A few weeks back I did an interview with Leslie Botha regarding the distribution of Depo Provera to women in developing countries. Recently Leslie shared with me an email she received from someone working in a family planning clinic in Karnataka, India. He described how he was providing the Depo Provera injection to women and finding that, after they stopped using it, they were not experiencing menstruation for up to nine months. He asked for advice – “what is the procedure to give them normal monthly menses….is there any medicine?”
I have written previously about one potential problem of providing women with Depo Provera – the possibility of continuous spotting and bleeding that would not only be distressing with no warning that this might happen and no medical support, but could also be difficult to navigate in a place with poor sanitation or with strong menstrual taboos. As women in developed countries are so very rarely counseled on side effects of hormonal methods of contraception, it seems unlikely women in developing countries receive such information. As we know, some women will instead experience their periods stopping entirely during use of the shot and, as we see from this email and from the comments on other posts written for this blog, long after use.
In this context I find it interesting that the Gates Foundation’s programs for contraception access have a very public focus on Depo Provera. The method was mentioned again by Melinda Gates in a recent TED interview and when she was interviewed as ‘Glamor magazine Woman of the Year’ the shot was front-and-center of the discussion of her work. Yet the Foundation also funds programs that provide support for menstrual management and sanitation. Continuous bleeding from the shot, or cessation of bleeding altogether, would seem to be an important connecting factor between these two campaigns.
Much has been written on the menstrual taboo in India and how this holds women back. In the US we have come to embrace menstrual suppression as great for our health and our progress as women. We see menstruation as holding women back in a variety of ways. However, in India could lack of menstruation also be seen as a positive outcome? Instead of dealing with the menstrual taboo with expensive programs that provide sanitary products and education, might suppressing menstruation entirely be seen as a far more cost-effective solution? It may seem like a stretch, but I am surprised this has not been brought up during debates about the need for contraceptive access in developing countries. Yet of course, the menstrual taboo may well extend to absence of menstruation – a woman who does not experience her period might also be treated suspiciously or poorly.
When Melinda Gates says women “prefer” and “request” Depo Provera I always wonder whether that’s after they’ve been told how it works (perhaps described as a six-month invisible contraception) or after they’ve had their first shot or after they’ve been on it for two years and then, via FDA guidelines, must find an alternative? How much follow up is there? As the self-injectable version is released widely how will women be counseled? Gates argues that the invisibility of the method is part of the draw as women do not have to tell their partners they are using contraception, but what happens when they bleed continuously or stop entirely?
It seems to me like there might be a real lack of communication – both between medical practitioners and their patients, drug providers and the practitioners, and those who fund these programs with everyone involved. It is often argued that the risks of pregnancy and childbirth in developing countries justify almost any means to prevent pregnancy – including the use of birth control methods that cause health issues. How much feedback are groups like the Gates Foundation getting on women’s preferences if they seem to be so unaware of the potential problems, even those that would greatly impact their wider work?
I’d given up reading the comments on online articles for the good of my mental health when a small slip last week steeled my resolve. In response to an article exploring the arguments made by “birth control truthers” a concerned father decided to have his say, taking the defensive arguments put forward by those in opposition to these “truthers” to their only logical conclusion:
“Perhaps we should market contraceptive pills as hormonal supplements to reduce cancer risk instead of as “contraception”? After all, it is only in modern times that women have hundreds of menstrual cycles throughout their lives. Even up until 1800 it was common for women to be either pregnant or lactating throughout much of their short lives.
The body simply wasn’t built to handle so many menstrual cycles, which raises the risk for cancer.
Who could argue with taking supplements to prevent cancer?
This may sound strange, but I am seriously considering putting my 11 year-old daughter on the pill (with no placebo) just for the health benefits. I just have to convince my wife first who is a little shocked by the idea…”
I cannot count how many times I have heard that the birth control pill “prevents cancer” – specifically “preventing” ovarian and endometrial cancer. In the last few months I have seen references to this benefit explained less and less so as a “lowered risk” and more and more so as a “preventative” action. I think this is significant as the word “prevent” suggests that the pill guarantees you will not get these forms of cancer. And yet, to remark that the pill is counted as a carcinogenic substance by WHO – due on the increased the risk of breast and cervical cancers – will get you tagged as a “truther.”
What is interesting, of course, is that despite the “cancer protecting” benefits of pregnancy, and early pregnancy at that, we do not see women encouraged to get pregnant in order to lower their risk of ovarian cancer. Criticism of child-free women does not generally include comments about their lax attitude towards their own health. The risk goes down further with every pregnancy and further still with breast feeding, especially breast feeding for a long period of time after birth. Women who have children young, and multiple children, have a lower risk of breast cancer than women who have no children or children after 30. Yet we see more talk of women having “too many” children at an age that is “too young” – in fact I was contacted via Twitter by someone who read this piece and who saw, in the comments, that one woman who uses natural family planning admitted to both liking the method and having 14 children. This admission disgusted the person who contacted me, even when I pointed out that it seemed the woman had very much chosen to have those 14 children.
It seems the people who are advocating prescription of the pill for cancer prevention purposes are not advocating women have children earlier, more children, or consider breast feeding for the good of their own health – in fact two of the loudest critics of my “birth control truther” book are vehemently against pregnancy and breast feeding being part of women’s lives (Amanda Marcotte and Lindsay Beyerstein). The risks of the pill are frequently compared to the health risks associated with pregnancy and child birth, but we don’t often hear women say they are choosing to not have children to avoid putting their health at risk for nine or so months.
Which leads me to this article in the LA Times that suggested nuns should also be on the birth control pill for its cancer-protecting abilities:
“And are the pills really unnatural? Our hunter-gatherer ancestors had their babies four or five years apart, because of long intervals of breastfeeding. As a result of that and their shorter life spans, they had as few as 40 menstrual cycles in a lifetime, while a modern woman can have 400. Though we can’t claim that today’s pills are perfect, their use is certainly less unnatural than enduring the hormone turmoil of hundreds of menstrual cycles.
The recent death of writer Doris Lessing led me to revisit her work a bit. *
Author of more than 50 books as well as an opera, Lessing was brave. She spanned genres, refused to tow a singular ideological line and used her Nobel Prize moment to remind us that privilege shapes greatness as much, even more perhaps, than talent. And Lessing wrote about menstruation when few others dared.
In her 1962 novel The Golden Notebook, protagonist Anna Wulf journals on the first day of her period—chronicling every thought and feeling her menses produced for her. In the passage below, Wulf’s disgust with her body is hardly a menstrual-positive standpoint (and isn’t something off with her cycle if she detects such an offensive smell?). But there is an honesty, here. A broken silence. Lessing brought to the fore the reality of the fraught and conflicted menstruating body in the early 1960s, and that was a bold move.
I stuff my vagina with the tampon of cotton wool … I roll tampons into my handbag, concealing them under a handkerchief … The fact that I am having my period is no more than an entrance into an emotional state, recurring regularly, that is of no particular importance … A man said he would be revolted by the description of a woman defecating. I resented this … but he right … For instance, when Molly said to me … I‘ve got the curse; I have instantly to suppress distaste, even though we are both women; and I begin to be conscious of the possibility of bad smells … and I begin to worry: Am I smelling? It is the only smell that I know of that I dislike. … But the faintly dubious, essentially stale smell of menstrual blood, I hate. And resent. It is a smell that I feel as strange even to me, an imposition from outside. Not from me. Yet for two days I have to deal with this thing from outside—a bad smell, emanating from me. … So I shut the thoughts of my period out of my mind; making, however, a mental note that as soon as I get to the office I must go to the washroom to make sure there is no smell (pp. 339-340).
Lessing is not alone among the brave who dare to Speak a Menstrual Language. In honor of Thanksgiving in the US, I offer this shout out to a short list of the courageous who inspire. Thank you menstrual champions.
Rachel Horn, of Sustainable Cycles, who cycled coast to coast this summer, promoting menstrual literacy and menstrual cup awareness.
Holly Grigg-Spall, who has put herself on the line with her new book Sweetening the Pill: Or How We Got Hooked on Hormonal Birth Control. Grigg-Spall has been challenged, sometimes pretty nastily, for suggesting that one can use a feminist reproductive justice lens to be critical of the pill.
And how about radical feminist pioneer of queer cinema, Barbara Hammer. Her 1974 expeimental film Menses playfully interprets, though a group of women enacting their own individual fantasies, what menstruation means to them. 1974!
Menarchists Jaqueline J. Gonzalez and Stephanie Robinson, who founded the Menstrual Activist Research Collective (M.A.R.C) in 2011, and just released their line of menstrual gear (http://www.etsy.com/shop/menarchists) at cost so you can help them spread the good word, or as they put, leave your MARC! We bleed. It is okay. We bleed.
Then there’s Arunachalam Muruganantham, the self described “school dropout” (and now the subject of a new documentary) who developed a table top machine that rural Indian women can use to produce and sell low cost single use menstrual pads. He wants to make life easier for Indian women (and he is not interested in getting rich). Yes, there are sustainability issues, here, but there’s also a widening of options for women.
Every teenager who, on the way to the school toilet, ever dared to walk down the hall with femcare-product-of-choice in open view.
Every menstruator who hangs cloth pads on the clothesline with the rest of the laundry.
Recently I was fortunate enough to be asked to lend an excerpt of my recently released book to the UK Sunday Times Style magazine. The mostly fashion-centric Style magazine is not really known for its edginess or risk-taking (except perhaps in the realm of shoe and make-up choices) and so I was happily surprised when the editor told me that the subject matter discussed in my book that she happened to find most interesting was, in fact, menstruation. I had expected her to want to focus on condoms perhaps, or just my personal story, but no, she was keenly interested in what I wrote about periods.
The argument I make in my book is that how we feel about hormonal birth control is inextricably linked to how we feel about menstruation. In a sense, many of the newer methods of hormonal birth control, as well as the newer uses (running packets of pills together, prescriptions for cramps or heavy bleeding) show an effort to get rid of the period completely, rather than just hide it away. I also discuss in the book, briefly, menstruation activism. However, I do defer to the far better work done by the likes of SMCR’s own Chris Bobel who writes on this topic with far more knowledge (not to mention wit).
You can read the feature in full here at my website (it’s otherwise behind an online pay wall and frankly I’m pleased to rob Rupert Murdoch of a few pounds by making it freely available).
In the end, the feature was not exactly an excerpt from my book – more so it was quotes from the book mixed with quotes from a long interview with the editor. Therefore I didn’t quite know what would be published in the magazine. The finished piece covered a range of controversial topics seen here at re:Cycling regularly – menstrual outing, reusable femcare products, the potential health benefits of ovulation…
If the high point of my career was getting the word “patriarchy” into the notoriously right-wing British tabloid The Daily Mail, I think I had another peak seeing this sentence in the Style (notorious for its high priced designer fashion spreads) – “This movement believes the act of stopping and hiding our periods with hormonal contraceptives and sanitary products is a mark of corporate ownership of our bodies.” I take great pride in also getting a discussion of menstrual extraction on to Style’s pages, and therefore onto the breakfast table of approximately one million British people – “an entire period’s worth of menstrual blood could be removed in a few hours instead of being experienced over days.” Well, if we can have Page 3, why not menstrual extraction?
The editor who did such a great job on this piece was Fleur Britten and in a funny twist of fate I realized, during our conversations, that in my first full time working position after college, at the publishing company Debrett’s in London, I worked as a production assistant on one of her books – Etiquette for Girls. At that time controversy surrounded Fleur’s section on the proper etiquette for one-night stands (I think it was something about getting out quickly, quietly, but leaving a nice handwritten note). So, it made me smile to see her skewer the etiquette of menstruation in the opening paragraph of this piece: “Many women are bored with having to take a whole handbag into the ladies rather than carry a tampon in their hand. Men say “I’m going to take a dump,” but we don’t say, “I’m just going to change my tampon.””
When I was carrying the proofs of Fleur’s book to the printers back some seven years ago, little did I know we would be conspiring to get the British public to say “I am menstruating” today over tea and toast.
I had the privilege of writing the foreword for Holly Grigg-Spall’s recently published book Sweetening the Pill: Or How We Got Hooked on Hormonal Birth Control. It’s astounding to me that more than 30 years ago, before Holly was born, I was asking some of the same questions she explores in her book. I thought we’d have more answers by now, but one thing is certain: Holly’s book has prompted long-overdue discussion and debate about issues related to hormonal birth control. Below is my foreword to Sweetening the Pill.
In a letter dated March 22, 1980, I proposed to the editor of an American woman’s magazine that they consider my enclosed article: The Contraceptive Dilemma – A Subjective Appraisal of the Status of Birth Control.
“Recent articles (about birth control) deal almost exclusively with the basic pros, cons, and how-tos of the various contraceptives available – matter-of-fact discussions that reduce birth control to a mere pragmatic decision. If only that were the case.
Contraception, like the sexual interaction that necessitates it, involves our emotions as much as it does the facts. Yet the subjective, personal aspect of contraception is so often ignored. In this age of scientific research we are expected to (subjugate) our emotional reactions to significant probabilities, our anger to logic. Very real fears and earnest questions are dismissed as irrelevant….”
Although today I wouldn’t use the phrase “emotional reactions,” it’s hard to believe that three decades later, the status of birth control and women’s relationship to it has not much changed. Websites, not magazines, now host information about the basic pros, cons and how-tos of available birth control methods. And it is writers like Holly, half my age, who honour women’s real fears and ask earnest questions that are still being dismissed as mostly irrelevant.
Just as my personal story with the pill – including over a year of distressing post-pill amenorrhea – set me on a course of research and advocacy, so too has Holly’s personal experience. Sweetening the Pill explores and challenges the ways in which the pill and other drug-based contraceptives damage women’s health, threaten our autonomy and thwart body literacy. What we don’t know about our bodies helps pharmaceutical companies “sell” their contraceptive drugs, and keeps us “addicted” to them.
At some point between my first attempt at non-hormonal contraceptive advocacy and Holly’s exploration of how we’ve become hooked on hormonal birth control, something disturbing transpired. Prescribing the pill, or other forms of hormonal contraception, has become, in the minds of most health-care providers, the “standard of care” for being a girl. It is all too common to subjugate a girl’s menstrual cycle to synthetic hormones that superficially “regulate,” but actually suspend the maturation of her reproductive system. And for many girls, the use of hormonal contraception continues well into their 20s, without awareness of what might be or has been sacrificed.
There are many women like Holly who are fed up with hormonal birth control. I’ve met scores of them during my 30 years involvement within the mainstream pro-choice sexual and reproductive health community, the one that prides itself on inclusion and diversity. Yet I’ve been unsuccessful in my constant advocacy for this community to accommodate a more inclusive, diverse approach to contraception, to provide acknowledgement, support and services to women who cannot or do not want to use drug- or devised-based methods. We pay lip service to the idea, but the message we convey is: “You’re on your own.”
I’ve found enthusiasm in other realms for my menstrual cycle advocacy and my belief that many women want to, and can, learn to use non-hormonal methods effectively and confidently. I’ve found scientific evidence of the value of ovulation to women’s health and well-being.
I’ve read, met or worked with several of the sources included in this book. Many have devoted their careers to understanding women’s bodies and our relationships with our bodies in ways the medical mainstream typically ignores and barely comprehends. They have made contributions that help us imagine a different way of thinking about fertility, contraception and our menstrual cycles in relation to our sexual, reproductive and overall health.
My forthcoming book ‘Sweetening the Pill or How We Got Hooked on Hormonal Birth Control’ began to take shape on the pages of this blog and much of the process of its development was spurred on by the work of members of SMCR. As such, it seems only fitting, with the release date of September 7th soon here, to share for my post this month an excerpt and to say thank you for the support of this community. I hope to have added something of interest and value to this on-going conversation.
Women often discuss menstruation and birth as happening to them, rather than as part of them and their experience. Emily Martin remarks in ‘The Woman in the Body’ that women often see their self as separate to their body. Women’s central image is that “your body is something your self has to adjust to or cope with” and therefore, Martin concludes,“your body needs to be controlled by your self.”
Martin explores the idea that women did not fit into the structure of the jobs that were open to them in industrialized society. These jobs most often required monotony, routine and repetition. Although in reality no more suited to men than they were women, it was women that were judged as innately unable to succeed in such positions due on the constantly changing and supposedly unpredictable nature of their physical state.
As Martin states, “Women were perceived as malfunctioning and their hormones out of balance,” especially when experiencing PMS and menstruation, “rather than the organization of society and work perceived as in need of transformation to demand less constant discipline and productivity.”
The rigidity of society was forcefully imposed on women as it was on men. For all, both men and women, it is inhumane but it was women that were required to adapt in a more dramatic and overt way. Men are viewed as naturally given to the industrious and disciplined way of life demanded of them and the structure of society is built on these assumed capabilities.
If we admit that women do change through the month, that we do menstruate, experience PMS, have differing moods week to week, we fear that this admission will be used as justification for negative judgment.
Martin counters the feminist refrain of “biology is not destiny”; “I think the way out of this bind is to focus on women’s experiential statements – that they function differently during certain days. We could then perhaps hear these statements not as warnings of the flaws inside women that need to be fixed, but as insights into flaws in society that need to be addressed.”
The idea that men are otherwise unchanging is falsified. Men also experience hormonal changes with studies suggesting they experience a cycle daily that is equivalent to the monthly cycle of women as well as changes in hormone levels across their lifetimes.
Women’s “experiential statements” as Martin describes them are often silenced in the discourse surrounding hormonal contraceptives. It is a betrayal of the feminist cause to speak out with openness about the side effects of the pill.
When Yaz and Yasmin were released the marketing strategy co-opted the idea of word of mouth. In a commercial women were seen passing along the “secret” of these new drugs with their host of beneficial yet superficial side effects. Receiving messages of increased physical attractiveness as the result of a drug that many women were using anyway, only a different brand, increased the transference of this experience from one woman to the next.
In the face of such powerful manipulation, what place does a skillfully worded informational insert have in women’s decision making process? The time of the Nelson Pill Hearings was a very different to today.
Naomi Wolf mentions the pill briefly in ‘The Beauty Myth.’ She remarks that it was originally marketed as a drug to keep women “young, beautiful and sexy,” concepts parallel to those promoted by Bayer through its contemporary advertising. Wolf quotes, in the context of the beauty industry, John Galbraith, “Behavior that is essential for economic reasons is transformed into social virtue.”
Guest Post by Holly Grigg-Spall, Sweetening the Pill
Last year the FDA made the decision to keep the birth control pills Yaz, Yasmin, and Beyaz on the market despite controversy over corporate corruption of the review process.These drugs are back in the spotlight.
The French health minister has called for doctors to stop writing prescriptions, 2,000 lawsuits against Bayer launched in Canada last month, and Marie Claire Australia dedicated five pages to an in-depth feature about the side effects, instigating an investigation by the country’s top current affairs show Today Tonight.
Bayer has gone about settling the 13,000 lawsuits in the US out of court, likely with the hope of keeping the details of confidential files regarding marketing techniques and research out of the public eye. Unperturbed by mounting reports from women of the myriad health issues caused by their products, the company launched Yaz Flex in Australia at the end of 2012. The first oral contraceptive on the Australian market presented as being for the purpose of preventing periods, Yaz Flex comes in a digital dispenser that records how many pills have been taken and alerts the user when she’s missed a dose. There are enough tablets to allow for just three breaks a year. In the US in April the FDA, equally unperturbed, ruled that pharmaceutical company Activis can start selling generic versions of Yaz, providing a low-cost version of what has been the most expensive oral contraceptive of recent years.
The feature in Marie Claire Australia generated 300+ comments on the magazine and television show’s Facebook pages. Many of the commenters were women who had developed blood clots when taking these brands. Some had made the connection at the time and others made the link only as a result of the coverage after months or years of not knowing why they had endured the injuries. Some of the women were presently experiencing the symptoms of a blood clot mentioned in the show and made the decision to stop taking the pill as they typed.
The piece was written by a long-time member of the Yaz and Yasmin Survivors forum and balances interviews with women who suffered the serious physical side effects with those who have been victim to the serious psychological side effects. I’m among those who experienced a long list of negative physical and psychological effects when taking Yasmin for more than two years and it was this forum that prompted me to stop taking it.
Monash University in Australia is one of the few facilities to have undertaken research into the correlation between birth control pills and depression. Professor Jayashri Kulkarni found that women on the pill were twice as likely to experience depression, anxiety, and mental numbness (known as anhedonia). The Yale Daily News reports that in the wake of her research receiving a little media attention Dr Kulkarni received more than 300 emails from women “clearly describing when they went off the pill that they felt subjectively more happy. The anhedonia, for example, disappeared, the irritability disappeared, the sense of poor self esteem disappeared”.
She is now focusing her attention on researching what she believes to be the particular psychological impact of the Yaz brands, those pills containing the synthetic progesterone drospirenone and low-dose synthetic estrogen.
Although there is no direct-to-consumer advertising in Australia these brands of pill gained popularity there just as they did in Europe and Canada. It is interesting to note that Marie Claire US ran an article in 2011 titled ‘The New Super Pill’ that named Yaz and Yasmin as the latest, greatest “no-acne, no-bloat and pms-be-gone” pills that also allow you to “shorten your period”. The pages of magazines such as Marie Claire in the US are usually scattered with adverts for Yaz and Yasmin, the NuvaRing, Nexplanon impant, and Mirena IUD. The print and television commercials often play on the same insecurities reflected and bolstered by the majority of the women’s magazine articles.
I’ve been wading through State of the Science of Endocrine Disrupting Chemicals – 2012. The 289-page report was prepared by a group of experts for the United Nations Environmental Programme and World Health Organization.
It is dense and complex, but what I’ve been looking for is any acknowledgement that hormonal contraceptives are endocrine disrupting chemicals (EDCs).
Hormonal contraceptives clearly act as EDCs according to the definition used in this report:
An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations. A potential endocrine disruptor is an exogenous substance or mixture that possesses properties that might be expressed to lead to endocrine disruption in an intact organism, or its progeny, or (sub) populations.
Adverse health effects would include, in this context, anything that disrupts the reproductive systems of humans (and wildlife) or contributes to other health problems such as hormone-related cancers, thyroid-related disorders, cardiovascular disease, bone disorders, metabolic disorders and immune function impairment. Hormonal contraceptives certainly disrupt the reproductive system and have been associated with increased risk of cardiovascular events, loss of bone density, decreased immune function and, in some studies, increased risk for breast cancer. Metabolic disorders? Recent research suggests that long-acting progestin-based birth control may increase risk in obese women for Type 2 diabetes.
The only mention I could find of specific contraceptive chemicals is in section 3.1: The EDCs of concern. In a table under the sub-heading Pesticides, pharmaceuticals and personal care product ingredients, two key components of hormonal contraceptives are listed: Ethinyl estradiol, the synthetic estrogen used in most oral contraceptive formulations, and Levonorgestrel, a synthetic progesterone used in combined oral contraceptive pills, emergency contraception, the Mirena IUD, and progestin-only birth control pills. Levonorgestrel is considered of “specific interest.”
The concern with these chemicals is not the effects they may have on women taking them, but on the possible reproductive impact on wildlife from the excretion of these chemicals into the aquatic environment. It seems ethinyl estradiol and levonorgestrel are considered safe contraceptive drugs when taken by choice to disrupt fertility, but EDCs worthy of concern when such disruption is unintended.
How would it change our perception of hormonal contraceptives if we acknowledged them as endocrine disrupting chemicals? Would we wonder why there is no discussion of how these EDCs might contribute to the health issues considered in the report? Would we ask why hormonal contraceptive EDCs are routinely used to “treat” (meaning only to alleviate symptoms of) endometriosis, fibroids and PCOS – conditions potentially caused by other EDCs?
Another relevant concern addressed in the report is the effect of “estrogenic agents, and their role in breast cancer.” The report states there “is good experimental evidence that estrogenic chemicals with diverse features can act together to produce substantial combination effects.” I have to wonder how hormonal contraceptive EDCs fit into this mix.
Here’s something to ponder. Last week news stories reported that the incidence of advanced breast cancer among young American women, ages 25 to 39, has risen steadily since 1976. Lead researcher Rebecca Johnson was quoted as saying, “We think it is a real trend and, in fact, it seems to be accelerating.” The increase is small in relative numbers, only 850 cases in 2009, but the “trend shows no evidence for abatement.”
Researchers can’t explain the increase. Lifestyle changes, obesity, sedentary lifestyle and toxic exposure to environmental chemicals are offered as possible factors. But what about the hormonal contraceptives many women of this generation have been taking since they were 15 or 16 years old? Surely these EDCs must be considered as potentially contributing factors.
On February 26, 2013, the Food and Drug Administration issued a news release saying that it had approved a medication called Osphena to treat a problem called postmenopausal dyspareunia (pain during sexual intercourse associated with changes in the vagina after menopause). The medical website Medscape reported that the news release had been issued. How to read these announcements? It seems as though FDA approval should be enough to know that a medication is safe and effective. However, what are some guidelines in reading and evaluating this announcement?
First, some background: After menopause, when estrogen levels decline, tissues (cells) of the vaginal lining can become thinner, drier (thus providing less lubrication during intercourse), and less elastic or flexible.
This can result in pain during intercourse, feelings of burning or soreness, inflammation, and irritation.
There are a variety of solutions for dealing with this. Regular sexual stimulation (intercourse, masturbation) is recommended to keep vaginal tissues healthy. Water-based lubricants can help reduce discomfort during intercourse. Expanded views of sexual pleasure that don’t include intercourse might work around the problem. Leaving enough time to become aroused during intercourse (extended foreplay), communication between partners about when sex is painful and when not, can also help. Herbs like dong quai and black cohosh are recommended, especially by complementary/alternative practitioners, although the herbs lack a research base. A low-dose estrogen applied to the vaginal area (as a cream, tablet, etc.), is effective. Local application minimizes estrogen being absorbed into the bloodstream, traveling through the body, and having effects, some of them potentially negative, distant to the vagina. There is, however, controversy about some estrogen being absorbed.
Now, to the FDA announcement: The FDA requires proof of a medication’s safety and effectiveness before it is approved. According to the news release: “Osphena’s safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena’s long-term safety in treating dyspareunia.”
Notice, first, that the drug’s effectiveness was tested for 12 weeks. This is not an unusual amount of time for such a study, but it is not very much time. Notice also that women treated with Osphena had a “statistically significant” improvement. As I discussed in a previous post, “statistically significant” means “unlikely to have occurred by chance.” In other words, there was evidence that Osphena really did have an effect, but we don’t know how big an effect—it might be very large or very small.
Safety was established by studying the experiences of women for one year: however, one year is not a long time for side effects to develop. Osphena is a systemic medication. That means it is not applied locally in the vaginal area, it is ingested as a pill so that it travels to all parts of the body in the bloodstream. It is a selective estrogen-receptor modulator, or SERM. SERMs act like estrogen in some places in the body while not in others. The idea is that a SERM like Osphena would act like estrogen in keeping vaginal cells healthy while not acting like estrogen to increase health risks like certain cancers. However, more time than a year might be needed for health problems to show up. Indeed, the FDA news release stated that “Osphena is being approved with a boxed warning alerting women and health care professionals that the drug, which acts like estrogen on vaginal tissues, has shown it can stimulate the lining of the uterus (endometrium) and cause it to thicken…. Women should see their health care professional if they experience any unusual bleeding as it may be a sign of endometrial cancer or a condition that can lead to it.” The FDA announcement also stated that “Common side effects reported during clinical trials included hot flush/flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating” and that Osphena should be prescribed for the “shortest duration consistent with treatment goals and risks for the individual woman.”
Bedsider has jumped on the LARC bandwagon. The online birth control support network for women 18-29 has launched the Works Like a Charm contest encouraging “the awesome women and couples” who use long-acting reversible contraception to share why they love their LARCs for the chance to win up to $2000. This is a variation of the Why I Love my LARC video campaign sponsored by the California Family Health Council last November, only with prizes!
To quote my blog post about the earlier campaign: “Throughout the contraceptive realm, LARCs are being heralded as the best thing since Cinderella’s glass slipper with little acknowledgement that for many women LARCs are more like Snow White’s poisoned apple.”
One long-acting, not-so-reversible contraceptive in particular – Depo-Provera – is causing grief for many women. Yet “the shot” is front and center in the graphic on the contest website.
Considering the rah-rah tone of the Works-Like-a-Charm campaign messages, it seems that bedsider.org, a project of the National Campaign to Prevent Teen and Unplanned Pregnancy, is oblivious to the misery caused by this contraceptive. Often, Depo works like a curse.
I acknowledge that Bedsider is doing good work: The website provides youth-friendly, accessible information about the full range of birth control methods. But, in my opinion, any organization that promotes Depo-Provera as a contraceptive method should be totally transparent about the ill effects many women experience both while taking and after stopping the drug.
Depo-Provera, to put it bluntly, fucks with a woman’s endocrine system.
The long list of ill effects while on or after stopping this drug includes: continual bleeding (from spotting to heavy), mood disorders, severe anxiety, depression, digestive issues, loss of sex drive, extreme weight gain (often without change to exercise or eating habits), lingering post-shot amenorrhea, intensely sore breasts, nausea, and ongoing fear of pregnancy leading to repeated pregnancy tests. (Not to mention its documented negative effect on bone density.)
These effects are why the continuation rate of Depo-Provera is only 40-60% after one year of use, and why women are filling online comment pages with stories of their struggles coming off this drug.
At Our Bodies, Ourselves, the blog post Questions About Side Effects of Stopping Contraceptive Injections has been attracting comments since November 3, 2009, with no end in sight.
On my April 4, 2012 re:Cycling post – Coming off Depo-Provera can be a woman’s worst nightmare - there are over 130 comments. All but six were posted since mid-November when the post caught fire. Not more than a day or two goes by before another women shares her story of distress, confusion or frustration. I read each one and respond occasionally. Rarely, a positive experience appears; one criticized other commenters for complaining.
It’s one thing to read or hear about potential ill effects while trying to decide whether or not to use Depo-Provera. It’s quite another to experience some or many of them for months on end without acknowledgement or health-care support from those who promote or provide this drug.
The Works Like a Charm contest website says about LARCS:
Reversible = not permanent. If and when you’re ready to get pregnant, simply part ways with your LARC and off you go.
“Off you go?” Tell that to the thousands of women who are waiting, months post-Depo, to get their bodies and their menstrual cycles back to normal. Most of them still aren’t ready to get pregnant.