Wednesday, December 14, 2011

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:

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:

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:

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:

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

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 to offer frank answers for all those questions you might be embarrassed to ask.”

The complete article can be found at:

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Powys , Wales, United Kingdom
I'm a classically trained dancer and SAB grad. A Dance Captain and go-to girl overseeing high-roller entertainment for a major casino/resort