Thank you very, very much for your patience. _

Dr. BENNETT. Mr. Chairman, may I make just one concludmg
statement?
Mr. SGHEUER. Yes. _
Dr. Ilnxxmr. I would like to apologze for the unavailability of
ou 1- three principal scientists, who were not able to attend the session.
Mr. Scm-zm-zn. And where are they?
Dr. BENNETI. Ono is ill, one has resigned, and one is on vacation.
Dr. Sr. Ii-.\nro>:n. I would like to nuilrc just. one comment that per-
haps this answer to the question that was raised concerning the lack
of a patient population could possibly be better answered by one, two,
or three pf those particular individuals, rather than by Dr. Bennett
or mvscl .
Mr. Sci-mm-zn. Im sure you can invite them to participate in formu-
lating an answer. \Ve certainly would be happy to have their views.
Thank you very much for your patience. You are welcome to stay
for the next panel. I think you might nd it very interesting and
stiniulating. Id invite you to stay at the table except that we have six
witnesses joining us.
They are Dr. Elsimar Coutinho, Dr. Mokhtar Toppozada, Dr.
Samuel Shapiro. i\Ir. Tieng Pardthaisong, Dr. Juan Zanartu, and Dr.
Allan Roseneld. Will all of you come and take your places.
Dr. Elsimar (outinho is Professor of Obstetrics and Gynecology at
the Federal Universit_\_' of Bahia. in Brazil. Dr. Mokhtar Toppozada
is Professor of Obstetrics and Gynecolog at Alexandria University
in Egypt. Dr. Samuel Shapiro is from the Drug Epidemiology Unit
at Boston University Medical Center. Hr. Tieng Pardthaisong is As-
sistant Profcssor in the Department of Preventive and Social Medicine
in Chiang Mai University in Thailand. Welcome to all of you.
Dr. Juan Zanartu is Professor of Obstetrics and Gynecology in the
Faculty of Medicine at the University of Chile. Dr. Allan Roseneld
is Professor of Obstetrics and Gynecology at Columbia University.
Again, welcome. Your statement will be printed in the record in fu l.
If you feel comfortable just chatting with us informally and hitting
the high spots of your testimony. and adverting to any of the discus-
sions youve heard here this morning, youre more than free to do that,
all right?
t n. Coutinho, please, wed be delighted to hear what. you have to
e us.
STATEMENT OF DR. ELSIMAR OOUTINHO, PROFESSOR OF OBSTET-
RICS AND G-YKECOLOGY, FEERAL UNIVERSITY OF BAHIA,
BRAZIL
[Prepared Statement in Appendix on p. 408.]
Dr. Coo-rnmo. In m 1 statement I describe how I rst got to know
Depo-Provera. and how we started using it in the treatment of pre-
maturity. That was in the very early stages of development of Depo-
Provera and it was in our clinic that we rst found, as a side eect,
that Dcpo-Provera was a contraceptive. The intention of, the reason
whv we have used Dcpo-Provera, was to prevent premature labor.
We have given this drug to women who were in premature labor
but it could not prevent premature labor. At the end of 2 years of un-
S

76
successful trials, we reported these ndings to the Upjohn Co. The
drug was no good to prevent premature labor, and that was it.
A year and a half later the women who had been treated for pre-
maturity kept- coming back to us and said they couldnt get pregnant
after the treatment.
Mr. Scmzmzn. For as long as 1% years?
Dr. Cotrrixnoz A year, but I should say that the amount of Depo-
Provera given for prematurity was in a dose much higher than what is
given for contraception. Were giving as much as'3 grams of the drug
to prevent premature labor.
_ Mr. Sonrzmm. Compare that with the amount thats normally
given
Dr. Coirrmuo. This is 150 milligrams. That was about 10 times more
than what we give for a contraceptive eect to last 3 months.
Mr. Scnnum. And they remained unable to become pregnant, for
how long?
Dr. COUTIXHO. One year.
Mr. Scunmtn. For 1 year?
Dr. Cotrrixno. Yes. \Vell, this has to be qualied because after wom-
en deliver, they remain infertile for some time.
Mr. Scmztmn. How long!
Dr. Cotmxno. Well. it varies. A minimum of 3 months; it may last
longer than a year if they are lactating. so in fact its a population in
whom it is very diicult to analyze the eifect of Depo-Provera.
It should be noted that the number of women that we have treated
was relatively small. It was about 20 women.
_ Mr. Twenty?
Dr. COUTINHO. Twenty, yes.
Ur. Scnntmn. Did you notice any abnormal characteristics of the
infants of the mothers who were treated with Depo-Provera during
pregnancy?
Dr. Covrxxno. Well, this is a dierent group because these 20 wom-
en received Depo-Provera during labor.
Mr. Scnntrnn. Oh. I see.
Dr. Cormxuo. This was an aftereect of the treatment dining pre-
mature labor. It was within the 24 hours preceding the delivery. We
later treated women who had had habitual abortions, to prevent abor-
tions. I would like to say that I still treat women that way, despite the
epidemiological information that Depo-Provera may not be as useful
as we thought in preventing premature delivery, or habitual abortion.
_- On the basis of favorable clinic results in my country, I would say
that most doctors still use Depo-Provera in the treatment of habitual
abortion.
Mr. Solmm-:n. But you told us thatjt is ineective for that.
Dr. Cormimo. No, I said it is ineective in the treatment of pre-
mature labor. Premature labor is dened as labor occurring when gesta-
tion has progressed over 6 months of pregnancy and the fetus is viable.
In these cases you should prolong gestation as long as you canup to
9 months if possible.
In women who have habitual abortion, who abort every time they
get pregnant, at the end of 1, 2, or 3 months of pregnancy, treatment
with Depo-Provera seems to be useful. The drug is given throughout
T

' 77
pregnancy at doses which vary from 100 to 200 milligrams every 2

weeks. Thats almost standard treatment. In Brazil we recommend it
dose of 150 milligrams every 2 weeks for the duration of gestation.
Of these women, this is a relativelgiemall number of subjects-Id say
that for the last 15 years that Ive n handling the drug and giving
it to women who do have habitual abortion, I have never seen a case of
malformation. Youd say, well, what would be the incidence you would
expect? Well, Id say not more than 1 percent and probably t e number
of subjects that we ave treated is less than 100, so we could not really
be sure that we would not nd an eect, if the population were larger.
From the clinical point of view, we have the feeling that the drug
would not cause abnormalities, but of course, well have the epidemiol-
ogists to say what to expect from the exarience that we have.
Mr. Scmzrmn. Id like to introduce ngressman Tony Beilenson.
who was the task force director for the 3 weeks of hearis that we had
on fertility and contraception. in the United States. es one of the
most productive and thoughtful members of this committee. I would
ask if you would like to take over the Chair and succeed your other
task force director, Congressman McCloskey from California, who left
moments ago.
Mr. BEILENSON. If you tell me who to call on next.
Mr. Scmznsn. OK, this is our rst witness, Dr. Coutinho, and if youll
then proceed and go riggit down the list seriatim.
Mr. lli:u.i:Ns0.\'. Dr. oppozada.
Mr. Scasmm. No. no, we re not nished with Dr. Coutinho yet.
Mr. Bsnrenson. You do it. [Laughte-r.]
Hr. Sermon. Dr. Coutinho is just getting started.
Dr. Courmno. Shall I go on?
Mr. SCHEUER. Yes, indeed.
Dr. Con-mmo. You had a question about the duration of the drugs
contraceptive effect with these women. Maybe I should elaborate
slightly on this issue, because it seems to be very important. When the
women who have been treated with large doses came back complaining
that they would not getsegnant the rst year following treatment, we
contacted the Upjohn . I wrote them a letter saying that maybe
their drug is not eective in preventing labor, but it has a contracep-
tive side effect.
They were interested in studying it, because no injectable contra-
ceptive drugs were available at that time. We started to evaluate how
much of the drug was eective as a contraceptive, and we came down
from the high doses of 2 or 3 grams, to just a few milligrams. We then
tested in small groups of women who desired an injectable contracep-
tion.
We reduced the dosage to 25 milligrams a month and it was still
effective as a contraceptive. As a matter of fact. in combination with an
estrogen, as little as 1 to 15 milligrams a month is eective.
Mr. Scmztnuz. A month?
Dr. Covrmno. Fifteen milligrams a month with an estrogen-
monthly injections. . .
Mr. Scnnmm. This is during pregnancy!
Dr. Cournmo. No, no, this is as a contmceptive.
Mr. Scmnrrzn. Now, you see, thats not w at we would call a long-
35 I19-78--6
V

78
lasting contraceptive. You did use it in high doses that gave a contra-
ceggive eect for agproximately 1 year.
r. Coirrnzno. ell, the approximate eective doses are 25 to 50
milligrams for 1 month, 100 to 150 milligrams for 3 months, 400 milli-
grams for 6 months and 1 gram for over 9 months.
Mr. S0111-IU1-m. All right. Lets assume that if were looking for the
perfect contraceptive, it would be long-lasting. There is certainly a
population group of women who know that at least for the next 9
months or a year they dont want to become pregnant. Thats a large
population group and they would get a 1 gram injection.
Did you notice any harmful health effects from that large a dose
when you gave it for the purpose of preventing premature labor?
Dr. Covrmno. It depends on what one calls harmful. The side effect
that we could nd out in every subject who had received high dose was
amenorrhea, lack of menstrual bleeding. Again, this population is hard
to analyze and compare regarding drug induced amenorrhea, because
women after delivery remain amenorrheic depending on whether
theyre lactating or nonlactating. This is an individual variation which
"is very large.
Sti l, all women who have been treated during labor remained
amenorrheic for at least 1 year with this high dose. After that time,
all of the women that have been treated-except one that we lost to
follow-upand this is very important, got pre@a-nt after 15, 16
months, even after that huge dose was given for treatment of pre-
maturity.
So, our records show that all of these women got pregnant after
this treatment, but 1 year or longer after the treatment was given.
Mr. SC-mmsu. Would you recommend that Upjohn or the World
Health Organization study and investigate the feasibility of using
1-gram,_doses as a normal contraceptive technique which would protect
a woman against pregnancy for 1 year?
Dr. COUTINHO. Oh, yes. As a. matter of fact, I had recommended
that to the Upjohn Co. many years ago. If youd really be looking for a
long-acting contraceptive we shoud aim at the higher dose, and the
patient who lives far from the cities and the centers were they could
get medical help. Getting one injection every year would be much
better than having to come back every 3 months or every 6 months.
Mr. Scrrewnn. With a much smaller dose?
Dr. Corrrxxno. With a much smaller dose. But, of course, by repeat-
ing the dose she might get more in the end than if she gets 1 gram a
year.
Mr. Scmnzrnn. They might get more what?
Dr. Cowmno. If they get 150 milligrams every 2 or 3 months, they
can end up having more of the drug in 1 year than if they have just
1 gram every year.
Mr. Scmzum. Yes.
Dr. Cotrrmno. So, as you see, the possibility is there, and I would
really think that its worthwhile looking into a long-acting
contraceptive.
Mr. Scnntmn. I would think that if there are no apparent harmful
health effects, other than amenorrhea, and in your Judgment. that
would not be too unpleasant or unacceptable, then the possibility of
U

79
an injectablc contraceptive, lasting for 1 year would be a tremendous

brealctltrough-particu1arly for rural areas m the developmg world.
Dr. Zanartu? _ _
Dr. ZANARTU. Thank you. Just following Dr. _Co_ut1nhos observation
in prevention of premature labor. \Ve did a similar experiment, but
in cyclic women with regular menstrual bleeding. We used the dose
suggested of 1,000 milligrams-1 gram-of Depo-Provera intra-
museulai-l_v once every 9 or 12 months. We gathered 1'21 women that
were followed more than 6,000 months. But t e reason why we discon-
tinued the study was the side e'ects. High doses produce rat-her severe
headaches in 2. number of these subjects. No. 2, amenorrhea was the
rule and with a. rather marked regression in the internal genitals that
was accompanied frequently by poor libido and lack of orgasm, a.
matter that meant some conict with the husband.
So, even though its very attractive, this idea of a dose once every
year, unfortunately this large amount is not clinically acceptable.
Mr. Scrrsusn. Did you nd those same side eects that Dr. Zanartu
is referring to?
Dr. COUTIXIIO. Well, again, the population is dilferent.
Mr. Scnmrnu. \Vell, in what sense 1s it dierent? Youre from Brazil,
so presumably you were treating Brazilian women-
Dr. Cov:'rn~rno. No, what I say is the population that I have treated
with hi__q_-h doses was a population of pregnant women in labor. You
know. they were in premature labor and Dr. Z'anartus patients were
a group of women who were not pregnant.
Mr. Scnsmzn. I see. You didnt give these high doses to any women
who were not pregnant.
Dr. Covnx no. No, we have not. For nonpregnant women we started
with the half gram, 400 milligrams, for the 6 months. That was a
tentative protocol that we have decided to explore with the company
because of the supplies of the drug. They had a right to suggest them-
selves what was feasible at that time.
The reason at that time that they objected to the higher doses was
a Galenic reason. It was diicult to concentrate the drug in a small
enough volume that would not obstruct the needle. When you go to
increa=e the dose with the same volume, it is very thickits very
dlicult. to administer and is held in the needle.
I would rea.ll_v like very much to look into the data that Dr. Zanartu
is mentioning. The amenorrhea will occur in most cases, whether there
is a small dose or high dose. The question of headache is something
that would, again, have to be looked int/.> very carefully because, some-
times in the control group youll nd such a high incidence of head-
aches that you wouldnt believe. Its so diicult to nd a woman that
<loesnt have a. headache in the period of 6 months with or without
the injection. To have a control group for headaches and other side
eects would be mandatory in a studv like this.
\Ve have the question of amenorrhea. I think it would be diicult to
nd which is the dose that will cause it. I think that with eve
dose you will have amenorrhea. And a-menorrhea becomes a desiralilye
side effect in many cases. I dont know whether I pointed out in my
written testimony, that the anemic, undernourished women who will
not bleed for that period of time will benet from the arnenorrhea.
\Vhy should these women bleed? Menstruation is not seen by women
>

S0
as something which is desirable. so if you tall: to the women and say
that they dont have to bleed while remaining healthy, that it s like be-
ing pregnant without a baby, then theyrc very happy with the concept
of amenorrhea.
As a matter of fact, we always try to demonstrate that if civilization
were not here, women would not really be very much aware of irregu-
lar bleeding, because they would not bleed regularly as primates. Most
of the nonhuman primates bleed if they are in a cage, but if theyre
free, theyre pregnant or lactating. If women would not be rest ined
by civilization, they should be free to become pregnant as't have
the rst ovulation and repeatedly become pregnant every ears. each
pregnancy being followed by lactation and lactation w d be followed
by another pregnancy; they would not bleed for ma y years.
_ So, the point is that the bleeding itself is unnecessary and in fact
sometimes its harmful. .
Mr. SCI-XEIJER. Yes. Dr. Roseneld wanted to make a comment.
Dr. RosE.\'rn~:|.o. Just one comment on dosage, which I think is rele-
vant to what were talking about. In the treatment of endometrial car-
cinoma, mentioned earlier, as much as 1,000 milligrams-or 1 gram-
daily is given for the rst week, and then I gram weekly for several
months, a massive dosage in comparison to what we use in contracep-
tion-150 milligrams every 3 months. To the best of my knowledge,
there have been no deaths from this high dosage and no major roblcms
other than the amcnorrhea. Ive not seen good data on headhches or
libido which suggest either an increase or a decrease on either of these.
Mr. Scmzura. If in these extraordinarily high dosages gven for ur-
poses of treating cancer, there are no abnormal side eects, wouldnt
that be probative of something that the FDA might consider?
Dr. Rosexrn-:z.n. I believe the FDA has reviewed the experience with
D.\-IPA in the treatment of cancer and endometriosis. I dont know the
thought processes of contraception versus the other. It is an approved
drug forI believe-for the .treatmeut- of endomctrial cancer at the
present time.
Mr. So-treusu. I understand that. but were talking about possibly
approving it as a contraceptive. The reasons they havent approved it
as a contraceptiic are. rst, because they dont see that there s a patient
population of suicient size to justify testing and. second, because they
found that in these small numbers of beagle dogs it has induced cancer
of the breast.
Now, I remember the uproar that came about a year ago when the
Food and Drug Administration wanted to proscribe saccharin, and
they did it on the basis of extraordinarily high dosages. What they
gave to the rats was the equivalent of, I think. 500 or 800 or 1.000 cans
of low cal soda a day. They explained it in a way that satised me. By
giving these extraordinarily high doses. they were able to compact in
time and space the amount of carcinogenicity that would be produced
by normal ingestion of Sweet n Lowlets say two, three, or four a
(lav for the average person. .
But by giving the equivalent of 800 a day with a much smaller
testing population, they could extrapolate andget results far quicker
and far more inexpensively than they could using the equivalent of a
norr. lal dose on mice. Now, wouldnt the same reasoning apply here!
<

1
/
,/ S1
;/
If on a particular small number of patients you have used these ex-

traordinarily high irsages for purposes of treating cancer, couldnt
they use that sam/g./' ' d of rationale? If there had been no untoward
health etl'ects-iivd traces of cancer of the breast or of the cervix-
among this sm/rill group of women wouldnt that information be of
interest? 1
Dr. Rosanrmm. The information is of interest to me, but in fairness,
the time frame probably is still too short, in terms of human carcino-
genicity. However, it is unusual that a drii to be used for another indi-
cation had already been used extcnsivy at much larger doses in
humans.
\\;e caiit say that because you use large doses of a drug that <2dnt
pror uce cancer to date, that its not in to be carcinogenic a er a
longer gestational period. I just d0Il%t:Zhl%lk we have the evidence on
the cancer issue one way or the other.
\Ve dont accept the FDA statement on the size of potential patient
population, as we discussed this morning, but thats a diereiit issue.
As far as acute, sh.ort~terni side ctfccts are concerned, I think this
data on the safety of De Provera is ver supportive. Regardinglthe
long-term effects, we stillpr?-eed ongoing followup studies, which It ink
cvcr_vone pro and con on this issue agrees. Long-term studies are re-
quired, as they are with the pill. as they are with any drug.
Mr. Sciii:Ui:ii_ I dont believe the FDA agrees because theyve made
it impossible to engage iii long-term studies. Its a Catch-22 situa-
tion. Let me rcad you one paragraph from the testimony of Dr. W11-
liiim Hubbard, president of Upjohn.
The FDA sta proposes n label that is so restrictive that the potential for a
large |irospecti\'e irlal ls sliarply diiiiinislied. In dictating to us =1 D!'_>-D9l*fl\'e KIWI)
design that is acceptable to tlii-iii. they the-n Fllllseqllnlly lam-I llllS design as un-
ferisilile liecaiise of the relatl\'el_r small uiiiiiber of patients avilililble f0 ellf $11011
:1 study. This ls. in etfect, a Catch-22 scenario.
Dr. ROSEXPIELD. As you know fmm m_v printed testimony. I do n_ot
agree with the FDA decision. I believe that this drug Should be Wall-
able. but that ongoing studies are needed.
Di-. Z.\x,\irrU. May I say a word in defense of FDA?
Mr. SCHEUER. Yesthe_v desperately need ii \\'0l(l Of defense-
[Laughten] _ _ _
Dr. Z.w.-\iri1;i. Its vei-_v true that for small nations like mine the
wiird of FDA is a serious consideration in making mll10I11 health
icy. ,
pMr. Sc-iii:n:ii. Th:its why were here today. _ _
Dr. Z.-\N.\R'lT'. That-s right, and _ih:its_wli_v I :i1ipi'1="B bl"?,}1_1:
too, to learn about your ci-iteria in trying to help make FDA s jiob
better. I think FDA is very iinportant. Let me tell you one good side
of the problem we are discussing today. '0 knew about this problem of
dogs developing tumors or carcinoma and in our study _with Depo-
Provera as a contraceptive. we were extremely careful to instriict our
women on this potent-ial danger and teach them to check their breasts
regularly, as well having them checked each time they g0 to 11116 <=l1I11-
Perhaps the very rst report on ndings in_ respect f0 521118" tum1's
and cancer was ours; it was reported in this book published by the
WHO. We found two cancers, as well as ii number of benign tumors.

<1
Y ' s2
Now, at the same time, we did the same study in people using intra~
uterine devices from our own clinics.
The incidence of benign tumors, as well as cancer, was about the
same. But we learned one thing that is important. We have to teach
our \l\0Illl6l1 that this is a risk and that they ave to check their breasts
regii ar y.
Mr. S0111-IUER. Im impressed by what you say. Lets go back to Dr.
Coutinho. and when _vouve nished your testimony, then well go right
down the list to Dr. Toppozada. ~ V
Dr. COI."I'IX!IO. To go on with the story, after trying to nd out what
1
the minimum e'ectii~'e dosage of Depo-Provera as a contraceptive was,
we found that 25 milligrams monthly with an estrogen, or 50 milli-
grams of Depo-Provera alone, would have a contraceptive effect. Te
started a study that has lasted 10 years12 years, for somewliicli in-
cluded about 400 women, of which 200 women were following ii. pro-
tocol for the 150 milligrams and 400 milligrams dose. Of these women,
approximately 30 percent, 30 to 40 percent only, completed the 10-
year trial. Some of them dropped out in the middle of the study at
the end of several years and the recorded experience that we have with
these women is very favorable.
Of those who have been treated for 10 years, we have 18 women who
went on taking Depo-Provera after the time that was predicted for
the treatment because they enjoyed the treatment so muc . So, theyve
been on Depo-Provera treatment for nearly 15 years.
Mr. SCHEUER. Eighteen women?
Dr. Coirrmiio. Eighteen women, yes.
Mr. SCIIEUER. I suppose youd neecha control group many, many
times that large.
Dr. COU'1INHO- Oh, yes.
Mr. Sci-mmzn. For that same period of time before youd begin to
be able to come to some valid-
Dr, COUTINHO. Yes, we realize that the numbers that each one in-
vestigator has is inadequate to make a conclusion, so as a. clinician I
can only say that my experience with Depo-Provera in Bahia where
a few hundred women have been treated for over 10 years has been
very favorable.
Mr Sorismin. I presume there were children born during those
years
Dr. Coirrixrio. Oh, yes.
Mr. SCIIEUER. No problems-- _ _
Dr. COU'I'L\'H0. No evidence of abnormality except clitoral hyper-
trophy in women who have been treated with _mass1ve doses through-
out gestation. Clitoral hypertrophy is increase in the size of the clitoris
in relationship to the size of the baby, but this becomes less obvious as
the girl grows up and its not really a side eect that we worry about.
We dont even consider it a malformation as such because we know
its an iatrogenic effect.
I think thats really all I have to add to my statement. _
Mr. Scmrtmn. Your testimony was extremely interesting, Dr.
Coutinho.
Dr. Cotrrmno. Thank you.

S

l r kw
83
Annrnoiur. Qunsnoss Asxr-:0 or Du. Ooirrmuo at rm: Canasta?!
Question 1. It asked, what advice would you give to the FDA about approval
of Depo-Provera for use as a contraceptive?
Answer 1. Depo-Provera should be made available as a contraceptive with
proper warning regarding short-term and long-term side efects.
Question 2. What groups of women could you identity that clearly have a favor-
able risk-to-benet ratio for use oi! Depo -Provera?
Which of these groups are unique to developing countries and which are idea-
tiable in both developed and developing countries?
Answer 2. Mental cases. Women with endometrial hypcrplasia who cannot take-
estrogenic contraceptives and should not wear IUDs. Undernourislieil women
for whom amenorrhea may be benecial. Women who do not tolerate oral estro-
gens and refuse to use IUDs.
The-undernourished are probably unique to underdeveloped countries. The other
groups are common to developed and underdeveloped countries.
Question 3. What issues of safety or eicacy do you feel need additional study
before one can teel with some assurance that Depo-Provera could be made avail-
able with tew it any restrictions?
iA:%vgr 3. Long-term eects on breasts and cervix should be properly evaluated
wt . .
Question 4. Do you feel the World Health Organization's Special Programme
in Human Reproduction is an appropriate agency to conduct further studies on
Depo-Provera?
Should the U.S. Government contribute to the Special Programme so that it
may, among other activities. support safety studies on Depo-Provera?
Answer 4. Yes. Contribution of U.S. Government to the Special Programme
would be quite appropriate.
Question 5. Would you encourage your wife to use Depo-Provem? It so, under
what circumstances?
Answer 5. Yes. In any of the conditions described in (2).
Question 8. It asked, what advice would you give to your own "FDA" about
approval of DP as a contraceptive?
Who should be permitted to use DP and under what circumstances?
Answer 6. I would recommend approval.
Mr. Scm=:m-21:. All riht, lets go on to Dr. Mokhtar Toppozada. Pro-
fessor, Obstetrics and ynecology at Alexandria University in Egypt.
STATEMENT OF DR. IOKHTAB TOPYOZADA, PROFESSOR OF OBSTET-
RICS AID GYIECOLOGY, ALEXANDRIA , EGYPT
[Prepared Statement in Appendix on p. 438.]
Dr. T0l'POZADA. I address myself in particular to the problem of
menstrual abnormalities and I will just mention, or try to summarize,
some highlights of what I thought of interest. As everybody knows,
menstrual irregularities and amcnorrhca are the most. common side ef-
fects of Depo-Provera and the commonest cause for discontinuation of
use.
Mr. Scrrnnm. How many women in Egypt have been treated for
approximately ho\v long with Depo-Puovera?
Dr. Torrozaoa. Well, we are using this drug for research purposes,
not for wide-scale use. So, we have had about 400 women that have
been treated for 5 years, -which is recent. In Cairo there have been
larger numbers treated, and in particular at the present time they are
testing the eect of that drug during lactation. .
As one of the major unacceptable side effects to some women in
Egypt is amenorrhea, so the expected physiological lactation amen-
orrhea. coincides with the drug amenorrhca, and so women dont mind

S;

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CPARH/BAHIA
CENTRO me Pl-_QUlSA E ASSISTENCIA EM REPR0nL~<;,\0 1uJ.\|,\N.\
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Cl'IN'I'R() DE PESQUISA E A$lSTl:1NClA EM RlCPR()l)UCA() HUM.-\.'\'.-\
R. Prado Vuludarcs, Z2, Numr. 'l'cL 243-877 I.
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Faltavam s 3 mescs
mas eu acabei abortando."
" Mcu panu foi um dralnu.
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Contracepção - ManicaDanielaTonelli

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Contracepção - ManicaDanielaTonelli

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Llanica, Daniela Tonell

Orientador: Maria Sibel; Kaine.

1. Coutiuhu, Elaiuulr LL - Biograa. 1. Couiracepgiu.

Tihn eminglis: nature and cultune: clashes and senses in lb:

Palan-as chares em inglis (kegwmra) : Cnnipun

Alli. e Cumcenbagiu: Anhnpnlogia Social

Tihagio: Doufor em Antmpnlogia Sada]

Data da dzfasa: 10-ll-I009

Program: e P65-Graduagin: Antrupologia Social

" Natureza e Clt

Tese apresentada ao Departamento de

Profa. Dra. a a \g|%\}<f te)

Prof. Dr. Layme s Santos (IFCH-Unicamp)

Prof. DI. Guilherme Jos da Silva e S (DA-UNB)

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