adverse events birth control

Why Aren’t Women Tested for Factor V Leiden and Other Clotting Disorders?

14606 views

When I had a stroke at age 28, my doctors did some tests and found that I have a fairly common clotting disorder called Factor V Leiden. They told me that this, combined with birth control pills, are what caused me to have the cerebral venous thrombosis (stroke). It didn’t occur to me then to ask what Factor V Leiden actually was. Or to ask why I hadn’t been testing for inherited clotting disorders before I was put on medication that increased my risk for blood clots. These things didn’t occur to me until much later, after I learned to walk again.

I spent most of the first two years after my stroke getting on with my life. It wasn’t until I was searching for a topic for my thesis that I revisited what happened to me. I had no idea that birth control pills could be so dangerous and I certainly didn’t know that I could have an inherited genetic condition which would make them exponentially more dangerous for me. “How many women have the same condition?” I wondered. “Why don’t we test them before they are put on hormones?” These are some of the questions I sought to answer with my research.

What is Factor V Leiden?

Factor V Leiden (FVL) is a 20,000-year-old mutation common in the general population and a major genetic risk factor for thrombosis. It’s the most common genetic clotting disorder, accounting for around half of all cases. It’s most commonly found in Caucasians (3-8%).

Patients with Factor V Leiden can be either:

  • Heterozygous: inherited one mutated gene from a parent

or

  • Homozygous: inherited two mutated genes, one from each parent

What Does It Do?

As my hematologist described, FVL doesn’t cause blood clots but once activated, it dangerously accelerates clotting. Researchers aren’t clear on why some people with FVL activate and others don’t but there is almost always a precipitating factor—surgery, trauma, immobility, use of hormones, etc.

According to a review in Blood, the journal for the American Society of Hematology, women with heterozygous FVL who also use oral contraceptives have an estimated 30 to 50-fold increased risk of blood clots, while women with homozygous FVL have a several hundred-fold increased risk.

It is the most common genetic cause of primary and recurrent venous thromboembolism in women.

We know that taking estrogen can increase the risk of blood clots, stroke, and heart attack in women. And estrogen, when taken by someone with FVL, can significantly increase the risk of blood clots. Whether women are taking synthetic estrogen in the form of oral contraceptives, or hormone replacement therapy or have increased concentrations of the endogenous estrogens due to pregnancy, they are at much greater risk of clotting.

FVL accounts for 20-50% of the venous thromboembolisms (VTE) that are pregnancy related. In the United States, VTE is the leading cause of maternal death. In addition to causing VTE in pregnant women, FVL has been linked to miscarriage and preeclampsia.

Perhaps the women most at risk for blood clots are those that have been placed on hormone replacement therapy (HRT). A recent review of data from several studies found that women taking hormone replacement therapy were at an increased risk of blood clot and stroke. Worse yet, women with FVL who are also on HRT were 14-16 times more likely to have a VTE.

Despite these risks, women are not systematically tested for FVL before they are prescribed oral contraceptives, before or during pregnancy, or before commencing HRT.

What Women Know about Birth Control and Blood Clots

Part of my thesis research included a survey to assess what women understand about the risks of birth control pills and clotting disorders. Over 300 women who had taken birth control pills participated. What I found was that most women do not understand the side effects of hormonal birth control, nor are they familiar with the symptoms of a blood clot.

As for clotting disorders, nearly 60% of the women surveyed had no knowledge of these conditions. When asked whether they knew about clotting disorders BEFORE they took birth control pills that number increases considerably.

Over 80% of women were taking a medication without the knowledge that they could have an undiagnosed genetic condition that would make that medication exponentially more dangerous.

This shouldn’t come as much of a surprise give that this information is not found in advertisements for birth control pills, on non- profit websites about birth control pills and their risks, or on literature provided with the prescriptions.

Why Aren’t Women Tested for Clotting Disorders?

The most common reason I found in my research for not testing women were cost-benefit analyses measured in cost per prevention of one death.

Setting aside the moral argument that you cannot put a price on a human life, because clearly the government and corporations do just that. (It’s $8 million in case you were wondering.) The cost of taking care of taking care of victims of blood clots is not insignificant.

Each year thousands of women using hormonal contraceptives will develop blood clots. The average cost of a patient with pulmonary embolism (PE) is nearly $9,000 (for a three-day stay not including follow-up medication and subsequent testing).

A hospital stay as a stroke patient is over twice that at nearly $22,000 (not including continuing out-patient rehabilitation, medications, testing, etc.). As a stroke survivor, I can tell you that the bills don’t stop after you leave the hospital. I was incredibly lucky that I only needed a month of out-patient therapy. Most patients need considerably more and will require life-long medication and testing. It’s important to note that due to the increasing cost of healthcare, the figures in these studies (PEs from 2003-2010; strokes from 2006-2008) would be exponentially higher now.

I’m not a statistician but I can do some basic math and while I wasn’t able to find data for the United States (surprise, surprise), the health ministry in France recently conducted a study that showed that the birth control pill causes 2,500 blood clots a year and 20 deaths.  The United States has 9.72 million women using the pill compared to France’s 4.27 million. This doesn’t include the patch, ring, injectable, or hormonal IUD, but for the sake of keeping things simple, let’s just use the pill. So we have over twice the pill-users as France, which means twice the blood clots (5,000) and twice the deaths (40). If we assume that half of the blood clots are PE and half are stroke, we come up with a whopping $77.5 million in hospital bills for these blood clots (not counting life-long treatment). Now adding the cost-of-life determined by the government (40 women times $8 million= $320 million) and we end up with nearly $400 million a year in damages caused by the pill. For the cost of only one year of damages, all 10 million women could have a one-time $40 blood test which would result in considerably fewer blood clots.

Furthermore, the research in my thesis shows that women would be willing to not only take these tests, but also to pay for them!

Of the 311 who answered the question, 82.3% (or 256) said they would be willing to take the test. Only 7.2% said no, with the other 10.6% “not sure.” More than 60% of respondents would be willing to pay for the test (up to $50).

In addition, the cost of a blood test is directly proportional to how frequently it is performed. An increase in testing will result in a decrease in the cost of testing.

Women Deserve Better

Putting aside the monetary costs for a moment, what about the emotional and physical toll for women who suffer these dangerous and debilitating blood clots? There is no excuse for women to suffer strokes, pulmonary embolisms, DVTs, multiple miscarriages, and still births because they have an undiagnosed clotting disorder.

That said, requiring a test before prescribing hormones to women would raise awareness of the dangers of these drugs and may reduce the overall number of women using them. Which leads one to wonder if the absence of testing for women is really just a public relations strategy.

Perhaps one of the most devastating cautionary tales of not testing for clotting disorders comes from Laura Femia Buccellato. Her daughter Theresa was 16 years old when she was killed from a blood clot caused by (undiagnosed) Factor V Leiden and birth control pills. Would Theresa be with us today if she had had a simple blood test? Would I have had a stroke? When we will demand better?

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

This article was first published in September 2016.

Sharing My Story, Feeding the Hope

4048 views

When I took this job—combing through the Nelson Pill Hearings, researching and writing about the risks with hormonal birth control, working on the Real Risk study—my mother said to me, “Are you sure you want to do that? Are you sure you want to dig up all that stroke stuff?”

“Mom,” I said, a little exasperated. “It’s been 10 years. I’m fine with it.” Duh was close to what I was thinking but didn’t say. The weird thing is, my mom may have been right. Okay, that’s not entirely fair. My mom WAS right. (NEWSFLASH: My mom is right sometimes!) This job has been hard, and not just because reading congressional testimony is draining and because I’m so passionate about this work. It has been hard because it has forced me, nearly every day since November, to examine what happened to me.

I had a stroke because of hormonal birth control and for a long time I believed my doctors (and much of the research I found when writing my thesis) when they said that I was special. That this sort of thing didn’t happen much. Because I thought I was an anomaly, I was able to bury my head comfortably in the sand and call that “dealing with it.”

It hit me that I had not been dealing with it when I sat in a room with Karen Langhart and the parents of four other young women who had died while using hormonal birth control. As they shared their stories, tears slid down my face. I knew I was not an anomaly. It could have easily been my mom sitting in that room and not me.

I’ve written about how important it is to share patient stories. And we’ve written about the importance of the Real Risk Study. I’ve participated in the study. I’ve written my story (all three parts of it: Part 1, Part 2, Part 3). But it has not been easy for me. Which means it has taken unfathomable courage and strength for the families who have lost their daughters. I had to face a sadness that was buried deep under a layer of “getting on with life.” But for these families, the sadness isn’t buried because there is no “getting on with life.” It’s right there, out in the open, raw and exposed. Their lives will never look remotely the same.

When we publish an article about a health crisis or a death related to hormonal birth control it is not because we are alarmists. It is not because we are whiny or dwelling in the past. It is because this work is important. This study is important. I was not an anomaly. The young ladies who were killed by hormonal birth control are not anomalies. They are daughters, wives, sisters. They could be you or someone you love. We share because we are not alone. We are a group of survivors and advocates.

One of the most amazing things that has happened to me from taking this job is that, despite the challenges, it has helped give meaning to what happened to me. I’ve met and connected with amazing people. While much of it has been cloaked in sadness, the thing that shines even brighter in these interactions is hope. And hope is healing. By sharing my story and participating in this research, I am feeding that hope.

It is my wish that you will help feed that hope, too. If you are a survivor of a blood clot or a family member of someone killed by a blood clot and you have been hesitant to participate, now is the time. If you aren’t, I guarantee that you know someone (a friend or relative or a friend of a friend) who has been affected by a blood clot while on hormonal birth control. Now is the time to share this link. Because there is hope in sharing. And healing in hope.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

Look Beyond Access – Demand Safe Birth Control

4528 views

Fair warning, this may get ugly. I’m mad. Bayer just announced the next in a long line of dangerous hormonal birth control options the Skyla IUD. Though not much different from the currently embattled and lawsuit ridden Mirena (which tends to dislodge and cause hemorrhage among other things) and likely not much safer than their oral contraceptives – the Yasmin line ($700 million in lawsuit settlements and counting) – women’s health and feminist groups are jumping on the support bandwagon. Now younger women can get a (dangerous) IUD too (Skyla happens to be just a hair smaller than Mirena), yippee.

Wake up, ladies. Medical devices and pharmaceuticals are not shiny new iPads. We cannot blindly support and recommend each and every new product in this market.

The fight to give women access to birth control as a point of equality is dead on and much needed, but ignoring the safety issues and not demanding safer birth control options is just downright negligent. Advertising these birth control options without understanding the serious dangers makes us pawns of pharmaceutical industry and complicit in the deaths and injuries of the women who use these devices and medications.

Women need birth control options. I support that – wholeheartedly. I am a child of the 80s-90s when access to oral contraceptives was unquestioned. Access to birth control allowed me to compete against guys in my chosen sport, allowed me to date, to pursue academic and career goals without worrying about pregnancy.  Easy access to oral contraceptives also, unbeknownst to me, elevated my blood pressure to dangerously high levels, caused progressively worse vertigo and syncope to the point of multiple hospitalizations, tests and desperation. I stopped taking oral contraceptives and all of the symptoms resolved. It wasn’t until years later that I understood the connection.

Like so many others, my physicians and I were blind to the legitimate dangers of hormonal birth control. Sure we’ve all read the package inserts (which are really the tip of the adverse event iceberg), but in a sort of cognitive dissonance we dismiss the side-effects as happening to someone else or as something to be tolerated in exchange for our freedom. Physicians often downplay the dangers hormonal birth control, even today, as more research comes to light.

Imagine, pregnancy versus possible death from cardiac arrest, stroke or a myriad of other adverse events; that is the choice we make daily when using hormonal birth control. We shouldn’t have to make that choice. As educated women and modern feminists we must be able to distinguish between fighting for the absolute right to have access to birth control from a stance that says all birth control options are good and safe. The later is most certainly not the case.

Not all contraceptives are created equal. Some really and truly, should not be on the market. Even among the safer birth control options, there are dangers. We should be fighting for more research, for better and safer birth control options and not promoting each new pill or device that comes on the market. Just because it’s new and the makers say it is safe does not make it so. The pharmaceutical industry has a long history of publishing only positive results for their products (here, here, here) and paying physicians to promote their products. If ever there were a buyer beware, it would be here – with birth control.

Finally, we should be boycotting companies like Bayer who continue to put women’s lives at risk. We boycotted Rush Limbaugh and the Koch brothers for their anti-women statements, why are we not as aggressive when it comes to companies that seriously injure women?  At the very least, we should not be promoting their latest, greatest assault on women’s health. Bayer is the maker of the Yasmin line of birth control, arguably the most dangerous line of oral contraceptives on the market. Bayer is also the maker of Mirena, the hormonal IUD with on-going class action lawsuits due to serious adverse events. Skyla is almost equivalent to Mirena and is simply repackaging and re-branding of that old, soon to be off-patent, dangerous IUD. It is neither new nor innovative and it remains to be seen whether it is any safer.  What are we doing ladies?

Post Script: Hormones MatterTM is taking the safety of birth control into its own hands. We find it unacceptable that the adverse events of many birth control options are poorly understood, that medication interactions are not investigated and that oral contraceptives (like many other medications in women’s health) are regularly prescribed for uses for which there are no data to support their efficacy. We are conducting our first of many studies on oral contraceptives and women’s health issues. If you have ever used oral contraceptives, whether you had any side-effects or not, please take the Oral Contraceptives Survey. Another woman’s life may depend upon it.

About us: We are an unfunded company, committed to improving women’s health through research. We believe so strongly in the need for better research that rather than wait for funding, we’re doing the research anyway.  We are crowdsourcing this research and would be much appreciative if you would also share the link throughout your social media networks.  To take another health survey, click: Take a Health Survey.

To suggest a survey, help create a survey, write a guest post or otherwise get involved: info@hormonesmatter.com

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.