The Ringlets, NuvaRing and dive-sex

The vaginal ring, NuvaRing, and its packaging

The Ringlets: A group of UNLV women graduate students in their mid 20s calling themselves the Ringlets because they all use NuvaRing have recently become interested in dive-sex. Having heard about me from Taryn’s friend they asked me for guidance in becoming sexually active underwater. Along with their boyfriends they have rented a live-aboard dive boat in Cancun for the holidays and needed basic contraceptive barrier (gas-guard) skills and necessary supplies. I’ve been talking to them about getting copper IUDs, but at this point it’s too late to change contraceptive methods before their trip. That’s because unless there is a serious problem with her current birth control it’s not a good idea to change methods just before a woman expects to have a high level of sexual activity. So since they all have been on NuvaRing for several years and none is experiencing any problem with it they should be ok.

NuvaRing description: NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a nonbiodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel and an estrogen, ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing® is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7mg ethinyl estradiol. NuvaRing is latex-free. NuvaRing® has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. [From the NuvaRing prescribing information at: http://www.spfiles.com/pinuvaring.pdf ]

Fitting the Ringlets: In addition to needing a gas-guard for upper reproductive tract protection - in case the vagina floods during submerged penetrative sex – a NuvaRing user needs something to prevent her ring from being hooked and pulled out by a partner’s penis as he withdraws after ejaculation while she is in the water. Having a ring pulled out is not uncommon especially if the man is well endowed and it is easily found in the bed clothes or in the car after vanilla sex. However having a ring pulled out while the woman is swimming is a different matter entirely. Submerged couples minds are often on air consumption and other things after the ecstasy of an underwater orgasm so a missing ring is easy to overlook and if noticed at all difficult to find afterward on the bottom of a pool and impossible in open water. So a diaphragm is a form of ring insurance for those women who don’t want to remove NuvaRing before a dive. There is a three hour maximum interval that the ring can be out w/o decreasing the effectiveness of the wearer’s protection. However there is very little privacy on a live-aboard for women to remove and insert their rings before and after dives, so wearing their rings under an Omniflex is becoming a popular alternative.

The diaphragm make and rim style I fitted the girls with was the Cooper Surgical Milex wide seal Omniflex (coil spring) rim. That was because they are all young with good vaginal muscle tone and all wear 70mm or 75mm diameter diaphragms which are large enough that the ring can safely and comfortably fit in the dome and the wide lip or flange around the inner edge of the rim helps hold the ring inside the dome. In addition I recommended that the Ringlets each take a spare ring and got them all two 12 applicator boxes of 10 ml DiveGel prefilled disposable applicators as well as a box each of FC2 condoms. A very good article (below) from Marie Claire earlier this year discusses NuvaRing and the possible adverse side effects of etonogestrel, a metabolite of desogestrel, used in it. The tips at the end of the article about clot control for women on the pill are particularly valuable.

Marie Claire
May 24, 2011
http://www.marieclaire.com/health-fitness/news/birth-control-safety
By Laura Beil

Is Your Birth Control as Safe as You Think?

Since NuvaRing hit the market, more than 700 women have filed lawsuits, claiming it has caused potentially life-threatening blood clots. The battle may change the way millions of women prevent pregnancy.

Christen Childs woke up on September 12, 2009, in the pitch dark of early morning with what she thought was a pulled muscle in her leg. She reached down to massage the cramp, trying to fathom how her left calf could be so achingly sore when she hadn't made it to the gym in weeks. This was a Saturday — by Monday, her leg was swollen and hot, and when she tried to stand, jolts of pain shot up to her spine. She consulted her brother-in-law, a doctor, and he told her to go to the ER immediately. He suspected what an ultrasound would confirm: Childs, 26, had a blood clot in her leg — left untreated, it could kill her. "When the doctor diagnosed me, I started crying," she says. "I was stunned by how close I had come to dying."

Death would come closer still. Later that day, the clot broke apart and traveled to her lungs. Straining to breathe, she remained bedridden in the intensive-care unit as blood thinners were injected into her stomach four times a day for six days. By the following weekend, she was released, instructed to return weekly for hematology checks to make sure new clots hadn't formed. Meanwhile, her doctors ran a battery of tests to figure out what exactly went wrong. After all, Childs didn't have any of the risk factors associated with blood clots: She didn't smoke, wasn't overweight, and had no family history of clots. After six months on blood thinners, Childs was finally back to her old self, with one exception: Her doctors wouldn't let her go back on NuvaRing, her birth control, which they determined was the likely culprit behind her near-fatal illness.

NuvaRing is one of the world's most popular forms of non-pill birth control, and recent data indicates that more than 5.5 million prescriptions were written in the U.S. in 2010, according to IMS Health, a health-care information company. But in recent years, serious questions have arisen concerning its safety. To date, almost 1,000 cases of possible NuvaRing-related blood clots have been reported to the FDA, and more than 700 women in the U.S. are currently suing Merck, NuvaRing's manufacturer, for downplaying its health risks. Most of those lawsuits have been consolidated into a massive, multidistrict federal case that's expected to go to trial in Missouri next year. The NuvaRing case is being closely watched by physicians and the pharm industry. If the litigants persuade a jury that Merck undersold the device's risk for blood clots — a big if, to be sure — it could have far-reaching consequences for several contraceptives on the market.

• When it was approved by the FDA in 2001, NuvaRing became the world's first vaginal birth-control ring. Inserted just once a month, it dispenses hormones directly into the bloodstream. Unlike oral contraceptives, which require taking a pill the same time every day, NuvaRing is marketed as a pill-free, no-muss/no-fuss alternative. Just pop it in and forget about it (the ring remains in for three weeks and comes out for a week during your period). That pitch clearly resonated with women. Last year, NuvaRing generated $559 million in international sales for Merck.

It's worth noting that all hormonal birth control with added estrogen carries a risk of blood clots. In the 1960s, the estrogen used in the earliest pills raised the risk of clots more than nine fold. A decade later, a second generation of pills containing a much gentler dose of the hormone, coupled with the synthetic hormone progestin, had been developed. Though these second-generation pills are effective and safe, drugmakers have sought new forms to market as better able to control conditions like facial hair and acne. NuvaRing contains a version of the third-generation progestin desogestrel. There's even a fourth-generation progestin, said to alleviate symptoms of PMS; it's the essential component of Yaz and Yasmin, two top-selling oral contraceptives.

The problem? Some researchers say third- and fourth-generation contraceptives — including those containing desogestrel — raise the risk of blood clots without adding any benefit. In 2007, the consumer watchdog group Public Citizen petitioned the FDA to ban oral contraceptives containing desogestrel. Although NuvaRing wasn't named in that petition because it was still fairly new, the director of Public Citizen's Health Resource Group, Dr. Sidney Wolfe, reached an unequivocal conclusion: "We've told people not to use these drugs and have advised women that the safest contraceptives are the older, second-generation ones." The FDA didn't act on Public Citizen's claims, even though during its own review process, the agency concluded that NuvaRing's label should "clearly reflect safety concerns about an increased risk" for blood clots.

In 2009, the British Medical Journal published two investigations of desogestrel and fourth-generation progestins that seemed to bolster critics' concerns. Both studies found that women taking third- and fourth-generation pills were almost twice as likely to get a blood clot than those who took second-generation contraceptives. Frits Rosendaal, Ph.D., an epidemiologist at Leiden University Medical Center in the Netherlands who has contributed to more than a dozen scientific papers on desogestrel, coauthored one of the studies that found a higher risk for clots in NuvaRing than in second-generation birth control. "To me, it's incredible that [Merck] used desogestrel and not a second-generation progestin. Why not go for the one with the lowest risk?" says Rosendaal.

But Merck and other scientists dispute claims that NuvaRing poses a higher risk than other contraceptives. In NuvaRing's product information pamphlet, Merck acknowledges the findings, but adds, "Data from additional studies have not shown this twofold increase in risk. It is unknown if NuvaRing has a different risk of [blood clots] than second-generation oral contraceptives." That position infuriates NuvaRing's critics. "Nine years after the product was put on the market, they still say the risk is unknown. To say, 'We just don't know' is not sufficient," says Thomas Lamb, a North Carolina — based attorney whose firm represents more than 50 women around the country who have filed suit against NuvaRing, Yaz, and other third- and fourth-generation contraceptives.

Among those wanting answers is Robert Bozicev, 37, of Tom's River, New Jersey. His 32-year-old wife, Jackie, had begun using NuvaRing shortly after the birth of their daughter in 2007. One Friday morning, as he stood in the kitchen making breakfast for their two kids, he heard her puttering about in their second-floor bathroom. As she was about to step into the shower, she called his name. He answered her, preoccupied with their son, 2, who was demanding another waffle. After she cried for him a second time, barely able to get out his name, he dashed upstairs and found her on the floor, unable to breathe. "She was in a lot of pain, rolling around, trying to get onto her stomach," he says. "My son was there, watching the whole thing." To his horror, Jackie started turning blue.

When an ambulance arrived, emergency techs tried to restart her breathing. Bozicev was gripped with terror. Doctors continued to try to revive her in the hospital but eventually had to give up. She died that day. The cause of death: massive pulmonary thromboemboli due to deep vein thrombosis. In other words, she died from a blood clot. Anxious to learn more about what had happened, Bozicev searched online and came upon reports linking NuvaRing to an increased risk of clots. Knowing Jackie had been healthy before she started using the device (she wasn't overweight and didn't smoke), Bozicev concluded that NuvaRing was to blame, and filed a wrongful-death suit against Merck in March 2008. "Even to this day — and this is three and a half years later — I still can't believe it happened," he says. Jackie's clothes remain in her closet. He is too heartbroken to take them out.

NuvaRing isn't the only pill-free contraceptive beset by litigation. When Ortho Evra hit pharmacy shelves in 2002, it was the first birth-control patch of its kind. Its selling point: Simply slap a Band-Aid-like adhesive on your arm, stomach, or back each week. Within two years, sales had swelled to nearly $400 million. But soon after, studies emerged indicating that the blood concentrations of estrogen in Ortho Evra users might be much higher than previously thought, resulting in a greater risk of clots. That's when the lawsuits piled up. In November 2005, Ortho Evra, under an agreement with the FDA, added a black-box warning to its packages stating that patch users are exposed to roughly 60 percent more estrogen than the typical pill user, resulting in a potential "approximate doubling of risk of serious blood clots." The warning also stated that the risk might not increase at all, but it was still enough to scare off doctors. By year-end 2010, Ortho Evra's sales had fallen 69 percent to $124 million.

Merck, hoping to avoid a similar fallout, is standing by its product. "The decision was made to use this particular form of progestin [in Nuva Ring] because of the long history of safety and efficacy," says Dr. Michelle Vichnin, one of Merck's medical directors. When contacted by Marie Claire regarding the pending lawsuits, a Merck spokesperson stated: "The company intends to defend itself against these lawsuits." Possibly helping their case: In March 2010, researchers from the Cochrane Collaboration, a respected international organization that reviews published scientific data, analyzed 10 randomized studies of NuvaRing involving 3,000 women. They found that only two women in the study group developed clots, and one was later found to have a genetic risk.

Often lost in the discussion is just how unlikely the average healthy woman's chances of getting a blood clot are, whether she takes a second- or third-generation birth control. The risk of blood clots for women on a desogestrel-based contraceptive is about 30 out of 100,000, according to some studies — still less than half a percent. You're more likely to get struck by lightning over the course of your lifetime. And that risk is still several fold less than that of a woman who is pregnant or postpartum. Another issue undermining the claims against Merck is the scope of prior studies, which didn't look at a large enough pool of NuvaRing users, according to Dr. Andrew Kaunitz, a professor at the Department of Obstetrics & Gynecology at the University of Florida in Jacksonville. (Kaunitz consults for several pharmaceutical companies, including Merck.) To investigate the effect of something so marginal, he says, scientists need to conduct much bigger studies on women who do not have any known risk factors for clots. "When you're looking at rare events, even small biases can throw off your findings," says Kaunitz.

Larger studies are on the way. Merck is currently underwriting a massive trial of some 30,000 NuvaRing and pill users — the largest, most comprehensive study of the contraceptive to date.

The company says it expects to publicize results next year. "The study was started because we wanted to answer questions that were being discussed in the medical community," says Merck's Vichnin. Meanwhile, all eyes are on the impending litigation against fourth-generation pills like Yaz and Yasmin, also under fire for their potential blood clot risks and set to go to trial in September.

So what should NuvaRing users do in the meantime? Don't be afraid to ask your doctor questions about which birth control is right for you, given your medical history and lifestyle. There are close to 100 oral and pill-free contraceptives on the market today, yet many women take whatever their gynecologist recommends, no questions asked. Says epidemiologist Rosendaal, "It's not like there aren't options."

Clot Control

A healthy woman's risk of a blood clot increases dramatically if she takes birth control with estrogen. Here's what you need to know to diagnose and prevent a clot:

• What is a blood clot? A tiny buildup of platelets and blood plasma proteins caused by decreased blood flow to the lower extremities. Pregnancy, obesity, or being squashed like a sardine on a flight to Hong Kong all allow blood to pool, which can lead to a clot. On top of that, estrogen from oral contraceptives increases the levels of four of the blood's 12 clotting factors, making clots more likely, says Barbara Dehn, a nurse practitioner with the Women Physicians OB/GYN Medical Group in Mountain View, California.

• Telltale symptoms: Cramplike leg pain and red, swollen, or warm skin. Chest pain, shortness of breath, and heart palpitations may signal a pulmonary embolism (meaning a piece of the clot has broken off and traveled to the lungs). If you have any of these symptoms, get to the emergency room. Doctors will give you blood-thinning drugs; in an extreme emergency, you'll get an injection of a "clot-busting" drug like TPA (tissue plasminogen activator).

• Preventive measures: Drinking 8 ounces of water every two hours when on a plane will make a clot less likely. And do five minutes of toe raises or calf flexes every hour while traveling, says Dr. Mark Melrose, an emergency room physician and cofounder of Urgent Care Manhattan, a walk-in medical practice in New York. If you're pregnant or have had a clot before, wear support stockings (thick, tight panty hose that encourages circulation). And don't smoke — it increases the risk by a factor of nine, according to one study.

• Genes count. Get a "clotting workup," a blood test to detect inherited clotting disorders like factor V Leiden or a protein C or S deficiency. The conditions are rare, but if a family member has had a clot, get tested. (It costs about $200 if your insurance doesn't cover it.) Dehn recently told a patient whose sister had had a clot-related stroke to take the test before starting birth-control pills with estrogen. It turned out she had factor V Leiden, an inherited clotting disorder found in, on average, 5 percent of Caucasians; 2 percent of Latinos; and 1 percent or fewer of African-Americans, Native Americans, and Asians. She chose a different birth control, totally "blown away she could've put her life at risk," says Dehn. — Sophia Banay Moura”

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.

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.

Gardasil in the news, again

Merck's Gardasil Has Higher Rates of Fainting, Clots

The Wall Street Journal - Health
AUGUST 18, 2009, 4:15 P.M. ET
By PETER LOFTUS

“Recipients of Merck & Co.'s Gardasil cervical-cancer vaccine had higher rates of fainting and blood clots than those receiving other vaccines, but it doesn't appear to raise the risk of certain severe adverse events, according to a new safety analysis.

A separate article accompanying the safety study, published Tuesday in the Journal of the American Medical Association, criticized Merck's marketing of Gardasil, including the company's funding of education campaigns by professional medical associations, which the authors said didn't provide a balanced view of the vaccine.

The two articles add to questions about the safety, effectiveness and marketing of Gardasil, which have dogged the vaccine since its 2006 introduction.

Doctors have questioned how effectively the vaccine prevents cervical cancer, given that its regulatory approval was for protecting against two strains of human papilloma virus, or HPV, that can cause cancer, but not all cancer-causing strains. Also, the vaccine was tested in only a few hundred 11- and 12-year-old girls, which some doctors said was too small a number to declare it safe for that age group. Critics assailed Merck's efforts to get states to require HPV vaccination, a push Merck backed away from in 2007.

Gardasil sales have stalled over the past year after brisk growth initially. U.S. Gardasil sales for the first six months of 2009 declined 34% to $363 million. Merck has had a particularly tough time persuading women ages 18 to 26 to get the shot--which costs nearly $400 for the full three-dose regimen.

The shot is designed to prevent infection by some types of HPV, a sexually transmitted virus that can cause cervical cancer, rarer forms of cancer and genital warts. Merck is seeking regulatory approval to market its use in males.

The U.S. health authorities who led the safety review say the vaccine is safe, despite the higher rates of fainting and blood clots they identified. The vaccine's benefits and potential to prevent cervical cancer outweigh the risks, said Barbara Slade, the study's lead author and a medical officer in the immunization safety office of the U.S. Centers for Disease Control and Prevention.

But others urge greater caution among doctors and patients in deciding on Gardasil vaccination. Cervical cancer takes decades to develop, and there are established methods for detecting and treating it, said Charlotte Haug, editor in chief of the Journal of the Norwegian Medical Association. Ms. Haug, who wrote an accompanying editorial in this week's JAMA, called Merck's marketing for Gardasil "pushy" and "disturbing."

Researchers at the CDC and U.S. Food and Drug Administration analyzed more than 12,400 reports of adverse events following Gardasil vaccination that were filed between June 2006 through December. During this time, more than 23 million doses of Gardasil were distributed in the U.S.

About 6% of the reported events resulted in hospitalization, permanent disability or death, Dr. Slade said. This was a smaller percentage than other vaccines, and the 32 deaths weren't higher than would be expected among the vaccine's target population--females ages nine to 26. Plus, nothing suggested that Gardasil caused the deaths, Dr. Slade said.

Of nearly 1,900 reports of fainting, 200 resulted in falls that caused head injuries including fractures and dental injuries. Anxiety and pain from the shot may be causing the fainting spells, Dr. Slade said. The study's authors recommended health-care professionals keep recipients in the office for about 15 minutes after vaccination to mitigate fainting.

Blood clots were less common, occurring 56 times, according to the study. They included four deaths due to pulmonary embolisms. But the authors say the clot data should be viewed with caution because 90% of those with clots had other risk factors, such as being smokers or using oral contraceptives.

Rick Haupt, program lead for HPV vaccines at Merck's research arm, said the study supports Merck's view that Gardasil has "high efficacy" and a "favorable safety profile."

In the marketing critique, researchers from Columbia University wrote that Merck's strategy maximized the threat of cervical cancer to adolescents, minimized the sexual transmission of HPV, and "practically ignored" the sub-populations most at risk, including African Americans in the South, Latinos along the Texas-Mexico border and whites in Appalachia.

Merck, of Whitehouse Station, N.J., funded professional medical associations to help spread the word about Gardasil, including groups of gynecologists and doctors working at colleges. These groups developed lecture programs and other educational materials that, according to the Columbia researchers, "did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits."

Spokespeople for the groups say their educational campaigns were developed with no oversight from Merck, and that the information used was consistent with recommendations by health authorities.

Merck said it provided about $750,000 to the three groups highlighted in the JAMA article to help improve understanding of HPV. Also, Mr. Haupt said, Merck's marketing focused on cervical cancer because two HPV types targeted by the vaccine are believed to cause about 70% of all cervical-cancer cases, and health authorities believe routine vaccination of adolescent girls will prevent many cases.”

Personal comment: There is no evidence in this research to suggest that Gardasil is more dangerous or less effective than the initial studies suggested. I think the most criticism is coming from religious conservative individuals or groups who are uncomfortable with anything that might protect women from the danger caused by some forms of HPV. Are there effective alternatives? In some cases there are, but not from genital warts if a partner is shedding cells. Do many women still die each year from cervical cancer? Yes, because they aren’t getting routine PAPs that will pick it up in time. Gardasil has a place as an effective vaccine for young women. As I’ve posted before all the students at St Lucy’s get the Gardasil vaccine as do all my female casino performers and escorts.

Travel risks and the pill

FemCap before the removal strap is trimmed off to be used as a sports shield

Travel more than doubles risk of blood clots: study

Reuters Mon Jul 6, 2009 By Amy Norton

“NEW YORK (Reuters Health) - A study published Monday strengthens the evidence that long-distance travel can lead to potentially fatal blood clots in some people -- showing that the risk grows in tandem with the length of the trip.

In an analysis of 14 previous studies, researchers found that, in general, travel was associated with a nearly three-fold increase in the risk of venous thromboembolism (VTE) -- blood clots that form in the veins, often in the legs.

If such a clot dislodges and travels to the lungs, it can cause a potentially fatal condition called pulmonary embolism.

Several high-profile deaths have brought attention to the risk of VTE among travelers, particularly those on long-haul flights. Experts think a combination of factors -- including dehydration and hours of sitting in cramped conditions -- explains why some people develop blood clots.

However, not all studies have found a clear link between travel and VTE. To look at the discrepancy, the researchers who conducted the current review, published in the Annals of Internal Medicine, analyzed 14 studies involving more than 4,000 cases of VTE.

Some of the studies compared VTE patients with a "control" group of people who had been referred for possible VTE symptoms, but were found to not have a clot -- a comparison that carries the risk of bias because the control group likely has a higher-than-average risk of blood clots.

In other studies, the control group consisted of healthy people from the general population -- which are more likely to capture the true VTE risk associated with travel, explained lead researcher Dr. Divay Chandra of the Harvard School of Public Health in Boston.

When the researchers looked only at those studies, they found that travelers had a nearly three-fold higher risk of blood clots than non-travelers.

What's more, the risk climbed along with the duration of the trip -- rising 18 percent for every two hours of any type of travel, and by 26 percent for every two hours of air travel.

But while the current findings confirm the travel-VTE link, Chandra told Reuters Health, "there is no reason for panic" because the absolute risk to any one traveler is still low.

Still, Chandra said, "people who travel long distances should be aware of the risk of blood clots and learn to recognize the symptoms."

Symptoms of a blood clot in the leg include pain, warmth, swelling and redness in the limb. If the clot travels to the lungs, it may cause sudden shortness of breath, chest pain or a cough that produces blood.

To help reduce the risk of VTE, experts generally recommend that long-distance travelers periodically move around and stretch their legs, and drink plenty of water to stay hydrated.

Certain people are at increased risk of blood clots, Chandra noted -- including cancer patients, people who have recently had major surgery such as a joint replacement, and women on birth control pills. They may want to talk with their doctors about any precautions they should take when traveling, he said.

SOURCE: Annals of Internal Medicine, August 4, 2009.”

Personal comment: Hormonal contraceptives can have some relatively uncommon but very serious side effects. We try to discourage the use of birth control pills where possible because of the added risk of venous thromboembolism (VTE) and recommend either a GyneFix IUD or a cervical barrier for St Lucy’s students. And, as returning readers know our casino’s entertainers; dancers, escorts and intimate services providers are all fitted with GyneFix implants as well as a strapless FemCaps used as sports shields for thrust buffering and over-pressure event protection.