hormonal contraceptives - Page 3

Can a Man Weigh in on The Pill?

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After many months of intense research, I firmly believe the birth control pill stinks, but who am I to say? I’m not an M.D. or a PhD. Even worse, I’m not a woman.

At the risk of being counter-cultural, I’d like to be completely transparent. I’m a bald, middle-aged, Catholic, white man from Texas. Clearly, I’m not allowed to have an opinion on The Pill, but I do. And, I’m passionate about it!

Now that I’ve given you every label you could possibly need to dismiss what I’m about to share, I plead with you to hear me out. My passion for this subject is not driven by a moral or political agenda. I have no deep-seated desire to tell women what they should or shouldn’t do. In fact, I have only one agenda – to expose the very real dangers of hormonal contraceptives.

I’m telling you who I am up front because we live in a culture of extremes. We’ve lost the art of moderation. It seems we are all either Conservative or Liberal; Pro- or Anti-; Us or Them… Defined by extremes, there is no middle ground. Regardless of which side we’re on, when someone offers a different perspective, we assume they are ‘one of them.’

I never dreamed I would be a women’s health activist, but that’s what I’ve become. I’m not even sure that label can stick to me, but I’m eager to wear it, even if I have to clip it on with safety pins.

My Distaste for The Pill

My distaste for The Pill predated any religion or spirituality in my life. For that matter, it also predated being bald, middle-aged, and Texan.

My wife and I were young and deeply in love. Somehow, that fact came up in a discussion with her doctor. She had gone in with allergies, but came out with The Pill. That was fine by us. We hated condoms, and this sounded like the perfect solution. The doctor didn’t mention any side effects, and since it had been on the market for decades, she never thought to question its safety.

On about the fourth month, a little pamphlet fell out as she opened the package. I picked it up, and started reading. I was horrified. “Honey, did the doctor mention any of these side effects to you?”

“What side effects?”

We sifted through the complicated text, and discussed some of the warnings — breast and cervical cancer, strokes, and heart disease. They were especially disconcerting given her family history. She asked whether the doctor would have given it to her if he thought it was dangerous.

Ultimately, it was a long, thoughtful conversation that ended with me saying, “I can’t tell you what to do, but for me, if taking this pill means I get to spend even one less day with you at the end of our lives, it’s not worth it.”

It surprised me how much relief that statement brought her. The pills had apparently been making her feel crazy, and she decided to stop taking them immediately. Beyond my wife, my attitude about The Pill was indifferent. I never thought to ask my sisters if they had read the pamphlet, or if their doctors had warned them. It didn’t seem like my place.

Was it my place? Am I even allowed to talk about that with women beyond my wife? Where do my rights and responsibilities end?

Years passed. Then, a series of events brought me in contact with information that left me a little smarter than the average bear… at least where The Pill is concerned. When you’re privy to information that you know most women haven’t been told about The Pill, does your responsibility change? I think it does. I have sisters and nieces who suffered consequences because I didn’t discuss The Pill with them sooner. I believe anyone who learns the truth about The Pill should act on the urge to shout the news, and drown out the silence of the doctors.

My Focus on The Pill

As a writer and media producer, it was work that first inspired my pill quest. Writing requires a natural curiosity. Whether I’m developing a documentary or creating a marketing piece for a corporate client, I’m always looking for an interesting story.

A medical project early last year brought me in contact with one of the world’s leading authorities on a certain disease (I will be more specific about the disease in future posts). I sat in on a meeting as this revered doctor spoke to a group of young specialists about the basics of the disease.

He said, “We’ve known from the beginning that estrogen plays a key role… because 75- to 80-percent of diagnoses are women, and we know the role estrogen plays in a woman’s immune system.” He explained how environmental estrogens get into our system, and mimic natural estrogen.

My ‘interesting story’ radar went off even though it had nothing to do with the project at hand. I pulled out my phone. A quick Google search revealed that the incidence of this disease began climbing rapidly in the early 70’s.

I benefited from limited knowledge. All I knew of the disease was a time frame, and what triggered it – chemicals mimicking natural estrogen. The only example I could think of was birth control pills. Based on what the good doctor had said, I assumed the connection must be well known in the medical community, but was surprised I had never heard about it.

I struck up a conversation with him after the meeting, and asked exactly what role The Pill had played in all of this. He replied, “None at all.”

I was dumbfounded. “That seems impossible.” I wasn’t doubting him. In fact, I completely believed him, regardless how impossible it seemed. After all, he was the world-renowned authority.

He doubled down, “There hasn’t been any evidence linking The Pill to [the disease].”

The conversation continued for a while, but didn’t advance. It concluded with him saying, “Certainly, there are more questions than answers. And more research needs to be done.”

I walked away feeling confused – as if he had waved his hand and said, “These aren’t the droids you’re looking for.”

That Nagging Feeling

I was still thinking about the encounter when I got back to my hotel room that evening. I pulled out my computer and did a search for the disease, plus “oral contraceptives.” Among the top results was an article about a new study that found women who take The Pill are 50% more likely to have this disease than nonusers.

I wondered whether the doctor had been unaware of this study. The question didn’t linger long. He was quoted halfway through the article. In black-and-white, the world-renowned authority told women they shouldn’t stop taking The Pill because of this study, and that they needed to weigh the benefits against a very small increased risk of developing the disease.

Had he lied to me? At best, he had certainly obfuscated the facts. Maybe he just thought it would be too deep for a simpleton, and it was easier to say that no connection existed.

During the next few weeks, I continued my search, and found several studies over the past 50 years that had linked The Pill to this disease. And for each study, it seemed there were always leading authorities who were eager to say the benefits still outweighed the risks. This was a pattern I observed frequently as I broadened my search to include other ailments.

Questions About The Pill

Those early searches left me with two burning questions that drove me to dig deeper:

  • Are doctors being forthright with women about hormonal contraceptives so that they can make truly informed decisions?
  • Why is the medical community always eager to downplay studies that find risks associated with birth control pills?

Answers to the second question tend to dance around the political landscape. So, for the purposes of my posts on Hormones Matter, I will focus more on the answers to the first question. However, I do think it’s important to lay a little more foundation to explain how I formed my opinions.

In my next post, I will tell you how a feminist, a crusty old reporter, and a 102-year old man fueled my continued interest.

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Birth Control and Blood Clots Study Final Week: Add Your Data Now

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A few months ago, Lucine Health Sciences and Hormones Matter began a pilot study looking at risk factors and warning signs/symptoms in women who have developed blood clots while using hormonal contraception. This study consists of a survey questionnaire, and a personal story/case report, which is shared on Hormones Matter with the study participant’s permission. We would like to thank all of the women who took the time to complete our survey and who courageously shared their stories to help inform our research.

This phase of the study will close on July 25, and we will then perform a full data analysis on all of the results. In the mean time, we have already written about some of our early results here and here. What we have learned so far from our survey results suggests that some information that is commonly accepted about the risks for blood clots on hormonal birth control may not be true, and that the risk information is not communicated to women in a realistic and truthful way.

What We’ve Learned So Far

Early Survey Results

Many blood clots develop after years of use. Although it is thought that the risk for developing a blood clot is highest in the first year after starting or restarting hormonal contraception, our data to date show that 75% of women developed clots after the first year on the medication, and only 25% developed clots within the first year. Many women developed clots even after significant lengths of time on the medication, in some cases, even after up to 21 to 30 years.

Smoking is a risk but not THE risk. Many women are led to believe, by information provided to them by pharmaceutical companies and their doctors, that they are only at risk of a blood clot if they are over 35 years old, and smoke. However, 94% of women in our study were not smoking at the time of the blood clot, and 78% had never been smokers. Smoking does increase the risk, but the idea that you are only at risk of you are a smoker is false.

Clotting disorders are not identified. We also discovered that women are not being tested for blood clotting disorders that significantly increase their risk of developing a blood clot while on hormonal contraception. Fully 89% of the women in our study did not have such testing prior to starting hormonal contraception, and a further 9% did not know if they had any testing. Only 2% of the women were able to state with certainty that they had been tested.

These results, as well as additional results, will be explored further when the study is complete. We will be looking at women’s ages when they developed blood clots, warning signs and symptoms, other side effects from hormonal birth control, additional risk factors, and more.

Personal Story Findings

At Hormones Matter, we believe strongly in the power of the personal story. Like case reports, they give us a breadth and depth of information that cannot be captured as well in the more quantitative results. As part of this project, we have been collecting and publishing these stories. In addition to the trends emerging from the survey results, we’re seeing several disturbing trends regarding whether and how risks for blood clots are communicated, tested for and/or identified. In most cases, there appears to be a significant disconnect regarding these risks.

Risks for blood clots are not communicated. What do these stories have in common? The women who developed clots were not aware that these serious complications could develop as a result of hormonal contraception. Laura Buccellato, whose daughter Theresa died at age 16 from a pulmonary embolism, said in her story

“Our doctor did not go over any of the side effects with us or what to look for if something were to go wrong. I trusted my OBGYN because I have been with her for most of my life and she had four children so I never felt she would put Theresa in any kind of harm.”

If women are taking a medication with the possibility for serious injury or death, they should certainly be informed of risks. They should also be educated about early warning signs and symptoms of blood clots.

Signs of blood clots are not recognized by physicians. Another common and disturbing trend has emerged from the personal stories: in the early stages, and sometimes even in the later stages of the blood clot event, blood clots are not considered in the differential diagnosis. More often than not, when women approach their physicians with signs pointing to blood clots, they are dismissed.  The possibility of having a blood clot is not investigated or even considered, and most doctors do not even ask the patient about their use of hormonal birth control. For example, Kerry Gretchen was suffering from the symptoms of a blood clot in her brain for a month, and was sent home from the emergency room twice and told that her symptoms were due to a migraine. This resulted in even more severe effects from her stroke. Susan Eklund McKenzie had taken her daughter Marit to the doctor twice for symptoms related to a pulmonary embolism, but unfortunately this was never investigated, and Marit died at age 18.

Blood clots are devastating. Another commonality is just how catastrophic these blood clots can be. The women who have had strokes (stories are here, here and here) all had to relearn how to perform the daily functions of life, such as walking, writing, showering and dressing themselves, and some of the women have lasting disabilities.

It is known that pulmonary embolism has a high mortality rate, and the women whose stories we have shared who suffered from a pulmonary embolism, all died as a result (stories are here, here and here). Brittany Malone had a massive blood clot in her leg, and as a result suffered pulmonary hemorrhage, respiratory failure, heart attack, irreversible brain damage, and death.

We would all like to think that this could never happen to us, but as Detrease Harrison said, in her story of having a stroke after 23 years on the birth control pill:

“I used to tell people I had no risk factors for having a blood clot, but almost everyone has some kind of risk factor.”

Participate In The Birth Control and Blood Clots Study

There are two weeks left in this phase of our study, and then the survey will be taken down and to analyze the results fully.

If you are a woman who has suffered from a blood clot while using hormonal birth control, we urge you to participate in our study to help us learn more about this important women’s health issue.

Because of the severity of some blood clots, including death or serious disability, we allow parents, family members, or partners to take the survey for the affected individual.

If you know someone who might like to participate, please share this article with them.

If you have begun the survey and haven’t yet completed it, please do so in order to enable us to use your data. We cannot use your data, if the survey is not complete.

If you’ve completed your survey but haven’t yet sent us your story, please do so.

We will be continuing to share women’s stories over the next few months, so please continue to follow the study on the Hormones Matter website, on our Facebook page, and on Twitter.

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Stroke After 23 Years on Birth Control Pills

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My name is Detrease Harrison and I am 46 years old.  A month after my 44th birthday I survived a stroke in my sleep. I didn’t smoke or drink. I just happen to be an African-American, and we are TWICE as likely to have a stroke. I was also taking Ortho Novum 7/7/7, a birth control pill that increases the risk of stroke. I had been taking Ortho Novum for 23 years prior to my stroke.

I got out of bed that morning and collapsed. By the grace of God, my mother happened to call. I told her I had fallen, and her quick thinking to dial 911 saved my life. I didn’t understand why I had fallen and I went back to sleep on the floor. Now I realize that it was weakness resulting from the stroke that had caused me to fall. At the time when I got to the hospital, I had facial droop and difficulty speaking. I had a CT scan and my stroke was quickly diagnosed. My doctors said it had been caused by my birth control pills and took me off the pills immediately.

I had a thrombectomy to remove the blood clot, and then was sedated for several days as I recovered. I was hospitalized for 44 days in total. I had the support and love of family and friends who encouraged me to relearn how to walk, dress myself, and sit without falling over. I have been lucky with excellent rehabilitation services in a comprehensive stroke unit at a hospital near me.

I would have to say my biggest motivation to get better was my dog Scooter and the Dallas Cowboys. See, my fan club was going to the Cowboys game in Nashville Tennessee and I wanted to go too. It was the first time I would be leaving the safety and comfort of my mother’s care since my hospital discharge and be on my own, something I had done many times before in my 44 years. With my neurologist’s permission and my friend Kim at my side, I packed a bag and boarded a plane to Nashville.  I tailgated and cheered my Cowboys to victory from my wheelchair. A text message from Jason Witten and a tweet from Dez Bryant were the motivation that I needed to continue doing the things I enjoy doing.

My stroke recovery has not limited me at all. I am back to work as a full-time accountant at Virginia Commonwealth University.  Friends make sure that I still attend all of the happenings in Richmond.

I did not realize that I was at risk of having a stroke because of my birth control pills. Now that I know more about it, I realize that I may have been having transient ischemic attacks (TIA) for about 6 months prior to my stroke. A TIA is just like a stroke, except that the blockage is transient. These episodes serve as a warning sign that a stroke is going to happen, except that I was not aware of this at the time. I had been having episodes of dizziness and headaches leading up to my stroke, and since my stroke I have not had any of these episodes.

In closing, I would like to say that I am here today because of my mother’s quick thinking. I had no idea why I couldn’t get up from the floor that morning and I’m not sure I would’ve called the paramedics. But time equals brain.  So know the stroke symptoms and get help immediately. Don’t wait to feel better. You must be your biggest health advocate, and if something doesn’t feel right go to the doctor.  I used to tell people I had no risk factors for having a blood clot, but almost everyone has some kind of risk factor.

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.

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Fatal Pulmonary Embolism with No Warning Signs

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As a recent 23 year old college graduate, our daughter was entering into an exciting new phase in her life, when it was tragically cut short by a pulmonary embolism caused by her birth control pill.

In April 2013, Alex graduated from the University of Pittsburgh with a double major in communications and writing. At the beginning of that year she had entered into a relationship. So, during her Spring Break visit to her family home in Houston, she and her mother visited a doctor where she was prescribed Lutera for birth control. She seemed to feel well on it and never complained of any alarming symptoms to her mother or me. Following graduation she found work with an oil and gas marketing company in Pittsburgh and decided to stay up there, moving into a house with several other young women.

On the afternoon of October 30th of 2013, whilst waiting for the elevator with a co-worker, she suddenly collapsed. The co-worker called an ambulance and she was taken to St. Clair hospital, the closest facility. Her co-worker said that she was having shortness of breath, chest pain, and heart palpitations before she collapsed. During the drive there, the EMT called us in Houston and advised that our daughter had had some sort of seizure and was being taken to hospital. Her co-worker told us not to worry too much as it seemed to be an epileptic fit or similar and that she’d be fine.

About one hour after the first call we received a call from the emergency room doctor who advised that, if at all possible, we should get up to Pittsburgh STAT. By this time her boyfriend and a good friend of ours had arrived at the hospital, so we were able to get regular updates as we rushed to the airport. The main issue seemed to be that they wanted to life-flight her to the main hospital campus, but that it was proving difficult to stabilize her. A CT scan had confirmed a pulmonary embolism in her lung. We arrived in Pittsburgh approximately six-and-a-half hours after the first call, but she had died two hours before our arrival.

In talking with her boyfriend he told us that everything had been fine, although on the morning of her death she’d mentioned that her ‘butt’ felt like it had a pulled muscle. In addition, Alex had eaten dinner with our friend the night before, and had apparently mentioned that she felt tired. But there were really very few warning signs that could have alerted her or us that something was wrong leading up to her death.

This sudden loss has devastated us, forever changing our lives. It’s vital that all women who consider birth control of any sort should be aware of the risks, particularly those arising from the use of hormonal-based contraceptives. There are too many tragedies like that of Alex’s.

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.

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Sharing My Story, Feeding the Hope

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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.

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Birth Control and Blood Clots: Where Do We Go from Here?

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When I was 28 years old, I had a massive stroke (a cerebral venous thrombosis in the sagittal sinus area) from a combination of birth control pills and a fairly common clotting disorder, Factor V Leiden. You can read my story here (Part 1, Part 2, and Part 3).

As I mentioned in a previous article, I’ve recently been contacted by an amazing group of people who are making it their mission to research and share information about the safety of hormonal birth control and other women’s health issues. In looking for answers about her daughter’s death from the Nuva-Ring, Dru West came across my thesis online and contacted me about my research. After a series of equally serendipitous events, I was then invited to be part of a research team who will further study blood clots and hormonal birth control. I’m embarking on this journey to share what I find—the good, the bad, and the ugly. I’m embarking on this journey with the hope that we can prevent what happened to me from happening to other women. I’m embarking on this journey for the countless women who lost their lives by taking these drugs for birth control, for irregular periods, for acne, or the myriad other reasons for which they have been prescribed.

My role in this project includes sharing my own story, the research from my thesis, and combing through 1500 pages of congressional testimony from the 1970 hearings about birth control pills. These documents, the Nelson Pill Hearings, have been fascinating and overwhelming. And more than anything they’ve made me want to know more. I want to find out what was known about hormonal birth control back then and how the research has or hasn’t changed since. I want to know why synthetic estrogen was banned in chickens because it caused cancer in animals at the same time it was approved for women (at 100,000 times the quantity). I also want to understand why no women were allowed to testify at these hearings (they were kicked out). And I can’t wait to share what I find with you.

Like so many issues, women’s healthcare is complicated and multi-faceted. And I plan to explore all the possible strings tied up in this knot. Starting with the research from my thesis, I’ll be writing pieces about risk communication, clotting disorders, what women really know, and what they need to know. I’ll be sharing what I find in the Nelson Pill Hearings. And I’ll be investigating other women’s health issues as they come up, or as you bring them to my attention. At times I may get angry, I may get snarky, I may get overwhelmed. But I promise I will try to be as thorough, honest, and real as I can. We may be a small community—those of us who know there are far more dangers in these drugs than the pharmaceutical companies want us to believe—but we are smart and we are strong. And when we all come together to share knowledge, we are powerful. I hope that you will join me on this journey. Unlike corporations who have no problem putting a dollar value on the life of a person, I believe that if we can save just one woman from what happened to Julia, to Brittany Malone, to Erika Langhart and so many others, then all of this work will be worth it.

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.

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Blood Clots while on Hormonal Contraceptives: Fact or Fear Mongering?

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A few weeks ago, someone posted a news article on Facebook about another young woman who almost died from her hormonal birth control. One Facebook commenter made a remark that she hated the fear mongering that goes on about hormonal birth control in the news. I, on the other hand, truthfully wish more women knew what to fear. My 29-year-old daughter Julia died in 2013 from massive bi-lateral pulmonary embolisms while using NuvaRing as her birth control. We had just celebrated her marriage to a wonderful young man. Julia had been married exactly five weeks on the day she died. I cannot even begin to describe the grief we feel about her death to this day.

That Facebook comment made me think about what I now see as the fear mongering that the medical community engages in when they insist that the risk of blood clots during pregnancy and postpartum (after delivery) must always be mentioned to put the risk of blood clots “in perspective.” I began to wonder if we really know enough about the risks of blood clots with hormonal contraceptives.

Beyond Fearmongering: Learning from the Families who Lost Loved Ones to Hormonal Contraceptives

My daughter’s death led me to meet Joe Malone whose 23-year-old daughter Brittany died in 2012, also while using NuvaRing. Our daughters’ deaths have taken us on a long and frustrating journey to learn more about combination hormonal contraception (CHCs) and why our daughters died.

Joe and I understand why the medical community wants to make sure that women use some form of birth control. Maternal mortality is very high, especially in third-world countries. There are many health complications and dangers for women during pregnancy and in the weeks after delivery from a variety of causes. The risk of a blood clot is high. However, we now see how the information given about the risks for blood clots during pregnancy and postpartum is presented in such a way that seems intent on scaring women into taking hormonal contraceptives. There is little discussion about safety between the various types of hormonal birth control (pill, patch, ring, IUD or shot), or other options, such as a copper IUD or other non-hormonal methods. Every hormonal contraceptive and every formulation is pronounced safe and the risk of a serious event is declared rare.

Women are told to talk with their healthcare provider about these risks to learn more. We have found that this suggestion is insufficient because many of these providers themselves, do not understand the different risks associated with each contraceptive formulation/brand.

Inevitably, accompanying any mention of risk from a hormonal contraceptive is the stark warning that the danger of a venous thromboembolism (VTE) – a blood clot in leg or lung) is higher while pregnant or postpartum. We have learned the hard way that the risk of a blood clot may be higher, but the possibility of death from a PE while using combined hormonal contraception is even greater.

Risk for Blood Clots with Hormonal Contraceptives versus Pregnancy or Postpartum

After careful review of data from various governmental and independent agencies (see below for discussion), we now believe that the overemphasis on the risk of VTE in pregnancy creates a false sense of security regarding the safety of combined hormonal contraceptives compared to pregnancy. It minimizes the reality that something very dangerous can happen to a small, but recognizable, percentage of women who use hormonal contraceptives. Women are led to believe that hormonal contraceptives are much safer than being pregnant due to the VTE risk in pregnancy. Women are not instructed on how to recognize the early warning signs of a dangerous and potentially deadly blood clot, and sadly, we also discovered that neither are their doctors. According to data from the CDC,

more U.S. women died from pulmonary embolisms while using a combination hormonal birth control than from pulmonary embolisms while pregnant or postpartum in 2011.

There were approximately 69 deaths in the U.S. from pulmonary embolisms during pregnancy and post-partum in 2011 (the latest date for which these numbers are available), compared with approximately 307 deaths due to pulmonary embolisms for women who used a combined hormonal contraceptive pill, patch or ring in 2013 in a recent analysis Joe and I completed. A full analysis is posted on BirthControlSafety.org.

We believe the reason there are fewer deaths from a pulmonary embolism during pregnancy is that most women who are pregnant or have recently given birth are monitored much more carefully than women who use hormonal contraceptives. A woman who utilizes birth control pills, patches or a ring is seen only annually by her physician and very rarely advised of the signs and symptoms of blood clots.

When signs of potential blood clots emerge, such as chest pain, difficulty breathing or leg pain, women are told that they have bronchitis, pneumonia, asthma or a pulled muscle. You can read first-hand accounts from both men and women on a site called stoptheclot.org. When you read these stories, you hear how the medical community has a very difficult time diagnosing deep vein thrombosis or pulmonary emboli. People who go to their doctor with the symptoms of a blood clot in their lungs or leg, are more likely than not, told to take an antibiotic, a pain reliever or muscle relaxant and come back later. For many, later is often too late.

Women Who Die from Contraceptive Induced Blood Clots

Our review of the data suggest more U.S. women die from VTEs while using a combined hormonal contraceptive than during pregnancy or postpartum. This is in contrast to what is commonly reported.

Tragically, a significant number of women do die during pregnancy and the postpartum period, but they die from a variety of reasons that have nothing to do with a pulmonary embolism. You can read the list of other reasons that women die while pregnant or postpartum in the list from the CDC website. Some of the reasons for these deaths are preeclampsia, hemorrhage, and complications of caesarean section: many conditions that only occur during pregnancy or postpartum.

A 2015 study by Vinogradova, Coupland, and Hippisley-Cox published in the British Medical Journal on the use of combined oral contraceptives and risk of venous thromboembolism [8] put the risk at an even higher rate than the rates we used from the European Medicines Agency (EMA). So it is likely that we underestimated death rates associated with contraceptive induced blood clots.

Next time you read the disclaimer that “Pregnancy and the postpartum period puts a woman at higher risk for a VTE” maybe you’ll remember that this claim may not be entirely true. From what we can tell, more women die of a pulmonary embolism while using combination hormonal birth control than while pregnant or in the postpartum. Hopefully, women will become better educated to take care of their health issues before, during, and after pregnancy. In the meantime we need to educate every woman about what combined hormonal contraceptives do to a woman’s body.

Calculating the Risk for Death by Venous Thromboembolism

The CDC monitors Maternal Mortality and publishes figures on their website. For all deaths reported in 2011, “702 were found to be pregnancy-related.” This total includes deaths that occurred for a full year after childbirth [1] they also report that 9.8% of maternal deaths during pregnancy and postpartum are attributed to thrombotic pulmonary embolism. We calculated that a 9.8% rate equaled 69 deaths in 2011. At present, there are no published mortality figures from the CDC for 2013.

It is difficult to find the number of women who die from a blood clot in their lungs while using a hormonal contraceptive. The FDA’s Adverse Event database is voluntary, inconsistent and difficult to interpret. Some columns, such as the Outcome column are left blank. Even the FDA has acknowledged in the past that only 10 to 15% of adverse events are reported [2]. The FDA requires that pharmaceutical companies report adverse events, but no one else is required to report to the FDA or even to the pharmaceutical companies. Many healthcare professionals do not bother to report to the FDA, and it is unknown if they report anything to the pharmaceutical companies.

To try to understand the number of deaths caused by blood clots in the lungs, we relied on the VTE rates that the European Medicines Agency (EMA) publishes. In 2014, the EMA circulated a table of VTE rates [3].  This table gives a range for each type of progestin hormone involved in each of the combined hormonal contraceptives.

In the U.S., the FDA allows companies to put a chart on the package inserts listing estimates of venous thromboembolism which are currently estimated at 3-12 events per 10,000 women, but that number is lumped together for all formulations of hormonal contraceptives. By combining the rate of blood clot for each of the different types of hormonal contraceptive, it is impossible to look more deeply at the figures, especially at which hormones might be causing more blood clots. The EMA information allows this type of review.

We also purchased the prescription data from IMS Health and used information from the CDC to determine the number of women in 2013 that used different combination hormonal birth control products. IMS Health is a leading global information and technology services company, providing prescription drug data to a variety of corporations, and groups, including the FDA. The EMA gives a range of VTE rates based on the type of progestin hormone used, illustrated in Table 1.

Table 1: EMA Risk of Developing a Blood Clot.

Table 1- EMA Risk of developing a blood clot (VTE) in a yearBecause the number of deaths while using a combined hormonal contraceptive is unknown, we decided to calculate how many women might die. We used information from the reference book Contraception Technology [3], which says that 66% of women with a VTE will have a deep vein thrombosis and 33% with a VTE will have a pulmonary embolism. They cited a death rate of 6% for women with a DVT, and a death rate of 12% for women with a pulmonary embolism.

Using the data for contraceptive methods published in 2013, which is very similar to the CDC’s 2011 data, we calculated that there were approximately 11,000,000 women using a hormonal contraceptive that contained an estrogen and a progestin. The basic information is shown in Table 2.

Table 2: Comparing VTE Impact (estimated) across 2nd – 4th Generation Combination Hormonal Contraceptives for U.S. Women in 2013.

Table 2 Data Points

Next we calculated the estimated number of women potentially affected with a VTE, DVT, or PE using both the low and high EMA rates. We then calculated an average of these numbers. The estimated average number of deaths in 2013 from a pulmonary embolism is 307 deaths. This does not include deaths from a deep vein thrombosis, stroke, cerebrovascular accident, or hemorrhage or any other cause triggered by a combined hormonal contraceptive. Table 1 looks at the estimated rate of VTEs for different generations of contraceptives while Table 3, shows our calculations for VTEs, DVTs or PEs events [5].

Table 3: Calculations for VTEs based on type of progestin.

Table 3- Comparing Annual VTE rate

Joe Malone recently calculated the number of deaths in another way. He took the number of U.S. births in 2013, published by the National Center for Health Statistics[6], and numbers from a study by A.H. James [7] who stated that “VTE accounts for 1.1 deaths per 100,000 deliveries, or 10% of all maternal deaths.”

Using information from James’ study, Joe calculated that approximately 43 women died because of a VTE in 2013. (See Table 4). This number is far lower than the 307 women we calculated to have died in our analysis of women on combined hormonal contraceptives. The lower number of deaths in James’ study may be due to several factors. For example, James’ study was of deliveries, not pregnancies. The number of deliveries likely is lower than the number of women who become pregnant. Another factor might be that the number of deaths reported on the CDC website of pregnant women includes women who died up to one full year after giving birth, which would result in higher totals.

Table 4: Comparison of VTE Related Deaths – Pregnancy & CHC Use

Table 4 Pregnancy & CHC deathsBy whatever numbers we used, however, the death rate attributed to blood clots was higher in women using hormonal contraceptives than in pregnancy or postpartum. Moreover, the death rate was significantly higher. By continuing to suggest that the risk for blood clots, and indeed, death as a result of those blood clots, is higher in pregnant and postpartum women than in women using hormonal contraceptives, we place the health and well-being of millions of women in danger; and for some, this risk is deadly.

When I think about the fear mongering comment made in regards to an article about hormonal contraceptive safety, I cannot help but wonder if more information were made available, fewer families would experience the loss of a daughter, wife or mother. Understanding the real risks associated with a medication shouldn’t be considered fearmongering, just the opposite. In fact, to elevate the risk of death due to blood clots in pregnancy or postpartum above those of the medication, is not only fear mongering but dangerous.

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.

References and Resources

  1. Pregnancy Mortality Surveillance System, Centers for Disease Control and Prevention, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion. Updated December 23, 2014. http://www.cdc.gov/reproductivehealth/MaternalInfantHealth/PMSS.html/.
  2. Hazell, L. & Shakir, S. A. W. Under-Reporting of Adverse Drug Reactions A Systematic Review. Drug Safety 2006; 29 (5): (pp. 385-396). Retrieved from https://www.eecs.berkeley.edu/~daw/teaching/c79- s13/readings/AdverseDrugReactions.pdf
  3. European Medicines Agency. (2013). Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation,. Press Release dated 11/22/2013. Retrieved from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 13/11/ news_detail_001969.jsp&mid=WC0b01ac058004d5c1
  4. A. L. Nelson, M.D. & C. Cwiak, M.D., MPH, (2011). Combined Oral Contraceptives (COCs). In Hatcher, R. D., MD, Trussell, J., PhD., Nelson, A. L., M.D., Cates Jr., W., M.D., MPH, Kowal D., M.A., P.A., Policar, & M. S., MD, MPH. Contraception Technology (20th Edition). Chapter 11, (pp.249-275). Bridging the Gap Communications.
  5. Malone, J., West, D. & West, J. (2015) Retrieved from www.birthcontrolsafety.org, http://www.birthcontrolsafety.org/data–references.html and www.Nuvaringtruth.com, http://nuvaringtruth.com/women-injured-or-died-from-combination-hormonal-birth-control-in-2013/
  6. NCH Data Briefs, Number 175, December 2014. Births in the United States, 2013. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db175.pdf
  7. James, A. H. (2009). Venous thromboembolism in pregnancy. Arteriosclerosis, thrombosis,and vascular biology, 29(3), 326-331. Retrieved from http://atvb.ahajournals.org/content/29/3/326.full
  8. Vinogradova Yana, Coupland Carol, Hippisley-Cox Julia. Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases BMJ 2015; 350: h2135. Retrieved from http://www.bmj.com/content/350/bmj.h2135
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Can the Pro-Choice Community Embrace a Birth Control Dichotomy?

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In 2004, when I was executive director of Planned Parenthood Alberta, I gave an introductory presentation on fertility awareness for women looking for alternatives to hormonal birth control. One young woman who’d been on Depo-Provera for five years had been recently diagnosed with severe osteopenia. After quitting the drug, she said she realized in retrospect that for those five years she had felt like she was living “under the surface” of her life.

Another told the story of how she had struggled with serious mood issues while on the birth control pill. She would stop taking it, rely on condoms and emergency contraception for a while, then visit her doctor who would urge her to go back on the pill. After a few of cycles of on-off-on, she quit the pill once and for all. She said she decided to “just stop talking to this doctor about birth control.”

I’ve heard scores of stories like these over the past 30 years, and read hundreds more from women commenting on blog posts and online articles. For decades women have stopped using hormonal contraception to improve their health and well-being. Advocating on their behalf has been a major focus of my work as a pro-choice activist.

The Birth Control Dichotomy

I’ve been a pro-choice sexual and reproductive health advocate since I was 15 years old. Today I turn 60, celebrating a 45-year commitment to pro-choice values. But I mark the occasion with frustration and disappointment because the sexual and reproductive health (SRH) community to which I belong has failed to adequately–unreservedly–serve women who won’t, don’t or can’t use hormonal birth control.

I believe that what is keeping them from doing so is failure to acknowledge and embrace the dichotomy that exists within the pro-choice contraceptive framework.

A dichotomy is division of a whole into two mutually exclusive, opposed, or contradictory groups. If pro-choice contraception is the whole, two mutually exclusive groups are:

  1. women who use and like, or want to use hormonal birth control (HBC)
  2. women who use and like, or want to use non-hormonal birth control (NHBC).

Both groups deserve equal attention, support and services to use the birth control methods they decide are right for them. But this is not happening.

Just as we who hold pro-choice values don’t judge or hassle women for the reasons they choose to have abortions, we should not judge or hassle women for the reasons they choose not to use HBC, nor try to deter them. Yet anecdotal evidence abounds that women who want to quit the birth control pill, have their IUDs removed, or learn fertility awareness based methods (FABM) are often actively dissuaded from acting on their choices. It takes extreme self-assurance to do what one young university student told me she did when her doctor questioned why she didn’t want to use HBC. Her response: “My reasons are none of your business.” She said she knew the doctor would try to overcome her objections to the side effects she refused to incur.

I believe that pro-choice sexual health advocates and care providers can and must find a way to do their work effectively within this birth control dichotomy. We must acknowledge the right of women to choose HBC or NHBC depending on which best serves their health and contraceptive needs. And it’s our obligation to help them use their chosen method effectively and confidently, without persuasion or dissuasion.

This is not being done to the standard I believe it should.

Media, social media, and the blogosphere tell us that young women are ditching HBC, but not finding much information or support from their doctors or sexual health clinics for doing so. So why aren’t SRH organizations researching this identifiable “unmet need” or offering workshops on successfully transitioning from HBC to NHBC?

A one-size fits all diaphragm is in the works, and another silicone version is on the market but incredibly hard to find, as is the spermicidal gel required to use with it. So why don’t SRH clinics have programs in place to make them more accessible to women who want them? After all, the diaphragm was the contraceptive of choice for arguably the most influential sexual role model of the last 15 years – Carrie Bradshaw.

Evidence-based medicine proves that pro-choice FABM are as effective as HBC methods, and can be used with condoms to prevent STIs and emergency contraception if indicated, just as for HBC users. So why doesn’t every SRH clinic or organization provide certified FABM training on site or seek collaborative partnerships with certified, secular-based instructors?

Bottom line? The SRH community is failing to fully meet the needs of women who won’t, don’t or can’t use HBC. The current hoopla over LARCs – long-acting reversible contraception including copper and Mirena IUDs and hormonal implants – as the next best birth control “technology” is mere tangent, not solution. Other than the copper IUD, these are still drug-based methods many women want to avoid.

Women who want to use NHBC effectively and confidently, or seek treatments for menstrual cycle problems that do not require hormonal contraceptives, are turning to care providers and information sources outside the SRH community. Is this what we want?

I don’t get it. If I can embrace the birth control dichotomy and retain my pro-choice commitment why can’t other pro-choice health-care professionals, non-profit organizations, and advocates do the same?

My pro-choice values have co-existed for decades with my advocacy for NHBC and menstrual cycle education. But I admit that because of my chosen focus, it is often wrongly assumed that I seek to deny options rather than to increase them, that somehow I cannot possibly be pro-choice.

Successfully using fertility awareness for birth control from age 27 through menopause (See p.4-5) did not keep me from serving 10 years on the board of Planned Parenthood Federation of Canada, or from bringing me back as a current board member of what is now the Canadian Federation for Sexual Health.

Promoting body literacy – acquired by learning to observe, chart and interpret our menstrual cycle events so that we become fully informed participants in health-care decision making – as a life skill that all girls and women should learn, did not keep me from being executive director of Planned Parenthood Alberta. The organization, which became Sexual Health Access Alberta and closed in 2010, distributed educational resources that included the most comprehensive Birth Control Demonstration & Sexual Health Promotion Kit still available for SRH professionals.

Sharing evidence-based medical information about the value of ovulation to women’s health and how to treat menstrual cycle disorders without the use of hormonal contraceptives, did not keep me from writing commentaries in support of abortion rights.

Within the pro-choice sexual and reproductive health community, I’ve chosen to focus on body literacy, menstrual cycle education, and advocacy for increased access to NHBC. At 60, I’m more committed than ever to promote a broader perspective within my community, one that will fully acknowledge and embrace the birth control dichotomy, one that will serve equally, without reservation, the contraceptive needs of all women.

About the Author: Laura Wershler, B.Sc., is a veteran pro-choice sexual and reproductive health advocate and women’s health critic who has worked for or volunteered with Planned-Parenthood-affiliated organizations in Canada since 1986. Laura graduated with a Certificate in Journalism from Mount Royal University in 2011. She has contributed columns on women’s health to Troymedia.com and blogs regularly for re:Cycling, the blog of the Society for Menstrual Cycle Research. Follow her on Twitter @laurawershler.

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