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A Stroke from Hormonal Birth Control: Part 2

Published on March 24, 2016

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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 the first part of my story here.

Recovering from a Stroke

The repercussions of what having a stroke meant began to sink in after I was moved out of the intensive care unit.

Once in a regular hospital room, a therapist came by to do some tests. She pulled my blankets aside and asked me if I could take off my sock. This test seemed ridiculously easy, but I was willing, just happy that my head no longer hurt. I leaned forward and confidently pulled the sock off my foot. “Great,” she said. “Now put it back on.” So I put the sock back on my foot. Only I didn’t. Because I couldn’t. I stared at the sock in my hand and then I stared at my foot, knowing that I should be able to complete such a simple task, yet unable to.

This was the first of thousands of tests during my recovery. And it was the first of a thousand times when I knew I used to be able to do something that I could no longer do. It is one of the strangest sensations I have ever experienced.

I spent a week in the hospital and another week in an in-patient rehabilitation facility. Before I was discharged to go home (for another month of out-patient rehab), the psychologist told me that things would feel like “Christmas at the mall” instead of say, an ordinary Tuesday afternoon. It was an appropriate analogy for how overwhelming everyday life would be and one that I would come to understand the first time I broke into sobs when I dropped a bowl of cereal on the floor. I was cautioned against trying things like swimming alone, as I might not remember how and accidentally drown myself. They also told me that I had lost millions, maybe billions, of brain cells that I would never get back. And that I might never be able to work a “real” job again.

At home, I set about re-learning things like how to hook my bra, tie my shoes, and wash my own hair. Once I mastered these, I began to wonder what else I could do. I was extremely lucky that I made progress every day, but some days it felt like I’d never be back to normal. I wasn’t sure what normal even was anymore. After the warning from the psychologist, I was scared that I wouldn’t be able to handle a full-time job. And because of the seizures, I could not drive for six months which was devastating and isolating, especially for someone as independent as I had always been. Since I was stuck at home, it seemed like a good time to force myself to relearn math (yet another thing I knew I had been good at but could no longer do). I began to study for the GRE and less than six months later, I was accepted to graduate school.

Searching for Answers

When it came time to write my thesis, I decided to use my stroke as an inspiration for my research. I wanted to know why I had had a stroke, why no one had ever told me the risks involved with taking hormonal birth control, why I never knew there was a possibility that I had a clotting disorder which would greatly increase my risk. In short, I was looking for a smoking gun; someone or something I could point my finger at and say, “Aha! That is where the breakdown occurred. This is who should be blamed!”

But what I found was much more complicated. What my doctors had told me, that I was an anomaly, seemed to be supported by the research that I found. Studies show that most people get a blood clot within a year of starting hormonal birth control. Mine happened 10 years later. I learned that Factor V Leiden is fairly common but that women aren’t tested for it before being prescribed hormones because testing that many women would be expensive. I also found research that said pregnancy is more dangerous than birth control.

Putting aside the false dichotomy that the only two choices a woman has are to be pregnant or be on hormonal birth control, the message I took away from all of my research was that my stroke was an acceptable risk to save countless women from pregnancy. That even though my stroke could have been prevented by a simple blood test before I was even prescribed birth control pills, my value as a human woman was not worth the greater expense. As a child of the 80s and a product of American capitalism, this didn’t shock me as much as it probably should have. After all, I lived in a world of the Ford Pinto. What I didn’t realize at the time and would only come to understand years later, was that I began to internalize the blame for what happened to me. Maybe it was my fault for not knowing the dangers, for not understanding the risks, for being so stressed out that my body failed me.

Was It My Fault?

In researching my thesis, I discovered that pharmaceutical companies intentionally make the risk communication in advertising, and especially in the package with the birth control, dense and confusing. And I also found that women who have taken hormonal birth control don’t adequately understand the potential side effects, nor do they even know the symptoms of blood clots. There is very little accurate information about clotting disorders online. Even if my situation was rare, these facts are extremely troubling. But what I have since come to learn is that my stroke was actually not so rare.

Recently I’ve been contacted by an amazing group of people; researchers, families who have lost their daughters to hormonal birth control, fellow survivors, writers, and scientists. They’ve helped make it clear to me that I’m not just an anomaly. As you can see from the other stories on this site, hormonal birth control has very real, very harmful risks. And we have lost far too many amazing young women to stand idle any longer. Our standard must be higher than accepting these women’s lives as collateral damage. Together with this group of health advocates, we are embarking on a journey to give women what they need-information to make the right choice for them. Because what happened to me was not my fault. It’s time to stop blaming myself. Yet even as I write these words, I still have some doubt. And that doubt shows me that I haven’t fully recovered from my stroke yet. I still have work to do on this journey. And that work may take me the rest of my life. For more on what long-term recovery from a traumatic brain injury looks like, see Part 3 of the series.

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.

A Stroke from Hormonal Birth Control: Part 1

by Kerry Gretchen

Published on March 15, 2016

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Stroke from hormonal birth control - Kerry Gretchen

I opened my eyes and saw my husband, Josh, holding my hand, looking very serious. He was telling me that we would get through this, that even if I had to learn to walk again, that whatever it took, we would be okay. I remember thinking, “It’s okay, honey. I just have a headache.” We had been married for a year. The next time I opened my eyes Josh was leaning over me. I was on my side in the emergency room and the doctor had just asked him to hold me steady while he gave me a spinal tap to check for meningitis. Josh held me so firmly, terrified by the risks of a misplaced needle, that his arms were shaking from the strain. I tried to tell him, “Don’t worry about holding me. I can’t move anyway.” I had lost the use of my limbs hours before, maybe even days. And now it seemed my power of speech was gone, as well.

The headache had started a month earlier. I remember exactly when because it woke me in the middle of night and I had never had that happen before. We were visiting friends in New York right before Christmas. I got up and took some ibuprofen and didn’t give it much more thought. But it never really went away. I saw a chiropractor. I took more ibuprofen. I checked out a book on meditation. By the time I saw a gynecologist, I also had an unexplainable pain in my left thigh. The gynecologist told me the pain in my leg was probably just a muscle strain and she prescribed Imitrex for the headache, a migraine medication that shrinks the blood vessels in the brain.

The migraine medication made the headache go from dull and persistent to unbearable. I visited a health clinic where the doctor suggested an appointment with a neurologist the following week. That night my left arm started to go numb. I called a local pharmacist who said it might be my birth control pills. That’s crazy, I thought. I’ve been on them for 10 years. I slept on the couch because I couldn’t bear the thought of having to move to the bedroom. The music that had been on the television roared in my head like it had been trapped there on repeat. The next day I called the health center again and they told me to go to the emergency room.

Over the course of the next two days I would take 3 ambulance rides, be sent home from the emergency room twice, begin to lose all control of my body, and be given a very stern lecture by a nurse who thought I needed to learn how to “manage my stress.”

The spinal tap in the emergency room was not the first time Josh had to hold me down. Earlier that day, he tried to restrain me while my body thrashed wildly. During the seizure, I told myself that if I just calmed down, it would stop. It must all be in my head since the doctors said it was just a “tension headache.” We locked eyes, both of us terrified of what was happening to me. When the shaking finally subsided, he asked me if he should call 911. Again. All I could do was nod.

I did not have meningitis. There were blood clots in my brain and because they had not been treated right away, one of the veins in my head had burst and was bleeding. I was having a massive stroke.

Later, Josh would tell me about overhearing the neurologist and the neurosurgeon arguing. The neurologist thought they should operate. The neurosurgeon thought it was too risky. Neither wanted to be there. It was Martin Luther King, Jr. day. (I have since learned never to get sick on a holiday weekend.) In the end, they didn’t operate. I don’t remember exactly when they told me that I had had a stroke. But I know I had no understanding of what that meant. (I find that even now, ten years later, I am still learning.) As far as I knew, that was something that happened to old people. I was 28 years old.

At some point, they told me that I had a clotting disorder and that this genetic anomaly coupled with the hormones in my birth control had caused my stroke. This wouldn’t mean much to me until after I learned how to walk again, do math again, shave my own armpits again.

Not long after I was discharged from the hospital, I had an allergic reaction to the anti-seizure medication. I returned to the emergency room at the request of my neurologist. This time they immediately took me to an examination room. When the doctor walked in, the same doctor who had finally diagnosed my stroke, he said, “I’m so glad to see you. I didn’t think you were going to make it.”

That statement stayed with me throughout my recovery. Because though intellectually I understood that the stroke could have killed me, I never really understood the gravity of the situation until he said that to me. And it made me begin to really consider what happened to me and why.

I was first prescribed birth control pills at the university health clinic my freshman year of college. I wasn’t even sexually active at the time, it just seemed like a rite of passage. Why did no one tell me about the dangers of the pill? I wondered. And why didn’t anyone tell me that I could have a clotting disorder without knowing it? How many other women have this clotting disorder? How many other women have had blood clots? How many have actually died from hormonal birth control? Throughout my recovery, I struggled with these questions. Eventually, I even tried to answer some of these questions with my master’s thesis. For more on my recovery and thesis work, see Part 2 of A Stroke from Hormonal Birth Control.

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.

Deadly Blood Clots from the NuvaRing: Erika’s Legacy

by Karen Langhart

Published on October 1, 2015

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Erika Langhart was planning to make a difference in the world. She was never given that chance.

At just 24 years old Erika was struck down by a massive, double pulmonary embolism (blood clots that had traveled to her lungs), as a direct result (per her pulmonologist) of the NuvaRing. Investigative journalist, Marie Brenner, wrote an in-depth report (“Danger in the Ring”) for Vanity Fair magazine about Erika and her classmate at American University, and Olympic Athlete, Megan Henry regarding the dangers of this drug.

CNN Anderson Cooper 360 was subsequently inspired to air a special report: Families, lawsuits, raise questions about NuvaRing.

It is our greatest hope, with what remains of our lives, to fulfill our daughter’s goal of making a difference in the lives of others by helping to inform women about the dangers of not only the NuvaRing; but all hormonal contraceptive drugs – the pill, patch, ring and implants. We believe women deserve to be informed of the full truth about these powerful drugs.

Erika Langhart’s Case for Wrongful Death was dismissed on September 10, 2015 because we refused to settle with Merck. We never agreed to anything other than having her case heard in front of a jury for the purpose of exposing the truth about the NuvaRing and Merck. Following is our statement read to the Superior Court of the State of California for the County of San Francisco, NuvaRing Products Case #CGC-12-520371.

We were promised that Erika’s case would be filed in the state of Virginia, via the rocket docket, for a jury trial by the end of 2012.
We can only imagine the outcome had this promise been kept. We believe the truth about this drug, and Merck, would have been exposed through this trial and hundreds of women’s lives since 2012 would have been saved. We now have the very dubious honor of being friends with the parents of many of the young women who, unnecessarily, lost their lives to this drug. We hope you try to imagine what that is like for a moment…we can assure you there is nothing more painful to endure than losing a child to, what we view, as murder.
How you were able to convince/coerce the FDA into changing the NuvaRing label to a WEAKER label in October of 2013, all while more and more reports of injury and deaths were being filed with the FDA’s own MedWatch is stunning…and disgusting. Of course by doing so, you have effectively shut down all legal avenues for women who have been injured or who have lost their lives to this drug…
So, Congratulations!…however, we believe Justice will eventually reach you.
May God have Mercy on your souls for allowing, and helping, these tragedies to continue. You are putting money and profits before the very lives of innocent young women – we do not know how you sleep at night…as, we believe, you will certainly, eventually, meet your deserved justice on your own judgment day.
How you are able to defend Merck, and other members of these legal (and we use this word loosely) drug cartel corporations, is beyond us and perhaps you would do well do pay heed to the words of Dr. Benjamin Rush – a signer of the constitution and George Washington’s physician….
“Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship…To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic and have no place in a republic. The Constitution of this republic should make special privilege for medical freedom as well as religious freedom.” – Benjamin Rush, MD.
You are, in our opinion, facilitating the dangerous, and by principle un-Constitutional, Medical Industrial Complex through your actions…which is unnecessarily taking the lives of an untold number of American citizens, all in the name of Greed.
Merck’s “official statement” in response to being questioned about the danger of the NuvaRing follows:
“Blood clots have long been known as a risk associated with combined hormonal contraceptives. The FDA approved patient information and physician package labeling for NuvaRing include this information. We remain confident in the safety and efficacy profile of the NuvaRing – which is supported by extensive scientific research – and will continue to always act in the best interest of patients,” as published in Vanity Fair.
A more truthful statement of risk might read something like this: (our additions to their statement are in bold)
“Blood clots have long been known as a risk associated with combined hormonal contraceptives”.
We cannot explain, except by pure greed, why these drugs continue to be given to women when there are safe and effective alternatives for Birth Control available.
“The FDA approved patient and physician package labeling for the NuvaRing include this information”,
as negotiated by our highly paid consultant, and former FDA administrator of the Women’s Health division, Dr. Susan Allen, for the benefit of Merck.
“We remain confident in the safety and efficacy profile of the NuvaRing – which is supported by extensive scientific research” –
Paid for by us with expected outcomes supportive of future profits from the NuvaRing but ignores the independent, unbiased, extensive scientific research conducted by Dr. Lidegaard which does not support future profits for Merck from the NuvaRing –
“and will continue to always act in the best interest of patients”,
which we have to admit is a lie as evidenced by our track record with many of our other drugs such as Vioxx.
Congratulations on the continued growth of Merck profits for the NuvaRing at the expense of women’s lives; $723 million last year (K-10 report), alone, achieved in conjunction with the injury and death of hundreds, if not thousands, more women who are apparently just “acceptable risk factors” to Merck.
A $100 million dollar settlement was really a bargain for you to keep these kinds of sales going – the settlement even helped increase sales for Merck! Unbelievable, and criminal, in our opinion.

These words have been spoken in honor and memory of our beloved daughter Erika and the thousands of other young women who have unnecessarily been injured, or have had their lives taken, by Merck’s drug – The NuvaRing.

We would like to note that the judge in this case said that he was truly sorry and could not imagine this kind of loss of life.

Readers may be interested in viewing a short video by Dr. Peter Gotzsche regarding Big Pharma operations.

Real Risk Study: Birth Control and Blood Clots

This story is one of a series about women who have developed blood clots while using hormonal contraception. These articles are part of the Real Risk Study: Birth Control and Blood Clots, a research project to help women gauge their actual risk with hormonal birth control. For more information, or to participate click here.

Five Half-truths of Hormonal Contraceptives – The Pill, Patch and Ring

by Joe Malone

Published on September 24, 2015

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Brittany Malone - Nuvaring precipitated fatal blood clot

Have you ever wondered if the pharmaceutical companies and doctors are telling you the whole truth about the risks for side effects with the drugs they sell or prescribe? Do the side effect warnings seen in advertisements or on prescription inserts make any sense to you? If you are like me, probably not. In fact, if you’re like me you probably don’t give side effects much thought at all. Or at least I didn’t, until my daughter suffered from a serious side effect of a common medication, a medication millions of women take every day for years. My daughter died last year from hormonal contraceptive induced blood clots. You can read her story here: Brittany Malone. Now, I have made it my mission to educate other women and families about the very real risks associated with hormonal contraceptives and the incredible lack of data and information available to women to make an informed choice.

Playing Fast and Loose with the Numbers: Hormonal Contraception Carries Real Risks

For too long, the pharmaceutical industry and most likely your doctor, have been telling you what they want you to know about birth control drugs; instead of educating you with the information that you need to know to help you choose the birth control method that works best for you.

The communication of risk and benefit is a core component of health care counseling and should begin with the most fundamental principles of medicine: “First, do no harm.” I am not sure that is what is happening now. It didn’t with our daughter and many of the women and families we have met who have suffered similar tragedies.

What women really need to know is how a particular contraceptive drug or method compares to other types of contraception in terms of safety and effectiveness. In more personal terms, you need to know what the chances are that a particular contraceptive formulation or device will adversely affect your health. What I have learned since my daughter’s death is that this information is not easy to come by. In fact, it either doesn’t exist entirely or the manner in which it is presented is so convoluted that it is indecipherable and utterly useless.

The terms used by pharmaceutical companies as well as some leading contraception experts to describe these risks are either gross simplifications of the actual risk to life, or are enveloped in complex statistical and/or medical jargon that the lay person and even the physicians prescribing these meds cannot understand.

Here is what I mean. Below is a list of the most common half-truths regarding hormonal contraceptives and the risk for deadly blood clots.

Half-truth # 1: Blood Clots with Combined Hormonal Contraceptives are Rare

The increased risk of developing a dangerous blood clot when using combined hormonal contraceptives (CHCs) is a well-recognized, serious and potentially fatal adverse event associated with these medicines. A recent study published in the British Medical Journal (abstract) says there are even higher rates of blood clots than previously thought see Fresh Evidence Confirms Links between Newer Contraceptive Pills and Higher Risk of Venous Thromboembolism.[1] Unfortunately, most patients are unaware of this potential risk and if they are aware, they have no idea that a blood clot “cardiovascular event” can lead to their death. More studies can be found here on Birth Control Safety. Any time a drug is prescribed that is proven to cause death, even if it is associated with a small percentage of the users, the provider is responsible for explaining the risks factually, and in terms a lay person can understand. Consider these data:

On average, 307 women die in the U.S. every year due to a pulmonary embolism (blood clot in the lung) as a direct result of the use of the pill, patch or ring – a combined hormonal contraceptive.
Up to 2,600 women in the U.S. will develop a pulmonary embolism (blood clots in the Lung) as a result of the pill, patch or ring. Pulmonary emboli are potentially catastrophic and can lead to death.
Up to 7,700 non-fatal cases of deadly blood clots in the U.S. occur each year, due to the effects of the pill, patch or ring.

If you are like most doctors and all patients, you will be shocked to learn how many women are harmed annually by hormonal contraceptives.

For a full report, see Birth Control Safety. This report compares the estimated impact of blood clots across 2nd, 3rd and 4th Generation Combination Hormonal Contraceptives.

Unfortunately, most doctors leave their patients believing that combined hormonal contraceptives (the pill, patch and ring) are safe. As you can see from the data stated above, these drugs are safe for some people and very dangerous for others.

Half-truth #2: Only Smokers and Women Over 35 are at Risk for Blood Clots

The reality is that the estrogenic effects of combine hormonal contraceptives increase the risk of a potentially life threatening blood clot (venous thromoboembolism or VTE) by between 400% – 700% for ALL women at any age including those that don’t smoke and those that do smoke.[2] (Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013). The risk of smoking increases that risk by 40% compared with non-smokers [3]. That means, the increased risk of blood clots effects all users by 400-700% and the risk associated with smokers and for women over the age of 35 is even higher. This form of warning is misleading as many who read this think, “I don’t smoke and I’m under the age of 35, so this cardiovascular risk doesn’t apply to me. I’m safe to use it.” Even worse, this false sense of security is proven to mask the early warning signals of a potentially deadly blood clot.

The following is included as a “black box” warning in the most recent version (2013) of the NuvaRing patient information and reads as follows:

“Who should not use the NuvaRing?” Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing®, are strongly advised not to smoke.”

This statement infers that if you are a non-smoker and under the age of 35, that you should be able to safely use the NuvaRing. It also infers that if you are a smoker, even though you need to be concerned, you don’t need to be too concerned unless you smoke 15 cigarettes a day AND are over 35. This is misleading; intentionally misleading, I think.

In the same 2013 NuvaRing package insert, under the heading “What is the most important information I should know about the NuvaRing? Comes the answer:

“Do not use the NuvaRing if you smoke cigarettes AND are over 35 years of age. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination hormonal contraceptives (CHC’s), Including death from heart attack, blood clots or stroke. The risk increases with age and the number of cigarettes you smoke.”

Again, I think this statement falsely misleads women who do not smoke about their risks for blood clots. A more appropriate warning label might say something like this:

The estrogenic effects of combined hormonal contraceptives increase the risk of potentially life threatening blood clots by between 400% – 700%.

Hormonal Contraceptive Risk Counseling Misses Real Risks

Below are three videos that exemplify the lack of appreciation physician give to the real risks of blood clots with hormonal contraceptives. These are videos used to train physicians, nurses, pharmacists and other healthcare practitioners.

The Contraceptive Counseling Training Video below is a perfect example of how doctors and nurses are being taught to promote the effectiveness and safety of the pill, patch and ring without counseling women on the fact that these drugs to cause great harm, even death to some users.

Contraceptive Counseling Training Video

I find it very interesting that time is taken to review the side effects of spotting, bloating, nausea and breast tenderness, but the discussion of the dangerous side effects like blood clots, strokes, heart attacks which can lead to death don’t even come up. This has to change. Given the reoccurring annual loss of life attributed to these drugs, the true risks and early wanting signals of a dangerous blood clot need to be reviewed and thoroughly understood.

This next video is a great example of a typical visit with a nurse practitioner can unfold with zero safety information being shared relative to the increased risk of blood clots. Even worse, the question is asked “do you smoke at all,” and when the patient says I used to smoke and the nurse responds with the doctor’s advised you that you shouldn’t smoke while using the pill, the patient responds with yes. This is a great example of how the pharmaceutical companies have brainwashed doctors and nurses to highlight the risks associated with smoking, which leave a non-smoking patient to believe they are not at all exposed to any increased risk of developing a potentially catastrophic blood clot.

Brenda Oral Contraceptive Pill Counseling

In this final video, a patient shares that she smokes 10-15 cigarettes a day and the recommendation of the doctor/nurse is as follows “I’ve reviewed your family history and is it quite safe for you to take the pill. What I suggest is that you take the combined oral contraceptive pill. This is an example of the clinical issues that are putting our loved ones and friends’ lives at risk. Given that the increased risk of blood clots with CHC’s is well recognized, serious and potentially fatal, this practice of uninformed counseling is dangerous and needs to change before more women are killed.

A Contraception Consultation in Pharmacy

In each of these practitioner training videos, the real risks for blood clots associated with hormonal contraceptives is minimized. Women are not given the data needed to make informed decisions. As a result, when these risks turn to reality, they often go unrecognized. There are hundreds of stories of young women that were perfectly healthy and didn’t smoke that died suddenly from massive blood clots linked to the pill, patch and the ring. Birth Control Safety: Women’s Stories.

Half-truth # 3: All Hormonal Birth Control Methods are Equally Safe

Evidence confirms that newer contraceptive drugs have a higher risk of blood clots. In fact, the 3rd and 4th generation contraceptives (Yasmin, Yaz, Ocella, NuvaRing etc.) increase the overall risk by an additional 200% – 300%, above and beyond the risk for blood clots associated with earlier formulations. I think women should know this before choosing a method of contraception. I think physicians should make this information very clear to their patients. Unfortunately, I don’t think this is happening. Most patients and physicians alike do not understand the different risk profiles that each formulation of hormonal contraceptive carries. Prescribers especially should be aware and consider how the risk of blood clot with a particular combined hormonal contraceptives compares with other methods (see table 1) and help their patients make informed decisions. Currently available data provides compelling evidence that both 3rd and 4th Generation CHCs have higher risk of venous thromboembolism (see table 1) than the older 2nd Generation drugs, despite attempts to develop safer contraceptives for women.

Table 1. Risk for Blood Clots with Different Hormonal Contraceptives

Half-truth # 4: Blood Clots are more Common During Pregnancy and Postpartum

Pharmaceutical companies maintain the enormous market for hormonal contraceptives by telling doctor’s and women that it’s safer to use the pill, patch or ring than it is to get pregnant. This is a false comparison and here’s why. These dangers are of an unnatural substance interfering with body processes. Pregnancy however is a natural process, which the body is prepared to deal with. The pill, patch or eing actually introduce cardiovascular disease (blood clot) into your body (Confessions of a Medical Heretic, p29)[4]. Women who have already made the decision to use contraception have taken pregnancy off the table, so the real question is, how does the pill, patch and the ring compare to other forms of contraception in terms of both safety and effectiveness?

Women in the U.S. have on average of 2 births in their lifetime. The risk of these two period of life, pregnancy and postpartum periods, that total 30 months of time, cannot be compared to the risk that a women experiences while using a combined hormonal contraceptive continuous over the course of their child bearing years which may be as long as 25 years. This type of comparison (that the risk of a blood clot or other complication is many times greater during pregnancy), defies both logic and science. Comparisons of contraceptives should be between the various methods of birth control as this helps women make the most informed decision of which method of birth control works best for them. They have already made the decision to control birth (not get pregnant), so there is no need to compare these drugs to pregnancy.

Pregnant women often pay more attention to their bodies because they are concerned about their own health and the health and safety of their unborn child. Medical professionals more closely monitor pregnant women than hormonal contraceptive users. The identification of a venous thromboembolism is more likely to occur in a pregnant woman, as she has more frequent contact with the medical community. When a healthy woman is prescribed birth control, there is a “set it and forget it” treatment plan where the health provider may say, “Call me if you have any problems and come back in a year.”

This false comparison of risk of VTE in pregnancy versus the pill, patch and ring creates a false sense of safety with hormonal contraceptives compared to pregnancy. It minimizes the possibility that something terrible could happen while using a combined hormonal contraceptive. This is like warning someone to watch out for the charging elephant but failing to pay attention to the charging buffalo. Yes, an elephant’s foot may be bigger and heavier, but if a buffalo charges you will still have a problem.

The oversimplified and inappropriate presentation of the risk during pregnancy minimizes the increase rate of risk between 2nd, 3rd and 4th generation combined hormonal contraceptives. Newer is not better. In fact, the newer 3rd and 4th generation drugs increase the life threatening risk of blood clots and bring no incremental benefits outside of expanded choice.

Half-truth # 5: Double a Rare Event is Still a Rare Event

Healthcare professionals need to stop using that phrase “Double a rare event is still a rare event” when it comes to women’s lives. This is a statistical view of the mathematics that make up traditional risk management practices that minimizes the very risk of serious side effects, including fatality, associated with these medications. Even if these side effects develop in a small percentage of the users, the patient needs to understand these risks and it is the provider that is responsible for explaining the risks factually and in context that patients can comprehend.

In reality, if we double the rate of venous thromboembolism and pulmonary emboli, the number of related deaths grows from an average of 307 to 614 per year. The number of women impacted by the most dangerous type of blood clot, a pulmonary embolism, which has a 12% mortality rate, grows from an average of 2,560 to 5,120 women annually. Pulmonary embolism survivors are subject to additional treatment, which typically includes anticoagulant medications (blood thinners) and varies in type of treatment and duration based on severity. Some women need immediate emergency treatment, others can be treated as an outpatient. Patients are typically treated for 3-12 months, but some must remain on blood thinners for extended period of time.

As you can imagine, this dismissive, although witty, statement does not attune the health care community to pay serious attention to the possibility that real people will die or be permanently injured. Furthermore, when you multiply a small number by a large number of users the impact of these “rare events” equates to many more deaths than anyone realizes. Rare events DO happen and they happen to real human beings! It is also an insult to the thousands of women (and their families) who have been injured or died particularly when there are much safer and more effective alternatives available

The Bottom Line: Hormonal Contraceptives Carry Significant Risks

FACT – Combination hormonal contraceptives dramatically increase the risk of dangerous blood clots.
FACT – Blood clots (acute thrombotic events) are known to lead to sudden death or lifelong problems.
FACT – Pulmonary embolism (blood clot in the lungs) are the most dangerous form of thromboembolism which has a 12% mortality rate.
FACT – 20%-25% of pulmonary embolism related deaths present as sudden death (No Warning) [5].
FACT – A woman is 20 times more likely to become pregnant if she uses birth control pills, a patch or a ring than if she uses an IUD or an implant [6].

References

Jick S, Fresh evidence confirms links between newer contraceptive pills and higher risk of venous Thromboembolism BMJ 2015;350:h2422 doi: 10.1136/bmj.h2422 (Published 26 May 2015).
Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013 – Birthcontrolsafety.org).
Goldhaber S, The Clot Blog of Medscape.com, VTE risk in women who smoke; http://www.medscape.com/viewarticle/801689 last sourced 9-15-2015.
Mendelsohn S, Confessions of a Medical Heretic, Chapter 2, page 28.
Beckman M, Hooper WC, Critchley S, Ortel T. Venous thromboembolism: a public health concern. Am J Prev Med. 2010;38(4 Suppl):S495-501.
American College of Obstetricians and Gynecologists, Frequently Asked Questions FAQ#184 Contraception: Long-Acting Reversible Contraception (LARC): IUD & Implant.

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

by Dru West, MFT

Published on September 15, 2015

5328 views

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.

Because 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.

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.

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

By 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

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/.
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
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
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.
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/
NCH Data Briefs, Number 175, December 2014. Births in the United States, 2013. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db175.pdf
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
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

Tackling the Contraceptive Conundrum: Questions and Answers

by Chandler Marrs, PhD

Published on August 17, 2015

3959 views

Last weekend I had the privilege of speaking at a much overdue conference on hormonal contraceptive safety – the Contraceptive Conundrum. I was charged the unenviable task of giving the ‘overview of everything’ talk and providing a framework through which to view these medications; not easy in a 45 minute presentation. Needless to say, there was a tremendous amount of information omitted from my talk. I will be sharing some of this information in series of blog posts over the coming weeks. The presentation was videotaped and I will post it when it becomes available. For the time being, however, I would like to offer up the power point (below) and answer some of the questions posed by audience members that I was unable to address or address fully given the time constraints.

Best Medical Journals

One of presumably less controversial questions I was asked was which medical journals I prefer. As it turns out, even this question inspires indignation on social media. I am strong proponent of open access journals and the entire open data movement. I believe that health research should not be hidden behind a paywall and the raw data behind drug safety trials ought to be readily available for independent analysis and scrutiny. Indeed, all science should be in the public sphere and a part of public discourse. As a matter of course, science should not be available only to the privileged few. The mere suggestion that I prefer open access journals, however, ignited a heated debate on Twitter; the instigators of which suggesting this preference supersedes attempts to access paywalled articles. Let me assure you it does not. I always track down primary sources. Nevertheless, for the reasons stated above and many more, my preference is for open access journals.

Hormonal Contraceptives and IVF

Another audience member asked about the research and risks associated with the use of hormonal contraceptives and IVF. I should preface my response with a disclaimer: I am no expert in IVF, however, I have written about fertility medicine on a number of occasions (here, here, here), mostly with regard to this specialty’s hubris and egregious lack of insight or concern regarding the longer term consequences of many of their practices. As a point of consideration, I write about the hubris and lack of research that pervades all of women’s healthcare. Those are my biases, do with them what you will.

As far as the use of hormonal contraceptives and IVF are concerned, the research is mixed at best and unacceptably limited in scope. The reasoning for using oral contraceptives in advance or in conjunction with IVF treatments ranges from the ease of cycle scheduling to a purported increase in oocyte yields. From an IVF expert:

In my view, it is not only acceptable, but even ideal to take the BCP [birth control pills] for at least one cycle prior to starting COH [controlled ovarian hyperstimulation] in preparation for IVF. Doing so allows one (without prejudice) to better plan and time cycles of IVF. Furthermore, since the BCP also suppressed LH, it is often especially advantageous in older women, in women with diminished ovarian reserve and in those with PCOS (in whom high LH levels can compromise egg/embryo quality).

Despite the perceived utility of these medications, some research suggests that perception diverges from reality. In fact, the use of oral contraceptives in IVF may not be beneficial in increasing oocyte yields or pregnancy outcomes, especially in older women with limited oocyte reserve. A recent study, Does hormonal contraception prior to in vitro fertilization (IVF) negatively affect oocyte yields? – A pilot study found that even in young women with sufficient oocyte reserve, combined oral contraceptives diminished the number of oocytes retrieved compared to women who were not given oral contraceptives. The androgenic contraceptives were most deleterious. This comes on the heals of a Cochrane Review that found that not only was there limited research on the topic, but oral contraceptives resulted in poorer pregnancy outcomes. Missing from these data are the very real risks to maternal health mediated by the cocktail of hormones used in IVF (Lupron being top among them, followed by dexamethasone) and the potential long-term consequences to the health of the children born from IVF. Despite the lack of data and the often contradictory research findings, the practice of using oral contraceptives in IVF is well entrenched.

Hormone and Other Differences Between Oral Contraceptives, Depo Provera, NuvaRing and the IUDs

From the hormonal perspective, the various forms of contraceptives differ mostly by the type of synthetic progestin used. Oral contraceptives use a variety of progestins (see here), while Depo Provera contains medroxyprogesterone, hormonal IUDs utilize levonorgestrel and NuvaRing uses etonogestral. Most of the oral contraceptives contain the synthetic estrogen, 17a-ethinylestradiol, as does NuvaRing. Depo Provera is a progestin only, injectable form of birth control while the hormonal IUDs are a slow-release progestin only contraceptives. In addition to the differences in formulation and dose, each of these methods utilizes a different different delivery mechanism. The delivery mechanism will affect how much of the drug is absorbed and bioavailable, how quickly, the duration of availability, and those variables (along with several others), then affect the risk for side effects. Videos on pharmacokinetics and pharmacodynamics can be viewed here (dynamics video follows).

How Do Oral Contraceptives Affect Mitochondrial Morphology and Replication?

While there is a noticeable lack of data in this area, there are clear indicators that ethinylestradiol induces both structural and functional damage to mitochondria in the liver and the kidney, at least in rodents. Liver biopsies of women using oral contraceptives have also demonstrated structural changes in mitochondria. I would suspect similar changes in mitochondria throughout the body.

Indirectly, we know that reduced endogenous estradiol concentrations (here, here, here) damage mitochondria and that women who use oral contraceptives have lower endogenous estradiol concentrations. We also know that oral contraceptives deplete vital nutrients that are critical for mitochondrial functioning. And we know that the metabolism of 17a ethinylestradiol, the estrogen used in hormonal contraceptives, oral and otherwise, does not follow the same path as endogenous estradiol, and thus, likely damages mitochondria. (Ethinyl estradiol metabolism produces what are called catechol estrogens. Catechol estrogens are both directly (DNA adducts) and indirectly (mitochondrial reactive oxygen species – ROS- evoked as a byproduct of the metabolism) implicated in animal models of cancer.) Complicating matters, however, endogenous estradiol depending upon the concentrations, can have both pro – and anti-oxidant properties and impact mitochondrial functioning both positively and negatively. Nevertheless, I would argue that the synthetics derail the balance of endogenous hormones and because of their very real structural and functional differences, evoke a number of processes that are not only distinct from those of the endogenous estrane hormones but are likely damaging in ways we have not yet begun to understand.

Presentation

Birth Control, Big Money and Bad Medicine: A Deadly Trifecta in Women’s Health from Hormones Matter

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Pill Bleeds Are Not Periods

by Lara Briden, ND

Published on June 3, 2015

12044 views

The Pill is not just contraception anymore. It has become standard treatment for everything from acne to endometriosis to irregular periods. Yes, hormonal birth control can mask symptoms, but it cannot “regulate” hormones or periods in any meaningful way.

Hormonal birth control does not augment or regulate hormones. Instead, it suppresses ovarian function and shuts down hormones completely. It replaces endogenous hormones with synthetic steroids, and that’s not good enough for women’s health. Real hormones have many benefits for health that synthetic steroids simply cannot deliver.

Real Hormones versus Synthetic Hormones

Our real endogenous hormones are estradiol and progesterone. In contrast, synthetic steroids are ethinylestradiol, levonorgestrel, drospirenone, and many others. Real hormones and synthetic steroids are similar molecules, but they’re not identical and as a consequence, synthetic steroid have many different effects on the body, some of which we are only now beginning to understand.

For example, estradiol improves insulin sensitivity. Its synthetic counterpart ethinylestradiol impairs insulin sensitivity [1] (which is one of the ways the Pill causes weight gain). Progesterone is beneficial for hair, brain health, and bone density, but its synthetic analogues levonorgestrel, drospirenone, and medroxyprogesterone have quite different effects. They cause hair loss, depression [2], and reduced bone density. Moreover, the drospirenone progestin found in the Yaz, Yasmin and Ocella series of birth control pills, increases the risk of heart attack and stroke six fold. Its modified shape blocks what are called the mineralocorticoid receptors. These receptors are responsible for salt and water balance (think swelling) and blood pressure.

The only way that ethinylestradiol and progestins are similar to real hormones is that they induce a uterine bleed. They can even induce it monthly, but only if they’re dispensed that way.

Why Bleed?

Who really cares about a bleed for its own sake? If women can’t have real hormones, then why have a monthly bleed at all? It is merely to give the appearance of a period, and reassure women that they’ve had a period (when they haven’t). A bleed does prevent excess build-up of the uterine lining, but it does not have to be monthly. It can be quarterly or yearly or any time we withdraw from the synthetic steroids. Regardless of when we choose to bleed, the pill bleed is not the same as menstruation. Remember, the purpose of oral contraceptives is to block ovulation and prevent pregnancy. Without ovulation, our bodies do not produce endogenous hormones. Indeed, as any woman who has gone off of the pill after a long period of usage will tell you, it takes some time for ovulation and hormone production to begin again.

Normalizing our Periods: A Myth

Interestingly, the “regulation” of periods was the Pill’s earliest cover story. When the Pill was first developed, it could not be sold as contraception because contraception was not legal. Instead, the Pill was ostensibly prescribed to “normalize” periods. “Normalize” was a quaint euphemism which really just meant to be “not pregnant” (wink-wink).

Five decades later, and the Pill’s early cover story has now taken hold as a kind of weird counterfeit reality. Doctors readily prescribe oral contraceptives for all manner of female reproductive disorders, the most common of which is to ‘normalize’ the menstrual cycle. What they, and most women, fail to realize is that the monthly bleed precipitated by the withdrawal of synthetic steroids, is not a real period. It is simply a withdrawal bleed.

It’s time to end it. It’s time to bring back real periods.

There Is Another Way

As a naturopathic doctor working in women’s health for twenty years, I want my patients to have real periods. More precisely, I want them to have a follicular phase and make estradiol. I want them to ovulate, so they can then have a luteal phase and make progesterone. In short, I want my patients to make real hormones and to enjoy their many benefits.

There’s another reason I want my patients to have real periods. A healthy, regular period tells me that all is well with her underlying health. If a woman does not have healthy periods, then I keep working with her until she does. We use her period as a helpful, useful marker guiding her health decisions. We think of it as her monthly report card.

It’s not always easy to restore healthy periods, but it can be done. But with a little perseverance, natural treatments such as diet, supplement and herbs work well, and they give women what they deserve: A real period rather than a pharmaceutically induced bleed.

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

Kojima T et al. Insulin sensitivity is decreased in normal women by doses of ethinyl estradiol used in oral contraceptives. Am J Obstet Gynecol. 1993 Dec;169(6):1540-4. PMID: 8267059
Kulkarni J et al. Depression associated with combined oral contraceptives–a pilot study. Aust Fam Physician. 2005 Nov;34(11):990. PMID: 16299641

Antibiotics during Pregnancy: Finally Pharmacokinetic Research

by Chandler Marrs, PhD

Published on February 5, 2015

2791 views

A common refrain of mine is the lack of drug testing in women, especially pregnant women and relative to the enormous hormone changes women experience across a cycle, across pregnancy or postpartum and frankly across the lifespan. Hormonally, a 16 year old is not the same as a 45 year old. A woman’s biochemistry is not the same early in her cycle as it is late in her cycle. Nor is it the same when she is on oral contraceptives or hormone replacement therapies compared to when she is not and most especially, the pregnant woman’s biochemistry is hugely different than that of a non-pregnant woman. And yet, despite the lack of testing, lack of data, and limited understanding about how medications work relative to a woman’s hormonal state, women, pregnant and non-pregnant alike, are routinely prescribed medications for which we have a very poor understanding of the basic pharmacokinetics (how a drug travels through the body) or pharmacodynamics (what it does and how it works).

Ever so slowly, this may be changing. A group of researchers from the University Chicago, recently published a study on the Influence of Body Weight, Ethnicity, Oral Contraceptives and Pregnancy on the Pharmacokinetics of Azithromycin in Women of Childbearing Age. Though the study was small with only 53 pregnant women and 25 non-pregnant women, it represents one of the few published pharmacokinetic studies done on a drug routinely prescribed to pregnant women that evaluates hormone state.

Azithromycin: the Most Common Antibiotic Prescribed During Pregnancy

Azithromycin, more commonly known as Zithromax, Azithrocin, Z-Pack or ZMax, is the most frequently prescribed antibiotic for a range of bacterial infections of the ears, skin, throat. It is believed to be safe during pregnancy, despite having a pregnancy category rating B (a designation given a medication that has not been tested in human pregnancy but appears to be safe in animal studies). Some research shows that Azithromycin appears to have no more adverse reactions than other antibiotics, but whether it is truly safe, whether pregnant pharmacokinetics are different than non-pregnant or how they are different had never been determined. The University of Chicago study demonstrated what many have always suspected:

pregnant women metabolize medications differently (more slowly) than non-pregnant women
oral contraceptives slow drug metabolism
and interestingly enough, African American women show different pharmacokinetic patterns than Caucasian, Hispanic, Pacific Islander or Asian women

Pharmacokinetics: The Basics of Drug Disposition

The disposition of a drug (how it travels through the body), is affected by a number of physiological variables including plasma volume (greater when pregnant, lower when dehydrated), protein binding (fat soluble drugs travel through the system bound and protected from metabolism-preparation for excretion- by carrier proteins), liver and kidney function (our waste removal systems). Any alteration to these variables affects how long a drug stays in the body, how much of the drug is available to exert its effects on the tissues or organs, and how effectively it is cleared from the system. Determining the disposition of the drug- the pharmacokinetics- is very important for drug dosing and ultimately, safety. Every one of those drug disposition variables is affected by the hormone changes of pregnancy, postpartum (menstruation, menopause, oral contraceptives, HRT, etc.).

In the case of Azithromycin, pregnancy significantly slowed metabolism and clearance of the drug in pregnant Caucasian, Hispanic, Pacific Islander and Asian women, but not apparently in African American women or women not taking oral contraceptives. Translated, this means that pregnant Caucasian, Hispanic, Pacific Islander and Asian women were exposed to more drug, for a longer period of time, than were African American women. Ditto for women taking oral contraceptives versus those who were not taking oral contraceptives.

The researchers did not investigate whether hormonally-related changes in immune function interacted with the pharmacodynamics of the drug–rendered it more or less clinically effective. Nor did they evaluate whether or how other medications may have influenced drug disposition. As an aside, women in the pregnant group were taking more medications, in addition to the antibiotic in question, than the non-pregnant group.

What this research does show, however, is that hormones, or at least ‘hormone state’ affects drug disposition significantly. Additional studies are needed to determine how and if more customized dosing is required in pregnant and non-pregnant women alike.

This article was posted previously in September 2012.

birth control - Page 7

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Half-truth #2: Only Smokers and Women Over 35 are at Risk for Blood Clots

Hormonal Contraceptive Risk Counseling Misses Real Risks

Contraceptive Counseling Training Video

Brenda Oral Contraceptive Pill Counseling

A Contraception Consultation in Pharmacy

Half-truth # 3: All Hormonal Birth Control Methods are Equally Safe

Table 1. Risk for Blood Clots with Different Hormonal Contraceptives

Half-truth # 4: Blood Clots are more Common During Pregnancy and Postpartum

Half-truth # 5: Double a Rare Event is Still a Rare Event

The Bottom Line: Hormonal Contraceptives Carry Significant Risks

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Risk for Blood Clots with Hormonal Contraceptives versus Pregnancy or Postpartum

Women Who Die from Contraceptive Induced Blood Clots

Calculating the Risk for Death by Venous Thromboembolism

Table 1: EMA Risk of Developing a Blood Clot.

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

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

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

Real Risk Study: Birth Control and Blood Clots

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Hormonal Contraceptives and IVF

Hormone and Other Differences Between Oral Contraceptives, Depo Provera, NuvaRing and the IUDs

How Do Oral Contraceptives Affect Mitochondrial Morphology and Replication?

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Real Hormones versus Synthetic Hormones

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Real Risk Study: Birth Control and Blood Clots

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