birth control blood clots

Birth Control Induced Pulmonary Emboli: Sudden and Slow

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Pulmonary emboli are notoriously difficult to diagnose clinically, especially in otherwise healthy young women. The early signs include such nondescript symptoms as breathing difficulties, chest or back pain, and fatigue; symptoms that are easily attributable to a host of viral and bacterial infections or other less serious respiratory conditions. As a result, and more often than not, it is not until complete hemodynamic collapse that PE is considered; a point at which survival is significantly less likely. Even then, for young women the prospect of pulmonary emboli is not always on the differential. We saw this repeatedly in our pilot study, the Real Risk Birth Control and Blood Clots study where the prospect of birth control induced blood clots was rarely considered. From a review of records and case stories, blood clots seemed only to be considered after everything else was ruled out. That is, they were near the bottom, if not absolutely last, on the diagnostic differential. When the emboli were in the lungs, this refusal to consider contraceptive induced hyper-coagulation has deadly consequences.

When we consider that the most commonly recognized risk associated with hormonal birth control are blood clots, one cannot help but wonder why birth control-induced blood clots are not automatically ruled out when women present to the ER in crisis, but they are not. Time and time again, the early signs of an imminent crisis were dismissed by healthcare practitioners. Neither the deep vein thrombi that frequently preceded the pulmonary emboli by as much as a month, nor the pulmonary emboli were immediately recognized. And as we reported previously, recognition was equally labored in women who developed cerebral venous thrombi, brain clots, often requiring 2-3 ER visits before the diagnosis is even considered. I am not sure why there is such a total break down in clinical acuity when it comes to birth control-induced blood clots, but by all accounts, there is.

Perhaps our familiarity with these drugs has bred a false sense of safety; one so firmly entrenched that even when faced with evidence to the contrary, when life or death hang in balance, we cannot bring ourselves to acknowledge their risks. Perhaps so strong is our desire and need to have effective birth control options, that we employ a sort of willful ignorance about the risks. Or more cynically, perhaps we have simply been duped by Madmen inspired, pharmaceutical funded half-truths and platitudes.

Whatever the reasons, the patient reports suggest that when confronted with evidence of blood clots, all involved tend to dismiss the possibility until all other causes are ruled out. Physicians especially seem reticent to consider blood clots, forgetting entirely that hormonal birth control hyperactivates blood coagulation cascades in favor of clotting – in all women, not just some women, but in all women. They increase pro-clotting factors by 170% and decrease anti-clotting factors by 20%, a change in hemodynamics that all but guarantees a propensity toward body-wide clotting, especially when other health or lifestyle variables are present. No matter the chemistry, however, when clots happen, we all seem genuinely surprised. If the results of this study show anything, it is that birth control induced blood clots are real and should be ruled out first, not last.

Sudden and Slow: The Two Faces of Pulmonary Emboli

One of the key goals of the Real Risk Birth Control Blood Clots study is to identify early warning signs of clotting. To that end, the women who took the survey were asked to identify the presence and severity of 35 symptoms commonly attributed to blood clots, at a month out, a week out, the day before, and the day of, the crisis. Although we found significant linear trends in the escalating severity of many symptoms across time for the group as a whole, more telling were the patterns that emerged when we divided the groups by diagnosis (DVT,  DVT + PE, stroke, etc.). There we see distinct patterns in the type of symptoms as well as the trajectory of expression and severity.

For example, when we look at the patterns of early warning signs of pulmonary emboli, we see two, possibly three, trends emerging. In some women, pulmonary emboli seem to appear suddenly with few if any warning signs. In other women, symptoms either increased over time or waxed and waned (or both), sometimes for months, until reaching an apex of severity. For the latter group, the waxing and waning seemed related to the movement of the clot(s) from the periphery to the lungs. That is, the localized pain, swelling, and temperature changes, either in the legs, pelvis, abdomen, or collarbone regions, would be severe for a week or a month before the event and then dissipate entirely, only to re-emerge as the crushing pain associated with the pulmonary embolism. We will be reporting more details in subsequent articles, but preliminarily, the data and the personal accounts suggest the possibility that PEs may be preventable, if the signs of deep vein thrombosis (DVT) are more readily recognized.

Listed below are descriptions of the events leading up to the crisis reported by women with pulmonary emboli who completed Phase 1 of the Real Risk Birth Control and Blood Clot survey. A similar report was published for women who survived strokes.

Sudden Onset

“my chest hurt to the point I could not lay down or move without excruciating pain” – during the crisis – no symptoms prior.

CS2 reports severe right thigh pain the day of the crisis, as well as moderate chest pain, shortness of breath and fatigue and mild back pain, but nothing before that point. The PE caused low blood pressure. Doctors were unable to detect blood pressure in her right arm.

JR began to experience mild discomfort the day before her crisis. The day of her crisis, she explains, “the symptoms [severe shortness of breath, chest pain, irregular heartbeat, dizziness, blackouts, fatigue, and mild to moderate headache, nausea, difficulty speaking, and stomach pain] worsened as the day went on.” She goes on to say that “right before I passed out and then once when I woke up, it was crushing burning pain and my heart was beating so fast that I couldn’t catch my breath.”

RF’s clots originated in the pelvis and legs and experienced severe pain and swelling in the pelvis the day before her crisis.

Tales of Traveling DVTs

“…right lower calf was swollen and warm to the touch, pain felt like a Charley horse. Chest pain was unbearable. It hurt to breathe and my heart was racing so fast that it hurt.” – per her data, leg pain developed a week before but disappeared; chest and heart pain appeared the day of the crisis; fatigue was moderate to severe from week before.

Twenty year old CS  reported moderate to severe right shoulder and chest pain a month before the crisis, along with moderate fatigue from a week out. The day of the crisis, the pain moved to lower chest. She describes the chest pain as: “Every time I took a breath in it felt like a knife was being stabbed into my chest on the right side.” Like so many others, she was sent home from doctor’s office day of crisis only to return to ER that night to discover her right lung was riddled with clots, necrotic in places.

KM had very few symptoms leading up to her PE, except a “sharp pain deep in my calf – I thought I had a badly pulled muscle or strain my Achilles tendon (up high) while jogging. The pain got much worse if I was standing for long periods of time, but got much better if I exercised.” She also reports shortness of breath climbing stairs or when giving a presentation.

ES described her symptoms: “leg pain felt like a bad cramp, almost as the back of the leg had seized up. I thought it was a pulled muscle because I lacked other symptoms. The PE pain was a crushing, hot pain in my chest, worse when breathing in.” Her leg pain began a month prior to the PE, peaked a week before and then dissipated entirely. While the pain from the PE began a week prior to the crisis and escalated.

FH rates all of the symptoms leading up to the crisis as mild, even though some of the symptoms emerged months before. She chalked up her leg pain to occasional muscle cramps and the shortness of breath to sinus issues.  It wasn’t until she began blacking out that she suspected something more serious was wrong. She notes on the day of the crisis she was cold and her blood pressure was extremely low.

KG reports that “a month before the clots my toes on the right side got red and swollen and felt throbbing. After working out at the gym had chest pain, shortness of breath, [my] ribs hurt, heavy chest that felt like extreme gas pains.”

KD describes how the pain seemed to move with the clot. “The pain in my left quad felt like an injury. Then when it moved to the ribs, it felt like I had pulled ribs. Then when it moved to the right side, it felt like a kidney stone and only hurt bad when I was lying flat on my back. My leg pain, after the clot had already exploded into my lungs, was like a bad Charley horse. My lungs had clots everywhere.”

SD reports severe leg pain 3-4 weeks before experiencing the difficulty breathing associated with her PE.

Waxing and Waning Symptoms

For 43 year old DW symptoms like dizziness, blackouts, and vomiting had emerged a week prior and then dissipated until the day of the event, when they returned along with severe shortness of breath, chest pain and heart palpitations. She describes the pain as “tight legs, stabbing pain and then collapsed. All happened within 5 minutes.

For DD the DVT that preceded the pulmonary emboli “felt exactly like a Charley horse. When it lasted more than two days and I started limping, I knew I needed to consult a nurse at the ER.” She too had symptoms that waxed and waned over the month preceding the crisis.

R indicated that she experienced breathing difficulties and chest pain that would wax and wane over the six months prior to her PE diagnosis and that it wasn’t until a few days before the crisis, that it became severe. “On the second night when I tried to sleep, I had severe pain in my upper back and left side of my chest, which started to radiate up to my neck and left shoulder. I experienced more pain in my chest if I tried to inhale deeply.”

Unremitting Fatigue as a Key but Non-Specific Symptom

Uncharacteristic and unremitting fatigue was one of the most consistently reported symptoms across all time points and diagnoses.

LL reports severe fatigue for at a least a month prior to the crisis as the leading symptoms. She notes the fatigue appeared well before the pain. “The fatigue leading up to this was very bad. It was such a struggle to get out of bed or do anything. It was there a good while before the pain.” She also reports restless legs, and “severe stabbing pains in my back” especially when “bending down to pick something up.”

Breathlessness and Speaking Difficulties

As one would anticipate with pulmonary emboli, difficulty breathing was a cardinal symptom of the impending crisis.

Breathing Difficulties

“felt like I had become rapidly, extremely unfit. Could not walk up the stairs in one go. Was struggling to get enough oxygen.”

J believes her symptoms emerged months before the crisis. She reports a “hairball-like cough” for months that was continually diagnosed as allergies. It was persistent and would not respond to allergy medicine. She experienced moderate to severe fatigue for the month leading up to the crisis, along with moderate to severe shortness of breath, irregular heartbeat, heart palpitations, cough, dizziness and nausea.

LT said “chest wall pain two weeks before diagnosis felt like soreness from lifting weights. When the back pain localized to my side and upper back, it felt like I had pulled muscles in those areas. The shortness of breath felt like I was getting out of breath way too easily; walking 30 feet felt like I had been running for half a mile, and slowly climbing the long escalator out of the subway station felt like I was trying to run up the stairs.”

SM experienced severe shortness of breath for at least a month prior to her diagnosis. She says she felt as though “…the middle of my chest was being pressed or squeezed.”

Speaking Difficulties

Many women report difficulty breathing in the months, week and day before the crisis. Speaking, because of the breathing difficulties, becomes increasingly labored.

NB said she would gasp for breath and was “only able to get 1-2 syllables between gasps.” She said she felt like she “had run for her life and just couldn’t catch my breath.”

JZ felt “very winded, even in casual conversations,” but otherwise didn’t report any symptoms.

Conclusion

These and other personal accounts of birth control-induced blood clots suggest that for many women, early signs are present but not recognized. Similarly, blood clots appear to be distributed throughout the body. This is consistent with the fact that hormonal birth control induces systemic changes in hemodynamics. To fully delineate the risks, however, we need more data. If you or someone you know has suffered from a birth control induced blood clot, please consider participating in the study.

We Need Your Help

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

Yes, I would like to support Hormones Matter. 

This article was published originally on November, 2016. We subsequently lost funding to finish this study. Nevertheless, we are still accepting stories about birth induced blood clots. If you’d like to share your story, send us a note: Write for us. Other stories and articles about birth control and blood clots can be read here.   

Photo: autopsy of birth control induced pulmonary emboli in a young woman.  

 

Stroke, Birth Control and the Nelson Pill Hearings: What They Knew Then

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I had a stroke from hormonal birth control at the age of 28. Prior to my stroke, I didn’t think much about the side effects of hormonal birth control, or any other medication for that matter. Like many of us, I took for granted that if a doctor prescribed the medication, it must be safe. Especially one as widely used and as cavalierly prescribed as birth control pills. I was so wrong. Nearly dead wrong.

Since that time, I have become increasingly aware of how little we know about the side effects of many medications and how many are under-researched before being “approved.” We can see that in the number of medications that get taken off the market. The pressure of the pharmaceutical companies to make a return on their research investment and their exorbitant advertising budget is putting human safety, and especially the safety of women, at great risk. I wrote my master’s thesis on risk communication, how women are informed of the risks of hormonal birth control, and what they know about blood clots. I’ll write more on that later but suffice it to say, the results were not promising. It appears that we are intentionally misled where drug risks are concerned. “Well, of course,” the cynic in me says. “After all, who is writing the risk communication in the first place?” The very people that need to minimize risks in order to maximize profits.

As mentioned in previous articles, I’ve recently begun a research project involving the Nelson Pill Hearings. Senator Gaylord Nelson scheduled these hearings back in 1970 after a number of reports, books (especially Barbara Seaman’s “The Doctors’ Case Against the Pill”), and studies brought up concerns about the safety of the birth control pill. Feminist groups and women’s health advocates attended the hearings demanding that women who had taken the pill be allowed to testify. To which Nelson responded, “I stated in advance of the hearings that every viewpoint would be heard on this issue… There will be women who testify… I will give you all the time—if you ladies will come to see me—would you girls have a little caucus and decide which one will talk one at a time, we can then decide what ladies will testify. Your viewpoints will be heard, don’t worry about that.” Then they were kicked out. And much of the testimony was never made public.

After a great deal of work from Karen Langhart, with the help of Senator Bernie Sanders’ office, and perhaps an invocation of the Freedom of Information Act, we were able to get a near complete copy of the Nelson Pill Hearing transcripts. (I say “near complete” because I have already found at least one instance of a page missing. But more on that later.)

A Massive Experiment

As someone who has survived a stroke directly related to the birth control pill, you can imagine how strange and challenging it is to read these hearings. Here I am pouring over 1500 pages of testimony from countless doctors who are describing problems, side effects, and dangers of hormonal birth control and as far as I can tell right now, they all seem to agree on two things. One, that putting women on birth control pills was (and I would say, still is) a MASSIVE experiment with millions of healthy women. Two, that there simply wasn’t enough research to understand even the short-term effects, let alone the long-term effects. Though these hearings were 46 years ago, I believe we have yet to discover all the ramifications of this experiment.

They Knew: Pill Induced Stroke

From a personal standpoint, one of the most frustrating discoveries I have made so far was found in the testimony of Dr. David B. Clark, a professor of neurology. Imagine my shock as I read him describing the exact symptoms of my stroke. This was particularly frustrating as my doctors indicated that the reason I was misdiagnosed and left untreated for so long was because my stroke was so highly unusual. And now I’m reading testimony from 1970 that says they knew strokes in young women on hormonal birth control occurred this way. Over forty years ago, these risks (and many more) were identified and, for the most part, ignored. Here is some of his testimony:

“It has been thought for a great many years that spontaneous cerebral vascular accidents are quite rare in healthy, nonpregnant women, especially the younger ones.”- Nelson Pill Hearings, page 6137

So seeing an increase in these should tell us something…

“Further, it was rapidly found, which was embarrassing, I think to all of us, that we did not have a really accurate idea of the incidence of spontaneous cerebral vascular accidents, spontaneous strokes, in young, healthy, nonpregnant women. We did have some comparable information comparing incidence in women with that in men.” -Nelson Pill Hearings, pages 6137-6138

This really isn’t surprising given that women were often excluded from medical research and are still vastly underrepresented in clinical trials.

“In looking at this group of strokes, it seems their time of onset is often prolonged, for days, and even weeks. In a considerable portion of the cases, the onset was marked by premonitory migrainous headache. The patient may have attacks of double vision, they may have transitory weakness in various parts of the body, which recovers for a time: they often report giddiness and fainting attacks, and this finally develops into a full-blown stroke.”- Nelson Pill Hearings, page 6140

These symptoms are almost identical to mine.

He goes on to say that these types of strokes do not appear to be related to arteriosclerosis (hardening or thickening of the arteries) or hypertension (high blood pressure), two normal precursors for stroke. I also had neither arteriosclerosis, nor hypertension.

“So I think it is possible that such premonitory symptoms for days or weeks before the full-blown stroke develops may be a reason for assuming a seeming association with the pill.”- Nelson Pill Hearings, page 6140

Expletives and Indignation

Needless to say, when I got to this testimony, I let fly several loud expletives that served no purpose but to release a decade of frustration and scare my dog. This was 1970! My stroke was in 2006. Where did this information get lost? Why didn’t my doctors know to check for stroke when I presented with an ongoing headache and transitory weakness? Maybe my OB-Gyn wouldn’t have thought I had a migraine and a pulled muscle. Maybe the doctor at the local health clinic wouldn’t have suggested an appointment with a neurologist a week later. Maybe I wouldn’t have been sent home from the emergency room twice. Maybe I wouldn’t have had to suffer the fear and pain of massive seizures. Maybe I wouldn’t have had to relearn how to tie my shoes and relearn how to walk and relearn how to do math.

And as if reading a near-textbook list of my stroke symptoms that no fewer than four doctors misdiagnosed wasn’t maddening enough—the very next doctor to testify at these hearings, Dr. J. Edwin Wood, said the question of whether strokes are caused by hormonal birth control is debatable. He goes on to say that there is “a definite hazard to life while using these drugs because of the side effect of causing blood to clot in the veins” (Nelson Pill Hearings, 6156). Now, I’m definitely not a doctor, but I do know that the majority of strokes are caused by blood clots. More cursing ensued.

So where does this leave us? For my part, I’m going to keep digging. And I’m going to keep telling you what I find.

We Need Your Help

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

Yes, I would like to support Hormones Matter. 

This article was published originally on April 18, 2016. 

Hormonal Contraceptives: Do We Really Know What We Think We Know?

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If you have read any of my posts, you know that this is one of the questions that pervades my work. Do we really know what we think we know? More often than not, the answer is no. Upon examination, what we hold true falls short. In the field of pharmaceutical medicine, where money plays an enormous role in determining what is known about a particular drug, finding the real and honest truth about a medication is difficult and sometimes impossible. Hormonal contraception, because it has been on the market for decades and because as women we really want it to be safe and absent negative side effects, is one of those drugs where what we think we know and what we actually know are two entirely different things.

Over the last few years, we have been commissioned for a two studies on the safety of hormonal contraceptives. One study, the Real Risk project, ended early due to a loss of funding. As a result, Phase 2 data were never analyzed. (We decided to continue collecting data in the hopes of finding funding to complete the study at some point. We haven’t found the funding yet.) Nevertheless, we learned a lot and what we learned should be public. Slowly, some of that information is making its way into blog posts.

Below is a portion of the final report covering the history of the pill, a sort of ‘what they knew when’ of side effects. Looking back at the history of the development of the pill and other forms of hormonal contraception, it becomes clear that the health and safety of the female population was not a primary objective. Indeed, more often than not, the serious side effects were ignored, particularly in the US, setting the precedent for the almost total acceptance of the drug’s safety that we see today. As a woman who used hormonal birth control and developed many of the side effects noted by early researchers, side effects that were ignored by my physicians, reading this is eye-opening. If I had known then what I know now I would have never used this drug.

The History of Birth Control Induced Side Effects

The first case of birth control induced thrombosis, a pulmonary embolism, was reported in 1961, only one year after the drug’s release. This was soon followed by the first contraceptive induced myocardial infarction in 1963. In the years that followed, research groups, primarily in Great Britain, began delineating the risks and mechanisms by which hormonal contraceptives induced the state of hypercoagulability that led to thrombotic events. Much of this research, along with the publication of Barbara Seaman’s book, The Doctor’s Case Against the Pill, formed the impetus for the Nelson Pill Hearings (NPH) in 1970.

Early on, British researchers noted significant changes in blood clotting mechanisms in the women using oral contraceptives compared to those who did not, but also compared to pregnant women. Hormonal birth control, it appeared, increased several pro-clotting factors while simultaneously decreasing anti-clotting factors; changes in hemodynamics that were in many ways, though not entirely, akin to late pregnancy and early postpartum where blood clots are known risks. This was in addition to systemic vessel wall damage that simultaneously set the stage for both clotting and hemorrhage. They also found that clot risk increased over time and was compounded by other variables such as exercise and smoking. In 1967, based upon the results of three studies, the British Medical Research Council issued a preliminary communication that stated:

“The sum of the evidence, however, is so strong that there can be no reasonable doubt that some forms of thromboembolic disorder are associated with oral contraceptives. The association is particularly strong in the group of women with no known medical condition predisposing to thrombosis.”

Politics and Money Rewrite History

These findings, though clearly implicating hormonal contraceptives in thrombosis, became immediately controversial and were all-but-entirely dismissed by American medical societies who argued an inherent difference between British and American women (NPH pages 6222-6259); one that supposedly predisposed British women more strongly towards blood clots than their American counterparts.

Additionally, according to testimony made in the Nelson Pill Hearings, the American Medical Association allowed industry experts to write and publish the early safety statements while simultaneously refusing to publish research and case reports indicative of risk (NPH page 6113). G.D. Searle, one of the early manufacturers of oral contraceptives, went so far as to ‘vote away’ the risk of thrombosis at a medical conference (NPH pages 6108-6133). Sales and marketing materials were designed to dismiss the risk and obfuscate the research (NPH pages 6218-6296). This led American doctors, researchers, and the population as a whole, to presume falsely that the pill was safe and without risks. It bears noting that by failing to publish the evidence implicating the pill in thrombosis and by allowing industry experts to write and publish the safety reports, the American Medical Association set the precedent for what has now become a complete abrogation of scientific and medical ethics, not only regarding contraceptives, but also, for every other drug on the market.

Beyond Thrombosis: System Wide Side Effects

A persistent notion in contraceptive research is that progesterone and estradiol, the two hormones mimicked in contraceptives, are singularly involved with reproduction. What follows is a presumption that these hormones have no impact on other tissues and altering them affects nothing but the intended target. Contrary to this popular belief, these steroid hormones are not solely involved in reproduction. Hormone receptors are distributed throughout the brain and the body, on every organ, in every tissue, and in every fluid. Hormones, thus, regulate every physiological system. When synthetic hormones bind to endogenous or native hormone receptors, they effectively override the body’s natural regulatory functions in ways we have yet to comprehend fully. It is not unexpected then that the use of hormonal contraceptives would have broad based effects. Thus, in addition to the higher incidence of thrombotic events in otherwise healthy women, physicians and researchers testifying at the hearings noted clear associations between the use of hormonal contraceptives and a broad array of disease processes. Some of those effects are highlighted below.

Metabolic Disturbances

Perhaps some of the least well-recognized effects of these hormones include those to a woman’s general metabolism. Hormonal birth control induces wide ranging metabolic disturbances in insulin and glucose regulation, lipid control, and in heart rate, rhythm and pressure leading to weight gain, diabetes, high blood pressure, and cardiovascular disease. One researcher testified accordingly:

“There are more than 50 ways in which the metabolic functions of the body are modified, and to say therefore that normal physiological function has been demonstrated in the years of oral contraception is to overlook a very large amount of information (Dr. Victor Wynn, NPH page 6311).”

“When I say these changes occur, I mean they occur in everybody, more in some than in others, but no person entirely escapes from the metabolic influence of these compounds. It is merely that some manifest the changes more obviously than others (Dr. Victor Wynn, NPH page 6303).”

And yet another said:

“These alterations, which have been demonstrated, include changes in carbohydrate metabolism, fat metabolism, protein metabolism, and the endocrine, liver, nervous and vascular system, among others. The findings are straightforward and reproducible (Dr. Hilton Salhanick, NPH pages 6382).”

Impaired Reproductive Capacity

Impaired reproductive capacity, likely due to the pill’s effects on the pituitary gland and its ability to prevent ovulation was noted (Dr. James Whitelaw, NPH pages 6009-6019). Case studies presented by the physicians indicated use of hormonal birth control often delayed fertility while the body re-adjusted to its non-pill state. In at least 1-2% of the women who used the pill, however, it caused permanent infertility. Ovulation never resumed. Additionally, women who used the pill were more prone to miscarriage, stillbirth, and chromosomal abnormalities in the offspring; abnormalities that as one researcher indicated were:

“…completely incompatible with live birth…”

Sadly, much of this research was disregarded and there has been very little work since. In fact, the use of oral contraceptives to regulate cycles in advance of fertility treatment is now commonplace. Despite research suggesting it is contraindicated.

Beyond the immediate effects to fertility and reproduction, early researchers postulated potential transgenerational effects. That is, when women use hormonal contraceptives, ovulation is suppressed unnaturally and germ cell damage to the ovarian follicles is possible: damage that may not only express itself in the first generation, but also in subsequent generations, e.g. in her grandchildren and great grandchildren.

“An unequivocal abnormality produced by estrogen-progestogen is the suppression of ovulation itself. It is only reasonable to consider the ultimate fate of the ovum that would have been normally released from the ovary. We do not know whether the ovum dies or survives. If it survives, is it altered in any way?”

Cancer

One of the most damning, but again disregarded and disputed, findings of the early researchers was the association between hormonal birth control and cancer. Researchers testifying at the Nelson Pill Hearings noted that cancer developed in all animal models tested when oral contraceptives were administered. In fact, the use of synthetic estrogens is banned in animal husbandry in Europe because it causes cancer in the animals and also in the workers. In the US, there is no such ban, owing partly to the decades delay in cancer onset but mostly to industry lobbying.

“I think here is the proper place to point out that when we talk about the pill being used by 18 million people in the prime of life throughout the world, we are in fact considering an internal pollution, the extent of which is not yet known, but the nature of which is indeed known. And we are threatening the destruction of a large segment of one of our most precious natural resources, the young women of our society (Dr. J. Harold Williams, NPH pages 6219).”

Liver

Liver function, because of its role in drug metabolism and detoxification, is inevitably altered by the use of any medication. To what extent the liver is impacted, is a key safety issue reviewed during drug approval considerations. As one might expect, hormonal contraceptives degrade liver function. At the hearings, researchers testified to four key changes in liver function.

  • A 40% reduction in the ability to clear sulfobromophatalein (a compound used to test liver function)
  • An increase in liver enzyme activity (a marker of liver damage) in 20% of the women who use hormonal contraceptives
  • Jaundice in 1 in 10,000 women that subsided after discontinuation of OC (Dr. Philip Corfman, NPH Pages 6391-6426)
  • Reduction in total plasma protein level (Dr. William Spellacy, NPH Pages 6426-6445)

Overall, the changes in liver function were summed up as follows:

“The immediate effects include the alteration of several of the laboratory tests used in medical diagnoses. Aggravation of existing liver disease, if present, to the point where jaundice may be seen has also been shown. There is no answer to the query of will permanent liver damage result from the use of the oral contraceptives.”

We have yet to answer the question of permanent damage, although a large study in 1997 suggests that liver damage abates upon cessation.

Disturbed Immune Function

One of the most commonly recognized but simultaneously disregarded effects of hormonal contraception include disturbances in immune function. Autoimmune diseases such as lupus and rheumatoid arthritis are significantly more common in women than men, especially in women who use hormonal contraceptives. Once again, the onset and increased incidence post-pill use was noted as soon as these medications hit the market, but because of the complexity of these diseases, all but disregarded. Early researchers noted that with new onset cases once contraceptive use ceased, symptoms resolved and most patients remained symptom free for at least the 2.5 years of the study period (Dr. Giles Boles, NPH pages 6086-6108). In recent years, awareness of this connection has increased somewhat.

“Over the past three years we have seen 22 young women who… after beginning oral contraceptives developed [arthritic symptoms]. The joint swelling was usually limited to the hands. On cessation of the oral contraceptive, the symptoms disappeared… We specifically inquire as to the use of oral contraceptives in all young women we see with rheumatic complaints…”

In addition to the increased incidence of autoimmune diseases associated with hormonal contraception, other immune system changes were noted, and again, dismissed.

“The Pill, by interfering with the natural secretions of the vagina, leaves women susceptible to a variety of infections, including syphilis and gonorrhea. Those who use the Pill develop VD, other sexually transmitted infections, and vaginitis twice as often as the female population as a whole.”

Namely, the use of hormonal contraception increases the incidence of bacterial and fungal infections and the risk for developing sexually transmitted diseases. More recently, researchers have identified the mechanisms by which contraceptives initiate these disease processes – via changes in cervical immune composition that increase a woman’s vulnerability to infection.  Hormonal contraceptives also predispose women to persistent MRSA infections.

Psychiatric Illness

Perhaps one of the more disturbing findings regarding hormonal contraceptives is their role in new onset psychiatric illness and their capacity to induce suicide. In the original trials, at least one women committed suicide while taking the pill. Her case, along with at least 18 other deaths (Dr. Edmond Kassouf, NPH pages 6108-6133), was omitted in the reports filed to the FDA.

“There is considerable incidence of mild to moderate psychiatric morbidity [disease] associated with the use of combination oral contraceptive agents… In three of the four studies, there seems to be agreement that those who have required psychiatric care in the past will be more at risk for the development of morbidity, including psychosis. One study also suggests that there may be some increase in the depth of illness the longer the medication is taken (Dr. Francis Kane, NPH page 6457).”

“The emotional or psychiatric problems are the complications which seem to me to have the most serious potential danger. Three patients have stated that they were desperately afraid that they were going to kill themselves… After the pills were omitted, the depression and suicidal fears of the three patients disappeared, as did the depression of the other patients (Dr. John McCain, NPH page 6473).”

“It is disturbing to consider the patients on the pills whose depression may have ended in suicide and/or homicide with no recognition of any association with the contraceptive pills… Personality changes could be a factor in other conditions such as automobile accidents and divorces (Dr. John McCain, NPH page 6473).”

Despite the early research, connections between hormonal contraceptives and mental health have been largely ignored. In fact, since the nineties, hormonal contraceptives have been marketed specifically for depression and anxiety in direct opposition to the data suggesting these medications cause and/or exacerbated psychiatric illness. As recently as three years ago, an epidemiological study suggested,

“…a protective association between hormonal contraceptive use and depressive symptoms, as well as suicide attempts, in a population-based sample of young, sexually active US women.”

Fortunately, the tide appears to be changing. Fifty years after the release of these medications and after generations of women have complained of serious mental health issues while using hormonal contraceptives, a large study published definitive data indicating that hormonal contraceptives did indeed induce depression, especially in adolescents. No doubt, industry sponsored studies will surface shortly and contradict these findings.

Hormonal Contraceptives Today

Today, 80% of American women will use hormonal contraception at some point in their lives, mostly oblivious to their risks for thrombosis or any other of the side effects. Indeed, most women and physicians consider the side effects extremely rare, if they consider them at all. This is largely due to the fact that the American College of Obstetrics and Gynecology and other medical associations routinely claim they are safe. At any given time, 62% of women of reproductive age are using at least one contraceptive method. In contrast to the perceived lack of side effects, the numbers tell a different story. Fully 60% of women will cease using hormonal birth control within six months of initiation because of side effects and 30% will try up to five different types of hormonal contraceptives, switching between brands to temper side effects.  Given that most brands may vary in name only, switching between brands is often a fruitless endeavor, something prescribing physicians seem not to appreciate.

That there are over 200 brands currently available on the market worldwide, suggests an abundance of options, but from a pharmacological standpoint, not much has changed in hormonal contraceptive technology over the last half century. The predominant estrogen used in contraceptives remains the same as was developed decades ago, a compound called ethinyl estradiol (EE2). With the exception of the fourth generation progestins, the progestins used in modern contraceptives involve only slight modifications to the original compounds. Even the ‘newer’ delivery methods, like the intrauterine device and the cervical ring, were developed decades ago, in the 1950s and 1960s. For all practical purposes, contraceptive technology remains as it was over half a century ago. Therefore, today’s contraceptives carry as many or more of the side effects and risks as their predecessors did.

Only now, our increased familiarity with these drugs has fostered a deeply ingrained but false sense of safety. Phrases suggesting that after 50 years on the market these are among ‘the most studied medications’ pepper the literature. When in fact, these medications were never studied properly before their release:

“Evidently, for whatever reasons, there is no sound body of scientific studies concerning these possible effects available today, a situation which I regard as scandalous. If we proceed in the future as we have in the past, we will continue to stumble from one tentative and inadequately supported conclusion to another, always relying on data which come to hand, and which were not designed for the purpose (Dr. Paul Meier, NPH pages 6548-6560).”

And they have not been studied conclusively since. For all intents and purposes, safety issues associated with hormonal birth control remain largely under-investigated and unrecognized. What research exists generally favors commercial interests, and if we’re honest, our interests as women. We want easy, safe and effective birth control. We need it and so we ignore the side effects and ignore any research that confirms our suspicions. We allow ourselves to accept the risks. Maybe it’s time we didn’t. Maybe it’s time we dig in and find out what is really going on and then fix the problems.

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This article was published originally in June 2017. 

Migraines and Birth Control: A Neglected Stop Sign

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No sooner had we landed than my phone began to convulse with a cacophony of bells and chimes. Most of the notifications were last minute details about the live broadcast that brought me to town. In one voice message, a coworker informed me that the producer cancelled our pre-production dinner meeting because of her migraines. He added, “When she eats certain breads, it triggers her headaches.”

This happened early in my research on hormonal contraceptives, but I had read enough to know that birth control could cause migraines, and women with migraines were at a higher risk for strokes. I also knew that doctors at the Nelson Pill Hearings testified that birth control pills affect the way a woman’s body metabolizes carbohydrates in myriad ways. I had no idea what the mechanism of action could be, but at that moment I would have bet my children’s milk money that our producer was on hormonal birth control, and I intended to ask her about it.

This was my client’s client. I wondered if it was safe to broach the subject of birth control with her, but I knew the answer before I could even fully form the question in my head. I wouldn’t be able to forgive myself if she ever had a stroke, and I hadn’t warned her.

The next morning she felt better and showed up for the load-in. When no one else was around, I asked some questions about her headaches, ending with, “I’m curious, did you start getting migraines after you began birth control?”

When you ask a question like that, you know there’s a better than zero chance the reaction could be negative. Thankfully, not even a glimmer of disapproval flashed in her eyes as she replied, “Oh no, I took The Pill for a long time before I had my first migraine.”

I said, “That’s still after you started.”

She laughed it off as a silly question. However, after sleeping on it, she approached me the next morning, “You know, you may be onto something. I hadn’t thought about it, but my migraine symptoms did get a lot worse when I switched birth control brands.”

Connect the Dots: Birth Control and Migraines

The correlation between birth control and migraines has been known for decades, as has their connection to an increased risk of stroke. However, two hurdles probably play a key role in preventing patients and their physicians from making the connection in the real world today – those being familiarity and latency.

Many side effects of hormonal birth control occur as extremely common ailments, such as breast cancer, strokes, and migraines. Not coincidentally, they’ve grown even more common in direct correlation to the introduction and prevalence of hormonal contraceptives. Paradoxically, they’ve become so familiar and so unremarkable that doctors rarely look for the primary culprit that causes the migraines. Essentially, they can’t see the tree for the forest.

Some side effects, such as migraines or depression, can happen almost instantaneously. (Even so, doctors frequently miss the connection.) However, it usually takes some time for the symptoms to precipitate. This latency can hinder even the most astute physician from considering hormonal contraceptives as the likely cause of problems. I’m being generous in my phrasing. In reality, I can’t help but wonder what role fear of litigation plays in this ‘blindness.’

Ultimately, why they overlook the correlation to birth control is less important than the consequences it creates, which include dramatic under-reporting of complications. In 1970 while discussing strokes at the Nelson Pill Hearings, Senator Gaylord Nelson expressed this prescient concern:

Every time the issue has been discussed here concerning the increased incidence of this disorder or that disorder, they always end up saying, “but the statistical sample is so small that there is room for error, and we can only make sort of an educated guess.”… I am just concerned with the fact that the reporting of these side effects and their effect on the cause of death may not be related to the pill at all. (Monopoly Subcommittee, page 6419)

Dr. Herbert Ratner added his perspective (Monopoly Subcommittee, page 6743), “For the first time in medicine’s history, the drug industry has placed at our disposal a powerful, disease-producing chemical for use in the healthy rather than the sick.” [my emphasis] Yet, forty-five years later, we still have no national registry, no way of tracking patients on birth control so that scientists can conduct comprehensive etiological studies that would connect the dots and precisely reveal the consequences of hormonal contraceptives. In fact, our healthcare reporting system is so fractured we can’t even put our finger on an accurate estimate of how many women take hormonal birth control. Estimates from trusted sources range from 11 million to 18 million.

The Pill, Migraines, and Strokes

The University of Virginia student health services published a document on their website outlining the definitive link between migraines and strokes. Beyond warning that the “increased risk of stroke is amplified by the use of estrogen-containing birth control methods,” the doctors who prepared the document boldly state,

it is strongly recommended that women with a personal or family history of migraine headaches should select non-estrogen methods of contraception. [Their emphasis]

This information should be part of every ‘informed consent’ conversation before a doctor writes the first birth control script. Not to mention the many other complications that need to be discussed. This kind of warning should be the norm. Unfortunately, it’s the exception.

Strokes Redefined

It took only three generations of users for hormonal contraceptives to redefine our perception of strokes. A young women starting on The Pill today may not even realize that when her great grandmother began birth control, strokes were considered an old person’s disease.

But, strokes aren’t just for grandparents anymore. A recent article in the Washington Post leads off with this troubling statement about strokes in young people:

In a study released Wednesday in the Journal of the American Heart Association, researchers found that between 2000 and 2010, hospitalizations for ischemic stroke, the most common type, dropped nearly 20 percent overall – but among people ages 25 to 44, there was a sharp 44 percent increase in the rate.

There are a couple of other interesting facts later in the article – or rather, one interesting fact, and another made interesting by its glaring omission. The first comes from a description of the study:

The data analyzed includes information on 8 million hospital stays and came from the Nationwide Inpatient Sample, the largest publicly available database in the United States on these patients.

In stressing the importance of a large database, the author underscores the necessity for a national registry to track patients so that important lines can be drawn. Of course, the second part is that the lines actually need to be drawn. Amazingly, here’s what the Post article says about what might have contributed to the increase:

Doctors attribute the apparent rise in strokes among younger adults to the same lifestyle risk factors traditionally found in older patients, such as obesity, diabetes and high blood pressure.

It isn’t until much later in the article that they include:

Each year significantly more women die from stroke than from breast cancer — and yet many women think of stroke as a man’s disease. According to a 2015 national survey, only 11 percent of the 1000 women surveyed could identify female-specific stroke risk factors, like migraine headaches with aura, hormone-replacement therapy, oral contraception and pregnancy, particularly in the final month and postpartum.

Talk about burying the lede. Maybe women would stand a better chance of identifying these factors if journalists dared include them in the “lifestyle risk factors” mentioned previously.

Testimony Without Equivocation

The science linking birth control pills to strokes hasn’t changed. As far as I can tell, no one has disputed the correlation since The Lancet first published Dr. Victor Wynn’s study in 1966.

Pay attention to this excerpt from Dr. Alan Guttmacher’s testimony at the Nelson Pill Hearings. Dr. Guttmacher was the founding president of Planned Parenthood/World Population, and was arguably the staunchest proponent of The Pill ever to live:

We know the facts about thromboembolism. I think this is pretty uncontested. We know the facts about development of high blood pressure in a certain small proportion of patients. We know the fact that certain patients get depressed on the pill. These are the facts we are all privy to. (Monopoly Subcommittee, page 6615)

Earlier in the hearings, Dr. J. Edwin Wood explained the phenomenon that caused healthy young women to develop strokes:

One of the major contributing causes of thrombosis in veins appears to be that of reduced velocity of flow of blood in the veins or relative stagnation or stasis of flow in the veins…

Studies of women taking oral contraceptive agents have led to the clear-cut finding of dilatation of the veins of the extremities – other veins as well perhaps but they have not been studied. These dilated veins carry the same amount of blood as before but since they are wider in diameter the blood flows more slowly.

The net effect of this series of events is a slowing of the blood flow during oral contraceptive therapy. This finding is distinctly abnormal and is not observed in any other circumstance in young women except during pregnancy or in the presence of varicose veins. (Monopoly Subcommittee, page 6157-6158)

The facts about hormonal contraceptives and strokes were well known in 1970, yet they somehow seem to have escaped the curriculum in today’s medical schools. It may be uncomfortable but if you know a woman who suffers migraines, don’t hesitate to ask her if she’s on hormonal contraceptives. Then, please share the facts about migraines and birth control.

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Blood Clots, Birth Control and Female Athletes: Are We Missing Important Risk Factors?

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Over the last several years, stories of young women, many of them athletes (here, here), suffering from dangerous and sometimes deadly blood clots have filled the press and academic literature (herehere, here). Often mentioned in passing is the fact that these women were taking hormonal contraceptives at the time of the event. As a mom of a female athlete, a lifelong jock myself, and a researcher, I cannot help but wonder if we aren’t missing critical connections between some very common real life variables that predispose young women to serious health risks. Are athletic women more at risk for hormonal birth control-induced blood clots than other women? I think they might be.

We all know, or at least should know, that hormonal contraceptives increase the risk of blood clots for any woman who uses them. We often don’t pay attention to those warnings, especially when we are young, consider ourselves healthy, and when we are athletes. We ignore the warnings because taking birth control is, in many cases, a practical decision. Hormonal contraceptives, whether in the pill, patch, implant, vaginal ring, shot, or IUD, regulate if and when we bleed. That is, we bleed on a schedule, controlled entirely by synthetic hormones.

Scheduling is wonderful for female athletes. With no control over the scheduling of competitions, the ability to schedule one’s period is a great advantage. Let’s face it, competing while bleeding and cramping is never fun and near impossible for women with painful periods. Who wants to spend years training for that one event, only to have her period start? No one.

Optimal athletic performance requires that we control extraneous variables to the extent possible. Controlling one’s period takes care of a major variable in the life of the female athlete. And since it prevents pregnancy, hormonal birth control is a win-win.

Or is it?

Aside from the fact that hormonal contraceptives impact athletic performance (a topic of great debate and conflicting research), induce a variety of unwanted side effects, and that pill bleeds are not periods, hormonal contraceptives increase the risk of blood clots, quite significantly. Conservatively, birthcontrolsafety.org, estimates that out of the nearly 11 million women who use hormonal contraceptives (pill, patch, or ring), approximately 20,000 will develop blood clots and about 600 women will die, every year. There are no data on how many of these women were athletes or exercised intensely; however, it is likely that the numbers are pretty high given the high rate of hormonal contraceptive use in the general population.

Intense exercise, which is the foundation of athletic training, increases the risk of blood clots independently of gender or birth control usage. Indeed, some research suggests that the risk for deep vein thrombosis, blood clots in the legs, may be significantly higher for athletes than the general population. An interaction between hormonal contraception and exercise is likely to increase the odds of blood clots rather significantly. As women, the combination of those two variables alone should give us pause, but when we consider all of the other real world variables that also increase blood clotting and that just so happen to be prevalent in the life of the female athlete, the risk becomes quite concerning.

When Clots are Formed: Virchow’s Triad for the Athlete

When we look at the mechanisms involved in clotting and bleeding, we should remember that blood clotting itself is a necessary and protective mechanism against injury. Without the ability to clot, all sorts of complications can arise from everyday activities. Equally important are the body’s compensatory mechanisms that are designed to prevent too much clotting and to clear out clots once the immediate danger has ceased. The balance of power between the factors that promote clotting and those promote bleeding must be maintained within a fairly narrow window. Disruption to either side creates problems. Hormonal contraceptives shift that balance towards clotting and the normal components of athletic training and competition, shift the balance even further. When we add a few more variables, in any combination, synergies develop and the cumulative effects make female athletes using hormonal contraceptive at risk for serious, and sometimes deadly, blood clots.

Blood Clots and Athletes: The Basics

Blood clot formation is more likely when there are disruptions in blood flow. This can happen with:

  1. Injury to the blood vessel wall (even microinjury induced by a medication or chemical exposure)
  2. Depression of blood flow dynamics
  3. Changes to blood constituents (clotting factors)

These factors constitute what is called Virchow’s Triad, after the German pathologist Rudolph Virchow who developed a framework in 1884.

Off the bat, by using Virchow’s triad, we can identify several potential risks for clotting that are likely more prevalent for athletes, male and female. For example, periods of intense exertion increase blood pressure, heart rate and the shear stress on the vascular walls (inducing damage and inflammation), which increases clotting propensity for athletes; while conversely, the athlete’s slower resting heart rate and lower blood pressure when not in competition, makes clearing those clots efficiently much more difficult. Similarly, periods of dehydration increase blood viscosity, slowing blood flow, as does inflammation and muscular hypertrophy via venous or arterial compression. Injuries and surgeries damage the vascular and arterial plumbing and slow blood flow. Extended travel compresses leg vasculature (and sometimes arm vasculature depending one’s sleeping position) and slows blood flow. Heck, even repeated movements can compress veins or arteries in different regions of the body and slow blood flow. What is athletic training if not repetition, hours upon hours of repetition?

Now consider these variables occurring against the backdrop of hormonal birth control, which changes the very balance of power between clotting and bleeding, effectively overriding many of the systems in place to ensure that clots don’t persist and causes problems. Throw in a few other decidedly female variables that also increase clotting, like monthly NSAID use to stave off menstrual pain, a propensity towards headaches and migraines, a latent genetic disorder or two, maybe even a less than optimal diet, and we have a recipe for disaster.

A Deeper Dive: Common Clotting Triggers for Athletes

Injury to the blood vessel wall

Injury to the blood vessel wall can develop by a number of mechanisms. The most obvious are those that result from direct injuries that occur over the course of training or competition. Surgery falls into this category. The rate of blood clots that evolve into pulmonary emboli after shoulder surgery ranges from 0.17% – 5.1% depending upon the type of surgery. Deep vein thrombosis after knee surgery, however, complicates some 2-13% of cases and upwards of 60% with some procedures. We cannot forget, also, that women are apt to have surgeries related to reproductive health issues, e.g. those related to endometriosis or ovarian cysts.

Less obvious are the micro-injuries or insults to vascular endothelial cells. Micro-injuries are surprisingly easy to induce over the course of athletic training and even in everyday living. They are not commonly recognized as risk factors for blood clots and there are few data that address these types of injuries; perhaps because their effects are likely part of a more complicated set of variables that combine to initiate and/or prolong the clotting, and are not immediately identifiable. I would argue that we ought to consider these risk factors especially in female athletes who use hormonal contraceptives because they are likely quite common. Here are just a few.

Contrast Dyes used for Imaging

Before any injury is surgically managed, imaging studies are common. The contrast dyes used for these studies induces micro-injuries to vasculature where the dye is circulated and are known to induce clots.

Vaccines and Medications

A number of medications and vaccines induce varying degrees of vasculitis or vascular microinjury. The most recent evidence of this is the HPV vaccine. For female athletes, something as simple as this or other vaccines, could initiate a clotting cascade that becomes difficult to end when hormonal contraceptives are involved. Similarly, the most commonly prescribed class of antibiotics, the fluoroquinolones (Cipro, Levaquin, Avelox and others), induce vascular microinjury among other side effects (tendon rupture, rhabdomyolosis, and neuropathy to name but a few).

Nutrient Deficiencies

Nutrient deficiency can induce vascular injuries via mitochondrial cascades. This one is a little bit more complicated and often a longer term process but one that adds to the overall propensity to clot. Briefly, mitochondria are responsible for and/or involved with a long list of functions ranging from bioenergetics (ATP production), to inflammation, steroid synthesis and cellular apoptosis, even platelet aggregation (an important variable in clot formation and dissipation). Mitochondria need several core nutrients to power enzymatic reactions. Most folks, even athletes, are deficient in several of these nutrients, especially if on hormonal contraceptives. Hormonal contraceptives deplete vitamins B1 [thiamine], B2 [riboflavin], B6, B9, B12 (worse if one is a vegetarian/vegan), C, E, magnesium (many athletes are magnesium deficient regardless of contraceptive usage), zinc, and CoEnzyme Q10. Simultaneously hormonal birth control may elevate vitamin K concentrations (which increases clotting), and also, increase copper and iron (too much iron favors hypercoagulation). Nutrient deficiencies and abnormalities cause mitochondrial dysfunction (and a whole host of other problems). Mitochondrial dysfunction leads to cell dysfunction, leading to molecular changes in the vasculature (and elsewhere), injuries, and a propensity for clotting ensues. Mitochondrial damage would also lead to changes in blood flow dynamics and blood constituents. So mitochondrial damage, though more subtle, can affect the entire triad of variables.

Blood Flow Dynamics – The Plumbing

Compression

Like the pipes in our houses, anything that blocks or compresses or otherwise slows the fluid through the pipes can induce a clog or, in this case, a clot. The most obvious of these factors is compression, as occurs on long plane/train/bus trips to and from competitions. According to AirHealth.org:

About 85% of air travel thrombosis victims are athletic, usually endurance-type athletes like marathoners. People with slower resting blood flow are at greater risk of stasis, stagnant blood subject to clotting. Also, they are more likely to have bruises and sore muscles that can trigger clotting. No other risk factor comes close to this. Age over 60 is supposed to be a risk factor, but these victims are younger, 82% of them under 60 [47% of air travel thrombosis cases are between the ages of 20-44].

According to some reports, the increased risk for clotting continues for up to 24 hours post competition, making the long trip home after an event particularly risky.

These are staggering numbers which are likely under-reported and under-studied. Imagine the risk for compression induced clotting to the female athlete who uses hormonal contraceptives. If she’s had an injury that required imaging with a contrast dye, or experienced any of the aforementioned other vascular insults, the risk increases.

May-Thurner Syndrome. Twenty percent of the population is believed to have a narrower than normal left iliac vein leading to blood clots in the pelvic region and left leg. May Thurner Syndrome, Pelvic ClotsMost do not know this until they end up in the hospital with a blood clot. For these women, the risk for deep vein thrombosis, particularly in the left leg is even higher, especially on birth control (most especially, I believe, though this is pure speculation, when using a cervical ring like the NuvaRing). Again, add long sit times, an injury perhaps, and we can begin to see how the risk for blood clots in the female athlete using hormonal contraception can be much higher than for her teammates who do not use hormonal contraceptives.

Paget-Schroetter Syndrome, an anatomical narrowing of the subclavian vein (just under the clavicle or collarbone) and repetitive use trauma either alone or together can initiate clotting from this region. Sports with high upper-body repetition such as swimming, gymnastics, rowing, tennis, baseball/softball, and others, are at most risk.

subclavian vein effort thrombosisIt is believed that the repetitive trauma that these sports require imposes strain on the subclavian vein leading to microtrauma of the endothelium and activation of the coagulation cascade. This alone is a risk factor for developing a blood clot, but when we add a few more variables, an intense competition, dehydration, a long flight home with upper body immobility and perhaps compression (sleeping on one’s arm), and enter these variables into an system primed for coagulation by hormonal birth control, the risk for dangerous blood clots increases significantly.

Viscosity

Sludgy matter doesn’t move through pipes too well. All manner of variables can affect the viscosity of blood. The most common in athletes is dehydration.

Dehydration

Dehydration is common in athletes, especially after a long competition. Dehydration increases the viscosity of the blood, slows the movement through the pipes. Put a dehydrated female athlete, who uses hormonal birth control on a long bus trip home, and clot risk increases. Add some past vascular damage, even minute and unrecognized, plus an injury or two, and the risk increases even more.

Blood Constituents – Changes at the Molecular Level

We can change the intrinsic clotting factors by a number of mechanisms: genetic, epigenetic and via medications (like birth control, NSAIDs and others) or environmental chemicals. There are over 20 proteins involved in maintaining the balance between clotting and bleeding and each of them can be altered towards a pro-clotting state by a myriad of variables (for a full list see here).

Genetics

Beginning with the genetic variables, 3-10 % of the population have heritable genetic mutations that increase their risk of developing blood clots quite significantly, absent other variables. Upwards of 50% of patients who have develop a clot carry one or more of these mutations. Unless there is a known family history of clotting disorders, most women who carry these mutations are unaware of their genetic risks. When these women utilize hormonal contraceptives, their risk of blood clots increases significantly by as much as 35x according to some data. I think all women should be tested for these genetic variables before being given hormonal birth control. Unfortunately, none are, until they end up in the hospital fighting for their lives. Now consider a female athlete who carries one of the mutations and is on hormonal birth control, travels, uses NSAIDs, has had an injury or two, and the likelihood of her developing deadly blood clots is very much increased.

With both genetic and acquired components, antiphospholipid syndrome (APS or APLS), also increases blood clot propensity. In fact, it is the most common cause of excessive clotting, and affects women more than men. APS is autoimmune condition that causes hypercoagulability of blood through unknown mechanisms. APS can occur on its own, or in conjunction with lupus and other rheumatic disease processes like Sjogren’s. Neither of these diseases is uncommon in female athletes, though hard data are difficult to come by. Anecdotally, Venus Williams has struggled with Sjogren’s and case reports abound of female athletes with Lupus (here, here).

Epigenetics

Epigenetics is a fancy term for events that happen above the genetic level. It is an emerging science where investigators look at variables that don’t directly alter the DNA, but rather, aberrantly turn on or off a particular gene. Environmental factors play a large role in epigenetics, medications, vaccines, other chemicals, diet and nutrition. So, just as a woman can carry heritable genetic mutations, she can also carry heritable epigenetic changes that turn on the genes controlling the clotting proteins or turn off those that prevent clotting. We can inherit these epigenetic changes from parents and even grandparents, but also, induce them via every day exposures and activities. I suspect that there are epigenetic components of one’s risk for blood clots.

Medication Induced Clotting

Here’s the big one that we don’t pay nearly enough attention to – medications and vaccines can induce clotting via multiple mechanisms, including changing the balance of power between clotting and bleeding. Briefly, and most importantly to female athletes are hormonal birth control and NSAIDs (ibuprofen and the like). The chemistry is a bit complex, but let us take a stab at it, because when these variables are combined with the normal activity of a female athlete, I believe her risk for blood clots shifts from the ‘if’ category to the ‘when’ category. For more information on the clotting cascade, here is a simple Khan Academy video.

Hormonal birth control increases all of our coagulation factors, but most especially, clotting factors VII and X, where plasma concentrations have been measured at 170% of normal. Fibrinogen (responsible for initiating the fibers that form the clot) is increased by 20%. Hormonal contraceptives also stimulate platelet aggregation (the initial plug that covers the injury), while simultaneously decreasing an anti-clotting factor called antithrombin III. Sit with that for a moment. This is the biochemical foundation that the female athlete is working with. Without doing anything else, her body is primed to clot.

Pro-clotting factors are increased to almost 3X their normal levels, while anti-clotting factors are diminished.

With this biochemistry, a body can only forestall excess clotting for so long. In fact, early reports suggest that clotting risk increases with time used. That is, clotting factors increase over the months and years one uses these medications. This may be why some of the most deadly clots, the pulmonary emboli and cerebral venous thrombi develop in women who have used contraceptives for years.

I have to add one more poorly understood hit to the coagulation system. NSAIDs alter platelet aggregation in some pretty complex ways and the mechanisms by which NSAIDs induce bleeding or clotting are just beginning to be understood. It is well known that NSAIDs like aspirin and ibuprofen can induce excessive bleeding. Gastric bleeds are one of the most common side effects of ibuprofen use. NSAIDs also carry with them increased risk of venous thromboembolism. Excessive bleeding but also excessive clotting–how is that possible? Certainly, it depends upon the formulation and which pathways the drug targets (Cox 2 inhibitors), but the emerging theory is that platelet aggregation may increase over time and become difficult to dissipate, because these medications block the enzyme responsible for keeping injured vessels free of clots while the damage is being repaired.

Another mechanism by which NSAIDs influence coagulation is via heart rhythm irregularities, like atrial fibrillation (at least for older populations, no data are available for younger athletes). With atrial fibrillation, we have a good chance of blood pooling which can result in clot formation. Finally, there is some evidence that NSAIDs increase vasoconstriction, which would impact blood flow. NSAID use is very common in the life of the female athlete and non-athlete alike with regular use both monthly, to stave off menstrual pain, and over the course of training to manage pain and injuries. It is possible that NSAID use may not only impact the post-injury healing process, but also, increase an athlete’s chances of developing a blood clot.

Now What?

Birth control is a personal choice. If pregnancy prevention is the only reason for using these hormonal contraceptives, there are non-hormonal options, including the old stand-bye, the condom, and newer devices for tracking. If scheduling is the primary consideration, I would consider whether or not the opportunity to schedule overrides the risks associated with using these products. Blood clots are a very real danger for athletic women without the additional risks that come with hormonal birth control. Are those risks worth taking?

Share Your Story

If you are a female athlete and have developed blood clots while using hormonal contraceptives, consider sharing your story. Contact us via this link: Write for Us.

We Need Your Help

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

Yes, I would like to support Hormones Matter. 

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This article was published originally February 23, 2016.

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

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

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

What is Factor V Leiden?

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

Patients with Factor V Leiden can be either:

  • Heterozygous: inherited one mutated gene from a parent

or

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

What Does It Do?

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

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

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

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

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

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

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

What Women Know about Birth Control and Blood Clots

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

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

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

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

Why Aren’t Women Tested for Clotting Disorders?

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

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

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

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

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

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

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

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

Women Deserve Better

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

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

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

We Need Your Help

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

Yes, I would like to support Hormones Matter.

This article was first published in September 2016.

I Had a Stroke From Hormonal Birth Control 

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A little over 2 years ago, on May 31st, I had a stroke caused by my birth control pill, Loryna. I had been on the pill for approximately 9 months before the clots developed. I didn’t even know what a stroke was until I was in the hospital and I kept hearing the word. Here I was 31 years old and in the hospital after suffering from a stroke.  

I was 6 months into a new manager position when the pandemic hit. We closed like everyone else. I worked for 2 days then I was off for the weekend. I woke up that Saturday and my left leg was killing me. I could barely walk, but I still managed to go back to my place of business to see if they needed any help. After work, I did some shopping and then went home because I couldn’t stand the pain anymore. I went to the ER later that day and they gave me an ultrasound. They said they found nothing. NOTHING! They were very dismissive and sent me home. 

The next morning changed my life forever. I woke up and my leg hurt even worse. I called my mom and told her what happened and told her that I wanted to go to a different ER. Things went downhill from there. I passed out and hit my head on my nightstand. By the time I woke up, my mother was there with the EMTs. I know I couldn’t breathe. I had an ischemic stroke and pulmonary embolism. The clot went up my leg, through my lungs, across my heart, and into my brain. I was in the hospital for a week. 

As I said before, I had no idea what a stroke was before this! I kept hearing it when I was in the hospital and they said my birth control, Loryna, caused the stroke. I also found out that I have a clotting disorder. I would think my doctor would have tested me for a clotting disorder before prescribing birth control, but I guess they don’t do that and they don’t tell women about the risks. I didn’t know that my birth control would give me a stroke. Think before you decide to get birth control. The birth control I was taking had low hormones, but I still developed a clot that led to pulmonary embolism and a stroke. 

I learned the hard way that doctors do not take the symptoms of blood clots seriously. I knew something was wrong, but I was sent home from the ER. If you feel like you have developed a blood clot from hormonal birth control and are being pushed away at your doctor’s office or ER, go to another one immediately. It could save your life. 

It has been just a little over two years since my stroke. The stroke affected me in many ways. I have issues with my speech. I had many panic and anxiety attacks that I still suffer from today. I was depressed, lost the best job I have ever had, and my confidence went right out the window. 

My stroke was pretty severe but they said because of my age and how healthy I was overall, I survived. After the stroke, it took a lot of people to convince me that I could do anything, as long as I put my mind to it. My first job was at a beauty supply store and currently, I’m working as a receptionist for a great company. They say in therapy that after you have a stroke, you are always recovering. I find that to be very true.

We Need Your Help

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

Yes, I would like to support Hormones Matter. 

Photo by Marcelo Leal on Unsplash.

Profits Over People: Medication Risk and Drug Company Misconduct

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If you haven’t read Chandler Marrs’ article on the safety of medications, take a moment to do so and understand that no medication is, as Marrs puts it, “perfectly safe.” I’m here to reaffirm this harsh pill to swallow (pun intended) through the telling of my own experience and the showcasing of research that reveals just how much sway Big Pharma has over the safety of medications.

I was 20 years old when I decided to take my doctor’s advice and go on hormonal birth control to help regulate my periods. I remember my mother, a registered nurse who worked in a local hospital, voicing her concerns about the oral contraceptive. At the time, she was seeing quite a few girls my age come in with clotting complications related to the pill.

Thinking I knew what was best for me, I ignored her advice to stay off of the medication. I was comforted in knowing that almost every single one of my close friends was taking some form of birth control, and they were fine. I’d be fine too.

I couldn’t have been more wrong.

Two months later, I was in the emergency room with a bilateral pulmonary embolism or multiple blood clots in my lungs. What I originally thought was a relatively safe medication turned out to be a life-threatening decision. Suddenly gone forever was my notion that any medications I was prescribed would be taken without risk.

After six months on blood thinners to dissolve the clots, I went back to living my life normally, both clot and birth control-free.

Fast forward four years, and I’m reading news stories discussing the thousands of lawsuits that have been filed against the makers of Xarelto, the same blood thinner I was prescribed to help me recover from my embolism. Although I suffered no complications from the medication, I was clearly one of the lucky ones this time. The anticoagulant, which is still on the market today, has no known antidote to reverse its blood-thinning effects, and it has caused so many severe internal bleeding incidents and deaths that legal action has been taken.

Prior to doing any research, my emergency room experience would have made me cast aside the lawsuits as frivolous. There’s a risk with any medication; I can’t deny that I knew the risks before I opted to take birth control. But, didn’t they also know the risks before agreeing to take the blood thinner just like I did?

Drug Company Misconduct

After digging deeper, I realized there was a bigger issue at hand. Drug companies wield an incredible amount of influence within the healthcare sphere that can lead to the approval of medications that should never find their way into patients’ hands in the first place. A major showcase of this influence is seen in Big Pharma’s ability to fund clinical trials.

These clinical trials must be conducted before a drug is approved for market, and funding has typically come from government sources like the National Institutes of Health. But in recent years, more and more industry-funded clinical trials are taking place, meaning that drug companies can sponsor their own medications studies. Critics of this funding allowance point to the fact that the potential for financial gain can lead to a conflict of interests. Companies that have a vested interest in a drug’s approval because it brings a boost in profits could favor positive outcomes while ignoring any negative results.

In the case of Xarelto’s industry-funded clinical trial, it was discovered that Johnson & Johnson withheld information from the FDA that would have highlighted the blood thinner’s inferiority to its comparison warfarin. During the study, 14,000 patients were given an overdose of the traditional anticoagulant due to the use of a faulty blood-testing device, decidedly skewing the results. The design of the company-sponsored trial also limited the distribution of Xarelto to once-a-day dosing that weakened the medication’s effects on participants. With less severe side effects being observed because of the smaller dose, Xarelto’s clinical trial looked favorable for the new experimental drug.

We see a similar story of clinical trial misconduct being told with another blood-thinning medication, Pradaxa. Pradaxa was put through an industry-funded study whose poor trial design led to FDA approval. Critics point out that there was probable cause for bias since it failed to be a double-blind study. Its trial participants were also made up of a demographic of people who were less likely to be prescribed the medication once it hit the market.

The FDA went on to approve the anticoagulant despite the lack of an antidote, but its decision was based on the fact that Pradaxa “wasn’t inferior” to traditional warfarin. This labeling could bring the drug to market, but it wouldn’t be able to give manufacturer Boehringer Ingelheim a leg up in its promotion of the medication. Therefore, the drug company requested that Pradaxa be labeled as “superior” to warfarin in its ability to reduce strokes so that it could make this claim in its marketing materials. The FDA granted the company’s request, decidedly ignoring its original concerns with the blood thinner.

Pradaxa hit the market without an antidote just like Xarelto, and I bet you can guess what happened next. Thousands of patients taking the medication suffered severe internal bleeding complications and even succumbed to the side effects. Like Johnson & Johnson, Boehringer Ingelheim faced a shocking number of Pradaxa lawsuits and created a $650 million settlement fund in 2014 to satisfy the claims.

Profits Over People

We cannot deny that every medication presented to us comes with some sort of risk to our overall health and well-being. I suffered the risks of birth control but miraculously avoided the complications associated with Xarelto. Costs and benefits are just a fact of the pharmaceutical industry.

But, the issue lies in the influence of Big Pharma. If drug companies, who are so clearly focused on boosting their profit margins, can impact clinical trials in such a way that it costs patients more than it benefits them, where do we draw the line?

It will take massive changes in the drug approval process and overall state of healthcare before we can start to see patient lives being placed above profits. But, what we can do is stay informed and educated on the prescriptions we’re taking. There is a lot going on behind the scenes before a medication makes its way into that little orange pill bottle, and it’s up to us as consumers to do our research, look into the possible complications, and voice any and all concerns with our doctors.

We Need Your Help

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

Yes, I would like to support Hormones Matter.

Image by Thomas Breher from Pixabay.

This article was first published in January 2018. 

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