First abortions of the school year

Oops! Guess who’s 4 days late starting her next pack of pills!

Birth control at colleges and Prep schools: Most female students still use oral contraceptives (mostly the combined, estrogen/progestin, pill) for birth control and many of them don’t take them correctly and consistently causing that method on average to be about 92% effective. We are about six weeks into the school year and are beginning to see the first of the students with unintended pregnancies come in for terminations.

Being on hormonal contraceptives takes more care than just taking a pill every day at the same time. That’s primary of course, but the pill and even implants, transdermal, and transvaginal methods, hormonal IUDs and injection methods can be compromised by other meds and supplements. There are a lot of reasons that young women don’t take their contraceptive meds as they should or take interacting meds or supplements: Lack of an effective regimen at the same time every day. Unpleasant side effects that tend to cause users to ‘forget’ to take their pills.

And things to avoid that should have been explained to them such as: weight loss pills taken to counteract the ‘freshman fifteen’ can speed the metabolism to the extent that the contraceptive hormones don’t stay long enough in the bloodstream to keep an effective level to suppress ovulation. Or taking the EC drug ella and then not using another effective method for the rest of that cycle, because the steroid in ella binds with the woman’s progestin receptors and prevents progestin from any pills taken for the next several weeks from being used by her body, leaving her open to ovulation and conception after the encounter of concern for which ella was taken had long passed. And then there is reduced effectiveness caused by some antibiotics. Or Vomiting within two hours after taking a pill and the hormones may not have been digested.

Hormonal contraceptive side effects:

Positives:

99% effective when used correctly
Regulates cycles
Decreases menstrual bleeding and discomfort
Can help clear some cases of acne 

Negative side effects for some women:

Estrogen withdrawal headaches
Vaginal dryness
Breast tenderness
Weight gain
Loss of libido
Hair loss
Depression
Small but real Increased risk of blood clots and strokes especially for Newer Progestins like etonogestrel (Nexplanon & NuvaRing) and Drospirenone (Yaz, Beyaz & generics)
Must be taken correctly, consistently and on time
Effectiveness lessened by some meds and supplements..

My Wards after school Jobs: I’m pleased that we got Bea, Cyndi and the Swan twins using GyneFix copper IUDs so they can continue to cycle while being very effectively protected from pregnancy. That way they can be as sexually active as they like with only having STIs to worry about. I’ve been able to get the twins onto the male escort trainee’s partners list so they will get the benefit of training with professionals. The wide range of escort trainee partners who are clean and frequently checked gives them a very large pool of gorgeous and very experienced men to train with just like Bea and Cyndi who are continuing to volunteer as partners to help train the escorts. Their volunteer effort is superb training for the girls as it lets them experience a wide range of male sexual techniques and they are being paid pocket money for something that they love doing.

Our termination clinic: We are seeing mostly college age girls as they are away from home and are not as closely supervised as students in female prep schools in the area, including St Lucy’s.  All so far have been either hormonal conceptive, or both condoms and hormonal contraceptive failures. From what the patients say it is the newness of their surroundings and the frantic pace of trying to be popular and do everything at once that has caused them not to put as much emphasis on contraception as they should have while sampling the physical delights that new male friends can provide. That part of our clinic is very private with individual waiting rooms (with shielded Wi-Fi for their personal electronics)  and separate entrances and exits so no one sees anyone else while arriving or leaving so the patient’s identities are protected.

At St Lucy’s we have already administered flu shots for the 2013-14 Flu season first thing if the student hadn’t already gotten one. I mention this here because many students who get Flu will try to treat it with an antibiotic retained from a bacterial illness or gotten from a friend; only to find much to their dismay that not only did the antibiotic not treat the Flu, but reduced the effectiveness of her birth control resulting in her carrying someone baby. If she is lucky she knows who’s so she can go to him for support if she wants to.

Most students seeking a termination want a vacuum aspiration.  While it is a bit uncomfortable it’s over in a half hour or so, while with Mifeprex, RU486, the process takes several days and still may require a vacuum aspiration. Too, there have been some fatalities with women using Mifeprex so it doesn’t have quite the cachet it had when first introduced several years ago.  

The swan twins and a LARC

 

A 4 bead mini GyneFix frameless copper IUD

Disclaimer: Some readers have asked me to provide medical advice. I am not a doctor.  This post does not represent and should not be considered individual medical advice.

Odette, Odile and GyneFix: Chris, our male Gyn, decided it’s best to take the swan twins off Beyaz and provide their contraceptive protection by a LARC (long acting reversible contraceptive) method, the GyneFix frameless copper IUD. An additional benefit is that it will eliminate the undesirable side effects of contraceptive hormones and with Yasmin, Yaz and Beyaz a possibly elevated potassium level. We have been closely monitoring the levels of contraceptive hormones in their bloodstreams since they joined us on Virgin Gorda and found them too low to be considered effective. And since they began their ballet training regimen which they will be on for at least the next year or two if they stay under my supervision it has dropped even lower. As returning readers may recall a 28 pill pack of Beyaz contains:

• 24 pink tablets, each containing 3 mg drospirenone, 20 mcg ethinyl estradiol (EE) as and 0.451 mg levomefolate calcium (a metabolite of vitamin B) which lowers the risk of having rare neural tube defects in a pregnancy occurring during Beyaz use or shortly after stopping
• 4 light orange tablets having no contraceptive value, each containing 0.451 mg levomefolate calcium

Low contraceptive hormone levels can usually be attributed to the woman not taking her pills correctly or taking dietary supplements or medicines that interfere with the hormones absorption into the bloodstream or vomiting within two hours after taking her pill.  The twins aren’t on interfering meds or dietary supplements, are taking their pills correctly and haven’t been vomiting so what’s left is a fast metabolism which caused the hormones to be purged from the bloodstream too quickly. I called Paul and asked if he knew anything about their high metabolic rates and he said the private school they attended in NYC mentioned that it was elevated, but their thyroids chemistry appeared to be within normal limits and that’s what their health records transferred to our clinic showed. Before someone asks I had the twins rechecked and they aren’t suffering from hyperthyroidism. They seem to have inexhaustible energy and put away quantities of food like football players w/o gaining any weight, an ability most women would kill for.

GyneFixed: The twins haven’t had any instances of breakthrough ovulation, that we know of, yet, but given their embarking on intensive sexual activity Chris feels the amounts of hormones in Beyaz are too low and with an abundance of caution he and I want them better protected w/o them taking larger amounts of hormones. We both think it better to have them use the mini-GyneFix, a frameless four button copper IUD, which is effective for at least three years. When properly inserted, the GyneFix frameless copper IUD offers several important advantages:

• High efficacy (99%)
• Efficacy does not decrease with time
• Low expulsion rate (1%)
• Reduced bleeding (4 bead GyneFix 200 Mini)
• Reduced pain complaints
• Long duration of action (3 to 5 years)

The twins were on their last pill periods so with the cervix naturally dilated a bit that was an ideal time to insert their IUDs. Chris inserted their mini-GyneFix IUDs Friday afternoon after their UNLV classes. They had taken 800 mg of Ibuprofen an hour before so after numbing them a bit he inserted Odette’s first as Odile held her hand. Then they swapped places. I went along for support, but they didn’t need me and would have done fine by themselves. I insisted on being there and I was glad I went to see how both handled the procedure. The worst part they said was when the anchoring knot was pushed into the muscle of the fundus.  They are fine and could have sex as soon as they felt able so they continued their pelvic training lessons on Saturday and they had a full weekend of energetic penetrative activity. More about that in a later post.

Coming off the pill: Taking the twins off Beyaz eliminated the likelihood of deep vein thrombosis (DVT) from the progestin drospirenone as well as avoiding the possibility of spiking potassium levels which could lead to heart problems. Having the twins begin cycling naturally again will allow them to take advantage of the burst of creativity that often accompanies a woman’s fertile interval and experience the full range of emotions due to cyclical hormonal swings.  Being off the pill should increase their vaginal secretions during arousal and they should experience a substantial increase in libido, not that they didn’t have healthy sex drives before. And by trimming off the GyneFix string as Cyndi and escorts who have IUDs as well as use cervical barriers do, they can safely wear a diaphragm or cap as flood insurance for upper reproductive tract protection during dive-sex.

The twins went on the pill at 14 to regulate their cycles and minimize their periods. Even when they switched to Beyaz they have had estrogen withdrawal headaches while taking their placebo pills and some breast pain as the estrogen from a new pack causes breast swelling both of which should disappear as their breasts decrease a bit in size. I don’t think that will be an issue since neither of the girls seems fixated on breast size and they are training to perfect their ballet bodies.  We don’t know for sure now that they are off hormones if their cycles will naturally stabilize, but we should know in about four cycles. In my case when I came off the pill it took three cycles for my cycle to return to normal. My period is relatively comfortable and I rather like the idea that bleeding is resetting my reproductive cycle to produce another egg and perhaps conceive and I hope to convince the twins to glory in their bleeding. My period is my secondary libidinal peak which is fairly common so perhaps they will have that positive experience as well.

Fellatrix class: Next week I’m going to begin the twins on a week of evening fellatio classes with some of the male escort candidates.  Not that that they had never given a blow-job, they just need practice in the nuances of the skill. Things like: massaging the frenulum with lips or tongue, collecting ejaculate in the mouth, forcing semen into his mouth during an afterglow kiss and how to force him to swallow it. It’s amazing how important it is to a man to have his partner swallow his seed, so it’s important to at least appear to enjoy swallowing regardless of the taste. Then there is the advanced course in deep-throating; how to manage the gag reflex, breathing during and how to keep semen from entering the lungs among other things

Deflowering the twins:

A fetish escort’s must-haves GM pointes and a Reflexions latex FS diaphragm

Fetish escorts: The economy is back in full swing; at least for the segment of the entertainment industry that supplies elite fetish escorts. We’ve been noticing an increase in interest in girls into kinky things at the elite level of beauty, education and physical skills and so we have revised our training program to concentrate on providing lovely well trained girls to fill that need. This means we have become even more selective in choosing fetish escort candidates. We are looking only for ballet bodies and training, both men and women. The classes will be smaller, longer and more challenging for the candidates to successfully complete, but they will be much better prepared to provide every client far more intense experiences than in the past.

Saying that I’m looking for ballet bodies doesn’t mean I’m against other body types it’s just that’s where the demand is right now. There are plenty of show-girl intimate training courses out here for statuesque generously proportioned girls, but our school isn’t one of them.

Escort training:  Odette and Odile have been to the Gyn for pelvic exams, serum pregnancy and full panel STI tests to establish a base line for their sexual health during their college years while they are in my care. They have deep post-pubic vaults and healthy and ideally positioned cervixes. In additional to sexual health the girls were given full phys exams including stress tests and echocardiograms to make sure there where no heart defects as the training can be quite stressful at times. In addition to thorough medical screening I had Gepetto’s custom shop measure the twins for Penetrator plugs that are custom fitted to each woman’s pelvic anatomy. And they have been equipped with fetish escort quality slit kits to cover almost every need.

Having successfully gotten this fat I’ve started them on some training preliminaries, like increasing the weight of their Ben Wa sets from the one inch diameter solid Pyrex glass balls weighing .65 oz each (for a total of 1.3 oz the set) that they have been using,  to one inch solid steel balls. Each one inch diameter solid surgical stainless steel ball weighs 2.307 oz. for a total of 4.6 oz when both are inserted. I call them my “McBalls”, as they are a quarter-pounder! They still wear the one inch glass balls to UNLV, but when home and for my ballet classes they wear their McBalls. Learning to pee and defecate with balls inserted is always tricky, but they mastered that challenge quickly so I’m very pleased.

I’m also pleased to say they are dropping them much less frequently than when they first got the McBalls a week ago, though they have to remove them for an hour or so occasionally to prevent severe cramping. The one inch steelies can really tighten a girl’s grip with just a few weeks of intense training and there is just a bit more maintenance with steel than glass. The balls need to be washed, dried  and coated with an intimate silicone lube (DiveGel+ in the case of the twins) before insertion (which makes them even harder to grip) to prevent the acidic vaginal pH from corroding them over time.

I’m also having them take a ninety minute ballet class 7 days a week primarily to strengthen their feet and legs for ballet-sex. Returning readers will remember that the purest form of that to my way of thinking is being penetrated from behind while sur les pointes a la seconde. Given that women in my circle typically like at least 20 – 25 minutes of foreplay and penetrative pleasure before reaching orgasm my goal is to have the twins comfortable while continuously en pointe for at least 30 minutes.   

So I’m having them wear GM pointes all the time they aren’t at UNLV and walk around sur les pointes as much as possible to strengthen and toughen their feet. They are doing that so much that I’m having them wear negative heel shoes to UNLV to keep their hamstrings stretched. Odette, the one with the submissive nature, does what I tell her to please me. Odile, the dominant and masochistic one, does what I tell her because she enjoys the discomfort and challenge. I think she is very much like me when I was her age. And of course they are wearing their 65 mm Reflexions FS cervical barriers with DiveGel+ (although they are still faithfully taking Beyaz BCPs) at all times to get used to the increased confidence wearing a cervical barrier can bring a sexually active woman. When I put them in training classes they will wear bright blue turtleneck thong-backed leos with pink tights over them to distinguish them from the IRL fetish escort trainees. That way the girls who are training to be IRL escorts will know I don’t intend the twins to hold the class back.

Deflowering the twins: I’m certain now that neither of the girls has been penetrated by a penis. They do lie to me about little things, but as yet don’t do it well enough to fool me about something as important as their virginity. Every woman remembers her first man. I was 14 and taken by a 16 y/o, another ballet student, while we were sunbathing on the roof of my dorm at ballet school in up-state NY.  So I want their experience to be safe fun and immensely pleasurable. Their pelvic exams showed no residual hymeneal tissue and there has been no discomfort when their hymeneal rings at the introitus were stretched to insert and open a speculum so there is nothing to impede a penetrating penis or even a partner inserting his or her fist. And as I’ve mentioned the girls have been inserting tampons, dildos, diaphragms, Ben Wa balls and riding a Sybian with no problems.

I hadn’t decided about which man or men would have the gift of their virginity until I realized I had the perfect man already available.  I don’t know what took me so long to realize I was right all along in leaning toward letting Chris (our male Gyn) have the pleasure and the responsibility and I knew that with all the attractive men in close proximity at UNLV I was going to have to decide soon or the girls would choose for themselves.

Chris is gentle and is an amazingly skilled lover who can determine exactly what a girl wants (or needs) and gives it to her with such energy and élan that she can hardly breathe from the strength of her orgasmic contractions. Returning readers will recall that Chris conducted the twin’s pelvic exams on Virgin Gorda and again here to establish their UNLV baseline values so they were already familiar and comfortable with him.  I’m hoping that being at UNLV will minimize the possibility of their becoming sexually fixated on Chris. I think there should be enough eligible suitors competing for their attention that they won’t develop a strong attachment to Chris as a permanent lover as Cyndi did while attending St Lucy’s, an all girls prep-school. Fortunately Cyndi has begun to outgrow her strong physical attraction to Chris, much to Chris’ and my relief. We are hoping her increasing interest in lovers other than Chris will accelerate now that she is at UNLV and has access to that pool of young attractive males.

And so it was that each of the twins was scheduled individually to see Chris today ostensibly for a re-check of their Reflexions fit and each was accompanied by one of my female security staff.  Its Labor Day here in the U.S. and UNLV is on academic recess. Chris had blocked out an hour for each exam which turned out to be just enough time. The exam rooms are soundproof and the security cam (to protect the medical staff against false charges of molestation) was on so I could watch and listen on a remote link from home. Each girl emptied her bowels and bladder before the exam began. She was tested for pregnancy as well as a finger prick to test for the progestin (drospirenone) levels to see if the contraceptive hormones were at the required level to prevent ovulation, in case he could take her bareback.  He was so gentle that before each girl realized what was happening he had her Reflections in his hand, set it in the exam tray and was so skillfully caressed the shaft of her clitoris that she was moaning and dripping wet with her labia engorged and parted before he even inserted a finger.  He asked if she wanted him to wear a condom and she murmured, “no”.  

He raised the exam table to the height of his pelvis and she guided him to her introitus. While keeping a gentle pressure from his glistening dripping glans gently against her introitus he raised the head of the table until she was sitting up and could put her arms around his back. Then had her raise her legs and swung away the stirrups and had her wrap her legs tightly around his waist locking him against her, told her to relax and asked if she was ready. She whispered in his ear, “yes”, which was easily picked up by the mike concealed in the medical lighting fixture above the table. Only then did he enter her, fully penetrating her in a single long smooth stroke that ended with his tip in her posterior fornix. She gasped in delight and he began his thrusting at a rate of about one per second.

Odette had gone first and she had been wound so tight that she began having orgasms in less than ten minutes. Once started they built to frantic G-spot orgasms where her back was arched, her contractions around his penis severe and she screamed, mewed and moaned between gasps for air as she clawed at his back with her nails. Not knowing what to expect Chris had worn a medical coat with a thick leather lining on the back to prevent his back being badly slashed by a partner in orgasmic ecstasy.   While he had scheduled an hour Odette was exhausted within half that time and fainted after her fifth major G-spot orgasm. The remainder of the time she was recovering her composure and strength to be able to be helped to the car by her minder.

Odile’s encounter with Chris this afternoon was virtually identical including her passing out after a half hour of extremely intense sexual pleasure. I think the main lesson the twins got from their virginity trysts with Chris was that men can be far, far more fun than toys, but there can be complications involved. Odile too is a slasher during orgasms so both girls should wear gloves when with a lover whose back is unprotected unless she intends to cut him up. So that’s another Item I can cross off my to-do list and can sleep well knowing that the Swan Twins have been introduced to the very best in heterosexual sex.

Fundamentals of Dive-Sex class, latex-grab

His condom burst! I’m fertile! I am SO fucked!

Casino dive-moms: Several women working in our casinos came to me asking that I teach a ‘Fundamentals of Dive-Sex’ course during spring break because they have daughters who will be taking courses at the University of Hawaii in Honolulu this summer and want to ensure they know how to protect themselves during an underwater sexual encounter. West coast girls have been taking summer courses at UH almost forever, but until recently there didn’t appear to be a need for gas-guards as underwater intercourse was fairly rare and if there were serious injuries none seemed to make the headlines. The students I taught will be at the University of Hawaii Manoa campus on the north side of H1 inland from Waikiki, but can easily get to the outer islands on weekend trips.

The Fundamentals of Dive-Sex course I taught included: Being fitted for FemCaps or Reflections flat spring latex diaphragms for use as gas-guards or as one student called her FemCap ‘Flood Insurance’, since its needed to prevent water being forced into the uterus if the vagina floods which, as returning readers know, is very common during underwater penetrative sex. I taught how to correctly insert their gas-guards, what lubricants to use and how to apply them and the use of Ben Wa balls for pelvic muscle toning. All the girls were on Yaz or Beyaz so I didn’t stress the normal need to use a spermicide with their cervical barriers, but they will be using DiveGel+ as their lube which has the O9 spermicide Semécide in it so that was covered. I also taught how to use the FC2 female condom – correct insertion technique and to make sure he reenters inside the sheath if he slips out - if for some reason they couldn’t use their cervical barriers for an underwater encounter.

Latex-Grab: Lastly I taught the girls about latex-grab. That’s where, if both partners are wearing barriers, a lot of their natural lubricant is trapped within each barrier and that is especially true for diaphragms since they cover almost the entire anterior wall of the vagina. An additional complication is if the woman is also on hormonal contraceptives. The progestin in hormonal birth control can dry up the normal vaginal lubricant for some women so that even when aroused they are relatively dry. In addition to the pain involved in having sex while not sufficiently lubricated, a potentially more serious problem is that the friction of the condom tip on the dome of the diaphragm can cause the condom to burst or pull the diaphragm off the cervix leaving her unprotected, or both. Latex-grab is particularly common when a couple is using both a latex condom and latex diaphragm though it can also occur with silicone diaphragms and polyurethane condoms.

The supplies: I provided each student with the necessary supplies for the course as well as what each should need for summer school. They were: a primary cervical barrier either the Reflexions latex flat spring diaphragm (because it is especially difficult to under-thrust) or a FemCap; two 25 count boxes of prefilled 10ml DiveGel+ disposable applicators; two doses of Plan B One-Step in case she forgets to take her pills. Plan B is better in their case since they will need to continue taking their regular birth control pills; a package of 10 FC2 female condoms, which are about $.90 each through our clinic. And since the students are dependents of casino employees they are covered under the casino’s reproductive health care insurance so they could be enrolled in the clinical trial to use DiveGel+.; and finally for the class each student was provided a set of (two individual) one inch diameter .6 oz Pyrex glass vaginal training balls.

Several needed to be SCUBA certified first and the five that ended up in the class I taught were very highly motivated and worked hard to get the technique down correctly so that if necessary they could teach their partners what they needed to get the most from the experience. It’s so nice when I’m working with highly motivated young women. The First summer session at UH Manoa is May 21 – June 29, and the second session July 2 – Aug 10, 2012 and my Vegas girls will stay for both sessions.

Label change for birth control pills containing Drospirenone: Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

“FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The full Safety Alert can be found HERE

The FDA Approved Oral Contraceptives containing Drospirenone are:

Drospirenone and ethinyl estradiol: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Ocella: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Safyral: Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
Syeda: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Yasmin: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Zarah: Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Beyaz: Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
Drospirenone and ethinyl estradiol: Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Gianvi: Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Loryna: Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Yaz: Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Security, privacy and personal electronics

The BlackBerry Curve 8350i

Training venues and personal electronics: In the training areas (gyms, pools and encounter sallies) at St Lucy’s and our escort center as well as Adolph’s facilities (Splash, and The Lorelei) no personal electronics are allowed for security and privacy reasons. It isn’t that big a deal at St Lucy’s. Security simply put jammers in the prohibited areas, but at Splash men complained, because many had been surreptitiously taking pics of the Towel Girls with the cams on their cells. Now the guys are given a choice leave their personal electronics with security before entering the club or be banned. At The Lorelei a few business women complained, but their need for the pampering, security and erotic delights available only at TL overcame their cell phone separation anxiety. Especially when they realized they needed to be safe from being photographed in a sweat soaked leo or while mounted by a favorite stallion. How to handle member’s personal electronic use while on premises has the training/health club industry split over asking members not to use their devices and hoping for the best or to put a zero tolerance policy in place. Having decided on zero tolerance Adolph hasn’t lost any business so it was the right business decision and in the long run avoids lawsuits for invasion of privacy by means of personal electronics.

A vaginal toning program at Splash: In keeping with well known Germanic training efficiency Splash has started a vaginal training program for all the Towel-Girls. The girls call it ‘very tight pussy’ training and it had been available as a training option for about a year, but was found to be so effective that it has been made mandatory. I think it was a good idea because it will standardize the intensity of the experience clients should expect to get at Splash. And for what they are charged that’s a very good thing! Inga was to teach the course and use training balls, Ben W sets, and Kegel trainers in addition to other devices to tighten and measure the strength of vaginal muscles.

However, since Inga’s death [For more about that see my December 18, 2011post entitled: Breeding diaphragms and ‘death rubber’] Abi, manager of Adolph’s Spa, The Lorelei, will be teaching the course until he can find a replacement for Inga. Most of the methods and equipment are the same as those I’ve been using to train escorts as well as my circle of friends who wanted to be able to ripple grip a partner to orgasm in spite of any attempt on his part to prevent ejaculation.

Of course, that’s why Cyndi progressed so rapidly up through the ranks of the Towel-Girls despite her youth and relative inexperience. Her apparent youth (though she is well over the age of consent in Nevada) her seeming innocence and the skill with which she uses her unbelievably strong vaginal muscles make her the most sought-after TG for servicing diving and breeding fetishists and the envy of the other girls.

FROM A SOURCE YOU CAN TRUST … NOT!

Saudi Gazette
December 19, 2011
By Mohannad Sharawi

Birth control pills are 99% safe: Doctors

“JEDDAH – Birth control pills are safe and do not cause medical complications such as blood clots and infertility, according to doctors who attended a medical seminar here recently.

Dr. Hisham Arab, secretary general of the Saudi Obstetrics and Gynecology Society (SOGS), said that studies conducted over the last six months by the Saudi Food and Drug Authority (SFDA) showed that there is no relationship between the pills and blood clots. He added that other family planning pills on the Saudi market are also safe.

Dr. Abdul Hafiz Khoja, a family medicine consultant, said rumors about the safety of certain products were the result of a “dirty trade war” between rival pharmaceutical companies.

Khoja said that SOGS had recently issued a medical bulletin to all obstetricians and gynecologists in the Kingdom confirming the integrity of such pills and outlining supporting scientific evidence.

“All the latest experiments and research conducted by many research centers and scientific bodies around the world have revealed and confirmed that family planning pills are 99.99 percent safe. These medicines are also known to prevent women from contracting some diseases especially cancer.”

Khoja said that research from the American Food and Drug Administration (FDA) showed that these pills are safer than other forms of contraception such as intrauterine devices (IUD) and injections. The FDA also rejected rumors that using such pills for long periods may cause infertility.

Dr. E’etedal Idrees, a faculty member at Dar Al-Hekma College, said the medical rumors are dangerous. “We should verify the news we receive from unknown sources especially from the Internet.”

He said that he tested birth controls pills such as Jasmine and found it to be safe. “I also talked to the SFDA here and asked them if they ordered the withdrawal of such pills from the Saudi market. Their response was negative.” ”

Personal Comment: This was written after the publicity in mid December when an FDA review board recommended stronger warnings on oral contraceptives containing the progestin drospirenone and on Ortho Evra, the Patch. It puts a different spin on the fact that an estimated 10 in 10,000 women will have a serious adverse event while taking pills containing Drospirenone. You have to love the male dominated society’s arrogant certainty in the opening sentence, even though it’s stretching the truth. There is a small (but absolute) increase in blood clots associated with all combined (estrogen/progestin) contraceptives and the risk with some progestins, like drospirenone, is greater than with others.

Edited on January 15th to reply to comment: First, Google/Blogger has (again) inserted bugs into the system while trying to introduce the Two Level comments feature, which in their wisdom they’ve made mandatory! Apparently the coders don't have the time to thoroughly test such a complicated feature before deploying it... Sigh! I hadn't opted to use 2-level, but I seem to have been caught in the process of trying to fix the initial problem so I'm locked out of replying to comments posted to blog entries, at least for now. So until the problem is fixed I'll be replying to comments as an edit, unless that gets fucked up too...

No Christmas tour, FDA activity and BVI vacation

The Ortho Evra birth control patch

There will be no hospital tours this year: I’m sorry to say that changes in hospital administration have made it impossible for me to take a few of my dancers to give intimate performances at military hospitals for wounded service personnel this year. We were fortunate to have been able to tour hospitals for the last few years to add a little spicy holiday cheer to the recuperating veteran’s lives. I was hoping our tour would become a holiday tradition, but I guess not.

Christmas on Virgin Gorda: Anya, Cyndi and I along with our boyfriends are going to my place on Virgin Gorda for the holidays. But first there will be a quick trip to see Taryn in Cambridge and go to Stonehenge for the Winter Solstice on Thursday December 22nd. Cyndi has never been to a Winter Solstice celebration at Stonehenge and she is looking forward to that as well as seeing the Duchess, her grandmother, again and we are all looking forward to swimming with the dolphins if a pod is in the cove this year. My ballet company is well into our Christmas performances and since St Lucy’s is on holiday for several weeks it’s given me the flexibility to take some time off. Having penetrative sex at Stonehenge during the Winter Solstice isn’t for sissies, especially if the weather is bad, but it is a huge thrill to be that much in tune with the Druid Gods if things go well.

Recent FDA activity: Recommendations have been made concerning Ortho Evra and BCPs containing Drospirenone. Neither of which is a surprise. While the risk of serious side effects is greater when using these hormonal methods it isn’t at a level that would cause them to be banned. The decision to deny off-the-shelf availability of Plan B to teens under the age of 17 is not surprising either. While making Plan B available to younger girls has merit I think HHS is picking its battles giving first priority to getting Catholic institutions to provide employees with birth control in their health insurance policies. HHS/FDA can always come back later and approve sale of Plan B to girls younger than 17.

FDA Panel Says Ortho Evra (the patch) Benefits Outweigh Risks: 12/10/2011 RTTNews – “Reports in the media Friday said Johnson & Johnson (JNJ)'s Ortho Evra birth control patch was determined by an FDA Advisory panel to provide benefits that outweighed the risk of blood clotting. The advice is not binding on the FDA. The Reproductive and drug safety advisory panel voted 19-5 in favor of the benefits of the patch. Panelists voted 20-3 with one abstention that the drug label is inadequate.” The complete article can be found at:
http://www.rttnews.com/Content/BiotechStory.aspx?Id=1778819&Category=FDAPanel

FDA advisors recommend increasing warning label info on Yaz, Yasmin: (Reuters) Thu Dec 8, 2011 - U.S. health advisers recommended a revision of labels for the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots. .” The full article can be seen at: http://www.reuters.com/article/2011/12/09/us-fda-birthcontrol-idUSTRE7B72KX20111209

HHS blocks sale of Plan B to teens 16 and younger w/o an Rx: Bloomberg - Dec 7, 2011 “Teva Pharmaceutical Industries Ltd. (TEVA) failed to win U.S. clearance for the first over-the-counter emergency contraceptive after an Obama Cabinet member overruled the head of the Food and Drug Administration on the issue.

Secretary of Health and Human Services Kathleen Sebelius ordered Margaret Hamburg, the FDA chief, to reject the application by Petach Tikva, Israel-based Teva, citing potential sales to girls under age 17. Hamburg, in a statement, said she was ready to approve over-the-counter sales based on “well- supported” and “science-based evidence.” The FDA said it’s the first time the HHS has reversed one of its decisions.

The product, called Plan B One-Step, reduces pregnancy risk if taken within three days of sex. As a result of Sebelius’s order, it will continue to be kept behind pharmacy counters and sold without prescription only to women 17 and older. Younger girls may obtain the drug with a doctor’s order.” The full article can be seen at:
http://www.bloomberg.com/news/2011-12-07/fda-rejects-over-the-counter-plan-b-birth-control-pill-for-girls-under-17.html

U.S. focus on birth control may raise new concerns: WASHINGTON Sun Dec 11, 2011 (Reuters) – “A ruling last week on the morning-after pill, as well as government recommendations on new forms of birth control, could have long-lasting effects on women's perceptions of its safety, health experts say. Last Wednesday, the health secretary for the first time overruled government scientists, refusing to make the morning--after pill available to users of all ages without a prescription.

In the days that followed, advisers to the Food and Drug Administration recommended revised labels on the best-selling class of birth control pills, as well as for a contraceptive patch, to better convey their higher risk of blood clots. Some women's advocacy groups worried the negative attention on the blood clot risk of a new generation of pills that contain drospirenone -- including Bayer AG's popular Yaz and Yasmin -- would create concerns about birth control in general.” The full article can be read at: http://www.reuters.com/article/2011/12/11/us-fda-birth-idUSTRE7BA0P820111211

Personal comment: I’m not sure that this sort of publicity will substantially affect the sale of combined drospirenone oral contraceptives. In Europe it’s been known that there was a higher incidence of blood clots for years and sales continue strong. Knowing that drospirenone pills cause 10 adverse events in 10,000 women Vs 6 adverse events in 10,000 for pills made with other progestins doesn’t seem to be that serious, unless you are one of the additional four.

On the other hand, the sale of Ortho Evra has declined considerably since it was determined several years ago that there was an average of 60% more estrogen in an Ortho Evra patient than if they were taking an oral contraceptive with 35mcg of estrogen per pill. From what Ex-patch users tell me it is the high average level of estrogen which cause swollen painful breasts and heavier periods that have caused women to come off or avoid Ortho Evra since there are so many combined pills now available that have 20mcg of estrogen or less per pill.

Too much information? Birth control choices abound

By LAURAN NEERGAARD
Monday - 12/12/2011
AP Medical Writer

“WASHINGTON (AP) - Worried about birth control in light of headlines about side effects from Yaz and the patch? Women have a lot of options that are safe and effective, including some that are even more reliable.

You can choose a contraceptive that's used daily, weekly, monthly, once every three months, once every three years, even once a decade.

Yet almost half of U.S. pregnancies are unintended _ and experts say confusion and uncertainty despite all the options is a big reason.

"We have a whole generation now of young adults, the vast majority of whom are sexually active, who are in a fog about modern contraception," says Sarah Brown of the National Campaign to Prevent Teen and Unplanned Pregnancy. "They don't know enough to make a reasonable choice."

Indeed, in a recent survey, the campaign found 42 percent of unmarried 18- to 29-year-olds said they knew little about birth control pills and two-thirds knew little about even more effective long-lasting contraceptives. A third said they believe there's a good contraceptive for their personal needs but they don't know which one.

To help, her center just opened a novel website www.bedsider.org to offer frank answers for all those questions you might be embarrassed to ask.”

The complete article can be found at: http://www.wtop.com/?nid=267&sid=2667081&pid=0&page=2

Increased clot risk for some hormonal birth control

Yaz birth control pills

FDA Details Clot Risk for Birth Control Products
By John Gever, Senior Editor, MedPage Today
Published: October 27, 2011

“Worrisome increases in thrombotic risk associated with hormonal contraceptives are not limited to those containing drospirenone, according to an FDA report issued Thursday.
Compared with hormonal contraceptives with relatively low estrogen doses, norelgestromin/ethinyl estradiol transdermal patch and etonogestrel/estradiol vaginal ring products were both associated with increased risk for venous thromboembolism (VTE), as were birth control pills containing drospirenone, according to the retrospective database analysis.

FDA researchers ran the analysis on records maintained by Kaiser Permanente for members in California and state Medicaid programs in Tennessee and Washington, covering a total of more than 835,000 women who received contraceptive prescriptions from 2001 to 2007.

After adjusting for demographic and other factors, the analysis indicated the following relative risks, with low-estrogen hormonal contraceptives as the reference:

• Drospirenone products: 1.74 (95% CI 1.42 to 2.14)

• Norelgestromin/ethinyl estradiol transdermal patch: 1.55 (95% CI 1.17 to 2.07)

• Etonogestrel/estradiol vaginal ring: 1.56 (95% CI 1.02 to 2.37)

Younger women (those up to age 34) appeared to be at higher risk for VTE for all three product types, the study showed.

And the clotting risk was not limited to VTE -- arterial thromboembolism was significantly increased among women 35 and older taking drospirenone products for the first time.

Thrombosis has long been a concern for hormonal contraceptives of all types and doses. But a number of studies have suggested that the risk differs among the multitude of product types now available.

Drospirenone came into the FDA's crosshairs earlier this year when two studies found that the VTE risk was doubled or tripled relative to levonorgestrel-containing pills.
Previous studies had also identified possible increases in risk associated with the patch and vaginal ring products, although the FDA had not formally announced a safety review, as it had done for the drospirenone products.

All of the previous studies were relatively small and fell short of the quality needed to form the basis for regulatory action, the FDA indicated.

Late last month, after reviewing the preliminary data from the Kaiser/Medicaid analysis, the agency said it still had not reached a conclusion about the degree of risk. That remains the case, according to the FDA this week.

It plans to present all the data to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting on Dec. 8.”

Personal comment: Birth-control pills that contain drospirenone include Bayer's Yaz, Yasmin, Beyaz, Safyral; Sandoz's Syeda and Loryna; as well as Barr Laboratories' Ocella, Watson Pharmaceuticals' Zarah and Teva Pharmaceuticals' Loryna. Etonogestrel is also used in the single rod implant Implanon.

It will be interesting to see what the FDA decides because they have known about the problems with Ortho Evra (the patch) – because of the much higher average estrogen dose - for years and have done nothing more than require warning labels for the product.

Size matters

An anxious student’s first look at her trainer’s equipment

Cosplay with latex hoods and ball gags: The UNLV Cosplay group is starting a project to play at being kinky escorts to service boyfriends, so Taryn’s friend asked if I would provide technical assistance and training. There is no money in that for me, but it gives me an opportunity to scout the sorority women for possible candidates as escorts. It’s a way for an attractive and adventuresome student to make money if she has talent and can get with a good service. However, with the economy like it is the competition for the available opportunities is brutal.

Anyway, the sorority girls wanted to learn about some basic D/S lifestyle clothing so they could get familiar with and dressing in BDSM gear for role-play, but found that hoods and ball gags caused some members problems. The compression and sensory deprivation aspects of tight latex hoods freaked out some girls and some didn’t like wearing ball-gags because they would appear too subservient (which is exactly what wearing a ball-gag is supposed to do) and minimize the noise if they scream when a well hung instructor/Dom rammed their cervix. Those who couldn’t tolerate hoods and ball-gags were dropped from participation immediately as they would never be able to stand more restrictive equipment like catsuits and ballet-boots.

I think some of them just fantasized about being BDSM submissives – none have the perspective or drive to be Dommes - and so when they had a an opportunity to experience a bit of D/S lifestyle reality they didn’t like the smell of sweaty latex and the taste of a ball-gag and the work to get in and out of the latex suits. You have to be a fetishist, at least to some extent to enjoy wearing latex even though you may be doing it to get a specific man’s attention. So I set up a scenario for the remaining six girls who wanted to wear latex catsuit. It was that that they were being accepted for training as escorts. It starts with an actual and very thorough pelvic exam and a full STI panel to make sure they were healthy and capable of taking at least an eight inch penis before I let them play with some of the casinos well endowed male escort trainers. I know most of sorority girls recently had full STI panels, but I wanted to see the results of our tests to ensure they were still clean.

Rebreather bags & asphyxia: My Advanced Sexual Techniques class at St Lucy’s is having latex rebreather bags fitted to their gasmasks and the FFMs they will use for dive-sex training. A fitter came on campus from Labia Labs the fetishist developmental group jointly owned by Jeff, Gepetto and me. I’ve gotten permission from St Lucy’s board to use Labia Labs even though I have a financial interest in it because they are the only BDSM development shop for creative design of BDSM clothing and equipment, among other things. They will periodically ask for audits of expenses which the Labs comptroller is happy to provide and they even send a young female CPA over to try out some of the designs herself. I’m afraid I’ve co-opted her making a closet rubberist out of her, but that’s human nature, to seek pleasure and she seems to have found it in a latex catsuit, Ben Wa balls, hood and gasmask. I wish everyone was that easy to mind-fuck, but I’m sure she was using toys, dildos and vibis, before I took her to the next level. Now she wants to try everything we teach in AST, “to make certain the school is getting its moneys worth” she says, so who am I to complain. She audits my training classes so she can safely use the equipment and the students rather like having a young beautiful member of the schools admin taking class with them as it makes them feel more adult.

We are training the girls with RBs connected to their gasmasks first. Then when they become confident in that application we will teach them the delights of rebreather bag use during dive sex, which is more complicated. Rebreather bags can be very dangerous since they are used frequently during solo sex and it is easy to get into trouble by trying for a personal best in continuous valve closure during asphyxia play. What we advise is during solo play that the student not shut the valve sealing her rebreather, but put her finger over the vent so that if she faints her hand will drop away and the open valve will allow her to breathe fresh air. Passing out during rebreather solo play with the valve closed has led to a lot of deaths and some that should have died as they ended up in a persistent vegetative state from lack of oxygen to the brain and will be on a ventilator for ever, unless next of kin decided to turn off the ventilator.

Under water rebreather bags: Our way of using an underwater rebreather bag is different from surface rebreathing in that the bag is connected to the exhalation port on a modified FFM that has had the exhalation valve removed and replaced by one at the end of the UW rebreather bag and a manual valve beyond that which can block exhaling into the water. There is also a valve on the air hose to the second stage reg on the FFM (or for added difficulty the tank valve can be used) so that the wearer can shut off her own air.

For normal breathing the valve at the end of the rebreather bag is open so that exhaled air can be released. To activate the rebreather the valve on the end of the rebreather is closed which allows the diver’s exhalation to fill the bag. Then the wearer’s air is shut off by means of the in-line valve or the main tank valve. We prefer a trainee use the in-line valve because shutting off the tank valve prevents buoyancy control by means of inflating her BCD or drysuit a complication a rebreather student doesn’t need at first. Once there is no air through the DV the wearer sucks air from the rebreather bag and the level of carbon dioxide quickly increases to the point where clear thinking is impossible and unconsciousness is imminent. She or her dive buddy has to be ready to restore to her second stage reg before she becomes unconscious. That it’s why we recommend never having solo dive-sex with a FFM fitted with a rebreather bag. There is almost no room to recover from a breathplay mistake while wearing a rebreather bag fitted FFM.

Colored oval crotch gussets: Now that autumn is here (the autumnal equinox was on 9/23) I’m glad to be getting back into fall leggings and convertible tights. I love my custom legwear with its brightly colored oval cotton lined crotch gussets. I love flashing bystanders when I wear them under micro-minis or getting head turning looks when I wear them in the casino hallways on the way to class and rehearsals. When I go into a restaurant I just wrap a pareo around my hips and slip past the dress code, but I wear it in a way that creates a hip-slit that clearly shows my leg from the waist to toes and a flash of colored gusset when I walk. Blood red, emerald green or canary yellow are my faves for drawing attention. I coordinate the colors with red being when I’m menstrual, green when I’m fertile and yellow when I’m luteal. I often wear red satin pointes during rehearsals as well when I’m menstrual since if I’m in costume one of my stallions interested in menstrual sex may have difficulty seeing the color of my crotch gusset. I’m CD9 and fertile today so my crotch gusset is a brilliant emerald green.

Drospirenone and blood clots: The FDA has issued a safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone. The link is: http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm Of the St Lucy’s students who are on the pill the majority are on a pill containing drospirenone, Yaz or one of its generics. While we haven’t had an instance of any female at St Lucy’s having blood clots while taking birth control pills containing drospirenone we are recommending that all students whose pelvic anatomy will permit, have a GyneFix frameless IUD inserted do so because the GyneFix has virtually no side effects and a very low rate of expulsion if it is implanted correctly.

FDA alert concerning COCs and Drospirenone

Birth control pills containing the progestin Drospirenone

Tuesday, May 31, 2011 3:34 PM
From: "FDA MedWatch" fda@service.govdelivery.com

Food and Drug Administration MedWatch
FDA Safety Information and Adverse Events Reporting Program

Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots

AUDIENCE: OBGYN, Family Practice, Patient

ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available. Read the drug safety communication for more information on these studies.


BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.


RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication and Questions and Answers, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm

Personal comment: It’s been known for some time that there may be an increase in serious side effects of combined oral contraceptives (COCs) containing Drospirenone. The risk, if proven, is still slight for young women who are not overweight and don’t smoke. St Lucy’s girls taking pills containing Drospirenone have all been counseled by the school’s reproductive health staff and most plan to stay on their current pill. No St Lucy’s students have had serious side effects while on pills containing Drospirenone.

Natalie Portman pregnant by choreographer

An Ortho progestin/estrogen pill dial pack

Natalie Portman to wed `Black Swan' choreographer
Associated Press December 27, 2010

“NEW YORK - Natalie Portman is pregnant with her first child and is engaged to Benjamin Millepied, the choreographer of "Black Swan."

A publicist for Portman confirmed Monday that the couple are engaged and expecting, but declined to give any further details. People magazine first reported the news.

The 29-year-old actress and Millepied, a well-regarded ballet dancer and choreographer, met during the making of "Black Swan," Darren Aronofsky's psychological thriller that stars Portman as a ballet dancer. She's been nominated for best actress by the Golden Globes and the Screen Actors Guild.

Millepied played a small on-screen role in the film as a dancer. Portman also stars in Ivan Reitman's upcoming romantic comedy, "No Strings Attached."”

Personal Comment: There goes her figure! Sigh! Because she isn’t a dancer she doesn’t have to stay in that great shape, but still… I wonder if there was a birth control method failure or if she forgot to take her pill or was taking another medicine that reduced the effectiveness of the hormones? Because of the timing that’s what I think happened. But, perhaps not, since she is almost 30 and nearing the age where her fertility will be decreasing. Maybe they just said “let’s go w/o protection and see what happens”… you think? Apparently this time the plumbing was working just fine.

And speaking of the effectiveness of hormonal birth control, below are the results of a large study testing the effectiveness of a 24/4 dosing regimen.


Real life tests of the effectiveness of oral contraceptives

A typical monthly regimen of oral contraceptives includes 21 days of active pills -- usually containing a combination of the hormones estrogen and progesterone -- and a 7-day break of inactive sugar pills.

Oral contraceptives boast annual unintended pregnancy rates well below 1 percent -- if used correctly and consistently, that is.

But in the not-so-perfect real world, longer lasting ingredients and shorter monthly breaks between active pills could prove useful in bolstering this form of birth control, hints a new study from Germany.

A typical monthly regimen of oral contraceptives includes 21 days of active pills -- usually containing a combination of the hormones estrogen and progesterone -- and a 7-day break of inactive sugar pills. The intent is to prevent pregnancy by obstructing ovulation, or the release of an egg during a woman's monthly cycle.

"Forgetting the first active pills of a treatment cycle has the biggest impact on contraceptive failure as this time interval may allow the process that leads to ovulation to start," Dr. Jurgen Dinger of the Berlin Center for Epidemiology and Health Research told Reuters Health in an e-mail.

To test whether decreasing the pill-free interval and using hormones with a longer duration of action may help counteract this common problem, Dinger and his colleagues studied more than 52,000 U.S. women who took part in the "International Active Surveillance of Women Taking Oral Contraceptive" study.

The participants' average age was 26 years, and each had started on a new contraceptive. More than 80 percent of the women had previously taken another version of the Pill.

The researchers did not interfere with the choice of oral contraceptive, but rather categorized the women into three groups based on their new hormone regimens: 21 days of 3 milligrams of drospirenone (progesterone) plus 30 micrograms of ethinyl estradiol (estrogen); 24 days of 3 milligrams of drospirenone plus 20 micrograms of ethinyl estradiol, or another regimen.

The 21-day drospirenone regimen is currently sold under the brand name Yasmin and the 24-day regimen, with longer-lasting progesterone, is sold as Yaz. Generic versions are also available. Bayer Schering Pharma, maker of Yasmin, supported the study.

Over the course of 3 years following the women, more than 1,600 became pregnant unintentionally. About 1,400 of these contraceptive failures were due to an imperfect use of the Pill.

Unintended pregnancy rates for the 21-day and 24-day drospirenone regimens were 2.8 percent and 2.1 percent at the end of the first year, respectively, and 5.7 and 4.7 percent after the third year.

Women older than age 30 were significantly less likely than younger women to get pregnant unintentionally. Women with a college education and who had never carried a child were also less likely to become pregnant.

Obese women -- who made up nearly a quarter of the U.S. women studied -- had about a 50 percent greater risk of contraception failure after accounting for age, education level and whether or not they had prior children.

According to the researchers, under all the situations studied, the 24-day drospirenone regimen yielded more protection against pregnancy than the 21-day drospirenone regimen, as well as the other oral contraceptives.

However, compared to findings from the same study conducted in Europe, U.S. women showed an overall four-fold higher unintended pregnancy rate.

Dinger suggested that multiple factors could explain this gap in effectiveness, from higher rates of obesity in the U.S. to cultural, behavioural and genetic differences between the regions.

Dinger also noted that most programs that have tried to improve the proper use of the Pill have failed. "Our approach," he emphasized, "did not intend to investigate ways to improve compliance but to look at whether specific oral contraceptive regimens are more 'robust' against incompliance than others."

"This should not mitigate the need for good counseling of female adolescents and women intending to use the Pill," added Dinger. "A highly effective oral contraceptive regimen in conjunction with good counseling is the only way to minimize unintended pregnancies."

SOURCE: Obstetrics and Gynecology, online December 3, 2010. The full text of the article can be found at: http://journals.lww.com/greenjournal/Fulltext/2011/01000/Effectiveness_of_Oral_Contraceptive_Pills_in_a.6.aspx

Personal comment: We have known since the introduction of Yaz in the U.S. that the long half-life of drospirenone reduces the chance of breakthrough ovulation during the hormone free interval. Most students on oral contraceptives at St Lucy’s are on Yaz the 24/4 dosing regimen of 3 milligrams of drospirenone plus 20 micrograms of ethinyl estradiol. There are no obese students and roommates buddy to make sure each girl takes her pill at the same time daily. Even so there are times when a student is on meds that decrease the effectiveness of her pills and will ovulate and a few of these instances will result in the need for emergency contraception to avoid an unintended pregnancy. The availability of ella (the five-day EC pill) has increased the effectiveness of EC for St Lucy’s girls.


FDA Approves Gardasil for Prevention of Anal Cancer in Both Sexes

December 23, 2010 — FDA on Wednesday approved Merck's human papillomavirus vaccine, Gardasil, for the prevention of anal cancer in people ages nine through 26, Reuters reports. The vaccine already was approved to prevent cervical, vulvar and vaginal cancers associated with HPV for the same age group.

On Wednesday, FDA cited data showing that Gardasil was effective in a study of men who have sex with men, a group that has a higher incidence of anal cancer than other populations. The agency said the data support the vaccine's efficacy in women because the disease is the same in both sexes.

Although anal cancer is less common than most other types of cancer, with about 5,300 new U.S. cases diagnosed annually, FDA said incidence of the disease is increasing (Krauskopf, Reuters, 12/22). About 90% of anal cancers are linked with HPV, according to Dow Jones/Wall Street Journal (Solsman, Dow Jones/Wall Street Journal, 12/22).

Karen Midthun, director of FDA's Center for Biologics Evaluation and Research, said, "Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important, as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure."

As of the end of May, more than 65 million doses of Gardasil had been distributed since its 2006 approval, with sales reaching $1.1 billion as of 2009 (Reuters, 12/22). The vaccine once was expected to be a blockbuster for Merck, but sales have declined as more individuals are immunized and GlaxoSmithKline's HPV vaccine, Cervarix, provides more competition, according to Dow Jones/Wall Street Journal (Dow Jones/Wall Street Journal, 12/22).

Personal comment: Starting last year our clinic began giving Gardasil injections to male dancers and all escort candidates as an off label use to protect men from anal cancer.

Natazia/Qlaira approved by the FDA

Qlaira; estradiol valerate/dienogest tablets to be sold in the U.S as Natazia

U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
05.07.10, 08:06 AM EDT
PRNewswire

“WAYNE, N.J., May 7 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Natazia (TM) (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Natazia has not been evaluated in women with a BMI of greater than 30 kg/m(2) [the equivalent of a 5’7” woman weighing 190 lbs]. Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman's body. Natazia is expected to be available in the summer.

Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company [in the U.S.] to launch estradiol valerate together with the progestin, dienogest.

"Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center, Torrance, California. "Natazia may be a good option for women to consider when making a decision with their healthcare provider about which birth control option is right for them."

Women using COCs, including Natazia, should be strongly advised not to smoke. Smoking increases the risk of serious cardiovascular side effects from COC use. The risk increases with age and the number of cigarettes, especially in women over 35 years old.

Natazia is taken once a day. The dosing regimen consists of pills with varying doses of estradiol valerate, and estradiol valerate in combination with dienogest, for specific days of the 28-day cycle.” The text in brackets [ ] was added by me for clarification.

Personal comment: I think Natazia should be available from U.S. pharmacies some time in the 3rd quarter of this year. It comes at a good time for Bayer because Yasmin/Yaz is under pressure from lawsuits claiming injury from side effects caused by the progestin drospirenone. Qlaira became available in Europe in May of 2009. Women interested in the patient information leaflet for Natazia are (for now) being referred to the Qlaira PIL at Qlaira.

Yaz and drospirenone, Caesar’s farewell

Yaz oral contraceptive pills

latimes.com
By Tammy Worth
Special to the Los Angeles Times
April 19, 2010

Birth control pill concerns bring lawsuits but few solid answers

Yaz and Yasmin complaints focus on the synthetic progestin, drospirenone. Studies have not found an increased risk with these pills, though.

When the oral contraceptives Yasmin and Yaz came on the market in 2001 and 2006, respectively, they were thought to be safer than other birth control pills because they contained a different kind of synthetic progestin.

But in a flurry of lawsuits against the pills' maker, Bayer HealthCare, attorneys claim that the progestin contained in the pills, drospirenone, is the cause of health problems, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease.

As of mid-February, about 1,100 lawsuits had been filed in the United States against Bayer, which stands behind the safety of the pills.

Research on the issue is divided. Some studies have found drospirenone to pose no greater health risk than other birth control pills; some studies show a sixfold greater risk of getting blood clots, even in young, healthy women. More research is being performed on the safety of the contraceptives, but for now, women considering taking the pills will need to weigh the contradictory information themselves

"There is reason to be concerned, I believe, about both of them [Yaz and Yasmin]," said Dr. Sidney Wolfe, founder and director of Public Citizen's Health Research Group, a nonprofit advocacy organization based in Washington, D.C. "When evidence like that comes up, people should pay attention to it."

Oral contraceptives control unwanted pregnancies by using hormones that block ovulation.

The first of these pills, introduced in the United States in the early 1960s, contained high doses of estrogen. They were quickly found to raise the risk of stroke, blood clots and heart attacks.

Second-generation pills introduced in the 1970s contained lower amounts of estrogen combined with synthetic progestins, including one called levonorgestrel. These reduced the risk of blood clots but caused side effects such as weight gain and acne in many women.

The 1980s brought third-generation pills containing different synthetic progestins, such as one called desogestrel. These were later found to be associated with a higher risk of deep vein thrombosis and pulmonary embolism.

The fourth-generation pills — Yaz, Yasmin and Ocella, a generic version — contain estrogen and yet another progestin, drospirenone. They were created not just to prevent pregnancy but to also reduce the side effects of previous pills and to treat premenstrual dysphoric disorder (severe cases of depression, anxiety, headaches and other symptoms).

Yaz is now the No. 1-selling birth control in the United States, grossing more than $391 million in the first half of 2009, up 44% from the same time period in 2008, according to health data provider IMS Health. Bayer received a warning from the FDA last year for overstating Yaz's effectiveness in treating PMDD and acne while minimizing the risks of the medication on its website and television commercials. In response, the company altered its advertising.

Now the contraceptives are not just the subject of lawsuits, they're also under scrutiny by groups such as Public Citizen over their safety. The FDA is testing the safety of Yaz and other pills in an ongoing study.

Two 2009 reports helped raise alarms. Published in the British Medical Journal, both assessed whether drospirenone is more likely to cause blood clots than other types of synthetic progestins.

One study looked at blood clot rates in Danish women ages 15 to 49 with no history of cardiovascular disease. From 1995 to 2005, there were 4,213 cases of various kinds of blood clots including in the heart, kidney, lungs and liver, 2,045 of which occurred in users of oral contraceptives. Researchers found that pills containing the progestins desogestrel, gestodene and drospirenone (the one found in Yasmin, Yaz and Ocella) were associated with a higher risk of blood clots than those containing levonorgestrel.

A second studied more than 3,200 women from the Netherlands. In this case, participants taking birth control pills containing levonorgestrel had a four times higher risk of getting blood clots than women taking no birth control, and for other progestins the risk was higher still: 5.6 times greater for gestodene, 6.3 times greater for drospirenone and 7.3 times greater for desogestrel. The greatest risk occurred during the first three months of oral contraceptive use.

"It clearly concludes that the safest thing to do is take the older [birth control pills], not the third generation or Yaz," Wolfe said.

Public Citizen had already placed Yasmin on its "Do Not Use" list because it can raise blood potassium levels, Wolfe added.

Rose Talarico, deputy director of external product communications for Bayer, said in an e-mail that Bayer "will defend itself vigorously against these lawsuits" and that patient safety is important to the company. She said the company's drospirenone-containing oral contraceptives "are safe and effective when used according to the product labeling."

Two studies, both sponsored by Bayer, found drospirenone to be as safe as other progestins.

In one, scientists at the Center for Epidemiology and Health Research in Berlin tracked for over a year more than 58,000 European women who had been prescribed various forms of birth control pills. They concluded that there was no greater risk of mortality, cancer or cardiovascular problems from pills with drospirenone than other oral contraceptives.

In the other, i3 Drug Safety, a company that provides pharmaceutical services to drug companies, followed for seven months almost 70,000 U.S. women taking various kinds of oral contraceptives, including ones containing drospirenone. The researchers concluded that more than 9,000 women would need to take Yaz or Yasmin for one extra case of deep vein thrombosis to occur.

Attorney A.J. de Bartolomeo, a partner at the San Francisco law firm Girard Gibbs who is helping shepherd lawsuits against Bayer, said women should be warned if there is even a slightly greater risk.

"We believe it's a dangerous drug, and the most important thing here is to allow women to make an informed choice and know what the comparable risks are before they put a drug in their body," De Bartolomeo said.

As of November, the Food and Drug Administration had received reports of 993 cases of pulmonary embolism (blood clots in the lungs), 487 of deep vein thrombosis (clots in the deep veins) and 229 of other blood clots for the two medications combined.

Some physicians think the attention the medications have received serves only to frighten women.

"Patients get hurt with these types of lawsuits," said Dr. Andrew Kaunitz, a professor of obstetrics and gynecology at the University of Florida's College of Medicine who has consulted with pharmaceutical companies, including Bayer. "They get scared not only with this one pill but all types of contraceptives."

Kaunitz said all types of oral contraceptives increase the risk of blot clots three- to fourfold. But, he added, pregnancy increases the risk of blood clots six- to 10-fold. He said he wouldn't recommend patients change their pills if Yaz or Yasmin are working well for them.

Dr. Anitra Beasley, a physician at the Leadership Training Academy of Physicians for Reproductive Choice and Health and a fellow at Columbia University in New York, has been telling her patients the same thing. She said many come in with worries after seeing commercials questioning the pills' safety — and that some have stopped taking Yaz only to return with an unwanted pregnancy.

"We've got great news from the FDA, that has looked at all of these studies and assures us that the best-done study shows that the risk of clots with Yaz is not greater than on any other birth control pill," she said. "And we have read all of the same literature and have come to the same conclusions — we didn't change our practices."

Dr. Anita Nelson, a professor of obstetrics and gynecology at UCLA's David Geffen School of Medicine who serves on the advisory board of Bayer, said the litigation runs the risk of "scaring the heck out of women."

"I have noticed a pattern, that every time a method of birth control gets popular it gets sued," she said. "The same thing happened for the patch; and we lost Norplant [for the same reason] even though it was very safe and effective."

Personal comment: Yaz is the pill most often prescribed for St Lucy’s girls on hormones. Our Gyns have found that with proper screening it is as safe as other pills with older progestins and it has fewer side effects as well as decreasing severe menstrual cramps other pills hardly touch. Our screening process is very thorough and encompasses a student’s parents and grandparents as well. St Lucy’s girls haven’t had any severe side effects from taking Yaz.

Caesar’s last campaign: It’s been a sad week. I’ve had to send my male tiger, Caesar, to a wildlife sanctuary. He was such a wonderful bedmate; warm, soft and cuddly, unless he rolled over on you. For a cat his size his purr or snoring was relaxing and could put me right to sleep, even if we hadn’t had sex. In the last several months it got so that his behavior was becoming erratic. He was cranky and wouldn’t eat and snapped at his keepers and his Vet could find nothing physically wrong except old age. He was always gentle with me. Well, in the context of what a woman experiences when having an intense sexual encounter with a 300 pound tiger which at best is always risky. But the adrenaline rush when he ejaculated in me was fantastic! Afterward I was always amazed that he didn’t break my neck while thrusting into me. He was just the most amazing lover! I was fortunate to experience in real life what most women can only fantasize about.