zinc after breast augmentation

[ silence ] >> ok, and i'm jeff spieler. i will be givingthis training course. and everybody-- i'm sorryfor those on the phone. everything that we haveis actually available electronically but i was notaware that we would need that. so you can get allof the materials-- almost everything'savailable electronically. that which isn't, there's plentyof copies in-- you can get them.

we'll bring themback to crystal city or the rrb [assumed spelling]depending on where you are. so i guess it's aboutthe third-- is the sound checkworking all right? >> yes. >> ok. so we're goingto be taped today. >> i'm not exactly sure why buti sort of wish the last one was because it was such agood success and i had such good jokes that everybodyreally enjoyed themselves.

>> share them in. >> but i got to see if ican remember those jokes that i've put intothe technology. so let me begin byintroducing myself. i have worked in theoffice of population and reproductivehealth since 1983. one of the few people thatspent their entire aid career in the same division,in the same office, although we changed ournames many times since 1983.

and prior to that,i spent 11 years in the human reproductionprogram at who working on contraceptive technology. and prior to that i was ina pharmaceutical company, and for five years, inmy last three years i was in the contraceptive researchand development program at lederle laboratory. so i've spent mywhole life working on what i have the mostpassion about and still do.

and on december 12i am retiring. >> that's why we'revideotaping you. >> although, i'm notgoing cold turkey. i'll still do a little bit ofconsulting at least next year on a very part time,minimal basis. so i really love to talkabout contraceptive technology and i hope you all do too. and you should all havea packet in front of you. and we're going to goin the order hopefully

that that packethas been organized. and it begins with the agenda to give you an idea whatwe're going to talk about. we have until 4 o'clockand depending-- i hope we can get througheverything on this program and maybe kara [assumedspelling] can keep me on track to make sure that we do. i would suggest thatyou ask any questions at any time that you want.

and what we're going to-- whati want to begin with actually, are three sort of handouts that i think everybody shouldhave amongst the many other things you all should have. and i don't know whatorder you have in them. so be-- after your agenda,what's the first document? [ inaudible remark ] the paper, ok. so here is a paper that royjacobstein, carolyn curtis,

myself and scott wrotefor a figo presentation. and this is one of the fewpapers that has, in my view, ever been written thatsort of-- not just-- doesn't just cover unmet need. it covers a lot of thingsrelated to unmet need. so if you haven't seen thispaper, at your leisure, read it. the next documentis the elements of successful familyplanning programs. how many people haveseen this already?

ok. so this was a result of asurvey of more than 700 people that jhu-ccp did and ispublished as a pop report and all i've doneis listed down the-- these 10 elements of the successfulfamily planning program. and we had people in the fieldidentify what they think were the most important componentsof family planning programs. and i've used thisslide many times. and depending on who i'm talkingto, i highlight certain things.

for instance, wheni talk to the-- when i go to jsiand give a talk, i highlight contraceptivesapplied logistics systems because that's oneof the main things that they contribute towards. and the-- so these aregood things to have and i would suggest that ifyou haven't read the pop report on the ten elements of successful familyplanning programs, you should.

the next item is avery interesting thing that roy jacobstein and i did. and at the last time i madethis presentation somebody said, "why don't you havesdm on this?" we're going to talk about sdm. so i was not cleverenough to figure out how to take this slide thatwas in the pdf at sdm. so i wrote it by hand. [ laughter ]

so the importance of this isjust to remind everybody about-- people use contraceptionbecause they want to prevent unintended pregnancy. and some methods aremore effective in doing that than other methods. and this table sort of puts outin order of most effective to-- least effective tomost effective methods and its typical use. and if a thousand peopleuse this method for a year,

how many pregnancieswould occur. and we had 850 ifyou used nothing. it's somewhere between800 and 850. and then you could relateeach of the following methods by how do they relate to 850 andi added sdm in there which falls between male condomand the pill actually, but really importanttake home message of it, like next to iuds, theyare 11 times more effective than the pill and implantsare 120 times more effective

than injectables. so it really setsit-- it sets the stage for understanding effectiveness. and we're going to talk a lot about long-actingreversible contraception. and that should be madeavailable to all women who want to use it and just because youhave it doesn't necessarily mean people are going to choose it. but if you don't havethem in your programs,

then there's no possibilityof choosing them. so the first-- so thoseare background documents for you to keep. ok. so the first methodthat we're going to talk about are oral contraceptives,right? that's on your list. and you actually have twohandouts on oral contraceptives and why do you have two? normally, you'd only havethe one-pager that i did,

and i try to update these and they frequentlyneed to be updated. i'm working with kara to updatethem because a lot of the data that i have in there--i think everything's-- everything in it is correctbut when i talk about the use of the methods in countries,we need to look at recent dhs's to see what's changed. and the reason that you havetwo versions of all of the-- of four methods is because,interesting, i was working

with alona white [assumedspelling] in sdi and-- on issue that came upin the philippines. so, all of you knowabout the philippines. you know that they passed thefamily planning legislation finally after years andyears of discussion. it would be very interestingto do the bubble graphs, if any of you haveseen mind gap. and to show what--how the philippines and thailand started off at thesame place in 1960, and the--

thailand is an asian tiger,very effective program and the philippines has justlanguished for many reasons, a lot of it due to resistanceof the catholic church to contraception and thisbill has just passed. but the mission needs that the-- the ministry of healthwants proof that all the methods itwill provide do not block implantation or cause abortion. so what we were working on,when i was working on with alona

and others is somethingcalled research literature contraceptive mechanismof action. and that's why you havethis document also. and you're going to haveit for four methods. it is not-- it's not very-- itadds a little more information about the method but if youwant a snapshot of the method, this one-pager does it for you. so the agent-- so, who doesn'tknow about oral contraceptives? so does everybody know whichoral contraceptive usaid buys?

it's on my little list,it's called microgynon, it's a combined oralcontraception-- contraceptive with aprogestin, levonorgestrel, and an estrogen,ethinylestradiol. and the package lookslike this that we sell. it's called microgynon. and we also provide-- andi'll pass these around-- the same product is alsosold-- has a commercial-- the social marketing of itis called combination 3.

it's the exact same product, just looks a littlebit different but it's the same combination but it's labeled forsocial marketing. and the-- one of theimportant things to know about oral contraceptionis that-- and most people don'trealize it. it has many other healthbenefits besides highly effective when used correctly.

so oral contraceptivesare highly effective but in actual use, they'reonly about 92% effective because people don'tconsistently use them. but the important thing is thatthere's no question with the use of oral contraception that thereis protection against ovarian and endometrial cancer andfunctional ovarian cysts and decreased risk forbenign breast disease and pelvic inflammatorydisease that causes the block of cervical mucus thatprevents ascending infection.

it works primarily byblocking ovulation. it also has anothereffect which the progestin in the combined pill causes thecervical mucus to become thick and it reduces sperm penetrationthrough cervical mucus so the sperm don'tget to the uterus. that's particularly morewith progestin-only methods but the progestin outweighs theestrogen in the pill in terms of block-- causingthat cervical block. like all other methods, otherthan male and female condoms,

we have to tell everybodythere's no protection against hiv, stis when youuse oral contraceptives. they require daily use. and on this list it has a few of the potential risksincluding potential risk on cardiovascular diseasebut it's a very small risk. and the absoluterisk is very low. and an interesting story to tellyou when i first started working in this field, in the u.k.,

oral contraception wasthe most popular method. it is the most popular method, universal method inthe united states. twenty-one percent of users in the united statesuse pills, use ocs. the most commonly used methodin the united states is male and female sterilization, because those numbers arecumulative, but in terms of reversible, it'soral contraception.

and in the u.k. whenthe first study came out that showed there'sa potential risk of cardiovascular disease inecs particularly in smokers. so you know if you'reover 35 and you smoke, combined pill is not for you. so, the family planning programthat i work with and i work with marie stopes backin those days, believe it or not, some long ago. they were all sure that, well,

these women wouldjust stop smoking. no, they stopped usingoral contraception because they wanted to smoke. so it was sort of theopposite public health message that we were tryingto give but they moved to other contraceptive methods. and the progestin-only pills that we provide arecalled microlute. ok? it's thelevonorgestrel-only.

it looks like this. and this differencebetween pops and ecs and combined oralcontraceptives, primarily has to do with one, when you'reon using progestin-only pills, you really need to takethem the same time everyday. now we tell women to take-- ifyou're on oral contraceptive, you take it at the same timeeveryday so you don't forget it, but if you took it, ifyou forgot and you take it in the afternoon andwhen you got home,

it wouldn't make any difference. pops are much more sensitiveto time that you take them, and they're not aseffective as combined pills. and they were primarily usedfor women who were breastfeeding to increase your effectivenessduring breastfeeding. of course, we couldtalk about lactational and amenorrhea method. you really don't need anythingfor the first six months. if you're fully breastfeedingand not

yet menstruating you'vegot over 98% protection against unintended pregnancy. so, any questions about ocs? >> how do you knowthat the progestin-only as a breakout there? >> pardon? >> if they're significantlyimbalanced. >> well, it would fallright under the pill. they're not significantlyless effective.

they're not quite-- andif you're breastfeeding, they're just as effective, butthey're a little lower rate. there is a pop on themarket that we do not buy, it's called cerazette,it's made by merck. it's a different kind of a drug. we don't buy. it's much more effective. it's as effective asecs-- sorry-- ocs. so staying in the fieldof oral contraception,

what is the nextoral contraceptive on the list on the program? >> ec. >> ec, emergency contraception. emergency contraception is aform of oral contraception, and you have a set of documents. and i put mine aside andthat set of documents, i didn't grab myown set of those. sorry, you do have it.

you got the ec briefer. you've got the ec briefer whichi've produced and you have the-- what else do you have? so you've got-- i needto pull up to see. [ inaudible remarks ] yes, ok, we havethree documents. so, we've got emergencycontraception briefer, we've got a document that came out from the internationalconsortium

for emergency contraceptionand figo that tells you everythingyou need to know about emergency contraception. and i also includedhot off the press. our colleague trishmcdonald sent out an email. did anybody see it? and that email was to the field. i'm sorry. i'm jumping ahead of myself.

that was in implants. what you have is the email thatwe sent out to the field on ec when we made the decision that we will begin purchasingemergency contraception. so it's usaid technicalguidance to the field on emergency contraception,looks like this document, ok. so, what's the mostimportant thing about emergency contraception? >> came from gc, i wantto know how it's different

from abortion. >> ok. >> because i know we have hadthat question over the past-- >> i would-- and we've hadbriefers to congress on that. >> that's right. >> ok. so how is itdifferent from abortion? what else? what else do we needto know about ec? >> do we need timing?

>> it's the only method that wehave right now that you can take after sex to prevent-- to tryto prevent unintended pregnancy. ok. the next thing that we needto know is that the dose of ec. the most popular you seeavailable right now is levonorgestrel-only and thedose is 1.5 milligrams a day in one pill. and if you have the two-pillpack, and i've got samples of both of them,you take both pills at the same time even though thelabel says, take the first one

as soon as possible and thesecond one 12 hours later. but research conductedby who clearly show that you take themboth at the same time and it's much more effectiveand you don't need to wait, so the one pill looks like this. and the two-pill pack which is750 micrograms-- not in there. i have them here. this is the two-pill pack, so you take them bothat the same time.

now, how does it work? well, it doesn't work ifyou take it more than four or five days after theunprotected act of intercourse. and how it works and evidenceis very clear on this, it acts like oral contraception. it prevents ovulation ordelays ovulation as long as you take it beforethe hormone lh peaks. that's the hormone thatstimulates ovulation. you take it before then, youhave a good chance of working.

if you take it after thelh peak, it will not work. so most women do not knowwhere they are in their cycles when they have an act ofunprotected intercourse. and health-- theguidelines are take it. don't worry about where you are,because we know it isn't going to harm you and weknow it has a chance of preventing anunintended pregnancy and that effectiveness rate issomewhere between 60 and 90%. the interesting thing

about emergency contraceptionis we never could do a clinical trial like you do atall other methods, where you use this method andyou use another method only, and then you see if youcould prevent pregnancy. you can't use emergencycontraception like that. so we have an estimate ofwhat would the likelihood be if you had unprotectedintercourse during the middle two weeks of your cycle oraround the time of ovulation and then how much protectiondo you get from this.

so who's done theselarge studies and we come up with this figure somewherebetween 60 and 90% effective. and the recommendation istake it as soon as possible after the unprotectedact of intercourse. there is a new product on themarket, it's called ellaone in the united states or ellain the rest of the world and that is made of a veryinteresting anti-progestin. it is not like ru486,it was synthesized so that it had very lesseffect on the endometrium

than ru486 or mifepristone has. and it works, it's moreeffective than levonorgestrel and it works a little bit later. so it will still work at thetime of the lh peak but not after ovulation,whereas levonorgestrel if you don't take it beforethe lh peak it will not work. so, it gives you anotherday of protection. it cost a lot more money andgetting back to that question, that caitlin [assumed spelling]astutely asked and that is

if you look at the labelin emergency contraception, even that approved by the fda, the label still says itcan prevent implantation. there's not one shredof evidence that it prevents implantation. however, that wasthe original thought of how it works beforethe studies were done to get a better idea of actuallyhow it does work and one of the world leaders in doing

that research is a guy namedhoracio croxatto in chile and he's a marvelous scientist. he was a marvelous scientist. he's not well right now. and he was very intenseon doing that research because all the womenthat they treated in a 97% catholic country, theydidn't want to use anything that would be consideredto prevent implantation which they defined as abortion.

i'm going to makea mention of that. we certainly have it clearin the background documents that i've providedabout what is abortion. so, he did the research to show that it actually had noeffect in implantation. and if you take itafter ovulation, it has no effect at all. and we tell women youcan't take it to induce, bring on your periodbecause it won't work.

but people will try anything if they think there'sa possibility. so, the same appliesto this ellaone which is ulipristal acetate. we don't have any evidence thatit would block implantation but the mechanism bywhich it works is one that we do more likely to possibly block implantationalthough we don't have any evidence of that.

we do not provide that product. it's not really availablein the public sector and i think it will soon becomeavailable in the public sector. so, any questions aboutemergency contraception? everybody clear? and i have these prop--we can circulate these. are we circulatingone of them right now? here's a single pill pack. >> right. keep it with it.

>> yeah. and thisis the ellaone. let me take it out of the pack. i'll take it out of the pack. we don't need to circulate that. and i should tell you bythat way the original-- go ahead, i'm sorry. i didn't see-- >> i just have a quick question. i remember hearing that if youtake two-pills at a regular--

>> yeah. no, you need to take atleast four with any-- and you need to take them twiceso you need eight of them. so, originally before emergencycontraception was widely available, many peoplecut up pill packs because it really is dirt cheapand you can cut them up so that they get the rightdose depending on-- you have to look at the dose oflevonorgestrel in the pill pack so that you could countthat you would have a total

of 1.5 milligrams. so, that's what you need to do. and people use totake the entire pack, all 20 of the progestin-onlypills that we provide because that would also workbut that's a lot of pills. so, the original emergencycontraception was called the yuzpe method. i didn't mention that andthat was using combined. so, al yuzpe in canadadiscovered

that you could prevent pregnancywith emergency contraception if you took high dose ofprogesterone and estrogen. so, take a high-dose pill,50 micrograms of estrogen. we don't providethat level anymore. and he called it the yuzpemethod and the first one on the market in unitedstates was called preven. and almost nobodyuses that product because that product has a verymuch higher degree of nausea and vomiting when you takethe higher dose estrogen

and progesterone together. so, the progestin-onlyhas a much lower incidence of nausea and vomiting. >> so there is no--they do progestin-only because the estrogenhas no effect on or emergency contraceptionor just-- >> it did have an effectbut you don't need it. >> don't need it. >> i mean it did have aneffect but you-- we found out--

who found out youdidn't need it. just take the progestin-onlyand it had-- it just-- it's even more effectiveand many fewer side effects. because if you'retaking this pill to prevent unintended pregnancy, then you throw it up,well, what do you do? you take another one,it makes you throw up. so, you're not gettingthe pill in your body. so, it's-- i don't know

if anybody is using cut-uppill packs and i don't think in the u.s. preven is beingsold and everybody's moved to progestin-only pills. and this technical guidance tothe field really talks about all of the legal issues,the policy issues. and deb, bless her heart, wasthe final editor of this version of the document that i workedon and she made it right. so, and it also mentions keyresources of who to contact at aid if you're interested.

these are-- we're probablygoing to be changing that, deb, because they're notgoing contact you anymore for policy issuesalthough they could. we could make anotherversion of this document. >> the updated resourceshere which you looked at-- >> yeah. but this is-- >> why not? >> yeah, they're all, it's allbut it's-- we have so many-- so we have so much materialand one of the pieces

that i gave you alsotalks about ulipristal. ok. next on our agenda. >> so-- >> go ahead. >> -- one of the questionsi came up last time-- >> please. >> -- [inaudible] wasabout women with high bmi on ec whether or notthey should [inaudible]. >> on ec? so why did you tell uswhat happened at the icec, kara?

so the international consortium for emergency contraceptionhas a jamboree every year and i have been going tothat for many years for aid. and i couldn't go thisyear and kara went and kara got attackedat that meeting. >> oh, no. >> so, what did theywant to know and how did you deal with it? >> no, but they attackedabout multiple other issues.

>> not related to the bmi issue. >> oh yeah. and go ahead. >> but they gave us a hardtime about two things, one was that we work with fbos because it was notclear to them. now i was told the exactphrase i'm supposed to use about working with fbos. but basically the phraseis that "everyone--

anyone that we work withsigns a document which says that they either will provideall methods or we'll refer to other organizations whowill provide all methods." so when we were out of theroom, not participating in the conversation that becamea huge issue about usaid. and, then the othermajor issue-- >> what was the issueabout that? >> yeah. that weworked with fbos. and so clearly what--the people we work

with are not gettingappropriate counseling about-- >> that they weren't-- >> -- oral contraceptivemethod like [inaudible]. and, then the other issue wasabout with dhs and whether or not we were--and basically how-- >> including this as a method. >> -- ec had been cut out ofthe dhs because of the new-- the edits to it, but thankfullyour dhs colleagues were able to refute that so we couldpresent the next data

and the new updated dhs. the questions about ec wouldbe in there and it would-- we would have appropriate data. the whole reason they broughtup that meeting was for you to talk about the bmi issue. >> ok. so there is someconcern that women with the bmi of above 30-- sothat's body mass index. most people do notknow their bmi. they know their height andthey know their weight.

so you could calculate your bmi. but it's largely the issue isobese women might have much less effectiveness with ecshould they use it and the-- rich [assumed spelling] came outwith the statement that said no. so, the jury is reallyout on how much reduction of effectiveness youhave with a high bmi. it just that we need towarn people that, you know, the best thing to do is youreuse routine contraception and then you don't need to relyon emergency contraception.

but should you rely onemergency contraception and you're overweight, itmight not be as effective as you would hope it would be. >> is the pills-- but ifthey already use the iud and the ec which-- >> has no effect on body weight. >> no problem. yeah. >> could we talk about thosewho may regularly use ec

and effectiveness of ec-- >> -- and other council on that? >> ok. so, that is anotherissue they came up that we dealt with from the field lastweek i think it was. so we don't recommendit as a routine method. and jim shelton has a very nicearticle that he could share with all of you thathe wrote on routine use of emergency contraception. so there are a group ofwomen who might choose

to not use routine contraception and use emergency contraceptionas their main method. the kind of womenwho might want to do that have very infrequent sexso they don't have a high risk of pregnancy all the time. you know, you don'thave a high risk of pregnancy outside thefertile period anyhow. so as long as you don't doit, use it more than a couple of times a month, it couldprovide you with protection,

not as much protectionas routine contraception and it won't mess up your cycle. but if you were to take ecthree, four times a month, your cycle, you'llhave great irregularity and you won't becycling normally. so, you don't know where youare until you restabilize. so we don't recommend it asroutine method and there's a-- in terms of futurecontraception, we have a lot of interest in what we callpericoital contraception.

and how could youincorporate some kind of an effective contraceptivemethod for people who don't want to contracept all thetime, and they don't need to use barrier methodsbecause they're not at risk of anything other thanunintended pregnancy. and who has just completeda very large study looking at the use of levonorgestrelas a pericoital method that you would takebefore intercourse, if you knew you're going to haveintercourse or immediately after

and you can take it five timesin a month in that trial. so they've just completed thatbig study and we're waiting for the results of that trialto see how well it worked, what were the pregnancy ratesand what were the side effects. >> and that's justessentially the same as ec-- >> yes, it's the same pill, yes. and each dose i think was 750micrograms per dose i think in that study. i'd have to check.

>> and that will like showus because we don't know now like say for instanceif someone is using ec as their primary method andthey're using it a couple of times a month, do we knowwhether it get less effective because of the, you know, likethe pregnancy of, you know-- >> no, i think pregnancyrate stays the same at each-- for each act. >> and the other big issue withec is that it doesn't protect for the next unprotected act.

so if you've been ontoprotected act today and you take ec tonight, and then you have anotherunprotected act in four days, that ec isn't going to protectso you need to take it again. so we've tried to use the useof ec as a point of departure to discuss with women,are you, you know, are you using yourroutine method and why not use yourroutine method. >> can you talk about iud as ec

or are you goingto get into it-- >> well, we can do it whenwe get to the iud, ok? >> but i think-- >> oh, you want to do it now? ok. ok. so the iud has beenknown as an effective method for emergency contraception. it is much more effectivethan the pill-- than levonorgestrel pills.

and we were alwaysvery concerned, at least i was very concerned,about doing anything about iuds for emergency contraceptionbecause we make this case that iuds work bypreventing fertilization. they don't block implantation. we have tremendousevidence when used as a contraceptivemethod it has no impact at all when you get to iuds. however, if you use an-- ifyou have an unprotected act

of intercourse and you insert aniud, it works for at least five or six days and it could have aneffect after-- it does have an-- it could-- can have aneffect after ovulation, and hence you couldhave fertilization. so we were always very skittishabout it but there's been a lot of research done on the method and a big clinical trialwas done and there's a big-- there's a systematic reviewdone and we really can't hide from the fact that itis an appropriate method

for some women. and we're working on atraining material right now with rcfbo [assumedspelling] to make sure that at least peopleknow how to use-- how you would use it andwhat would be the criteria for using it and as-- you know, we have something calledthe pregnancy checklist. who has heard about thepregnancy checklist? ok, so maybe that's anotherdocument we should provide

to everybody, you know,there's a pregnancy checklist. so i'll just jumpquickly to that. so john stanback at fhidiscovered that the major reason that women were deniedcontraception was they weren't menstruating at thetime of the visit. and we know very well and he dida big study in kenya on this. you know very well, if youdon't serve a woman when she-- you have her, you maynever get her again. so he ended up-- he found outthat a major reason for denial

of contraception inkenya, but it's everywhere, was they're not menstruatingand they want to make sure that you're menstruatingbefore you start a product. so they'll tell you togo home and use condoms until you get your periodand then we're going to give you something else. so he did this study andhe created a checklist, and that checklist essentiallyeliminated through an easy to use checklist thelikelihood that you are--

that you could be pregnant. for instance, youdidn't have intercourse since the last timeyou-- since the visit. no chance of pregnancy. so there's a-- he has this nicechecklist and at the completion of that study, it was consideredthe most powerful piece of information thatwe had ever shown in the family planning programto increase the take home rate. when he institutedthe checklist,

30% more women went homewith a contraceptive method than before the pregnancychecklist. so we've dealt with iuds, we deal with thepregnancy checklist, we've got to makesure that you all have that pregnancy checklist. so let's move to injectables. >> jeff? >> sorry, jeff.

this is elaine ying [assumedspelling] on the phone. i just wanted to let you allknow that fhi is continuing that work like puttingin the checklist as a mobile app inseveral languages. when that's ready, i'llsend that out to everyone. >> great. >> mostly for chw studentsbut any provider could use it. so we'll send that out. they're almost completed.

>> yeah. and we needto probably-- elaine, we probably needto send that check-- when we're done with ourchecklist and everything is done on the use of the iud. and it's very much related to the pregnancy checklistthe way it's set up. we need to make sure thateverybody has that also. back to the iud for a minute,in most of the countries that we work, it's veryimpractical to think of the iud

as a method of emergencycontraceptive. one, in much of sub-saharanafrica, it's very hard to get an iud. and even though psi with a largegrant from the dutch government and from the buffett foundation, i won't say large anonymousdonor because for those of you who know, the large anonymousdonor is the buffett foundation. they have done amazingwork to demonstrate that if you put allthe pieces together,

you have trained providersand the methods available, you can really increaseiud use in countries where this use isvery constrained. but it really-- it takes aneffort and in most programs, we don't have that effort. so iuds are still totallyunderutilized in most of sub-saharan africa. so if you wanted to use an iudfor emergency contraception and you're living in a countrywhere it's hard to get an iud,

first you have tofind an iud provider, secondly we make it veryclear in the document that should you use an iudfor emergency contraception, the provider needsto counsel the woman that this should nowbecome a routine method. it would be very costineffective to put it in and no pregnancy then remove it. you need routine contraception,you accepted the iud, keep it in and you will not ever have afear of an unintended pregnancy.

so that-- there's theprogrammatic side of the use of that method and maybe thatwould be a good way to lead into more use of a veryhighly effective method of contraception andaccepted by half of china. when we give you the--when we give you the use-- worldwide use of iuds, we alwaysremove china from that list because about half the iudsin the world are china, it's a favorite methodin china right now, so. ok, let's move to injectables.

so we have-- we have about--we have one, two, three, four documents on injectables. and they include theinjectable briefer and they include theliterature review on injectables and they include twodocuments on sayana press. so do you all have that? >> no. >> what don't you have? oh, you know, i thinkthere should be two

of sayana press there. now, there was only--yes, there was only-- i made 26 of most documentsand i don't think we're more than that number of people. so the second piece onsayana press is this one. so there's two--there's two sheets. one, i don't think you have--you all have the color versions. they look like this, ok. so let's just startoff with injectables.

so-- >> jeff. >> can i just have-- this is ann[assumed spelling] on the phone. >> first of all, i'msorry i'm not there. first, i have like contractors in the basement fillingup my sewage line. but anyway, so-- >> call in, but i havea question on pills. can i ask it real quickly--

>> of course. >> -- injectables? >> what's the-- what do youthink about usaid advocating for kind of over the counterdistribution of pills? and like in thailand,you know, they have, you can buy pills at 7-11. >> and have pills anywhere. what do you do-- i mean, iknow that a lot of countries, you know, you can buy--

even a [inaudible]without prescription, you can go in thepharmacy to get it anyway. but what about usaidadvocating for, you know-- >> well-- >> distribution of [inaudible]-- >> well, i-- >> non prescription. >> we already do it. >> the fact is it's onlyin the united states

that you need a prescript-- that you actually have to use the prescriptionto get the pill. prescriptions are requiredelsewhere too and including in some developing countries,but nobody follows that rule. and in fact, we've had a hugemovement in the united states to go to the fda to getpills over the counter. we got ec over the counter and we now need pillsover the counter.

and the problem is that thepharmaceutical companies don't really care because itsort of protects them to have by prescription only. but i can tell you thatthere's more negative evidence of the effect of aspirin,tylenol and ibuprofen than there is on the pill. it is the most single, themost studied drug in history. and there's no reason that itshouldn't be over the counter. and throughout all the world,everywhere i've traveled,

you can get pills everywhere. we've got, you know,in social market-- sorry, not only insocial marketing but in distribution programs. for instance, inindia, malladi is the-- is a pill that's given out by-- given out [inaudible] andnobody doesn't buy prescription. you can get them anywhere. so we do not-- and we-- pillsshould not be by prescription

and we ought notworry about that, and we don't worry about it. >> ok, yeah. >> and even some countries use or sometimes [inaudible],the use [inaudible]-- >> -- prescription. >> even though it's not-- >> you know, that's--yeah, that-- >> some groups i thinkthere's a barrier.

>> that's ageism, i mean,it's particularly terrible when you have a veryyoung married woman, and we know about the problemof the child bride, i mean, she has-- she's one of themost disadvantaged women in the world. you know, she's-- programswon't deal with her. so we've-- yeah. for youth too, i mean,it's totally appropriate and it should be madewidely available.

so moving on to injectables, so the first piece is theprogestin-only injectables, dmpa. and that tells youeverything you need to know about depo medroxyprogesteroneacetate. so the drug is megestrol,god almighty, tongue tied. the drug is medroxyprogesterone and depo means it'san injection, ok? so that drug, mpa,is well-known,

it's been well studied andi've got a ton of information in this form about it and whichcountries use it most widely. and it comes providedwith a vial and an auto-disable syringe. so we shake the syringe, theproviders taught you just shake that syringe, you don'twant to really shake it hard because it could froth, andthen you turn it upside down and then you use an auto-disablesyringe to draw it out. now, this auto-disablesyringe is already been used,

so i can't use it again. but what you can do is youdraw it out of the vial and you just watch itdraw every bit of it out and it's been overdosedby a tenth of a cc. so there's a teeny bitleft but you're going to get the 450 milligrams and then you injectit intramuscularly, and these auto-disable syringes,once you've injected it, you can't pull theplunger back out.

that's the advantageof auto-disable, it can't be used again. and we only provided--we only provide dmpa-- we buy it from pfizer, andhence it's called depo-provera, the generic name is dmpa. and we buy it with the vial,an auto-disable syringe and a safe disposalbox for 100 syringes. and that's how we package it. we were the only donor thatpackages it altogether.

so we made sure that we hadthe auto-disable syringe and we had a safe disposal box. and we have been providingdepo-provera since the '90s, and it's very popular. it lasts for three months, and the reinjectionwindow is actually a month, although it says in allthe papers two weeks. but we know for a factreinjection window actually lasts four months.

so you need to have yourreinjection within four weeks after the third monthof use, ok? so it really lastsfor four months. you don't want to golonger than four months and you can reinject oneweek early if you want. so widely very popular,highly effective, can be used verydiscreetly for women who do not want theirpartners to know that they are contracepting,one of the best methods

because there's no way yourpartner will know that. highly effective and the onesheet i gave you tells you we pay 80 cents for thiscombination right now. and-- so it's private,it's certainly-- it's unrelated to your--once you've got an injection, your behavior is not going to affect how effectivethe product is as long as you get reinjected. so the new guy on theblock is sayana press.

now, who has heard about that? >> jeff, has depobeen used for ec? >> like have peoplelike said hey, can i go after that'sbeen studied like-- >> -- you know, [inaudible]injection, that works the same? we can do it over and over-- yeah. i don't think we've ever-- you know, i don't thinkit's ever been studied. it hasn't really been studied.

>> readily available, thatseems like it might be in-- >> it's a good question. well, i would think itwould definitely work but it's never been studiedfor emergency contraception. and the only thing we don'twant to do is inject it into an pregnant woman, althoughthere's no evidence at all that would have any impact on the fetus should you bepregnant and be using depo. but it's just goodpractice not to use it

if somebody is already pregnant. no effect on breastfeeding because there's noestrogen in it. and disadvantages are,you know, is again, no protection from hiv. there's a delay inreturn of fertility. go ahead. >> you know, jeff, yearsago when depo was first out, there was some question

about how soon could youstart it after birth. >> based on combinationof lam and depo, lam was like number onepreferred and depo was second. >> but still is thereany sort of resolution-- >> -- about when youcould start it and-- >> we've had-- i'mglad you asked that. it applies to allprogestin-only methods. right now, who has in themedical eligibility criteria and i don't know if wegave everybody the wheel.

are we giving everybodythe wheel, the mec wheel? ok, so we're going to get youall the medical eligibility criteria wheel whichgives you all methods and what is the recommendationunder different conditions. so who considers that youcan't use a progestin method until six weeks after birth when the us medical eligibilitycriteria says you can use it immediately and the uk medicaleligibility criteria says you can use it immediately.

and the last steering committee of the medical eligibilitycriteria, who reviewed theevidence and we won't know until march i thinkwhat the result was, but i am quite confident,particularly given the amount of pressure i've placed onwho on this issue as well as many others, is that when youcan start using your progestin method as soon as-- right-- immediately postpartumor as soon--

or soon thereafter,within 48 hours. there's no evidence for it. the only concern was ahypothetical effect seen in some animals ofsome effect on brain. and everybody was worried aboutthat but there's a complete-- there's no data for itand i'm quite convinced that the medical eligibilitycriteria will be changed for immediate postpartum use as it should be,and it is right now.

so there's a fewother-- go ahead please. >> i have a questionabout the different-- we talked about progestin-onlyoral contraceptives and the progestin-only ec. and now we have progestin-onlydmpa. >> and implants. >> and implants we'regoing to get to. so what's the differencein all of the amounts of progestin that's dailyand what effect does

that have on [inaudible]? >> ok. so if i wouldhave shown slides, maybe i will next time ido this if i do it again, i would show you apharmacokinetic profile. so it's how the bodymetabolizes the drug. and when you take an oc daily,what happens is you ingest it. and then a short time later,you start to get a spike and you get your maximum bloodlevels, and by the next day, it's down to almost nothing.

you take another pilland you get a spike. it goes down to almost nothing. so that's why you needto take it everyday, and if you miss aday, you're supposed to take two pillsin the next day. ok, so we have all these guides,what to do with a missed pill and that i hope everybody isgoing to take the green book on, you know, family planningguidance for providers. it tells you all that, right,and it's a marvelous resource,

it's really our bible, globalhandbook for providers. so that's ocs. now, how does injectables-- soit's all related to the dose and how it is administered. the doses are different inevery one of these products. so depo, if you were to do apharmacokinetic profile of depo, what happens is you take the-- you get a shot, and all of a sudden your mpa levels goesreally high up and over a 30--

over a three to four-monthperiod it decays and it starts to come down, itlooks like this. and after four months, youstill-- after three months, you still have a dosehigh enough in your blood to prevent pregnancy, and we nowknow after four months you do, but then it starts to fall down. so that's called a first orderrelease, high dose, drops down. implants, which we're goingto talk about in a minute, has what's calledzero order release.

you put it in the body and youget a little bit of a surge but very low and then-- so itgoes from nothing up like that and then it's almoststeady state. and it's called zeroorder release. it just stays steadyuntil there's no drug left and that's five yearsfor implants and it's three to four months. so, for implants and vaginalrings work the same way. so any of these longeracting preparations

that are not injectableshave the zero order release. so the dose is much lower and that's a 20 micrograma day dose. so it is much lowerdepending on the-- depending on howit's administered. so with injectables, there's-- on the back sheet of the primarypiece, it talks about dmpa and risk of hiv, dmpa risk ofstis and dmpa and bone loss. so i can't help but mention hiv.

there is some evidence thatdmpa use could be associated with the increasedacquisition of hiv. the jury is out on that issue. right now, the who guidanceand our own guidance to the field is be awareof the fact that people at high risk could possiblyhave a higher acquisition rate of hiv because of depo. we don't know for sure but there's some evidencethat it is possible.

so for high risk women, theyneed to be warned of that which means that we should bealso counseling on condom use and we should also,in those countries where depo is reallywidely used like 60% in south africa wasdepo, we should be trying to expand the methodmix so women have access to other methods notjust injectables. and we will participatewith the gates foundation and other donors in a trial

that will start some time nextyear called the echo trial where it's going to bethe first randomized, open label so everybody is goingto know what they're using, controlled trial ofdepo, iuds and jadelle, the implant, [inaudible]implant. and the purpose of that trialwill be to look at safety, effectiveness and incidence ofhiv in high risk populations. and we're hoping that thatrandomized trial will give us better evidence thanthe observational trials

which we're currently using to help guide us onwhat the risk is. just because we do a randomizedtrial doesn't necessarily mean we're going to get anunambiguous result. it just-- we got a betterchance at an unambiguous result. but confounding, peopleare going to be randomized between those three methods, you'd all get themethod you really wanted, do you discontinuation--do you discontinue earlier.

we're very worried about useof condoms, different methods. people have a higherrate of condom use. so if you don't have the samecondom use by each group, you know, we're advisingeverybody, if you receive hiv,use condoms also. so we're going to have tofind the incidence of hiv in the presence of people who'vebeen invited to use condoms but don't use condoms. so it's a very hardkind of a study to do.

and we, you know, as long as the discontinuation ratesaren't higher amongst certain methods and the-- is in abigger difference in condom use between the differentgroups, we might be able to get a better estimateof the real risk of hiv in these three differentmethods. >> what's the hypothesizedmechanism of action of the-- >> there's four of them. so i'd prefer not to go into itright now but i can give you all

that information because we'renever going to get further on. but there's fourpostulated mechanisms, and we don't reallyknow which one. it was originally thought. the first mechanismwas it caused thinning of the vaginal epithelium. but that happened in monkeysand didn't happen in women, so. ok, so we have depo andi've shown that to you. and i'm going to go to sayanapress, but before i do,

there's another injectablecalled noristerat, enanthate. has anybody heard of that? ok, it's only used by like 2million women in the world. it's made by bayer and itcomes in these old ampules that you have to have alittle saw and you have to break it off,and you put it in and it's an oil suspensionrather than an aqueous suspension, soit's a more painful injection. and you need to takeit every two months.

although there's some evidencethat after the third injection, you can then go toevery three months. it's not very widely usedand there's not a lot of-- we never used it because thefda has never approved it. and schering and now bayer don'twant to do what you would need to do to get fda approvalbecause they'd have to repeat all the toxicology. it'd be very expensive. so that's the other injectable.

>> do you know whereit's used in the world? >> oh, some use itin south africa. i mean, we could ask bayer,guatemala, tell me, yeah. >> [inaudible] indepo and [inaudible] >> so they already have like2 million users in the world. so i want to moveto sayana press. so what pfizer did was they--we've been working with pfizer since the mid-90s to tryto get depo into uniject. does everybody knowwhat uniject is?

so this is what it looks like. it was developed bypath with usaid funding. in fact the very firstauto-disable syringe called soloshot is an inventionof usaid because path developedit with our money. and they went on to developuniject with our funding and then they sold it to bectondickinson, the largest maker of syringes in the world. and it's a-- you know, sothis is what it looks like.

i can send it around. that's without the depo in it. and we've started working withpfizer in the mid-90s to say-- the project that i wasleading to get them to put depo-provera into it. and the project stalledand it largely had to do with the preservative that wasused and we couldn't get it in and we couldn't get itinto uniject and get it to be released properly,and they gave up on it.

that was in the mid-90s. so depo is no longer-- is ageneric product right now. so pfizer cleverly realizes that if they made a subcutaneousformulation of depo, they could get a patentthat last till 2020. and nobody else hasthat product. so you've now got aproprietary product that nobody elsehas that's patented. and they market thatin the united states

as depo-subq 104 provera. and the rest of the world, it'smarketed as sayana, s-a-y-a-n-a. as an aside, i wonderwhy they named it sayana. anybody have any idea? does anybody know how thename kodak came about, you know, eastman kodak? how did the wordkodak come about? so some very cleverperson figured out that there wasn'ta language on earth

that couldn't say kodak. and that's how theycame up with kodak. it's like tea, tei, chai, chei. there it is, the entire world. so they-- so i think sayanawas done the same way, sayana, and you can just say it injust about any language. so they ended up puttingthe subcutaneous formulation into a prefilled glasssyringe and they market it in the united statesas depo 104 subq,

sayana in the rest of the world. and then we started adevelopment program with them to put this subcutaneousformulation into uniject, and they did it. and that product iscalled sayana press. why sayana press? because it's sayanaand you press it. so the way you use the-- i'm going to get one thatdoesn't have the sayana in it.

so that is actuallywhat it looks. this is one with sayana. if you want to circulate that. this one has saline, so theway it's used, very novel. again, path inventedit, pd's perfected it. so all you do is you press thecap in and that breaks the hub. then you take the cap off andit's a subcutaneous injection. so, you can lookat the difference between those two needles.

which one would yourather be injected with? >> this one. >> ok. so by the way, properrecapping if you ever are to recap a needle is younever do it with your hands. because the major way to getinfected is with a needle stick, so you lay the cap on thetabletop and you do it like that, if you everhave to recap a needle. we tell people never recap it. throw it away uncapped thenyou prevent needle stick.

so you make that connection and then you give thisteeny subcutaneous. it can't get into yourmuscles, the needle is so small, so you just squeeze yourupper arm or your belly or your thigh andyou then squeeze. it's saline so i'm notpoisoning anything. pardon. >> do the needle-- >> no. it's only inthe united states.

i'm glad you asked that? are you a healthcare provider? >> well, no, i'm not. >> ok. well, in the usyou can't sell needles that aren't retractable. so they want the needles todisappear after you've injected or at least be covered over. no, it doesn't come that way. so, they created sayana pressand we have worked with bayer

-- sorry, with pfizer on this. and you have this onesheet that looks like that and that tells you almosteverything you need to know. you know, it's only104 milligrams, so it's a third less drug. it is 0.65 cc's or65 ml's versus 1 ml, so it's 35% less fluid. it's given subcutaneously. it's just as effective asthe 150 milligram dose.

it has the same sideeffect profile, even though it tends towardsbeing a better profile, but not statisticallysignificant better profile. the sayana press was approved bythe european medical authority with the british beingthe regulatory authority. it's already been registeredin several countries. it has not gone to thefda nor will it ever go to the fda for approval. i don't think they feelthe need to do that.

and one reason they don'tfeel the need to do that is that their advisors tellthem there's no market in the united statesfor sayana press because we have theprefilled glass syringe. and i brought the medial advisorof planned parenthood with me to a meeting at pfizer. i'm on the medical advisorypanel for planned parenthood. and we had this meetingwith pfizer and vanessa collins[assumed spelling] said,

"are you kidding? we'd love to have thisproduct in ppfa clinics around the united states,"but i don't think it's going to ever be available in the us. and introductory studieshave begun in five countries, two more coming on board. we supported the acceptabilitystudies in senegal and in uganda and overwhelmingly, the clients and the providerspreferred sayana press

over dmpa, over depo-provera. not universally, but it wasdefinitely the preferred thing because it's easier. the all-in-one combination makesit impossible to have vials and no syringes orsyringes and no vials, so it's all in one thing. it can't be reused andit's a prefilled dose. you can't make amistake on the dosing. and we had a supportedstudy that showed

that if you injected it in thearm, it worked just as well as in the thigh and in theanterior thigh and the abdomen because that's the labelused by the company. and one of the nice things aboutthis is it's also appropriate for self-injectionor at-home injection. and pfizer had nointerest in that, but now they havean interest in that so they have supportedsome research by anna glazier [assumedspelling] in scotland.

and they have anapplication in front of the british medical authority for label changefor self-injection. and we're about to embark onthree self-injection studies. we're funding one, the missionin malawi is funding a trial and the gates foundation issupporting path-organized trials in senegal and ugandaon self-injection. and-- well, very astute remark.

so my position has been idon't want to do self-injection until we have introduction,until providers and the medical people areall on board because we could and in fact, i've writtenan editorial that appeared in the may issue of thejournal of contraception which is all about depo. i wrote the leadeditorial on sayana press. and i worried about, youknow, getting pushback if we got too far outon self-injection.

so the proper approach is to doit through facilities and then through communityhealth workers. you know, we've beenvery successful and victoria grahamhas led the effort. there's very few countries that won't let us traincommunity health workers to give intramuscularinjections. there are still some holdouts and we think they will changetheir policy with subcutaneous

because there still is fearthat you can go in to a vein which just doesn't happen. but there is-- with thatrecognized, there is still, you know, i think both--they'll be introduction as well as self-injection studies. and for bill and melinda gates, they see the game changerand i call my slide. that slide is called, you know,this is a potential home run. i used to say game changer,but i just thought, you know,

that word was used-- toooverused, game changer. but they-- but bill andmelinda see the game charge is in self-injection,so they want gates to be doing self-injection. so the other piece therejust gives you a very-- better comparisonif you needed it. what the difference betweenthe two products are including needle gauge size. so, any other questionsabout injectables?

highly popular method. >> did you say somethingabout bone density and like what-- how young-- >> you would recommend-- >> well. >> like there's-- >> there is a black box warningon the fda label about loss of bone mineral density. and depo-provera is theonly progestin we use

that causes 100%hypoestrogenicity. in other words, your bodydoesn't make any more estrogen when you're using depo. >> uh-hmm. >> whereas with levonorgestrelyour body still makes estrogen. so it causes hypoestrogenicityand hypoestrogenicity leads to bone mineral density loss. one reason, menopausalwomen who aren't on hormonal replacementtherapy can lose bone.

guess what else causesbone mineral density loss? looking that downunder the table? >> what? menopause? >> pregnancy. [ multiple speakers ] >> breastfeeding. women produce no estrogenswhen they breastfeed and that is transient. you stop breastfeeding, yougain back all that loss.

so here was the fear with depo. if you gained back theloss, your bone grows back. so the fear with depo wasthat if young women took depo, they add-- before they reachtheir full bone growth, they might not regainall their bone growth. and that if other women,who weren't young women, that they may have an increase in fracture ratesif they're on depo. well, the evidenceis to the contrary

and including onthe adolescents. pfizer has completed abig study and it looks like it is not an issue, but theblack box stays, so it's nothing that we need to worry about. and who has a guidance on there. it is in no way should affectthe use of the product. ok. so we move to implants. so implants. we have three documentson implants.

we have the one-pagerthat i did. we have the piece thati worked on with alona that gives even moreevidence on all the implants and we have the training forthe introduction of implanon nxt that trish mcdonald justcirculated to everybody. so contraceptive implants, ihave in front of us jadelle which i can circulatein two directions. i have the original norplantwhich was six capsules. it was replaced byjadelle which is two rods.

and i also have sino-implantwhich i mentioned in that thing which is made by dahuain china and it is a-- it's a copy of jadelle. it's not exactly like jadellebut it's a copy of jadelle and that's the chinese label, chinese packagingfor sino-implant. >> do they have the same length? >> no, that's slightlydifferent, slightly differentlength than jadelle.

so jadelle lasts for five years,highly effective, it's inserted with a trocar thatlooks like that. they are disposable trocars. it looks like a reallybig needle, scary. >> yeah. then-- >> and you don't need to makeany kind of incision in the arm. you just, you-- what you dois you put it in under the-- very superficiallyunder the skin. the more superficial theinsertion the easier it is

to remove and then you-- onceit's in, you put one rod in and you push it in and thenyou turn it a little bit and you take this plunger outand you put the second rod in and you push that one inso that you have two rods under your skin, right here. and that's a disposable trocar. it releases levonorgestrel. it's highly effectivefor five years. it has the same side effectsas progestin-only method

that causes someirregular bleeding. some people becomeamenorrheic with it. it's highly effective. you need good counseling about the side effectsbefore you provide it. it's safe for breastfeeding. you have immediatereturn of fertility as soon as you remove them. there is less menstrualbleeding,

less risk of ectopic pregnancy. again, it doesn'tprotect against hiv. the bleeding pattern changes arethe most important side effects, spotting and someheavier bleeding at least in the first year of use. it needs to be inserted bytrained people and removed by even better trained people. and it is less effective ifyou use it with certain kinds of drugs, rifampicin, andanti-seizure medicines

and there is now concern andi think we just sent some to the field on thatalso, that the-- one of the componentsof triple therapy, art therapy is efavirenz. and there are some evidence, and jim shelton finds theevidence compelling although others don't findit so compelling that you can have 30% reductionin protection against pregnancy if you're taking efavirenzand using levonorgestrel-based

or etonogestrel-based implant. >> was it 30%? >> i think it was 30%. so that's questionable butit's still highly effective and if it's still your method of choice you justneed to know that. so i think the jury is outin that who, jim has asked who to look into this in theprogrammatic guidance that we go to the field and so we'restaying on top of this issue

because it is the most-- one of the most commonmethods in triple therapy. it doesn't have-- if youwanted to use an implant, you wanted the tripletherapy, there are alternatives to efavirenz, maybe notquite as effective but-- so that's one of theissues and i mentioned that in this-- in this briefer. so i passed around thejadelle and we also-- and the interesting thingabout the product is and same

with implanon is that themanufacturers signed after fp, as far as the fp2020bayer the volume guarantee that if the donors andcountries bought 27 million over six years, they areproviding for $8 and 50 cents. so the price dropped fromeight-- the price started at $23 and then we were paying 18.50. and then it droppedto $8 and 50 cents for five years of contraception. very, very low coupleof year protection.

merck produces implanon whichis a single rod implant. it contains the progestinetonogestrel, a different form of progestin, a laterstage progestin and then it's just one rodand it's easier to insert because it's one and it'ssomewhat easier to remove but for trained insertersi've got, i have another site i can giveyou that choose the average time of insertion removal and itisn't that big of a deal. so this product is labeledfor three years only.

so if you wanted an implant, atleast if i wanted an implant, i'd choose to have the tworods and get five years than the one rodand get three years. however, who has just completeda very large multicentered trial and they compared jadellewith implanon and the iud. and the original design in thatstudy was implanon was going to be replaced to three yearsand i consider one of my-- one of my accomplishments toconvince who to not do that. to keep the implanonin because i--

because there was already five-- four-year published data oneffectiveness of implanon at four years and iwas quite confident that the company knew it lastedfive years but they liked to sell it for three years. why? three years is aperfect birth spacing space so for birth spacers,you put it in. in three years, you take it outand you have your next baby. three to five saved lives.

so i said yes, threeto five saves lives. if you want an implant,more or less 30 years, if it has to be takenout, if you could. so i got who to keep the trialgoing and to use an increase in pregnancy rateto stop the trial if they saw the pregnancyrates of implanon up to year three increasingcompared to jadelle. well, guess what happened. there were three pregnanciesin both groups at three years

and no pregnanciesin either group between years four and five. so implanon lasts for fiveyears, it's just as effective as in five years as three,it's even more effective and same effectivenessas jadelle and the company has agreed nowthat when they get all the data and if they can doan audit of the sites when the trial was done, theywill go for a five-year label. so if all things were equal andyou get one rod for five years

and i'd probably opt for this but as you can seethere's been a change. and that email that thetrish sent out is what-- what the company has doneis they made a new inserter that makes it almost impossibleto do a deep insertion because we've learned fromall the studies that we did, we need to have a verysuperficial insertion just under the skin. it's easy to get it out.

you put it deep in the muscle. you got to fish it out. so they've createda new inserter that almost makes it impossibleto do a deep insertion, and plus they've added thatradiopaque dye to the product so that if you want tomake sure it was there, you can x-ray it and find it. because most of thepregnancies that have occurred in implant userswhen they study them,

they didn't have anyhormone in their system. and what happened, it fell out of the trocarbefore it was inserted. so nothing got inserted andthey didn't know it fell out. so that can happen. >> you can keep the angle right? >> well, it can happen. it can happen. so now, with the radiopaque dyeyou can easily check if you want

to make sure that it's there. of course, you don'tneed to that if you're really carefulabout the insertion. so that's implanon. we can circulate that. and here is another one,circulate in both directions. and then there is sino-implants. now, the advantageof sino-implant, so sino-implant wasinvented in--

developed in china and markussteiner from fhi came across it and he got the gates foundationto give him a grant to study it and to collect data on it and to do quality assurancein the manufacturer. and sino-implant is just likejadelle, a little bit longer, same release rate andit only last four years, stable for four years of use. the advantage of sino-implant-- it's not been approvedby the fda.

it's not been approved bydma and it's going to who for prequalificationand it hasn't received that who prequalification yet. and the advantage ofit originally was, it was available for $8. well, actually, itstarted like a 4.50 or 5. it worked its wayup to 8 and 8.50 when everything else is $18. so it would reallymake a big difference

on how much you could buy. now with the volume guarantee,they all cost the same. so what's the advantageof sino-implant? well, there are some countriesthat will not have access to the volume guarantee so theywon't have a low-cost implant and they could use sino-implant. secondly, fhi iscollecting data for-- to demonstrate that it last forfive years, not just four years. and they feel, and i'mon their advisory board,

that part of that volumeguarantee-- these-- i've been part of bayer was toput the kibosh on sino-implant. who would ever buy a five year,two item implant from china if you could buy the tradename for the same price? so, you would-- nobodywould do it. i mean, who is going to buy a-- a yugo if you can get amercedes for the same price? nobody. so-- and i think there'sstill going to be a market for sino-implant because of--

for those countries thatcan't get the other implants at a low cost. >> how long is that-- that priceguarantee going for it too? >> well, that priceguarantee is six years. however, in my experience nobodyhas ever been able to go back to the original price. and the only reason thatthey would ever go back to the original price isif they had no volumes. >> right.

>> so what-- what bayer didis they had the capacity to manufacture many moreunits than they were and the price volume guaranteegot them to make more units. so if you're making a lotmore units, the marginal cost to making the additional unitsis very low so you get offered for a lot less moneyand not lose money. so i think implants are verypopular and they're going to continue to be popular. so i don't think we'll eversee a reversal in those prices.

if the people like implantsthen we'll continue to use them. >> just to get more background, part of the reason whytrish [assumed spelling] has to send the e-mail is because-- well we have thevolume guarantee and the price reductionfor the implant product than these products wassometimes different placebos and they are very costly. >> yeah, training arms.

>> plan. the placebotreatments of the blanks. >> yeah-- >> -- in a device so merchantshad plans set out ever since and they're $5 each so it [inaudible] their pricereduction is not as good as-- >> yeah, i was verydisturbed by that. >> so that's part of whywe're sending [inaudible] and her doing that is becausethey have the money for it. >> yeah, well if you read that--

you have a chance and if youhaven't done it already take a look at that-- on thatrelease that trish says because it's veryconfusing in many respects because what's going tohappen is merck has agreed to do training of trainers. so they're going to have a kindof trained trainers trained, but the programs that want totake advantage of them have to pay for the trainersto train their own people. and they want to either have ablank device and it's expensive

to buy that blank device. so we got to sort this out andhow many do you really need. maybe you will need a couple ofthem, you know, we don't want to spend much money to do that because thetraining is really easy. >> i mean, i'm nota clinical provider and i did the norplanttraining with six capsules and i found it very easy. so i went-- i didthe training for it

and it's a very easything to do. particularly if youguys experienced already with the implant on. >> my understandingwas also the issue of nexplanon was the inserter and they have huge medical wasteissues because it's ginormous. >> right, we're talking tothem about that too, right. >> sort of [inaudible]special need. >> absolutely.

well, and, you know as i'dsaid, i worried very much about waste particularlyin developing countries because nothing getsthrown away. please. >> sorry, i forgotto ask about the-- your response on the sayanapress and the whole chicken and egg thing question, which seems to have beenthroughout there in terms of the-- now the priceis at $1 that it's better

than it has been because it'ssomewhat around 80 cents. what are your thoughtsas to the-- >> -- being stable. >> most people don't know and iwill share with you that it's $1 because the gates foundation and the children's investmentfund foundation are buying the price down. that's why it's a dollar. and the company says theywill provide it for a dollar

when they reach about volumesof six to eight million a year but it's going to take a longtime to ramp up to that level of volume because itdoesn't happen overnight. and [inaudible] we'll try it, but it takes a long timeto get a lot of use. so we're doing theseintroductory studies. so if the volumes do getup, and if it's found to be really popular thenwhen they get to the volumes, at a certain volume they willprovide it at that amount

of money becausethey're figuring out how to make it cheaper andcheaper as they go along, by making more volume right now. so the intent is to get it down. and we're workingwith somebody else that could possibly give us thesame price for about 80 cents. so it is an important issue. right now, for the dollarit's worth, it's worth it to pay a little bit more

to at least get someprogram experience with it. and i said, the homeinjection issue and also the communityhealth worker. it's really a piece of cake and it might expand theseamong community health workers compared to intramuscularinjection. ok, so the next product on ourlist are iuds, are they not? i don't know wherei put my little-- >> yes, yeah.

>> -- agenda. >> [inaudible] of this, yes. >> ok. so for iuds, you'vegot-- we've got my one pager. well, it's actually twopage front and back. you've got the research,the literature review. so you've got those documentsand usaid buys a copper 380 iud and we buy it from injeflex. it's called the optima iud. i'll pass it around, soyou can see what it is.

it's a state of thearthritis iud. iuds do not blockimplantation as i said before. they create a hostileenvironment for sperm in the uterus. and that's what the copper does. so sperm function is destroyed,fertilization does not occur when the woman is using acopper iud for interval use. and that's an important piece. we pay 63 cents for thatiud and it lasts 12 years.

>> twelve? >> wow. >> ok, i think it'slabeled right now at 10, but we have at least 12 yearsof data and who has 14 years of data on that product. and most people don't-- it'sa terminal method for men-- depending on when you use it,you know, this and other method. it works regardlessof you behavior. it's the most cost-effectivecontraceptive method

that we have. approximately 145million uses worldwide and i list the countrieswhere it's wildly used. it's going to work regardlessof what your behavior is. it's good for spacesand limiters because the spacerjust has it removed. you have immediate return offertility when you remove it. by the way, we-- depo, thereis a delay return to fertility, if you read that signand it can take up--

so remember afteryour last injection, you've got four monthsof protection and probably a little bit more, so you couldn't possibly getpregnant for four months. and it takes usuallyanother six to eight months for everybody who's going to getpregnant to get pregnant again. so it can take-- afterthe-- your last injection, you've got 12 months toget a normal fertility rate and people need to be told that,

but it doesn't causeinfertility. >> and how about for delayers. >> for iuds, well, if youwanted to use it to delay, and you wanted a newchild in three years, you take it out in two years. depo, you sub-- you depot,this doesn't have any effect. the iud is not. >> ok. so the iud-- >> iud, there isno effect at all.

it's the immediatereturn of fertility. i'm saying for depo is you--if you're using it to space and you want to use itall the time, you just-- you want to stop it a yearbefore you want your next child to make sure thatyou are fertile when you wanted to be fertile. iuds, you have immediatereturn to fertility. pid, there's verylittle incidents of pid and jim's done a review of that,and who's done a review of,

but there is an increaseparticularly if you insert an iud in somebodywho has chlamydia or gonorrhea, or any reproductivepractice section, because you could bring itin with the iud insertion. ectopic pregnancy rate ismuch lower in iud users than the users of no method. however, should you becomepregnant while using an iud, then the chance of an ectopicpregnancy is relatively high. so women who do become pregnantand the iud is in place,

need to be investigatedfor ectopic pregnancy. people worry about theexpulsion rate on iuds. i don't worry about it. i don't worry about itbecause the only expulsion that is really worrisomeis the unknown expulsion. and women are usually toldto check for the string. they usually check tomake sure you can find the monofilament string. and if you can't,then you need to go

to your health care provider. but the expulsionrate is relatively low and it's very much relatedto a quality of insertion. >> just a quick quest-- we all provide iuds frompregnant women and in men. >> ok. yeah, so for onecountry only, right? >> oh, pakistan. >> pakistan, ok. so, yeah, i knew that.

>> i should have said that, but it's only one countrywe're buying pregnancy-- and it's the same iud. it looks exactly the same. >> exactly the same. >> thank you. so, fhi did two importantstudies. there was a concern thatiuds could not be used by nulliparous women, becausethey cause them to be infertile.

fhi did a big study inmexico, showed no relationship between iuds and infertility. there was a concern thatiuds couldn't be used by women with hiv. fhi did a big study in kenya and the iud did not cause anincrease in acquisition of hiv. and in women who hadhiv and it was inserted in them did not cause anincrease in progression of hiv. so they're totally appropriatefor use in high incidence of hiv

and in women with hiv. the-- so that is the--we buy that copper 380. and i wanted to also talk about thelevonorgestrel-releasing ius. has everybody heard ofthat, what-- it's sold us? >> mirena. this is what mirena looks like. so the only differencebetween mirena and the lng-ius, ihave one of each.

it has zero to dowith the device. they are exact samelevonorgestrel-releasing ius, intrauterine system. it's the inserter wherein it hasa single hand inserter system and they're evenimproving on that. so you can insertit with one hand. the lng-ius has a tube inserter. you usually need twohands to insert with that. it's very similar toanother iud insertion.

experienced providers havezero problems with this. the debutants or the newproviders find it a lot easier to have the expensive inserter. i called the lng-iusthe best of both worlds. it brings together all of theadvantages of oral contraception and all the advantages of intrauterine contraceptioninto one device. and this device has importantother health benefits besides contraception.

you heard me talkedabout the fact that with oral contraception,you have a much lower incidence of endometrial andovarian cancer. ok, so that's a verypositive important effects. with the lng-ius, you have aproduct that's very effective to reduce menorrhagia,very effective in women who are anemic. severely anemic women, youwould not put a copper iud in because it causesmore bleeding

in their hemoglobin drops. you put a mirena in themand the hemoglobin rises. a guy named luis bahamondes,a famous research scientist in brazil, did aninteresting study. he took all women waiting for hysterectomiesbecause of fibroids. and he inserted thelng-ius in all those women. and 60% of them neverhad their hysterectomies. it reduces fibroids.

very interesting. highly effective. when the-- when jeffreypeipert from the university of washington in st. louis, did his big studycalled the choice study, some of you may haveread about it. the buffett foundation providedthem with free contraceptives and they offered, inall their clinics, free contraception anymethod that a woman wants

in dozen clinics,and at no cost. and when cost was takenaway from the equation, the highest chosenmethod was mirena. in the united states,it's $700 to $800. so-- and it's notcovered by all insurance. so, the most popular methods in his study werelong-acting reversible methods, particularly amongstyounger women and they also demonstrateda reduced rate of abortion

in those women becauseof long-acting reversible contraception. the study was a bitbiased in favor of long-acting reversiblemethods, although they offeredall methods. but this device is a marvelousdevice and in the briefer, i have the website forthe ica foundation, i see it on the board of thatfoundation, it was created by the pop council, and it's

in one pager-- oneand a half pager. pardon? we only buy a copper. >> and why is that? >> because it's marvelousand it's very cheap. and we can't get a publicsector price for this product. ok. so, the ica foundation willprovide them free to programs in developing countries who want to get some experiencewith them. and i put the website downso if you're in a country

that would be interestingto try it, the develop-- putting a project proposalin is very easy thing to do. go ahead, ask me aquestion about this. >> i just wonder if we haveany data about follow-up, like how many of those womenkept it in for five years. i personally-- >> oh. >> i personally got mirenaput in and it strictly hell. so the pelvic painwas like excruciating.

and i got it-- andit was expensive. and i got it takenout two years later because we felt itduring intercourse. that's crazy, right? but like i wonder-- >> and what did you feel? >> so it hurt really bad,it was really expensive. felt like, "ok, i have it in, iwant it for five years", right? but then--

>> so pain didn't subside because the painusually subsides in-- >> -- we felt, like duringintercourse, we, like-- >> oh, really? >> so you can clip thestring-- first of all-- >> they said-- i went back and they said theycan't cut them anymore because then they'lltuck behind the cervix and then you can'tget them or something.

>> no, i don't knowwho told you. >> i had a very badexperience with mirena. >> well, boy. >> i'm just wonderinglike women-- >> i want you to-- >> -- agreed option, but if-- i wonder if you followup with these women and-- >> -- put in, you know. >> so here's the string,so you could see right now

that this is howlong the string is, so they cut the stringafter they inserted. >> but you can cut thestring off completely. the only thing awoman can do is to-- but we can tell thatyou have it in your body because what you need todo is take a blood sample when you get levonorgestrelin the blood. so we have a biomarker for use. but if i were you, imean, i don't know who--

what provider told you,they could have cut that string off completely. >> how would theytake it out then? >> huh? >> they take it outwith a grasping forcep. >> oh, provider issue. >> because women cantake them out themselves. >> but i also hurt-- >> you can feel itwomen with string.

>> -- so you also say they'reappropriate for spacers and limiters, but youdon't say delayers. and i know that it's-- >> well, that's-- >> -- less pain after you'vegotten through a child birth. >> is that correct? >> well, i can tell youthat there's a new product on the market, whoknows what it's called. come on.

it's-- the fda just providedinformation about it. it's approved this year-- last year, or maybe thisyear, early this year. what's it's called? >> skyla. >> skyla. and what is skyla? nulliparous women. it's a smaller device. >> where the inserter is small?

>> are you nulliparous? >> the actual-- iud, no. >> it is. the actually--i actually like-- >> kaleen [assumedspelling], are you nulliparous? have you had a child yet? >> so you used sky-- >> maybe you could havea child or something. >> so skyla. so i want to tell you something.

i'm going to give you-- i'm going to tell you whoto contact that were-- >> [inaudible] actuallyabout this. >> if you're interested,kaleen, i'll get you a skyla. >> in the us, there--the new [inaudible]. >> all, any, [inaudible],no copay, no-- >> no anything, no, right? >> that's obamacare. >> wrong time, too.

>> so i think it's-- ithink your experience -- i've not heard that but everybody has theirown experience, so. >> so that's thelng-ius in mirena. there is two other optionsavailable right now. one of them is made by pregna, it's called alora [phonetic]it has not been widely studied, it's only available in india and it's a very similardevice, i'll circulate that.

and there is novosert[phonetic], which is an iud that'smade in belgium, it's now-- it's made by a company calleduteron, isn't that a nice name for a company that makesan intrauterine device? u-t-e-r-o-n but itwas booked by actavis. and medicines360,an organization in the united statesled by victoria hale who began one world health,if you ever remember hearing about that, she has got a grantfrom the buffet foundation

to do the clinical trialsin the united states. paul blumenthal who isthe medical director for psi particularly for thislarge grant that they have on iuds and implants, hewas one of the investigators in the clinical trial. they've got three-yeardata and the fd-- it's gone to the fdafor three-year approval. it was approved in portugal for five years alreadybased on the release rates.

medicines360 will continuethe trial for five years, so they have a five-year data. so anybody who would havethe device inserted next year for instance, by thetime they've got one year of use they've gota four-year label and by the time they havetwo-year use they get five-year label. so anybody who wouldget the device with the three-year labelwould be told by the time,

if you want to continue touse it, by the time you get to year three we'll be ableto have a label change. and medicines360s has theworldwide rights to the product. actavis is going to sell it ineurope, in the united states and canada and medicines360can sell it anywhere. they pay a royalty perdevice and they are working on some introductorystudies in sub-saharan africa on the device right now. and my guess thatwhen it's available,

it will be probablyfor around $15. so very different than mirena,not different than the lng-ius because you can getthat for free right now and i've been talking to bayer about why don't theyconsider dropping the price of mirena drasticallyand-- please-- >> i heard lng-iusand implants do-- does the drug comeout at the end of the tube or through the tube?

[inaudible] >> on the implants,it's released-- it comes out of the tube. not the ends, it's just[inaudible] and just like mirena it doesn'tcome out from the ends, it comes out from the sides. and i have a nice slidethat i didn't give you that shows how it's released,going through this in the sides in a very steady rate.

ok, so i think sdm wasthe next item, wasn't it? that'll be good. thank you. so sdm, who knows about sdm? who doesn't know about sdm? >> there's a whole day nextweek that i'm [inaudible]. >> ok. so when i passed down ansdm is this-- is it-- it is-- it's our two documentsand i want to throw your attention to them.

one comes from the irh websiteand it's funny the way it prints out with like it's funnyirh website top can be-- when i printed from the website,it comes out a bit funny but it describes the device. and then i pulledanother one off the web on the standard days method,which has wonderful information about it and a lot moreteaching materials but it comes from a natural familyplanning organization. and i'll tell you whatthe differences based

on the orientation of who'sproviding the product. so sdm is a scientificmethod despite the fact that some people want tocall it a traditional method. and it's-- the data tocome up with the days eight to 19 is the fertile periodis based on clinical data that i collected at whoin 7,415 women in the '70s who used the billings methodcalled cervical mucus method and we had charts on allthose women and the length of their cycle and theirdays if intercourse

and when they got pregnant andthe estimated day of pregnancy. the majority of people who use afertility awareness-based method have an unintended pregnancy because they don'tabstain on fertile days. it isn't because theymiscalculated the fertile days, it's a behavior issue. so even though this was doneat georgetown university, and i'll tell you a funnystory about that and we can let that go on to tapei don't really care.

georgetown neverhad the position that during the fertile dayswhen the bead gets to the-- those days that youhave to abstain. if you want to avoid pregnancyand you're highly motivated to avoid pregnancy,abstaining those days and you won't get pregnant. however, should you like tonot abstain in those days, if you use a condomeffectively on those days, you will not get pregnant.

and the clinical trialthat was conducted, published in the journal ofcontraception showed actually that the people who abstained on those days had a slightlyhigher effectiveness rate than the people who reportedlyusing condoms on those days. because one, condoms aren'talways 100% effective. and two, condoms aren'talways used correctly. so we don't know why thathappened but it is 95% effective when it's used correctly and88% effective in typical use.

so i said we collectedthese 7,000-- i've collected 7,500 cyclesthat georgetown was able to get their hands on andthey had their scientists and those scientistsincluded virginia lam-- ginsey [assumed spelling]lam, practiced-- does anybody know ginsey? she used to work with us. she's monitoring evaluationfor us, she worked there with erith [assumed spelling]at the georgetown institute

and they put all the cyclestogether and they figured out if you were going toknockout at least 95 to 98% of the pregnancies, whatwould be the fertile window? and they came up withdays eight to 19. and the differencebetween the document that georgetown producesin the wonderful document that was produced by whoeverthat i have from this website is that it says, "you have toabstain on the fertile days." so that's choice.

so the difference between thefertility awareness-based method and natural family planning,they are the same thing, you have some way ofdetermining the fertile period. but in natural familyplanning, by definition, you abstain on fertile days. and if you don't abstain, you're not practicingnatural family planning. and it's much more of a--it's sort of a political issue for them because they don'tbelieve in contraception.

and hence, using somethingduring the fertile period you're contracepting. and my position has been, you're contraceptingif you're doing this. >> yeah. that's-- yeah. >> so not too muchdifference, you know. and in fact it was aninteresting thing written by john paul ii that when youuse natural family planning for the wrong reasons,you're sinning.

so that's all politics. all right, what was after sdm? >> condoms. ok. male and female condoms. so on the condoms you've got-- i've taken from our websitebecause most of you don't-- might not know that we haveseveral really interesting documents that i wasresponsible for helping to write and edit on the hiv website.

one is how a condom is-- condomuse, how it relates to hiv and sdi prevention andthere's another one on addressing condomsupply and demand in-- >> can somebody check[inaudible] right by the speaker if--they're difficult to hear. >> sorry. >> ok. and then there's-- so wehave the technical issue brief in oha website, we haveaddressed in condom supply and demand on the oha website.

and i also had a piece thati did on the effectiveness and cognitive preventingsexually transmitted infections that was handed out. and i also have a pieceon the female condom, because when we'retalking about condoms, and that is the technical brief, it's from the ohawebsite on female condoms. you all should have that too. it says technical issuebrief female condom safe

and effective. that's the second page, so somebody holdingup the back page. it's four pages. >> that's the one with the-- >> no, we don't want that. [ inaudible discussions ] >> you have it there. >> i think it's aftervasectomy because i've--

>> ok, anti-vasectomy. you still need to use condoms after vasectomy,for some people. so i think the importantthing to know about-- i mean, everybodyknows about condoms. it's widely known method andthe big issue is how do you get people to use them andhow do you get them to use them correctlyand consistently? and we have some countryexamples where it works.

and we know that somesex workers are very-- can very effectivelynegotiate condom use and you can get condom use upto 90% but our big problem is that only about 5% arecontraceptive prevalence worldwide for contraceptionis condoms. and that in marriage orwithin intimate partners it's frequently very difficultto negotiate condom use. when used correctlyand consistently, condoms are highly effective

and preventing unintendedpregnancy and hiv and sdis. they are the only dual purposemethod we currently have right now, both male andfemale condoms. and aid provides a wholerange of condoms and if-- i didn't bring it with methis time but i should've, so may be you can makesure everybody had-- we have a wonderfuldocument on all the products that we've provideand what do they cost and how are they packaged andanybody going to the field,

i usually have-- i thoughti had that in my box but i didn't haveit, anybody going to the field should alwaystake with them that document because it would-- letme see if i have it here. it gives you all theinformation you need to know about all the productsthat csl through the-- so our central commodityprocurement provides how they're packaged, what form do theycome in, the different brands. and it also gives you--let me see if i have it,

it also gives you theprice list on everything. so i do have my price list. so we provide a whole varietyof male and female condoms and i've got samplesof all of them. and the female condoms that we've provideright now is called-- it looks-- let me get one out. it's got-- actuallythere's new packaging. it is now a beautifulpurple package.

it's called the fc2, it'smade of nitrile and it's-- it comes prelubricated. has every-- who isn'tfamiliar with female condoms? who is not familiarwith the female condom? everybody's familiar with it? how many people have tried itif you're willing to fess up? ok. so it's really aninteresting thing to try by the way just-- because i'vetried everything i've worked on and--

>> what? >> everything that i'veever worked on i have tried. other than long acting methods because my wife didn'twant that. so that's what thefc2 looks like. got an inner ring that's usedfor insertion and an outer ring that stays out, ok, it islubricated and we also sell it with a sachet ofadditional lubricant because some people want morelubrication and they tell me

that well endowed men reallydemand much more lubrication and hence it's providedthat way. so that is the femalecondom we provide. there's another female condomcalled the woman's condom. how many people haveheard of that? so the woman's condomwas developed by path with usaid funding, the fundingwent to conrad and to path and it's a totallynovel approach. this is what it lookslike undeployed.

ok, it's made in chinanow and sold in china. and the clinical trial hasbeen completed of this product and we'll get fdaapproval probably next year and it will also be goingto who prequalification. and the interesting thingabout this product is that-- so it comes withlike a little capsule and that's a disposablecapsule, not disposable, it dissolves immediately. as soon as you put it--if i dip it in water,

it would dissolve immediately. as soon as it goesinto the vagina, and interestinglyenough, i've always said that we could probably put amicrobicide into that also. so it would dissolvewith the microbicide but we don't have anmpt project using that. so when it is deployed,and i don't want to deploy that one, it looks like this. this is also-- and the wayit stays in the vagina,

which is differentthan the female-- the fc2, this stays in becauseit's got an inner ring that sets in almost like a diaphragm. this thing has thesehydrophilic pads on the side, so when it opens up inthe vagina they adhere to the moistness of the vaginalepithelial and they cling to it. they don't cling so tightthat you would go ouch when you pull itout, but they cling. and so the negative side of thisis it can't come prelubricated,

because if would prelubricateit those pads wouldn't work. so they are sold with a satchelof lubricant and you need to lubricate the insidebefore you use it. >> what's in the capsule, jeff? >> the entire condom. so if i were to fold thatup, it would look like that. >> so inside the condom areall those hydrophilic pads and the full length of it. but it's done this wayso it's easy to insert

because you got this little-- it's almost like apesser you would insert and you just push it right inso it's very easy to insert. and in the acceptabilitytrials of this product, much to my surprise, i'm happyto admit, it was much preferred over that and theready-latex condom. people liked it better. >> i would think that thewhole lubrication factor like having it separatelyif that would be

like impediment [inaudible]. >> so you'd thenchoose this one? >> than this one. >> so more choice, you know. so-- but this issold with lubricant, but it's just separate. you'd have to add thelubricant but a lot of people add additionallubricant to this. so those are maleand female condoms.

i think female condomsare totally underutilized, i think they are areally good option. and the advertising materialfor the female condom, it says you've got to use itthree times before you make a decision. don't make a decisionbased on one use. the original wasmade of polyurethane and people complainit made noise. now it's made of thisnitrile, this synthetic latex.

and it really is-- the bestpractice is use it a few times, get used to it and then youwill more appreciate it. it is a bit strange, youknow, and it's, you know, nice to use it with thelight's out, i think. and the other thing onmale condoms, i should say, is that i spend an awful lotof time years ago working with manufacturer's tomake better male condoms. once that, you know,i had this pipe dream that if you can make a malecondom that was so acceptable

that it made sex better with it than without it then itwould not be difficult to get men to use it. but the regular condoms,tight-fitting condom is that many times people havecalled it taking a shower with a raincoat on and mencomplained about the lack of sensation that is causedby the use of condoms. and we discovered from research that a loser-fitting condomswere much more acceptable

than the tighter-fittingcondoms. and dr. reddy [assumed spelling]made a whole range of condoms that looked likedairy queen cones and it was a lot morematerial and it was more of a accordion style that wouldride the penis that was claimed to cause much more pleasure. and-- but we were alwaysunable to demonstrate that there was an unambiguouspreference for that product. the gates foundationhas 10 grants out--

all right, now grand challengeson condoms and three-- i've reviewed allof those and three of them looked very promisingto me and i was interviewed for, i forget what magazine,on my views on condoms. and gates told me toget in touch with this. i had tried to do whatthey're trying to do right now. and interestingly i wastotally misquoted in the article because i have somefaith at a couple of their projects mightlead to better materials

but i'm very skepticalabout our inability to determine preference. because what happens in the mostof the studies is you give a man or a couple threedifferent condoms. there are very different. and then you got a, b, andc and you randomly allocate, who starts with the a, whostarts with b, who start with c. and then after they're donewith two weeks of using that one they go to b and then--

or they go to c or they go to cthen they go to a, then they go to b. so, after about a month orsix weeks you've tried them all and you recruit people whowill have at least two acts of intercourse a week so thatthey use one for two weeks and then one for two weeks,another one for two weeks and then the third one fortwo weeks, and they have to each act they fillout a form and then after using all threeacts with one of them, they fill out a form and whenyou're all done they fill

out another form. and then, we try to figurepreferences and then it's like through gestalt and peoplesay well, i like condom a, but then when you say, "whichone are you going to recommend?" they recommend condomb. it's very confusing. and i've come to the conclusion that our weakest link is ourability to measure acceptability and one reason for that is thatspeaking from my own experience and i'm sure everybody elseexperience is that not every act

of intercourse is the same. it's not just mechanical thing. they didn't make mechanicalmachines by the way to test condom strength butnot every act is the same and you carry differentbaggage and, you know, and like george costanza said,"make up sex is the best sex." so, if you're doing condomnumber three with make up sex maybe youreally like it a lot. so, we don't have thecapacity to do a good job

of measuring effectiveness. so, one of this that we'vedone in fhi has been a leader in this is that we do theselike market search surveys, where you go to a marketarea and you all have condoms and you offer thecondoms to people. pick any one you want, pick themall, try them, and come back. and then, after they've usedthem they come back and say, which one do they prefer. and in the trials that we'vedone, after the trial was

over we then say to thepeople in the trial, ok, we're going to give you ahundred of the-- one you want. which one do you want? and we try to get anidea of effectiveness but we've never been ableto find any condom that 90% of people said this is-- ireally like this product. so, we're stuck. and i said that to theinterview that i was skeptical that we're going to beable to determine that some

of these materials are so muchbetter than other materials that they would bea better seller and i was misquoted on that. huh? >> i can't remember which one. >> you can't-- >> i'm the one that emailed you. >> i wanted-- oh, my god. >> i did the new yorker.

i did one in the newyorker which was a-- which i got a lot of heat for-- >> is that the oneyou sent it out? >> i don't know, maybe. i don't know. no. >> [inaudible] it said somethinghim, the skeptic, something-- >> yeah. that was theeconomist i think. >> the economist.

>> and i wasn't a skepticbut i did one for the-- i think it was the newyorker i'm not sure. and i said that years ago wheni was trying to develop a condom that makes sex better,duff gillespie was the head of the office then and hesaid, "look jeff," he said, "i don't want congress tocome beating down on us that we're tryingto make sex good." and i said, "are you kidding." i said, "every congressmanwould be thanking us."

all right. so, the next-- so,we're done with condoms, male and female condoms. so, before we end iwant to talk about-- what i have next on that list? >> permanent. >> [simultaneously] permanent. >> oh, permanent, ok. let's do permanent.

so, what we don'thave for you is -- i do not have for you afemale sterilization document. but i have sisyphus, right? vasectomy. so, did you-- doyou all have that? >> [simultaneously] yeah. >> that's a presentation i madeat-- in a gender health meeting. i was given that as the title. and the title, well, do youremember sisyphus, you know,

he push the rock up thehill and he just couldn't-- he never get it-- henever got it up the hill. and it was -- that wasthe analogy to vasectomy where we just can't seem to get too much tractionwith vasectomy. and vasectomy is amarvelous permanent method. it's much preferred interms of ease of performance than female sterilization yet it isn't the malewho gets pregnant.

so, some women are not sure that the man is really had avasectomy so we have that issue. and also vasectomy isnot 100% effective. and i've written a thing onthe gender aspects of vasectomy because if a man is vasectomized and his wife gets pregnantshe could possibly suffer from domestic or, you know, intimate partner violencebecause, i have a vasectomy and you must be sleepingwith somebody else.

so, you can't ever sayit's a hundred effective because there can bere-anastomosis which means that the cut-- vasdeferens reunites or more commonly men don'tnecessarily wait the 12 weeks it takes before it works and ifyou have sex before that period of time, you couldstill be fertile. that's a marvelouspostpartum method for limiters because there is usuallypostpartum abstinence for the same periodof time that it takes

for the vasectomy to work. so, in the piece that trishmacdonald [assumed spelling] did on postpartum familyplanning method, it was once called the call toaction, but it changed its name. we weren't allowed-- iforget what it's called. there's a document. i think we're providingit to everybody on postpartum familyplanning and in that we talk about vasectomy as a goodpostpartum method for limiters

for just, for that reason. and it's easy to perform. there is a no scalpel technique. they keep saying the newno scalpel technique. that new method isabout 30 years old now. so, it isn't new, but, and it isn't nonsurgicalalthough it one thinks it is. so, rather than using a scalpelwe have sharpened hemostat that is used to puncturethe scrotum

so that you can haveaccess to the vas deferens. so, they say nonsurgical, butit isn't really nonsurgical. however, it is much lesspain and much less hematoma and less side effects thanthe standard scalpel vasectomy that was done. and for tubal ligation whichwe don't have a piece on it yet and we're going toproduce one, aren't we, kara [assumed spelling]. the interesting thingabout tubal ligation

when i first started workingin the field, everything, and this was in the70s, we were locked in at laparoscopicsterilization. and companies like karl storzwhich is a german company that makes this equipmentmade a fortune because everybody was usingthose scalpel, i'm sorry, was using these laparoscopictechniques, so you had to havea laparoscope. and we quickly learned thatwe couldn't keep them working

and they are expensive and youneeded a high level of training and spare parts were hard toget and if they weren't working, they aren't any sterilizationsand when i was at who we did a comparativetrial between nurse midwivesdoing a minilap and doctors doinglaparoscopic sterilization and the nurse midwives won out. it's so much easier,so fast, so easy to do and so minilap is themost popular technique

for tubal ligation right now. relatively easy to perform, itonly requires local anesthetic and it's, you know,highly effective method and it's the most popularmethod as i told you in the united states andseveral other countries. sterilization is thenumber one method. well, when they'resterilizing [inaudible] and use any other method and in many countriesvasectomy rates are higher

than female sterilization rates. jumping back one second,i forgot to mention to you that an iud, i want tojump back one second. i forgot to mentionppiud, postpartum iud. so, if you did an immediate postpartum insertion, it used to be that you needed a specialkind of a long forceps so then you could,you'd use a speculum and you then would insertthis thing deep to get to the fundus, immediatepostpartum.

so, you need an instrument. and our friend, paulblumenthal said, "gosh, we don't need an instrument,we just need a longer inserter. so, he had pregnamake a ppiud inserter, and i brought it with me. so, you can compare thelength of these two inserters. so here is an interval inserterand here is the ppiud inserter. so, all you need isa longer inserter and then you canjust use an inserter.

you don't need any instruments. so, pregna now makes for us, idon't know if we're buying them. >> not yet but we are hoping to. >> yeah, we've had acouple of presentations and then paul iscoming isn't it? >> when? >> in two weeks. >> ok. so, there's going tobe a presentation in ppiud. so, if you want to see that.

sorry, i forgot to mention that. i apologize. >> are the recommendationsstill like two weeks postpartum? >> no, you can do immediate. you can do immediate. you can do beforewithin 48 hours and then you wait four weeks. that's the recommendationright now. but we would like to seeimmediate, post-placental,

insertion of the, youknow, but of course you got to do counselingbefore child birth. you do it on the tableand you got to make sure that the woman has beenwell-informed and has decided to select this method. and if you haven'tdone then you wait. >> and there's nota higher chance if it's immediatelypostpartum of expulsion? >> there is a slightly higherrisk, but if it's done well,

it's minimized and again wedon't worry about expulsion as long as the woman knowsthat she is supposed look and make it hasn'tbeen expelled. ok, so, we've donewith sterilization. >> what makes minilap, mini? >> the incision. so, it's right above thepubic hair, below the belly, it's a very small incision. that's why it's mini.

>> it's that small? >> it felt like a mini cooper. >> that's small. >> it's about that wide. that's pretty small. rather than that itused to be years ago. >> yeah, but man, what was the-- >> i would say we openyou up completely. >> we do a surgical method.

it was a laparotomy. it is what's called laparotomy. you know, surgeons will openyou, open, much bigger incision. >> i don't get how it'snot a 100% effective. but what do you do andwhy is it not effective? >> depends on whatyou, well on vasectomy. >> yeah >> let's go to vasectomyfor a minute. in the united states, so, wedid a study and i was the one

who was in charge of hfr, iwas very involved with hfr and in gender health whichwas absc at that tine. during the first studywe had very poor guidance on how long do you wait aftera vasectomy to be infertile. and the guides wereall over the map. after 16 weeks, after20 ejaculations, we didn't have good data. so, we organized the studies todemonstrate what was the data and it turned outto be 12 weeks.

so, it doesn't have--nothing to do with the number of ejaculates, 12 weeks afterthe procedure you're infertile. ok. and the reasonthat it doesn't work is that what do you do whenyou expose the vas deferens? so, when a male has a vasectomy, you have to get tothe vas deferens. those are tubes thatcarry the sperm, ok. so, what do you with them? so, some people used tocut them and tie both ends.

some people usedto just cut them and tie not the end that'sclosest to the testis, but the other end becauseif you tie end closest to the testis there issomething called blow out. there is a lot ofpressure that's build up. and then when that escapesyou could possibly cause an re-anastomosis. so, they only tiedthe other end. some people cut out twocentimeters like an inch,

two and a half centimetersto an inch. some people cut outlonger distances. some people are worriedabout cutting too much because if ever had, there wasany regret and then we're going to try to reconnect them,if cut out too much, you could never do that. some people take thefascia, so that a little bit of tissue that's around thevas deferens and around-- many of your organs and theywould wrap it up and fold it

around and so they closeit and then tie it. that's interfascialposition that it's called. and then we did a study and yousaw that if you cauterize it, cauterize both ends, that'slike the most effective way, but then you need a cauteryand fhi was involved with path in making a handheldthermal cautery device. so, in the united statesbecause of litigation and people who do vasectomy do everything. they cut it, they take thefascia and they wrap it around

and they cauterize itand then they tie it. they want to do everythingin their power to minimize the likelihood thatsome men is going to come back and sue you becausethey had a vasectomy. >> had they madelike an experiment where they go irreversiblevasectomy? >> or they just like? >> we've tried. >> i think that wouldbe good to have.

>> a lot of moneyhas been spent. >> like everybody getsvasectomized and no. >> we've spent a lot ofmoney on research on looking at reversible vasectomy. >> it's very hard to do. those sperm in that organ-- vas deferens as well as the fallopiantubes, they're an organ. they're muscle, theycontract, they restrict.

and the body is madefor that sperm to get through that vas deferensand cause pregnancy. and it's how we're constructed. and the fallopian tubesare made to carry that eggs from the ostium after the eggsis released from the ovary through the tubes andget it into the uterus. of course fertilizationoccurs in the tubes. it doesn't occur in the uterus. so in the men when we try

to do all these differenttechniques nature was fighting us that we had a thing calledthe shug [assumed spelling], it was a combination of aplug and a shunt that was put into the vas deferens. and we actually had two unitsput in because one didn't work to try and make sure thesperm couldn't get around it but the sperm get around it. and if you made it bigenough to block the sperm, it usually rupturedthe vas deferens.

a very difficult task to makea reversible method and then of course, the simplestidea was wouldn't it be nice if you had a littlestopcock, no pun intended. and you put that in the vasdeferens and you can just like reach in and just turn iton and open it and close it. and that happens. but one our priorities ishighly effective nonsurgical sterilization because i believe that many more peoplewould accept sterilization

if it wasn't a surgicalprocedure. they just don't wanta surgical procedure. so we have a big nonsurgicalsterilization mandate. and in fact, there's an apsthat will go after research soon from rtu and amongstthe technologies that we're asking peopleto submit applications for will be nonsurgicalsterilization. ok. so moving right along, i want to mention acouple of other things.

i know i have some newmethods on there, right? >> implants ringand vaginal rings. >> right. so vaginal rings,who knows about vaginal rings? what's marketed right now? >> nuvaring. and do we know what it contains? >> nuvabling. >> what is it? >> what's in that,that was having this.

so i don't have anuvaring with me but i got their advertisement. >> oh, my god. >>has left the conference. >>so this is nuvaring. it's about that sizebut it's not that color. and it releases etonogestrelwhich is the same drug in implanon plusethinyl estradiol. ok? and it only lasts a month.

ok. so you need toreplace it every month. and it-- we don't have apublic sector price on it. it is not widelyavailable and you can't-- it's hard to find itin developing world. and there are some privatesector places you could find it. it's a very popular methodin the united states, lots of women like it. and, you know, it's-- vaginalrings, they release drug at a steady state andlots of people say

that it doesn't interferewith intercourse. in fact, some people sayit makes intercourse more pleasurable becauseit sort of floats and it touches spotsthat cause pleasure. so that's the only ringthat's available right now. the pop council has tworings but i'm only going to talk about-- one ofthem is progesterone only and it's for lactating women. it releases naturalhormone progesterone.

progering it's called. but the more important onthat i'm most interested in is called the cvr,contraceptive vaginal ring. it looks like thisand i will pass it around so people can feel it. and there are two implantsthat are put into that. one releases theprogestin nestorone which is a novel progestinwith some very special benefits and the other implant that goes

into that ring releasesethinyl estradiol and nestorone. the ring lasts for one yearand you wear it for three weeks and then you takeit out for one week, just like a cycle of pills. in the week that you take it out you have a breakthroughbleeding. and then, you put it back in and you wear it forthree more weeks. and then you takeit out for a week.

and it lasts for a year. so one ring gives youa year of contraception and people say do youhave to take it out? and the answer isabsolutely not. you can leave it in all the time but the pop council doesn't havethe data to support that claim. but we know with oralcontraceptives for many women, they never went to the placebo,they went from active to active to active because theydidn't want to menstruate.

and then, in the unitedstates and other countries, they sold seasonalewhich is an 84-day pill. and now in the united statesthey have a pill called lybrel which you take everydayfor 365 days. you never have apill-free interval. well, this ring was made tomimic the menstrual cycle that you wear it in three weeks and one week out,lasts for a year. so it will be theonly long-acting,

female-controlledhormonal method. so once a woman has that ifshe likes it she continues to use it, if she doesn'tlike it, she doesn't have to visit any healthcare provider to never put it back in. so we have great hope for that. the pivotal clinical trials havebeen completed for fda approval. and then, the fda requiressome additional studies because the progestinis a new chemical.

so pop council is justcompleting those studies right now and hopefully-- >> that progestinand estrogen or-- >> estrogen and progestin. >> and so that's also animmediate return to fertility? you take it out. in fact it returns thefertility so quickly that if you don't wear itproperly you'll get pregnant. so if you take it out ofbody too much, you're allowed

to take it out of yourbody for two hours a day and not affect youhormone levels. but if you take it out forlonger than that, it will. and in fact in clinical trialsthat were done, they had-- interviewing women and theyused acasi, this automatic, this assisted computerizedinterviewing technique that's used. and they found with acasi wherepeople are much more likely to tell you the truth if they'renot talking to the provider

that in almost allthe pregnancies when they interviewed women who got pregnant theyadmitted having taking it out and leaving it outlonger periods of time. >> why? do they feel it? >> they just-- no, they justdidn't put back in, in time. they just-- >> why did they take it out? like why--

>> well, you might wantto take it to wash it. you might-- when you defecate,depending on who you are and what your facilities are. there were-- most ofthe expulsions occur-- is not allowed in expulsions butmost of them occur when you're in a squatting position and ifyou defecate over a latrine, if that goes down thelatrine, you're in trouble. so, one idea is takeit out before that, so then you got toput it back in.

so, you know, there's-- butyou don't have to take it out. you never have to take it out. and some people justlike the way it feels. and you can feel it and that's,there's a lot more soft silicon in there and people, you knowpeople say that they like it and so it had a highacceptability. partners found it acceptableand we're hoping by-- would be launched in 2016. the biggest problem isit's very expensive.

and the gates foundation isgiving money to the pop council to make a cheaper version because we would neverbe able to buy that ring. it ended up being too expensive. so interesting form ofcontraception, liked by lots of people, so theother thing i wanted to show you was the silcsdiaphragm, who's heard of that? what market it has? >> one size fits all.

>> yeah and what'sthe name of it? >> caya. >> c-a-y-a. has anybody seen theadvertising on caya? how did they comeup with that name? maybe the same reason. so this is reallyunique in many respects. and the way it wasdeveloped is very unique. so we gave moneyto path who came--

they're great on design to comeup with a better diaphragm. so what they did is they tookdiaphragm users and women who were nurses who were--helped fitting diaphragms and they got them ingroups and they sort of followed icpd approach,a woman-centered approach. get women to designwhat they want. and they gave them anall flex ortho diaphragm. how many people have heardabout that, standard diaphragm? guess what, prescription only.

boy, that's a realabused product, isn't it? so if you're a diaphragmuser and you know your size. i'm a 75 millimeterdiaphragm user. my husband and i havegone away for the weekend and i forgot my diaphragm, yougo to a pharmacy and say look, i need an ortho all-flex75 millimeter diaphragm. where is your prescription? how foolish is that? well, nevertheless, thisis one-size-fits-all

so there's no fitting. so through the-- aniterative process of women saying what theylike, what they didn't and the engineers makingchanges and they went through this process fora long period of time, they also made woman's[inaudible] in a similar way but this was the first ofthose iterative processes. they came up with this design and this one-size-fits-alldiaphragm-like device has some

very unique properties. one, it doesn't looklike a standard diaphragm which is a big round, medicallooking, latex type device, even those made of silicon. this is lilac so it's alittle bit more attractive. it's also much more ergometricand it has little dimples on the sides so they can'tslip out of your hands. so there was an episodeof seinfield when elaine's diaphragmpopped out of her hand.

where'd my diaphragm go? there's also sponge worthy. that was another good episode. so, but the diaphragmflipped out of her hand and she couldn't find it. so meanwhile thesethings got little dimples so that it can't slipout of your hand. secondly, when you squeezethose dimples, it inverts. so it makes it mucheasier for insertion

which is like that, ok? there is an arrow that tellsyou which way it goes in. so there's an arrow onthe top that will tell you that it goes that way. and it has a littledimple on the bottom. so when you removeit, it's very-- you don't have to getyour hand around the ring. you can just put your handin that little dimple. so it's one-size-fitsmost, not all.

women with heavily inverteduterus would have a hard time fitting it. parity doesn't matterwhich is very interesting. and it can be providedwith a lubricant. so, it can be soldwith a spermicide. and conrad [assumedspelling] is studying it with acid form, right? >> tenofovir >> tenofovir and acid form too.

who's doing with the acid form? yes. so, if you wanted to make adual purpose method out of this, what you can do is addantiretroviral like tenofovir for which we have dataon hiv prevention. and you can also add a-- you canmake the tenofovir spermicidal. so you would have increasedthe contraceptive effectiveness with the spermicide thatwas also an anti-hiv. there's also another spermicidecalled acid form amphora which women careglobal is working on

and that could beadded to this product to make it more effective. so it's a nice product. it's been approved by the fda. it's being sold. and, you know, it'sa very nice product. another product that weworked on and i always love to use this one forthe sniff test. does anybody know whatthe sniff test is?

the sniff test isyou look at something and you go, ooh, i like it. and lots of things neverpass the sniff test. here's a product that neverpasses the sniff test. could you imagine that--using that product as a cap? it looks big andbulky and strange. and this was calledlea's shield, we helped to developed this. it's available onthe internet only.

and it's also aone-size-fits-most. and people would say, oh gosh, i would never putthat inside myself. look how bulky and hard it is. and when we did the clinicaltrial, women didn't complain at all and men didn'tcomplain at all. they did not findit uncomfortable. but it looks likesomething that you would not to be putting inside yourself.

and hence i havethat little picture. does anybody have thatpicture that i have? what is that? you want me to do-- >> so i usually-- before i showthese devices, i always show that slide because, youknow, who would want that and then another one that weworked on, it's also available for sale is called thin cap. and thin cap comes in threesizes depending on parity

and again, it's acombination of-- it's like a cervical cap witha thing that pulls it out and we're not providing them. and the inventor was amom-and-pop operation and they did a clinicaltrial with a device that did not have this on it. and then they decided theyneeded to add that later but it's not been approvedby the fda this way. it was proved without it.

so, it's another barriermethod that we worked on. so, the last thing thati will mention to you and then we can talk aboutother things if you like, is this multipurpose preventiontechnologies which i alluded to when we showed youthe silcs diaphragm. so, a big initiative inthe research division and other programs is tocome up with technologies that provide protectionagainst unintended pregnancy and other health benefits,like prevention in hiv.

so the three big prioritiesare, contraception in hiv, contraception in hsv,herpes simplex virus which is a major cofactorfor hiv acquisition and contraception in hpvhuman papillomavirus, i don't know how many ofyou know that the cause of cervical cancerwas oncogenic types of the human papillomavirus. and if you don'thave an oncogenic of the human papillomavirusyou're not going

to get cervical cancer. there is a little chance that there can be someother antecedents, and jim shelton wrote a paperon parity and cervical cancer. and he tried to control for hpv and in very high parity womenthere is cervical cancer. and i think it has to dowith damage to the cervix, but i'm not a 100 percentconvinced that is it also a type of hpv that has notyet been identified.

but there are oncogenictypes, cancer causing hpv and if we could prevent thoseyou would prevent almost certainly 99 percentof cervical cancer. so, we have thisprogram ongoing right now and there are several productsthat are in the pipeline. one of them is a vaginal ring that would containlevonorgestrel and tenofovir and another one isa vaginal ring that contains the nnrtidapivirine which is

in clinical trial right now for hiv preventionand levonorgestrel. and then the pop councilhas a ring also that's going to have miv-150 nnrtiand zinc, ok. so, we have, we have,so there's a-- we have good leads thatare being pursued right now that might affordus the opportunity of having highlyeffective contraception and hiv preventionat the same time.

the big problem onthe hiv prevention is when you use an arv basedprevention technology, it can't be over thecounter quite yet, because you wouldnot want to put that in somebodywho already has hiv. >> oh, oh, ok, ok. >> because you don'twant to cause resistance, although dr. denzil [assumedspelling] thinks is a very low incidence of resistancewith tenofovir,

it would be a good practicethat you would not give arvs for prevention to people whoare already hiv-infected, who might need to go on therapy. and we had a lot ofgood data right now on arvs for prevention. i'm sure you've readthose, the prep studies, there's a whole bunch ofstudies that came out. the big issue is,who could afford arvs and if you don't have alimited amount of arv,

they said they want touse it for treatment. so, but arvs for preventionare highly effective and we are looking at thecombination of contraception in arvs for hiv prevention andthe nice thing about tenofovir from the state that wedid the caprisa 004 trial that showed its effectivenessin preventing acquisition of hiv in high-risk women was, itcut the risk of hsv in half. so, it's effectiveagainst hsc also. so that's the story andif you have any questions,

i mean we're finishedbefore four. if you have any questionsi'd be happy to answer them. any remarks, anytechnologies you think we need? [ applause ] >> can you talk about[inaudible] or describing a lot[inaudible] concern about-- not taking certainmethods or wondering which methods will affect their[inaudible] there are materials to talk about that or?

>> no, no we don't talk aboutthat and it's very, you know, there's not a lot of gooddata on the effect of libido. there's a lot moredata on the effect of libido after pregnancy. we don't have a lotof data on libido. i know that some of the steroidsthat are used in contraception like levonorgestrelhas some androgenicity and that is good forlibido for women. >> the one that i havemostly essentially

about and [inaudible]? >> for men, so, youknow, for sex offenders and depo-provera i don'tknow if you know this or not. so the standard treatmentfor a sex offender in the united states years agowas to give them depo-provera. you give depo-provera to a man, his libido is shot,completely shot. and sex offenders weregiven depo-provera and they still sometimes use itand men will do that voluntary.

>> every three months forthe rest of their life? >> well as long youwant to cut the libido, they'll have no libido at all. >> so old men, theycan be dangerous, no? >> even as an old men, they canbe dangerous, so you're going to want to do itand so will they? >> well, well not everybodyis a sexual abuser i guess, i don't know but the depo,there is that, that's been, it's noted as one of theissues but it's very uncommon.

you should all begetting the document on contraceptivequestions and answers? >> yes i send it via-- >> contraceptive technologyquestions and answers, it's written by, i wrote it withmia foreman [assumed spelling] at prb and it goesthrough every single method and it has the most commonrumors, and what's the truth and it's a, and i think, if idon't mind saying so myself, it's very authoritativebecause i didn't do it alone,

i was the primary author. mia was the primary editor andshe did a lot of the research to get-- she helpedme because she pulled up all the most recent evidence. so, we have a goodreference library but i went to other experts. for instance, i went to chelseato help me with the chapter with the sectionon hiv acquisition and progestins, so she did that.

i had somebody else, i hadann burt [assumed spelling] from hopkins who iwork very closely with, pull up the mostrecent data on cancer. so, it's, you know,there is this issue about depo and breast cancer. so, i address that verycarefully and that, so i use-- i rely on other sourcesto help me with writing the bestpossible response we can write. so i think it's veryuseful and i've given it

in journalist trainings thati've been involved in with prb and i did it in addis [phonetic] at the international,were you there? did you go to addis? well at the internationalconference of [inaudible] thatwe had in addis. monica was there, you werethere you helped with the-- we did a journalisttraining and i handed it out to all these journalists.

you know, we had question andanswer with them and i went to each one of them, igave it to them and said, look when you do astory on contraception. you know, you hear all thisrumors and you want to write about it but do us a favor. when somebody tellsyou something negative, go into this littledocument and look at it before you writeyour paper and make sure that you're not fosteringa myth.

ok, well thank you all. no they're all gone. they all disappeared ages ago. >> does anybody havea-- any questions? >> yes, this is anncan i ask, is it ok? >> yes, sure. >> so going on this whole ideaof rumors and provider bias, jeff do you have any suggestionsfor kind of how to combat, at the country level,what we could do

to combat provider bias,particularly for methods, long lasting permanentmethods for use. and i know that, you know, andso since we had kind of thought about this contraceptiveroad show, working through ob-gynsocieties, nurse, midwifery associations but, doyou have any kind of suggestion for interventions thatwe can do to, you know, combat some of thesemisconceptions. i know that also in some caseswe had a thing like, if you had,

your tubes tied you turnedinto a sex maniac, you know, it's the opposite ofreduced libido but, you know. so any suggestions on combatingprovider bias and misconception? >> well on that last one iwant to tell you something, there's a littlebit of truth in it, you don't become a sexmaniac, but the fact is when people don't fearunintended pregnancy they report more satisfaction insex because of the-- for many women the fear

of having an unintendedpregnancy really impacts sexual satisfaction. so, when they're gettinghighly-effective contraception, particularly sterilization,they -- both men and womenreport better sex lives because they're not worriedabout having a pregnancy. but i think you've answered someof them, professional societies but i think it's training, ithink it's provider training and i think it's, you know,and working with journalist

at the country levelto get out the truth. it's very hard toovercome these issues. iuds are a perfect example. i was invited tomalawi years ago after fhi completed theirtrials on hiv and iuds and the mission staff then werejoan larosa [assumed spelling] and i forgot the otherone's name, andrews, lynd andrews [assumed spelling]. they were both there and theysaid, look, will you speak--

we're going to organizesomething with the ministry of health and we're goingto bring in all the doctors in lilongwe, canyou do a seminar? and go over contraceptiontechnology and include iuds. we really want toincrease iud use. so, we presented there so, igot all the late-breaking data on iuds and i focused mypresentation on all methods but i focused on the iud andpopped the myth on hiv and stis and causing infertility.

and i provided all thedata to all these doctors and when they wereall done, they said, tell us about implants. they couldn't care less. they'd already hadtheir minds made up. they didn't want iuds andmy evidence wasn't going to do anything tochange their views. they just had a biasagainst iuds. so, i think, you know,getting good news, you know,

in the country work withjournalists who are reporting. you know, prbs and allthese journalist trainings. so we had the names ofjournalists in countries. fhis and journalist trainingand we've got to work with the journalistswho are writing in the papers thatare being read. there's a very popular magazine in latin americacalled paraty, for you. and it's read throughout-- yearsago i was involved with them

to get articles inparaty about contraception because all the latin americanwomen, you probably read it, no? yes, so, they will allread this thing, so, let's get good articles there because they're notreading medical journals, they're reading theselocal magazines. >> right, ok, thank you. >> thank you everybody. >> thanks jeff.

>> you're welcome, thank you. >> thanks.