Three months ago, the US Department of Health & Human Services took the unprecedented step of overruling the FDA and thwarting a move to ease access to Plan B, which is also known as the morning after pill. The contraceptive is currently available only to women age 17 and older without a prescription, but behind counters. The FDA was willing to make the pill available in store aisles, which would have made it possible for younger teenage girls to purchase without assistance or a prescription.
The move, as you know, caused a fracas. The Obama administration was accused of playing politics with science and trying to appease conservative voters in a presidential election year, since some people believe that Plan B prevents a fertilized egg from implanting in the womb, and equate this with abortion. Since then, a coalition of reproductive rights advocates asked a federal judge to reopen a 2005 lawsuit that challenged FDA access restrictions but was effectively ended by the HHS decision.
Now, though, the data that the FDA reviewed use to guide its original decision has been published. And for those wondering what prompted the agency to reach its initial conclusion here are the results: There were 345 females enrolled in the study, and 279 were younger than 17. Of 340 participants who were included in the final analysis, 91.5 percent were able to appropriately determine when to use, or not use, the pill. Of the 298 who took the pill, 92.9 percent followed instructions correctly.
The bottom line: selection and correct usage were not associated with age. The authors also noted that 57 participants, or 18.8 percent, used additional emergency during the study period and seven participants, or 2.3 percent, who took the pill became pregnant. The pregnancy rate, by the way, was expected. The pill is not fool-proof, so to speak, and is known to reduce pregnancies by 89 percent, but some will occur.
"Restricting young females’ use of a single-tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access," the authors wrote. The study was supported, in part, by Teva Pharmaceuticals, which sought FDA approval to market a newer version of the pill called Plan B One Step that has a different dosing regimen, but with the same active ingredient and indication as Plan B (here is the study).
The HHS decision was "about social and political concerns. There are no medical concerns," says Cynthia Harper, who is one of the authors and an associate professor in the Dept of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco. "But I shouldn't have been surprised. I’ve been doing research on emergency contraception from the begining with first OTC application. But I was very surprised, because this was done by the Obama administration."
Just the same, she says, the data is now on the record for all to see. "As policies are made and decisions are made, the data will be there now," she tells us. "I don’t know how it'll play out, but the data will be there for people to review if policy makers do look at it again."
Meanwhile, Washington state health officials asked an appeals court to reinstate a rule requiring that pharmacists dispense emergency contraceptives even when doing so violates their religious beliefs. Last month, a federal court judge blocked the regulation and ruled the state may not force pharmacies to sell the pill or other emergency contraceptives, because the purpose of the law was to suppress religious objections by pharmacists, not to promote access to those who may want or need the pill (back story).
The law was opposed by two pharmacists, who argued the state does not have the right to compel individuals to violate their religious beliefs. But the state Department of Health and Board of Pharmacy asked the Ninth Circuit Court of Appeals to overturn the ruling. "This isn't about religious objections," a department spokesman tells Reuters. "This rule is meant to ensure that people have access to time-sensitive medications."
14 Comments
May I observe that the follow-on reasoning was that the clinical data submitted was for a diiferent formulation of PLAN B? It was for the 'two step' instead of the simgle pill formulation that was requested for OTC classification. Which may be an incorrect recollection or considered irrelevant by others, but as I recall it, TEVA made a material error of fact.
About the timing of things - the second you roll over doesn't mean squat :-):
http://answers.yahoo.com/question/index?qid=20080719180040AAr8IMP
This study looked at girls ages 11-17. Is an 11 year old considered a teenager?
Should a 10 year old be allowed to take it? How about an early developed 9 year old?
If not, why not?
Chronological age means nothing here. See the attached survey showing that some females attain menarche by age 10, and the median age of menarche has dropped markedly over the past 25 years That's why we need to introduce these contraceptives to preteenage girls.
Park your Victorian notions about morality at the doorstep. These kids are having sexual intercourse, period. Abstinence education, which I favor has been an abject failure, unless your name is Tim Tebow. We aren't going to put that bit of toothpaste back in the tube.
http://pediatrics.aappublications.org/content/111/4/844.full.pdf+html
Cut and pasted from yahoo answers that I attached since most people won't read it...."The fastest swimmers (article talking about sperm) may find the egg in as little as 45 minutes, while the slowest can take up to 12 hours. If they don't find an egg in the fallopian tubes at the time of intercourse, the sperm can wait there in a resting stage for up to 72 hours...."
@oii - I suggest you visit the site of the Ukranian girls who call their radical antics group "FEMEN" - ...filthy rich men don't all go hunting for *Lolita* with impunity like they do here in USA without the women pushing back...you do know it's the PARENTS who can be blamed for monkey-see, monkey-do behaviour...?
dz, I would argue that if middle school girls didn't dress like hookers there might be less of a "Lolita" thing going on.
OOI and DC---I am really not sure what exactly the two of you are arguing about and how it relates to plan B.
But as a parent (once upon a time) of a middle school girl, I can say: they are not trying to emulate hookers, they are responding to the powerful forces of their own puberty--hardly something that you can blame them for, even while you hope, encourage, etc. better behavior.
If you ask instead: "why do hookers dress like middle school girls?"....you might decide that has an answer.
Near as I can tell, this observation is as irrelevant to the plan B discussion as the dialogue between you and DZ, but some may find it a useful insight into human behavior.
"they are responding to the powerful forces of their own puberty". As a parent I would respond to my hormones that tell me to tell my daughter to lower her hemline, ditch the spaghetti strap halter tops, lose the makeup and the heels, etc. Maybe they will be having fewer "rainbow parties" ( you'll have to look that one up).
From the article above, "The Obama administration was accused of playing politics with science and trying to appease conservative voters in a presidential election year, since some people believe that Plan B prevents a fertilized egg from implanting in the womb, and equate this with abortion."
Only point I wanted to make is that it is a possibility that for up to 72 hours, no sperm met an egg...perhaps in the future, nanobot helmuts can be attached to each sperm and send a signal to your local congressman that mission was accomplished once it embedded in an egg - with a billion $$$ in *stimulus* funding handed over to the Brookings Institute, the new world R&D can at least *study* the possibility of equipping sperm with helmuts.
FEMEN chant, "Ukrainia is not a bordello!".
Monkey see, monkey do...
Beyond Brilliant
Plan B (levonorgesrel) blocks ovulation but also significantly thickens cervicovaginal mucosa, slowing down sperm and enhacing contraceptive efficacy. There is a period between ovulation and implantation that pretty much a Schoderinger's Cat, but if implantation has occurred, Plan B DOES NOT cause abortion. Based on some animals studies, levonorgestrel does not interfere with implantation either.
@Tim - are you suggesting that a 9 or 10 year old carry a pregnancy to term? do you think that having access to this pill will turn children into nymphomaniacs?
if yes, why so?
harpy, they may not be able to carry a pregnancy to term, but they don't know this fact without sex education. Today's 10 year old girl knows more about sex and its infinite varieties than my wife did at age 21.
Thanks, olcranky :-)
Issuing IPOs later this month to conduct initial research - maybe Brookings will buy 20,000 dollars worth - but is this announcement *insider* information or is Pharmalot public domain - can an *institution* go to jail as a person for insider info, or just a *corporation* is a person? Gets confusing, don't it?
My other idea is to have scanner codes embedded into the cash I *circulate* so that I can track the 5 bucks I gave to the Girl Scout - I can keep her records for 5 years now, no questions asked, by then the 5 dollar bill could end up in a the hands of a *terrorist* and that'll teach her to stop selling cookies....
Will only hire unemployed *whistleblowers*, btw :-)
Considering what some of the regular bloggers come out with and knowing that they ARE the *bosses* who steer the future of medical research by having the *power* to hire and fire - it's safe to say a lot of quality of life discoveries
ain't never gonna happen now :-))