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Plan B Completely Useless for Fat Women

November 29, 2013

Frankly Friday

Fat HealthFat News

Thanks to my Facebook feed I found this news story last night and am sharing it with you to raise the alarm: the Plan B or morning-after pill (an emergency contraceptive available over the counter at the pharmacy here in Canada, as well as the United States and Europe) is COMPLETELY INEFFECTIVE for women over 176lbs. For those of you keeping track, that’s pretty much average size for most segments of the female population ’round the world.

From Mother Jones:

The European manufacturer of an emergency contraceptive pill identical to Plan B, also known as the morning-after pill, will warn women that the drug is completely ineffective for women who weigh more than 176 pounds and begins to lose effectiveness in women who weigh more than 165 pounds … Data for the years 2007 to 2010 show the average weight of American women 20 years and older is 166.2 pounds — greater than the weight at which emergency contraceptive pills that use levonorgestrel begin to lose their effectiveness. The average weight of non-Hispanic black women aged 20 to 39 is 186 pounds, well above the weight at which these pills are completely ineffective. A CDC survey published in February found that 5.8 million American women used emergency contraceptive pills from 2006 to 2010.

My question is how the fuck do you make a pill that is completely ineffective for fat women and not realize it? Is this just a glaring example of fat bias? The thinking that fat women aren’t having sex, therefore they couldn’t possibly need emergency contraception? And the solution isn’t even to just make the dosage larger; the people behind this pill have literally NO IDEA how to fix the problem except to recommend “alternate forms of emergency contraception,” except there AREN’T ANY. If your condom breaks, you miss a pill, you’re raped or whatever, going to the pharmacy and grabbing Plan B is the ONLY WAY to prevent a pregnancy from happening. Getting an IUD inserted might work, but that’ll cost you hundreds of dollars in the US and you’ll need to make an appointment to get it done. At most, you have 72 hours post-sexy times to do that, so good luck.

I’ve used Plan B once when I was heavier than I am now. I walked to the pharmacy, grabbed the box, paid, went home, followed the instructions and had total peace of mind. Millions of women around the world have now been robbed of that peace, thanks to their size. This is completely unacceptable, but what do we DO about it? One place to start is contacting Teva Pharmaceuticals, which makes Plan B, and let them know we want and need a product that works for us. That’s money in their pocket, which is a win-win situation. It’s not enough to just change the packaging to tell us fat ladies “Sorry, this wont work for you.” Make us something that DOES work and hurry the hell up about it.

Denise Bradley
Vice President, Corporate Communications, Teva Pharmaceuticals
Email: denise.bradley@tevapharm.com
Phone: 215 591 8974

Plan B One-Step® Information Center at 1-800-330-1271.

Teva Women’s Health, Inc.
ATTN: Plan B One-Step® Marketing Team
41 Moores Road
Frazer, PA 19355-1133

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28 Comments leave one →
  1. November 29, 2013 9:34 am

    Seriously.

    I’ll send them a letter. This is ridiculous. Up till now my back-up form of BC was Plan B; our primary method has been condoms for over a year since I got my IUD removed (not doing that again, thank you very much). We’ve been talking for a while about finding another method as well and had just decided to do it when this news broke.

    Running to the doctor’s now.

  2. vesta44 permalink
    November 29, 2013 11:56 am

    What they also don’t tell you is that those birth control pills you might be taking are also less effective the more you weigh. I weighed 175 lbs when I got pregnant with my son back in 1975, in spite of taking my BC pills religiously every day. Oh, and those IUDs? They didn’t work for me when I weighed 325 lbs. I got pregnant twice with an IUD, back in 1978 and 1979, way before there was ever a Plan B – back then, Plan B was either to have the baby or have an abortion, that was it for options. Seems like those are the same options you’re going to have to choose from now if you weigh more than 165 lbs. (sarcasm) Because of course, fat women aren’t having sex, therefore they can’t get pregnant, therefore they don’t need effective birth control.(/sarcasm) For me, the only effective birth control was a tubal ligation – good thing I knew I didn’t want another child, no matter what, and that that was a viable option for me. It isn’t, not for every woman. But it was a whole ‘nother battle getting that tubal when I was single, only 25, and only had 1 child. I got the whole “But what if you get married and your husband wants more kids?” spiel. My response was that I would never marry a man who wanted kids other than the one I already had, and if any man I married happened to change his mind about that after we got married, then he could just leave and find another woman to do that for him. Considering that I didn’t get married until I was 53, I think I totally made the right decision for me.

    • Mich permalink
      December 2, 2013 2:14 am

      Your story sounds an awful lot like a friend of a friend’s. She had a kid, then got the IUD, got preg. again, and then he got “fixed” and she got preg. for a third time. After that she decided on the tube-tie. He didn’t get abortions, they kept all their babies and love each of them. But obviously these methods aren’t universally effective.

      I guess Plan B in the past meant Plan Baby.

      • December 2, 2013 9:41 pm

        You’d think in the year of our Lady 20 freakin’ 13 Plan B would no longer mean “Plan Baby”. It’s just so frustrating. SO FRUSTRATING.

  3. Kala permalink
    November 29, 2013 1:08 pm

    Clinical trials are by their nature, not done on representative populations, and it’s often not reasonable for them to do so. With a drug like Plan B, getting good data is even more difficult. It’s not like this is some blood pressure medication where you can give it to a whole lot of people with established blood pressure issues and see whether or not it works. There are far more ethical constraints in this situation and makes the design and execution of the trial very difficult. To know whether or not emergency contraception works, contraceptive failure is required, and that’s not a condition you can beset on people ethically, nor can you really plan for it in terms of demographics. It looks like the European manufacturer didn’t catch the issue either until well after the drug was on the market, supposedly because of new research done on levonorgestrel in general.

    http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf

    “Plan B One-Step was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study
    medication were included in the safety analysis: 1,379 women in the Plan B One-Step group, and 1,377 women in the Plan B group (2 doses of 0.75 mg
    levonorgestrel taken 12 hours apart). The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese,
    12% Other Asian or Black, and 34% were Caucasian in each treatment group.”

    It appears that the trial for Plan B One-Step for the US market was done primarily in China, not the US. The median Chinese woman is a whole lot smaller than 175lbs, overweight and obesity far less common there, and black women as well as women from other ethnic/racial groups are are not represented well in in trial. It doesn’t surprise me that they didn’t catch anything.

    Do I think this is something Teva needs to figure out and deal with? Absolutely, they marketed this pill to all fertile American women and it doesn’t work as advertised. But I don’t consider this some kind of purposeful negligence. And the people that worked on this pill weren’t sitting around chuckling to themselves about how fat women didn’t need emergency contraception because they don’t have sex.

    The numbers for this whole situation are kind of odd, but I think it’s just a byproduct of the analysis. There’s an emphasis on the number of 175lbs, but in terms of body composition that means wildly different things for women of different heights. If the issue with levonorgestrel has to do with body fat for example, then that approximate effectiveness weight number might be way lower for women who are very short, or way higher for women who are taller.

    About this article in general?

    There’s no way that the following statement is accurate: “For those of you keeping track, that’s pretty much average size for most segments of the female population ’round the world.” Like this is simply not a true statement, and I think it’s there for you to attempt to make the point that Plan B has been shortchanging a far larger swath of women than it actually has. 176lbs is not the average size for most segments of the female population round the world, it’s probably about the average weight for American women of reproductive age, sure. Also average is not median, so when you say average, there’s no clear meaning as to what percentage of the population the statement applies to. I think you should keep that in mind.

    • JeninCanada permalink
      November 30, 2013 11:55 am

      “But I don’t consider this some kind of purposeful negligence. And the people that worked on this pill weren’t sitting around chuckling to themselves about how fat women didn’t need emergency contraception because they don’t have sex.”

      It may not have been intentional or malicious but it’s just another example of fat bias in the medical field. When all the doctors and news outlets are screaming about an obesity epidemic, how one in three or four are obese or overweight, you’d think that they’d make sure their medication works for that large (no pun intended) segment of the population.

      • Kala permalink
        November 30, 2013 2:39 pm

        I have no doubt that there will always be selection bias against fat people in clinical trialing, especially for people who are very fat.

        Designing and implementing clinical trials is an conundrum. They’re insanely expensive in the best situations, the number of people who can be included in a best case scenario is limited. So just by the nature of that, even if everything else were perfect, you’d unlikely to get all that many people who are very large.

        If we’re talking about Stage 3 of a clinical trial, this is the trial portion that includes the most people and is supposed to determine the efficacy of a drug.

        Representation for groups that are typically disadvantaged for trials of general medications is just about always poor. And even if you could recruit those people into trials, they’re the group most likely to fail to comply with treatment instructions, and poor compliance obscures the pharmacological efficacy you’re typically interested in when developing a new drug or new drug application. As an example, poor people are more likely to be fat in the USA, and poor people are also more likely to have lack of access to transport and healthcare, low education, ESL issues, cognitive difficulties or mental illness, any number of things that adversely affect whether or not they’d find the trial at all as well as compliance.

        Including fat people specifically in trials also presents an ethical issue. Fat people are far more likely to carry any number of co-morbidities. With co-morbidities come a wariness of testing new medications on them, especially if there are alternative treatments available. This goes for both the efficacy trial but also the trial (Stage 1) in which they determine what the therapeutic dose of a medicine is, which is far smaller than the Stage 3 and typically only includes healthy people.

        Unless the regulatory agency for pharmaceuticals in a specific country makes a concerted effort to require more of trials, I don’t expect any of this to change all that much. There’s too much money at stake and too much risk involved for the companies to go down the road on their own.

  4. inge permalink
    November 30, 2013 2:36 pm

    How is it even possible to make a pill going from high to zero efficiency over a measly 10-lb interval, regardless of genetics, height, age, hormone status, body compostion, and, dunno, sun spots?

    So I wonder what is going on here. Does anyone have the link to the original release from the manufacturer? (Most of my friends are well over 200 lbs and might want to know, but I’d prefer to first have a look at the source.)

    • Kala permalink
      December 1, 2013 9:25 pm

      The HRA Pharm company rep explains in the following article that in their data analysis they found that weight alone correlated the highest with a lack of efficacy, regardless of other variables. It’s not like this is some journal study that you can go look up, it’s proprietary industry information. They seem like they may release it publicly in some form at some point though.

      http://www.motherjones.com/environment/2013/11/levonorgestrel-morning-after-pill-not-work-obese

      You can have a disturbing trend in data that indicates a required change in the standard of care, without understanding precisely from a biochemical perspective what is going on in the human body. Any number of things could be going on, but humans aren’t lab rats, you can’t measure everything even in a clinical trial, let alone once the drug is already out in market.

      Also I doubt it’s actually “zero” efficacy. It went from high to some unacceptably lower level, I doubt it went down to zero. “Completely ineffective” doesn’t not mean zero. But you can’t go out selling a drug to prevent pregnancy without a warning if in some women it’s going to work 40% of the time.

  5. Dizzyd permalink
    December 1, 2013 4:41 pm

    Crazy! You think that these “experts” would have made contingencies for this sort of stuff. That’s why you can’t really put stock in what these “experts” think or say. What do they know? Besides, the way I think of it, if birth control doesn’t work on fat women, we’ll be giving birth to more fat babies, who grow up to be fat adults, so there’s even MORE of us! Mwahahaha! Won’t that give the obesity epidemic people nightmares? XD

    • Kala permalink
      December 1, 2013 9:29 pm

      What in your mind constitutes an “expert” versus an actual expert. Who are the fake scare quote experts in this situation, Dizzyd? Is it the pharma scientists? The regulators? The company reps? Doctors?

      Why are you so dismissive of these lines of work? Do you think science is just some big load of bullshit? I just don’t get this attitude.

      • JeninCanada permalink
        December 2, 2013 9:48 pm

        Us fat acceptance and health at every size folks are used to ‘science’ being used as an excuse for all kinds of fun attitudes and behaviours towards fat people. SCIENCE says there’s an obesity epidemic! But people are living longer, healthier lives in general. SCIENCE says that being fat is TOTALLY BAD FOR YOU but it also creates an obesity paradox (google that one for more info). SCIENCE says if you just put down the doughnut and move more you’ll lose the weight, but SCIENCE also says that fat is a genetically inherited thing roughly 70% of the time. I could go on but I’m hopped up on cold meds. Thanks, science!

        For the record, I love science. I love trying to explain the universe around us using logic and experiments and all that. I ❤ Science in a big way and wish that I lived in the Star Trek universe so that being a scientist was a respected, well-funded and admired job, not a punchline on late-night TV (I'm looking at you, Big Bang Theory!) Sadly, science is influenced by people, and people can be horrible.

        • Kala permalink
          December 2, 2013 11:13 pm

          There, now it’s “science” in scare quotes. When does it become “science” and not science for you Jen? When the research comes to conclusions that you don’t agree with? When it’s funded by an institution that you don’t personally trust? How, as someone with no scientific or medical training, do you evaluate what is science and what is “science” (or SCIENCE)?

          People are living longer, healthier lives, and that could be for any number of reasons. And those lives could be even longer, and healthier, without the disease burden that stems from obesity. The fact that lives are longer and healthier doesn’t prove that obesity is benign. Also, total survival is not a measure of quality of life, but of quantity of life. We don’t really have good ways of measuring quality of life, but it’s inarguable that the presence of chronic conditions, far more common in the obese, eats at quality of life.

          If fat was almost an entirely genetically inherited thing, where were the droves of obese people generations ago? I think it’s very likely that a propensity for obesity given an obesigenic environment has highly heritable factors, heritable from both a genetic sense and from a social sense. But the argument that obesity in of itself is mostly genetic and thus not preventable from a population perspective is nonsense.

          I’m well aware of the obesity paradox, no googling necessary, but it’s no where near as paradoxical as people seem to think. It’s not mind-blowing that a demographic could be more likely to get a disease than another demographic, but also be more likely to survive longer with that disease. Also, the protective benefit that is found among people who are overweight of obese in terms of survival is clustered at the smaller end of those groups, people who would likely qualify as in-betweenies in FA, there’s no protective benefit for obesity for people who are of average height and 300, 400lbs.

          • Queenie permalink
            December 3, 2013 7:55 am

            If you think there’s an obesity epidemic and there’s a “disease” burden, then what the fuck are you doing here?

          • Kala permalink
            December 3, 2013 1:18 pm

            Queenie, thank you for your comment, it really added something to the conversation.

            • Denise Mayosky permalink
              December 3, 2013 7:18 pm

              Kala – I’m not against science OR experts, I’m against it being used as yet another weapon to beat us over the head with about how we fat people should be dropping dead – preferably sooner rather than later. Why are you being so ‘concern troll’ all of a sudden? ATTN: Everyone – I saw an article saying there’s no such thing as ‘healthy obesity’. According to some study with ‘caveats’, we may be ‘fat and fit’, but your sins will catch up with you eventually, fatty, and when they do, the rest of us will be sitting back feeling smug thinking ‘We told you so!’ – IOW, the same old same old. I’m sure atchka will be alerting us to it soon.

            • Queenie permalink
              December 3, 2013 8:06 pm

              Still didn’t answer. This isn’t a site for you to concern troll. It’s a site where fat people congregate to salvage some dignity. You don’t seem interested in that.

          • Kala permalink
            December 3, 2013 8:26 pm

            Queenie,

            This isn’t a space for circlejerking, where the site owner is going to ban people who dissent, as much as you want it to be.

            http://fiercefatties.com/philosophy/

            Where in the philosophy statement do you get the impression that this site is only a safe space for people to congregate and salvage their dignity?

            Also I’m not some boogeyman, who is over here representing everything you dislike about the medical institution or about society as a whole. I’m not here criticizing your body, nor your lifestyle. I don’t care whether or not you lose weight, I don’t wish ill on anyone here, nor do I wish for fat people to be shamed or tortured into not being fat.

            But I do frequently criticize science denialism and the conspiracy theorist attitude that a lot of people seem to have when it comes to research, and that’s about it. When science that agrees with your beliefs is science that you accept wholeheartedly, and science that doesn’t is “science” that requires a deeply critical look, you’re only interested in research in so far as it assuages your own confirmation bias.

            • Denise Mayosky permalink
              December 4, 2013 6:23 pm

              Kala, Well put. Science is just science. But it gets dicey when people try to use it as a weapon to beat people over the world with, no matter your viewpoint. That’s the point I was trying to make. Sorry for any confusion.

  6. vesta44 permalink
    December 3, 2013 9:16 am

    Kala – There’s science and then there’s “science”. The first takes an honest look at something, tries very hard to look at all sides of the question, doesn’t worry about whether its conclusions are what whoever is paying them is looking for, and does a good job of explaining why something happens/works/doesn’t work, etc. The second one, however, isn’t honest. It takes a theory, explores it, and only comes to the conclusion that’s wanted by whoever is paying for the research. That second kind of “science” is usually the one that’s used to browbeat fat people into trying to change their bodies, blames them for being fat, tells them that it’s easy to change to being not-fat, and the list goes on and on and on.
    So yes, there’s science and “science”. Sorry that you think that fact isn’t true, but I’m getting just a little bit sick of you coming here and making nasty comments about our thoughts on matters fat-related. If you don’t like what we have to say, why do you keep coming back and reading our oh-so-wrong-according-to-you posts and comments?
    Oh, and you want to know where all the fat people were years and years ago, before the so-called “obesity epipanic” was created? They were out there in the world, living their lives, contributing to society, and largely ignored by the media – we didn’t have Facebook/MySpace, computers, and all the instant access to information then that we have now. We didn’t have the internet anonymity then that we have now – where people can go online, make up a name, and spew their hatred and bigotry with no consequences. Yes, the very fat were told they needed to lose weight, but they weren’t ridiculed like they are now. You didn’t have it screamed at you from every news source and by nearly everyone you saw that you were disgusting, ugly, lazy, stupid, gluttonous, and generally not worthy of the air you breathed, thousands of times a day, like fat people are now. So pardon us if we say “science” and science, even though some of us aren’t scientists and doctors. Just because we didn’t spend a fortune to “educate” ourselves in science and/or medicine does not mean we’re stupid (even though we may be fat) and does not mean we can’t look at both science and “science” with a critical eye.

    • Kala permalink
      December 3, 2013 1:16 pm

      First, please point to where my comments are nasty. Is it nasty to point out to someone that they have no qualifications in an area? Because that’s about the only personal note I left on any of these comments.

      There is well performed science and poorly performed science and a spectrum of things in the middle, you misunderstand me deeply if you don’t think I believe there are problems in science. My point is that the average Fat Acceptance advocate, including yourself, has next to no ability to tell the difference between these things, and whether or not they believe the credibility of research has more to do with whether the research confirms their beliefs and who may or may not have funded the research.

      I’m an actual statistician, and the fortune of time, energy, and money that I’ve spent in my years of post high school education does make me exponentially more qualified to talk on these subjects than you do. Years of regimented education assembled by highly educated teachers does not measure up the same as 10, 20, or even 30 years of self guided reading and learning on one’s own. We are not equal. And despite all this education, even I can not expressly tell just by reading a journal article or a MedPage summary of an article how robust that work actually is. So how can you do it Vesta? How can you and Jen sift out the science from the “science” when even I can not without vastly more information than what would be presented in a research article?

      Your idea of what “true science” is skewed and unrealistic. There’s plenty of research that looks at one thing or another but can not ultimately explain why something happens or works, this is in fact most science. There’s plenty of legitimate science that in no way attempts to look “very hard at all sides of a question,” but more likely only one side of that question. You have this romanticized notion of science in your head, and Jen expressed a very similar thought process. The nitty gritty of actual science work is nothing like a romanticized ideal, and you would know that if you worked in science yourself.

      You really delude yourself if you think that obesity has not grown in this country over the last several decades, and that the only difference is how we treat fat people, and not how many actual fat people there are.

      • December 25, 2013 3:23 pm

        From ASDAH’s page:

        “It was the National Heart, Lung, and Blood Institute (part of the National Institutes of Health) that changed the definition of overweight and obesity. Before the change, those with a BMI (kg/m2) of 27 or more were considered overweight. That was changed to 25 in 1998, and an additional 30.5 million people in the US became overweight with the stroke of a pen. This represented a 43% increase.”

        Just saying.

        • Kala permalink
          December 25, 2013 10:40 pm

          This is not news to me. I am completely aware that the BMI definitions for overweight have changed, and that doesn’t change anything I wrote.

          • December 26, 2013 9:18 am

            Really? To me there’s quite a difference between saying that more people actually became fatter than in America in 1998 than in 1997, versus changing the standards of what defines fat people in order to proclaim that more people became fatter.

            I remember the proliferation of panic articles in the newspapers and soundbites on the news starting around that time. I always find it curious how they all seemed to forget about mentioning the moved goalpost when they got us all whipped up into a frenzy about how we were all gonna’ die from our bulging midsections.

        • Kala permalink
          December 26, 2013 11:12 am

          I was talking about obesity, which if we’re going to go by the BMI definition, since you brought up BMI, is a BMI over 30. In the late 90s, they changed the American cut-off for *overweight* from 27 down to 25. It is my understanding that the *obesity* cut-off did not change at all. There was no magical 40% overnight increase in the number of *obese* people in the USA. You can argue that increasing the number of overweight by moving the threshold changed the rhetoric out there in the media fat debate, but it fails to negate my argument that the actual number of obese people in the USA grew substantially through the last few decades. It was not as if they were not previously considered obese and were then reclassified into being obese.

          Also since you bring up this point, the average individual that has a non-obese BMI isn’t even going to register on the Fat Acceptance radar. These folks with a BMI of 25 or 26 that got moved from normal weigh to overweight in the late 90s don’t even register as a blip in this movement, I doubt they’d even be considered in-betweenies, let alone actual fat people.

          This also wasn’t some willy nilly change done to create a panic about fatness, it was to bring the USA in line with international standards. Do you personally think that the cut-off was moved down from 27 to 25 merely to create a panic about fatness? Or could it be that perhaps it was moved because 25 more accurately reflected a grouping at the population level of risk groups.

          BMI is not an optimal diagnostic with which to make recommendations for an individual, but it is a fairly adequate population-level tool.

          • Denise Mayosky permalink
            December 26, 2013 5:49 pm

            In a word – yes. I’d believe it more if the health and diet industries weren’t so invested in ‘weight-loss-at-any-cost’. Just sayin’.

          • December 28, 2013 1:27 pm

            Since the great goalpost shift was used by the media to shriek at millions of people that they were either fatter than they used to be or in imminent danger of becoming fat, it’s worth harping on anytime an individual carries on about how much fatter we all are. If there are methods and criteria being used in these articles that aren’t disclosed to the reader, it’s impossible to get a clear picture of what’s really happening. Hence it’s worth bringing up.

            BTW, I never said that this adjustment was some kind of malevolent agenda on the part of scientists or statisticians. That’s all you. Stop putting words in my mouth.

            Oh, and I have no idea why you’re busy suddenly making proclamations about how this relates to who does and doesn’t come under the radar of Fat Acceptance. Again, I didn’t bring that up at all. Maybe you’re nursing some kind of grudge against the movement, but that’s not really relevant to my point. Oh, and having read HAES: The Book, I can tell you that actually Bacon’s commentary and analysis speaks to the POV of everyone whose ever had weight issues. She talks repeatedly about how the fear of being fat is not good for even “normal-sized” people. She also talks about her own struggles with dieting and weight control.

            You can have the last word if you want it. I’ll pass on talking to you in the future, because your shtick gets old in a big hurry.

  7. Leila Haddad permalink
    December 3, 2013 8:51 pm

    I have been watching and waiting to see if someone else picked up on this but here goes: when Kala pointed out how the clinical trials were conducted on the Plan B drug, myself having used this, who knew? guess I was lucky,, She states that the subjects could not be obsese because of the co morbidities associated with obesity. Now, correct me of I’m wrong but, isn’t the whole point of having this website is to address this very issue? That thin people have co morbidities as well? That a drug should be made to be equally effective for both thin and fat people alike? That diseases exist in all body types, not just with the obese? and on another note. Yes, I do agree with Kala, there seems to be more obesity than say 50 years ago but I attribute that to the change of economy. The loss of agricultural work, the rise of college educated professionals that do not use manual labor in their work as they had. But that doesn’t necessarily mean we are less healthy. we live longer, certainly ,and mostly enjoy a higher quality of life. From the simplest things like, having a bathroom IN the house for example…

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