Blog of the Society for Menstrual Cycle Research

Yaz and Yasmin Back in the Spotlight

May 9th, 2013 by Elizabeth Kissling

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.  Continue reading...

Tags: , , , , , , , , , , , , ,
Posted in Birth Control, coming off the pill, Pharmaceutical | 1 Comment »

Little Girls! Just Say Yes to Your Dreams!

March 18th, 2013 by Chris Bobel

Seen this one yet? (or the (eerily) related “Birth Control on the Bottom“?)

We posted “Sassy Girlz Candy Birth Control Pills” (written by Carissa Leone in 2011) in our regular installment Weekend Links on Feb 2. I had a mixed reaction. And when a couple re:Cycling readers described the video as “nasty,” I knew we needed to dig in a bit.

Let’s discuss.

There’s something very absurdly funny about eating birth control, even if the women are still tweens and the birth control is merely mulit- colored jelly beans intended to get young girls in the pill-popping groove before they are saddled with a baby and an half-finished high school education.

First of all, women CAN eat their birth control, donchaknow… Warner Chilcott brought to market their chewable, spearmint flavor oral contraceptive, Femcon Fe, for women who have difficulty swallowing pills and apparently, find stopping for 30 seconds to swallow water.

But I digress (I guess I just want to be clear that we are ALREADY munching our pills).

It is hard not to love how this sketch takes down the pandering to the girl tween market. Oh lordy. There’s so much potential there! (one estimate figures that kids aged 8-12 years are spending $30 billion OF THEIR OWN MONEY and nagging their parents to spend another $150 billion annually!) Little girls quickly move from Disney to diets, from fingerpaint to fake eyelashes, from tutus to belly shirts…..I have seen it with my own girls and it feels, frankly, like an inexorable force.

Viral sketch writer Carissa Leone graciously replied to my questions regarding the piece. When I asked her what inspired her, she channeled her Women’s Studies training (go team!) and supplied her two main reasons:

(1) “I saw a little girl on the subway,holding a baby doll in one of those pretend baby slings…and I thought, “If only she really knew what motherhood was like. I wonder if anyone has explained the authentic experience. I wish she were carrying a briefcase and reading a teeny issue of Ms. magazine instead… “

AND

(2) “The idea that women can/should have it all, in terms of relationships and families and career still seems to be put forth as a tangible (and”correct”) goal in Western culture. It’s a pressure I and many other peers feel, and one that I don’t think is truly possible, or necessarily awesome.”

And Big Pharma takes a hit, too, per the spot’s director, Brian Goetz, who offered this when I asked him about what led to the sketch:

“I wanted to do the video because the script spoke so well to the branding of pharmaceutical commercials, where no matter what the product, as long as you say there’s a problem and that you have the solution, throw some happy people and fun b-roll in it, you’ve got a successful campaign. On top of that, it’s always fun to legitimize terrible ideas in sketch comedy. And if that means having multi-colored jelly bean birth control pills, all the better.”

But I think there’s more to it that that.

Why do I find myself laughing and crying at the same time? Well, I just finished my advance copy of Holly Grigg-Spall’s forthcoming Sweetening the Pill  or How We Became Hooked on Hormonal Birth Control (out this Spring with Zero Books). In it (and here as well, on this blog), Grigg-Spall makes the case the hormonal contraceptives have become so normative that we, as consumers, permit an imperfect (at best) product to flourish even while other options may be more appropriate. The one-pill-fits-all mindset is so pervasive and bores in so deep, so young, Grigg-Spall argues, that when someone says, ‘hey! I don’t want to be on the pill,’ these—what she calls “pill refugees” — are hastily branded as irresponsible, antifeminist, or just plain dumb. That is, the pill gets constructed as our savior, our liberator, our saving grace, even when its not.

And that’s where this spoof enters….since the pill IS all these things, let’s get those girlies on board NOW! Why wait? Good habits start young, after all. And product loyalty is not just for toothpaste and laundry detergent….

And so, “Sassy Girlz Candy Birth Control Pills” is super smart feminist critique. It calls out the enduring wrongheadnessness of romanticizing motherhood and co-opting what I would call a tragically hollowed-out pseudo feminism harnessed to push product:

  • Little girls playing Mommy is cute, and kinda bullshit!
  • Its never too early to teach little girls about options!
  • She’ll know that birth control means winning a college scholarship

Yup. There’s lots of problems with that. Thanks to the feminist satirists to help us see.

But I have to say one more thing.

Leone and I discussed (what I consider) the unfortunate below-the-belt invocation of gender dysphoria to as she put it, “most absurd, heightening beat” in the sketch (here’s another, more recent example of same, on SNL). I don’t think trans or gender queer or otherwise gender variant people should ever serve as punchlines, as I told Leone so in our email exchange. When I inquired about this moment in an otherwise spot-on sketch, she said that is was never intended it as a negative perception of transgendered kids. But still  it is, and I think it points with a big fat finger at how much work we still need to do to move trans issues from margin to center.

Let’s push forward without leaving anyone behind. Let’s laugh at feminist satire that avoids (even unintended) transphobia. Let’s keep our targets clear and our allies clearer. Let’s say YES to that dream, for real.

Tags: , , , , , , , , ,
Posted in Advertising, Birth Control, Communication, Film, Girls, Health Care, Humor, Independent Film, Internet, Language, Media, Pharmaceutical, Pregnancy, Reproduction | 4 Comments »

Medicating the Postmenopausal Vagina

March 4th, 2013 by Paula Derry

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.

Andreyeva by Ilya Repin // Public Domain via Wikimedia Commons

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.”  Continue reading...

Tags: , , , , , ,
Posted in Menopause, Pharmaceutical, Sex | 4 Comments »

Could use of the pill be linked to insulin resistance?

October 3rd, 2012 by Elizabeth Kissling

Adapted from a photo by anna marie-grace // CC 2.0

The pill is one of the most intensely studied drugs in history, and believed to be among the safest – safer than aspirin, as an editorial in the American Journal of Public Health noted twenty years ago. Yet young women seem to be quitting in droves, for a variety of reasons: to restore feelings of psychological and emotional health, regain lost libido, relieve cardiovascular symptoms and disorders, or ease anxiety about these or other health issues.

When women report these side effects of birth control pills, physicians often recommend they try another brand, but many of these side effects are common to hormonal birth control, especially oral contraceptives. A new study published this month in Human Reproduction suggests there may be yet another common side effect: Researchers in Finland found that oral contraceptives may worsen insulin sensitivity and are associated with increased levels of circulating inflammatory markers.

The study was very small and ran only for a short time, so drawing conclusions is premature, but since the beginning of the year, I’ve been following several online discussions of young women quitting the pill. Although I have yet to see development of Type 2 diabetes or insulin resistance cited as a reason to quit the pill, I have seen such a variety of health issues and medical problems described that this study caught my eye immediately. Current estimates indicate that 12.6 million, or 10.8 percent, of all U.S. women ages 20 years or older have diabetes (diagnosed and undiagnosed). Could it be related to their birth control? Perhaps in those already genetically predisposed.

Research from the Guttmacher Institute indicates nearly 60% of pill users take it for non-contraceptive reasons, such as for cramps or other menstrual pain, menstrual regulation, acne, endometriosis, as well as for prevention of unintended pregnancy. Fourteen per cent of US pill users (more than 1.5 million women) take birth control pills solely for non-contraceptive reasons. If the Finland study proves to hold true for larger groups over extended periods, there’s another reason to be more cautious prescribing the pill.

 

Tags: , , , , , , , , , ,
Posted in Birth Control, coming off the pill, Health Care, New Research | 10 Comments »

Hormone Imbalance: Breaking the Silence

September 5th, 2012 by Elizabeth Kissling

Guest Post by Leslie Carol Botha Women’s Health Freedom Coalition Coordinator, Natural Solutions Foundation

I still remember the first Society for Menstrual Cycle Research Conference I attended in Tucson, AZ in June, 1999. The statement that made the most impact was the collective concern that in ten years there might no longer be a menstrual cycle. It turns out the truer words were never spoken.

In the past 40 years, the pharmaceutical industry has spewed out and packaged and repackaged so many synthetic hormone contraceptives – pills, injections, and implants that virtually eliminate the menstrual cycle.  It also amazes me that in the 30 years I have been involved with the women’s health movement condoms and spermicide are still the safest and most effective contraceptive on the market.

However, a new trend is emerging as condoms and birth control pills are being pushed on the back burner because of ‘human error’. Women and men are not always diligent or careful about condom use, and many girls and women forget to take their pills.  What is now being prescribed to adolescent girls – whether or not they are sexually active — are implants and injections. Health considerations are not taken into consideration, nor are hormone levels. Somehow the pharmaceutical industry still views this as a one-size-fits-all prescription for all women, no matter their age of their state of health.

Menstrual cycle advocates are most aware that birth ‘control’ is about control…controlling the woman’s body with potentially harmful synthetic hormones. What has been overlooked are education and natural methods of fertility awareness.

While our focus recently has been on the politics of birth control, another ugly monster has reared its head and that is the silent epidemic of hormone imbalance. Not only is this the result of taking synthetic hormones for birth control but our environment, our foods, and water supplies are filled with estrogen mimickers upsetting the delicate orchestration of hormones in our bodies.

Another concern is the excess estrogen stored in women’s bodies and passed on genetically to their offspring.  It is possible that their children are hormonally imbalanced at birth.

Either way, the damage has been done. I believe we are at the tip of the iceberg in this silent epidemic and that hundreds of thousands of women are being misdiagnosed and over-prescribed. In most cases, thyroid imbalance is not considered as a cause of depression, and the prescribed fix is generally Prozac or a higher dose of synthetic hormones.

In 2009, I posted an article to my blog, from eHow editor, Shelly Macrea titled: What is Hormone Imbalance?, a very informative article and probably one of the first pieces for a general audience on the myriad of conditions that hormone imbalance can cause.

At the time I had three responses (with an average of 30,000 unique visitors a month.) In June of this year, another post on the article (which by this time was buried in my archives) appeared from a woman suffering anxiety due to hormone imbalance. And then another post appeared and I decided to bring the article out of the archives and re-post it. What ensued was a steady stream of women commenting on almost a daily basis on their extreme anxiety and depression and the myriad of misdiagnosis and drugs they were prescribed. I am posting the link here so that others can read what I believe should be of concern to all of us: Hormone Imbalance Anxiety, A Precursor to Other Health Issues.  Continue reading...

Tags: , , , , , , , , , ,
Posted in Birth Control, coming off the pill, Hormones, Pharmaceutical | 1 Comment »

Flipping the Image: Try New Semen-Off!

June 11th, 2012 by Chris Bobel

Cartoon created by Lisa Leger, with photo by Λ |_ ν- Γ Ø // CC BY-NC-SA 2.0

At the 2007 conference of the Society for Menstrual Cycle Research, a presenter cited the famous satirical essay by Gloria Steinem, If Men Could Menstruate, as inspiration for ”flipping the image”  to raise awareness about an issue.

 

Remembering this and frustrated by the marketing of cycle-stopping contraception, Lisa Leger created this spoof ad for a drug that suppresses an integral part of the male reproductive cycle.

She says,

I work in a pharmacy setting and monitor the medical journals to observe how the pharmaceutical industry markets drugs to both doctors and patients. An ad framing male ejaculation as a bothersome and icky inconvenience mirrors the way cycle-stopping contraceptives are marketed to women as a modern way to escape the hassles and mess of menstruation. By flipping the image and taking the same marketing tactics that are used toward women and using them toward men, the absurdity of suppressing a vital body function for the sake of convenience is revealed.

 

Lisa Leger is an SMCR member and fertility awareness educator who works in a community pharmacy setting on Vancouver Island. Her cartoons featuring the adventures of Wanda the Wandering Uterus have appeared in Femme Fertile, the newsletter of Justisse Healthworks for Women.

 

Tags: , , , , , , ,
Posted in Humor, Men, Menstruation, Pharmaceutical | 2 Comments »

O Canada! Gardasil® Vaccine May be a Medical Experiment on Older Women

June 5th, 2012 by Elizabeth Kissling

Guest Post by Leslie Botha, Broadcast Journalist

It appears that women ages 27 to 45 in Canada are being subjected to the same type of Gardasil® advertising campaign adolescents and their families are in the United States. The full page advertisements are running continuously in magazine supplements in Sunday newspapers north and south of the border.

‘Now women ages 27 to 45 can benefit from Gardasil®’. Say what? Benefit from what? ‘Talk to your health care professional today.’ Now, I am not sure of what is going on in Canada – but in the U.S., healthcare professionals have nearly become pharmaceutical sales representatives, and women cannot go in for a doctor’s exam without being pressured to go on the birth control pill or get vaccinated. In fact, a stamp is now placed on a patient’s chart to remind doctor’s if the adolescent is in the process of getting the three-shot Gardasil® series or has been ‘counseled and refused’ vaccination.1

According to the U.S. FDA, there is no health benefit to getting Gardasil® for women ages 27 to 45. Then why is the vaccine being offered to older women in Canada?

Only the Facts Ma’am

In April 2011, after a long awaited decision the U.S. FDA ruled against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil® use to an older population of women.

In a brief statement Merck stated that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL® was updated to state that GARDASIL® has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.”1

Within the same month Merck issued a press release announcing Health Canada had approved use of Gardasil® for women ages 27 – 45 for preventing cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by HPV strains 6, 11, 16, 18. Health Canada was surprisingly silent on the HPV vaccine issue and did not release a statement of their own.2

This should have been the first red flag for Canadian women. According to Pharmalot, “Although Canada is a smaller market than the U.S., the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue.”3

The needed revenue is due to the decreasing uptake and non-completion of the three-shot series in the U.S. Health insurance records have shown that among 19 to 26-year-old women who received their first Gardasil shot, the number of 19 to 26-year-old women completing the 3-shot series dropped from 44 percent in 2006 to 23 percent in 2009. A similar decline was seen in the pre-teen demographic where 57 percent of girls in 2006 completed the vaccine series, compared to 21 percent in 2009.4

Perhaps another notable step for Merck will be to go back to the FDA with data from Canada to prove that Gardasil® can be demonstrated to prevent cervical cancer in this older demographic. This is a highly likely scenario, since the CDC has stated: “While there are well-established cancer registries in the United States, it will take decades before the impact of the vaccine on cervical cancer is observed.”5

What is potentially wrong with Gardasil® use in older women?

The CDC estimates approximately 20 million Americans are currently infected with HPV. Another six million people become newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives. 6  Continue reading...

Tags: , , , , , , , , , , ,
Posted in Health Care, Pharmaceutical | 4 Comments »

Coming Off The Pill: Considering “forget-about-it” birth control?

May 30th, 2012 by Laura Wershler

If you quit the pill would you replace it with forget-about-it or mindful birth control?

How you feel about your body, your menstrual cycle and your sexual relationship(s) will influence your choice. Another consideration might be your attitude towards an unintended pregnancy.

Photo: Public Domain // LARC birth control methods are highly effective, in part, because women can "forget about them."

On the Coming off the Pill (COTP) MIND MAP GUIDE I proposed in an earlier post in this Coming Off The Pill series, mindful methods dominate the Birth Control branch: condom, spermicide, diaphragm, fertility awareness and copper IUD. Only the latter could be considered forget-about-it birth control.     Have it put in, then forget about it.

What got me thinking about this dichotomy is the Contraceptive CHOICE Project, a new study by researchers at Washington University School of Medicine in St. Louis. More than 7500 participants were free to choose, with all costs covered, from a range of contraceptives. (Diaphragms and fertility awareness training were not included.) Contraceptive failure rates over the course of the study were compared for the methods offered. The key result?

“Women who used birth-control pills, the patch or vaginal ring were 20 times more likely to have an unintended pregnancy than those who used longer-acting forms such as an intrauterine device (IUD) or implant.”

The difference in effectiveness was even more profound for women under 21 who used the pill, patch or ring. Their risk for unintended pregnancy with these methods, versus long-acting reversible contraceptives (LARCs), was almost twice as high as for older women.

The reason for the higher failure rates is human error. Women, and especially women under 21 it seems, don’t always remember to take their pills, change their patches, or check to ensure their rings haven’t fallen out. These methods require a certain degree of mindfulness. The reason that LARCs are more effective, according to senior author Dr. Jeffrey Peipert, is “because women can forget about them after clinicians put the devices in place.”

There are several things I find troubling about the researchers’ contention that forget-about-it birth control is better just because it’s more effective, and that these methods should be among the first offered to women by clinicians.

Firstly, they fail to acknowledge that many women do not tolerate these “forget-about-them” methods. Among the choices made available to study participants were the contraceptive shot, which I presume was Depo-Provera, and an unspecified hormonal implant. (Implants are slow-release hormonal devices inserted under the skin of a woman’s arm.) Side effects and ongoing problems with such methods abound, and are anything but forgettable. IUDs, both copper and the hormonal Mirena, have fewer drawbacks but they aren’t problem free either. Women experience a range of side effects with the copper IUD. As for the Mirena, some women love it, others hate it.

Secondly, the implication that women under 21 especially should be encouraged (perhaps coerced?) by clinicians to use forget-about-it LARC birth control methods just makes me sad. I get that preventing teen pregnancy is an important public health goal, but the potential for harm to young women’s overall health and psycho-sexual development by the use of such methods, Depo-Provera and contraceptive implants in particular, should be cause for caution and concern.

Maybe it’s time to research mindful birth control methods. Might more women choose barrier and fertility awareness based methods if expert training and support to ensure confident, effective use of these methods were provided free of charge, as were the expensive LARC methods in this study? I guarantee researchers would have no trouble finding women to participate.  Continue reading...

Tags: , , , , , , , ,
Posted in Birth Control, coming off the pill, Health Care, Hormones, New Research, Pharmaceutical | 10 Comments »

“Lives will be saved” – the FDA decision not to ban Bayer’s birth control pill

April 18th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall

 

Photo by Monik Markus // CC 2.0

How many of us read the inserts included in a packet of pills? How many decide not to take the pills on the basis of the information enclosed?  The rapidly reeled-off list of side effects stated at the end of a televised advert for a new drug has more comedic value than serious consequence to most. If we do have doubts, many of us will rely on the reassurance of a doctor, and then take the pill anyway.

I recently wrote a piece for Ms. Magazine Blog outlining the FDA reappraisal of top-selling oral contraceptives Yaz and Yasmin. It was discovered that drugs such as these containing drospirenone held a significantly higher risk of causing blood clots. Research by the FDA and other bodies suggested this conclusion was definite, while research funded by the pharmaceutical company behind these billion-dollar products, Bayer, suggested the opposite conclusion to be true: that there was no increased risk evident. A team of experts, some of which had financial ties to the company, voted against having the pills taken off the market when presented with the question of whether the risks of taking these pills outweighed the benefits.

Bayer is facing 11,300 lawsuits from women who have been seriously injured and family members of women who have died after taking one of the company’s bestselling hormonal contraceptives. They have settled the first 500 addressed with a total of $110 million in payouts. When discussing this process with a lawyer representing many of the women I was told that Bayer would do anything to avoid a trial wherein the full spectrum of their marketing strategies would be revealed.

The FDA came to the decision to add into the insert included with these drugs a statement of the discovery of “conflicting” research that suggested the pills had a higher risk of causing blood clots  (up to three times higher) – acknowledging the discrepancy of the research funded by Bayer and giving it equal standing as that performed by other bodies including the FDA itself.

Prior to this decision being announced a number of women’s health groups got together to write a letter to the FDA asking that they look again at the question put to the board of experts. They argued that the correct comparison for the board to consider would be between drospirenone-containing contraceptives and other oral contraceptives, and not between Bayer’s drugs and unwanted pregnancy. In the final sentence, they remarked that they believed that “lives will be saved” if the pills were no longer on the market. They met with the FDA and one representative asked that the FDA strongly reassess its acceptance of Bayer-funded research. Another asked that the drugs no longer be prescribed and that the FDA “get back to the arc of history and progress that protects women while supporting their contraceptive needs.”

The new labeling will state the “conflicting” findings and advise that women speak to their doctor if concerned. The official statement on this decision, relayed through the media coverage, reminded women that when compared to pregnancy the risk of development of a blood clot was insignificant. They also asked that women currently taking the drugs not stop doing so. Despite the FDA studies suggesting the blood clot risk is particularly high for women under 30, the statement compounded the understanding that the issue is only relevant to those over 35,  those overweight, those that smoke, and those with relevant medical history.  Continue reading...

Tags: , , , , , , , , , , ,
Posted in Birth Control, Law/Legal, New Research, Pharmaceutical | 3 Comments »

Coming Off The Pill: A Mind Map Guide

March 7th, 2012 by Laura Wershler

Everybody can use a good map to help them get to where they’re going. Why not women heading to the land of non-hormonal contraception?

In my post on January 11, 2012 I asked if coming off the pill was a growing trend. I proposed to write a series of posts about the issues associated with the decision to stop using hormonal birth control.  For the purposes of this discussion assume that “coming off the pill” refers to quitting any method of hormonal contraception including the pill, patch, ring, shot, implant or Mirena intrauterine system.

As I was preparing a list of possible topics, I realized that one way to represent the complexity of issues involved in this decision is with a mind map: “a diagram used to represent words, ideas, tasks, or other items linked to and arranged around a central key word or idea.” It also occurred to me that readers could then add to this schematic, filling in important points based on personal or professional experience. So I got out my colored markers, did a little brainstorming and came up with Coming Off the Pill: Mind Map 1.0. I invite readers to comment, offering additions under the key headings I’ve noted and suggesting other categories that should be included.  Could this become a talking, planning or process guide for women considering the transition to non-hormonal birth control methods?

If you’ve thought about or been through the experience of quitting hormonal contraception, or if you’ve helped others through the experience, please contribute to the development of Coming Off The Pill: Mind Map 2.0 by posting your comments and suggestions. (I’ve already thought about other headings I could have included.) Besides providing me with a guide for writing future posts, what other ways can you imagine this mind map might be used?

Tags: , , , , , , , , , , , ,
Posted in Activism, Amenorrhea, Birth Control, coming off the pill, Communication, Dysmenorrhea, Health Care, Hormones, Menorrhagia, Menstruation, Ovulation, Pharmaceutical, PMS, Reproduction | 10 Comments »

The pill, reduced period pain and the ongoing delusion

January 20th, 2012 by Laura Wershler

Is there a woman over the age of 18 anywhere who doesn’t know that taking the birth control pill can make her periods lighter and less painful? Most women know this, but not many know why. The news stories swirling around a new study about the pill and period pain will not enlighten them.

Photo credit: Ceridwen, Creative Commons 2.0

A 30-year longitudinal Swedish study has finally proved the worth of what is accepted practice in North America and Europe: the prescribing of combined oral contraceptives (COCs), or birth control pills with synthetic estrogen and progestin, to treat painful periods known clinically as dysmenorrhea.

Of course, pharmaceutical companies that manufacture COCs are probably eager for this research, as prescribing the pill for dysmenorrhea is still an off-label use in the U.S. (unlicensed use in the U.K.). Pill manufacturers may be able to use this finding to lobby the FDA (or equivalent agencies in other nations) to approve the pill as treatment for menstrual pain, leading to increased sales and insurance coverage. Perhaps that’s why news media have been treating this discovery as breaking news.

Take this headline: Yes, the Pill CAN ease the agony of period pain: Scientists confirm what millions of women already know, or this one: The pill ‘does ease period pain’, or this one: Combination oral contraception pills cut menstruation pain, or, really, any of these.

You can read the abstract of the study by Swedish researchers Ingela Lindh, Agneta Andersson Ellström and Ian Milsom, published this week in the journal Human Reproduction, here: The effect of combined oral contraceptives and age on dysmenorrhoea: an epidemiological study. The conclusions are simple: “COC use and increasing age, independent of each other, reduced the severity of dysmenorrhoea. COC use reduced the severity of dysmenorrhea more than increasing age and childbirth.”

Forget the age factor for the purposes of this discussion. The fact that COC use reduces the severity of dysmenorrhea is not astounding. This is old news. So says Dr. Steven Goldstein, an obstetrician/gynecologist at NYU Langone Medical Center in New York City, quoted in a USA Today story:

“The study results are not surprising. It’s gratifying to see researchers documenting scientifically what practitioners have been seeing for a very long time. The amount of discomfort from a woman’s period with a combination birth control pill is a fraction of what it is without the Pill. There is a diminution of pain from the Pill.”

What is astounding is what Dr. Goldstein, and other OBGYNs, didn’t say in responding to the study. That the reason the pill reduces menstrual pain is because the synthetic hormones in the pill shut down a woman’s own menstrual cycle. The “period” women experience when on the pill is technically known as a “withdrawal bleed,” brought on by seven days of placebo pills. While it feels like a period to menstruators, it is not the same physiologically as the period they experience when NOT on the pill. That’s why it doesn’t hurt as much.

The point is, the pill is too often credited with regulating the menstrual cycle. It does no such thing. The pill does not regulate any woman’s menstrual cycle; it supercedes it. This research, and the many news stories that reported it, once again ascribe power to the pill – this time the power to cut menstrual pain. This is an incomplete truth.

Tags: , , , , , , , , , , ,
Posted in Birth Control, Communication, Dysmenorrhea, Health Care, Menstruation, New Research, Pharmaceutical | 6 Comments »

Off the Pill, Off the Magazines

January 12th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall

“Less stressed, thinner and more interested in sex.” – but not buying magazines.

In a recent issue of the UK’s Stylist magazine — a weekly women’s glossy that is available for free at tube stations and selected clothing stores — there was an article headlined ‘What does 10 Years On The Pill Do To You?‘ As a result of my on-going blog, Sweetening the Pill, which documents my experience of coming off the contraceptive pill, I was contacted by the writer to provide some quotes for this piece. Unfortunately, I was edited out. As a journalist myself, I understood this situation has little to do with the writer’s choice of content and more to do with the magazine editor’s final say on what was most fitting for the feature. Yet the title question is the very crux of my blog: having taken the Pill for 10 years, stopping as a result of discovering the answer to this very question.

 

Photo Credit: Anthony Easton // CC 2.0

According to the Stylist piece the answer is that the Pill changes your memory skills, lowers your libido, makes you attracted to the wrong kinds of men for you, changes weight distribution, prevents you building muscles, make you retain water, make you depressed and jealous…and how can you tell if this all is just you or the Pill? You can’t and you shouldn’t try to find out, is the message here. We are advised to not take a break from the Pill, not even for a week, and if you are concerned, just ask for a different brand from your doctor. There is no discussion of non-hormonal alternatives. There is also no discussion of the benefits of not taking the Pill, of allowing your body to ovulate once a month.

 

My answer to this question was: “The Pill has a whole body impact. Taking the Pill shuts down a woman’s hormone cycle — and the ovulation and menstruation that is an essential part of this cycle — and replaces it with a low stream of synthetic hormones. This has an affect on every organ in the body — the impact is wide-reaching and crudely administered. The peaks, troughs, and plateaus of a woman’s ‘natural’ cycle are wiped out. The monthly hormone cycle is integral to many of the body’s central functions, including the metabolic, immune, and endocrine systems. This changes everything — from your sense of smell to your libido to your ability to absorb vitamins from your food.

 

Many women have said to me that coming off the Pill was ‘life-changing’ and, as someone now two years off the Pill after ten years on, I have to agree with the description. The life-threatening potential effects of the Pill get publicity — the blood clots and strokes — but the quality of life-threatening and the emotional and mental effects are barely discussed. Fatigue, muscle loss, urinary tract infections, bleeding gums, stomach disorders, flu-like symptoms, hair loss — relatively minor physical issues caused by the Pill that together can make life very hard. Depression, anxiety, panic attacks, rage, paranoia — all issues brought on by the Pill, due to a combination of switching off the hormone cycle and vitamin B deficiency. I experienced the whole package and when I wasn’t bordering on nervous breakdown I was flatlining, barely able to feel anything at all.”

   Continue reading...

Tags: , , , , , , , , , ,
Posted in Birth Control, Health Care, magazines, Pharmaceutical | 1 Comment »

« Older Entries
Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.