blood clots

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?

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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.

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This article was first published in September 2016.

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COVID Notes: The Blood Clot Problem

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This is the second in a series of articles adapted from twitter threads where I explore different aspects of the COVID-19 pandemic. The first can be found here.

COVID and Blood Clots

Let’s talk about blood clots and COVID-19. It seems the latest of a long list of problems COVID is suspected of causing is hypercoagulation. Here is just one of the many articles that have come out recently.

The most telling sentence: “It’s not necessarily the virus killing people, it’s the organ failure that happens as a result of the viral infection,” Barrett said. “If you can support people through their organ failure… the immune system will eventually clear out the virus.”

One that seems to be summarily ignored or obfuscated by the fundamental presumptions of causation – what constitutes causation and the subsequent considerations of what constitutes acceptable treatments – something we will return to in a moment.

With each of these new realizations about the process of COVID deaths, we seem only ready to attribute these symptoms to either the virus or to the pre-existing ill-health of the patient.

Never in these discussion are questions regarding how medicine contributed to either variable.  Pharmaceuticals, as all chemical toxicants, while sometimes necessary, also elicit damage capable of inducing a myriad of pathologies, including hypercoagulability.

Might it be the medications that we are hurling at humanity from birth to death, but especially in the rapid fire environment of the ED and in association with COVID that might be conspiring with an already altered coagulability profile to induce thrombogenesis? It might.

A good portion hypercoagulability is acquired and even when there are genetic variants that predisposed to clotting, they often are activated or induced by environmental variables – drugs included.

For background – thrombophilias affect 10-40% of the pop, varying by coagulation defect, race and region. Those that have both a genetic and acquired element are far more prevalent.

Which ones have both genetic and acquired components?

Hyperhomocysteinemia (MTHFRs); APS, antithrombin, protein C, protein S, dysfibrinogenemia, dysplasminogenemia all have environmental activations – read illness, medications, diet, lifestyles, sitting, immobility, etc. COVID could easily be a stressor capability of activating.

Immobility too.

However, and this is a big however, so too would all of the drugs given to patients to fight this virus.

Especially against a backdrop of longstanding polypharmacy.

Reports suggest viral, bacterial and fungal infections are linked to increased risk of clotting. Rarely however, do they dissociate the actions of the pathogen from that of the drugs used to quell the infection or reduce other symptoms.

For example: Environmental Triggers of Autoreactive Responses: Induction of Antiphospholipid Antibody Formation

From my own work – from which much of these data are shared.

Digging a little deeper. From 50% – 70% of patients who develop thrombosis carry one or more genetic and/or acquired thrombophilias.

That is a huge proportion of the population that is at risk for developing clots given the right circumstances.

Current estimates suggest that 7-10% of the population carry genetic thrombophilias and up to 60% develop factors that may lead to an acquired state of hypercoagulability.

Again – 60% of the population carries factors that may lead to hypercoagulability.

Just how common are clots? Very common.

Consider: according to US. Hospital discharge records (2007-2009) show 548,000 annual hospitalizations related to peripheral blood clots or venous thromboemboli (VTE).

Among those, 349,000 were deep vein thromboemboli (DVT) and 278,000 were pulmonary emboli (PE).

These numbers, may be underestimated.

Another study, that included both hospital and community events, showed annual rate of 909,793 clotting events (378,623 DVT; 531,170 PE), and fully a third were fatal.

The rate of annual VTEs has been steadily increasing over the last decade and researchers project that by 2050, the US healthcare system may be burdened with a staggering 1.82 million VTEs annually.

Mind you, not only are these numbers underestimated, they reflect late stage clotting – clotting that causes death directly or at least noticeably and where someone noticed. These numbers do not reflect the widespread mini-clots that don’t yet cause death and go unnoticed.

Autopsy reports of women who die from birth control related blood clots report widespread clotting, not just the clots that lead to fatality.

That is because hypercoagulability is systemic and only becomes noticeable when it blocks something fully.

It is not unreasonable to assume those dying of COVID with clots observed, didn’t also develop coagulation problems long before and/or concurrent with the illness but not necessarily relative to the illness itself, but rather to the drugs given to treat the illness.

So, maybe COVID is only indirectly involved. It may be our treatments that are causing the clots and the multi-organ failures observed with these cases.

Before jumping on the COVID-causes-X bandwagon, consider other culprits. It might just reframe treatment possibilities.

References for above cited statistics are included within: Testing for Thrombophilia Before Contraceptives Are Prescribed: Background, Laboratory Tests, and Economics.

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Holidays and the Immeasurable Cost of Birth Control

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Trigger warning – this article may be difficult for anyone who struggles with grief or a sense of loss over the holidays.

I’ve spent the last few years of my life writing about the (somewhat) measurable side effects of hormonal birth control. The impossibly diverse list of consequences range from strokes and skin cancer to migraines and multiple sclerosis. Some of the associations are easier to prove than others. Regardless, signs abound that all of these devastating consequences are underreported.

However, there are some consequences that are absolutely impossible to measure, and those are the ones that have consumed my mind over the past few weeks.

Holiday Grieving

If you’ve lost a parent or grandparent who really helped make the holidays special, you know this time of year can become a little more melancholy than in the past, but losing a family elder is expected. It’s not easy, but it’s normal.

Imagine a loss that isn’t normal or expected. Imagine losing a child, a young spouse or sibling. Those of us who have been blessed to not experience this kind of loss can’t possibly grasp the enduring pain or understand how the holidays can amplify the anguish. For many, the holidays can become a time they dread.

This isn’t the first year that I’ve known families who lost a daughter to birth control, but it is the first time the full weight of it hit me. During the week leading up to Thanksgiving, two mothers contacted me to ask if I knew how they might be able to connect with other families who have lost their daughters to birth control, while another mother who had shared her story with me previously, committed suicide.

Layers of Tragedy

Her name was Laura, and she also shared her story on Hormones Matter. Her daughter, Theresa, started taking Ortho-Cept with assurances that it was the lowest dose available. Laura trusted the doctor, and knowing that Theresa was young and healthy, she agreed to let her take The Pill. Theresa died from blot clots caused by her birth control just weeks after her 16th birthday.

Laura lived with the pain and the guilt for nine years before taking her own life. That’s the dimension that separates this form of grief from normal and expected losses. When you lose a parent or grandparent, you expect the coping to become a little easier from year to year, but the rules about grief no longer apply when you lose a child. There are some wounds even time can’t heal.

3 Women Today

I had just started sharing images of young women who had been killed by birth control along with the hashtag, #3WomenToday, when Laura passed away. The meme is intended to bring attention to the fact that we lose three young women in the United States every day to birth control related blood clots. But, as powerful as that number is, the meme is really about connecting faces to the statistic. We lose three women – each one is a daughter, sister, mother, niece, aunt. In other words, she isn’t the only victim. The tragedy doesn’t end with her death. In fact, it’s just beginning for an entire family whose sense of normal has just been permanently shattered.

One of the other mothers who had already agreed to let me share her daughter’s image on the meme reached out and asked if I would share Theresa’s image to honor both the mother and daughter.

Many of these families have connected and are able to support one another, but this isn’t the first time they’ve seen a member of their group overcome with grief from the loss of a daughter. Four years ago, just after the calendar flipped to a New Year, one of the leading advocates in this fight to educate young women about the dangers of hormonal birth control took her own life as well.

Karen Langhart was a strong woman. After her daughter, Erika died, she battled against the drug companies. She wanted to honor Erika’s legacy by making sure no other family would ever have to go through this. Of course, that was an impossible task, but it physically hurt her each time she heard a new story of a young woman who had died from birth control. One of the fathers who reached out to Karen seeking answers after his daughter died, told me that she was already crying when she got on the phone. She told him she was sorry that they hadn’t been able to do enough to save his daughter from the same fate that ended Erika’s life. Many of the parents carry this burden. They desperately want to stop it from happening again. Karen carried this load for four years before it became too much for her to bear.

Stopping the Ripples

As this year draws to a close, it’s sobering to realize we have lost nearly another thousand young women in the United States to birth control related blood clots. That’s a thousand families struggling through their first holiday without her.

It’s a sad reality, but hopefully it’s enough to anger us to take action. If there is a young woman in your family, communicate with her. Make sure she knows about the dangers and risks that her doctor probably hasn’t shared with her.

Then, give her a big hug– and be thankful that you’re able to.

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What Is A Woman’s Life Worth? Birth Control and Blood Clots

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I recently began a new project tackling the economics of testing women for clotting disorders prior to receiving prescriptions for hormonal contraception. Hormonal contraception induces chemical blood clotting cascades in all women, and thus, developing blood clots while on hormonal birth control is a very real risk. In women who have genetic clotting disorders, those already pre-disposed to hypercoagulability, the likelihood of developing a clot while on birth control is exponentially higher. In these cases, hormonal birth control and all synthetic hormones should be avoided, but they are not. Most women have no idea that they carry a genetic predisposition towards clotting; that is, not until they develop a clot and find themselves in the ER fighting for their lives. If they are lucky enough to survive, and many are not, the consequences of not knowing include a lifetime of potentially avoidable health issues. For the loved ones left behind, all that remains is the devastation.

It should be a no-brainer that we test for these clotting disorders before prescribing a drug that induces clotting and poses a very real risk for death, but it is not. Indeed, every report I have found thus far suggests that the economics do not add up, that it is just not worth the economic outlay to test. Testing costs too much and prevents too few deaths, they say (see also, herehere, here, and here). Identifying clotting disorders would cause the loss of hundreds of millions in pharmaceutical revenue annually, a strong disincentive for economic value. And perhaps the most absurd, the old trope and common justification for inaction in women’s healthcare, some researchers indicated that knowing one carried a risk for blood clots, risks that could be minimized if one knew, would cause undue anxiety; anxiety, apparently the fragile female mind is incapable of handling. Therefore, they reasoned, we should not test.

Flawed Assumptions Mean Flawed Calculations

When we look at the economic assessments that dismiss the value in preventing, what are entirely preventable injuries and deaths, they are rife with flawed assumptions, some obvious and others not. Inevitably, the questions asked involve some variation of this: if it costs X dollars to test all women before receiving hormonal contraceptives and testing may prevent, (because we don’t really know), Y blood clot events in this population, and if those events cost hospitals Z dollars in care, is it economically viable to do the testing? Aside from the general callousness of an economic argument for what is ultimately a medical and ethical question, the underlying assumptions about who is tested and what is included or excluded from the ‘cost’ side of the equation suffer from some serious flaws that inevitably skew the results.

One Year of Risk?

Almost all of the studies look at risk for developing clots only over a year of use. Most women use hormonal birth control for years. Limiting the duration of the study period though procedurally expedient is not realistic. Some women develop clots early on, within weeks or months of beginning the prescription, others withstand the hypercoagulability for years, even decades before clotting becomes symptomatic. Our research showed that most clots develop after a year or more of use. It is true, however, that many women with genetic clotting disorders will develop blood clots early on; many, but not all. Some women escape symptomatic clotting while using hormonal birth but go to develop symptomatic clots during pregnancy, postpartum or even during menopause when synthetic hormones come into play. By limiting the duration of the study period, of when women might develop symptomatic clots, we likely fail to capture the totality of events, and thus, surely underestimate the costs of care associated with a clotting event. Strangely, however, if the study encompasses a longer duration of usage, the math seems to reduce the risk of clotting over time, to extent that if we carried the reduction out, it would eventually become zero or perhaps even a negative number. Again, this is not only nonsensical, but underestimates the cost of clotting events.

Limited Type of Clotting Events Studied

In addition to limiting the duration of the study period, most of these studies constrict what is considered a clotting event to the most obvious culprits – the venous thromboemboli (VTE) of either the deep vein thrombosis (DVT) or pulmonary embolus (PE) variety. While it is true that those are the most obvious and most common, contraceptive induced hyper-coagulation affects the body systemically and produces events indiscriminately. From 85% to as high as 96% of all cerebral venous thrombosis (a type of stroke) in young women are a result of hypercoagulability induced by hormonal birth control, often in conjunction with a hereditary prothrombotic condition. In our study, 40% of the clotting events resulted in stroke.

From the Cleveland Clinic, we know hypercoagulability encompasses far more than DVTs or PEs.

“Hypercoagulable states can be defined as a group of inherited or acquired conditions associated with a predisposition to venous thrombosis (including upper and lower extremity deep venous thrombosis with or without pulmonary embolism, cerebral venous thrombosis, and intra-abdominal venous thrombosis), arterial thrombosis (including myocardial infarction, stroke, acute limb ischemia, and splanchnic ischemia), or both. Venous thromboembolic disease is the most common clinical manifestation resulting from hypercoagulable states. Although most inherited conditions appear to increase only the risk of venous thromboembolic events (VTEs), some of the acquired conditions have been associated with both VTEs and arterial thrombosis.

And yet, none of the economic models consider these data relevant. Not assessing the full complement of contraceptive induced clotting events significantly underestimates the incidence of such events, and thus, the cost of care associated with them.

Limited Genetic Factors

The economic models tend only to assess the cost/benefit ratios for the most common clotting disorders, Factor V Leiden (FVL), activated protein C resistance (APC) and sometimes the prothrombin mutation (G20210A). On the surface, this makes sense, a higher population prevalence should equate to greater number of clotting events. We know from non-economic based research, however, that this assumption is not accurate. Testing done post clotting event, shows that most folks who develop clots have more than one genetic susceptibility (and multiple acquired factors where clotting in increased) and that it is the cumulative effects of these variables that correspond to the risk, not necessarily a single mutation or risk factor itself. This suggests that when we limit the genetic testing to the FVL/APC dyad and then try to construct our cost/benefit ratio, we’re missing a whole bunch clotting events that could be prevented if identified before the contraceptives are prescribed. And to be fair, it also means we have to increase the cost of testing to include a more comprehensive panel.

False Independence

One of the more egregious errors that these studies make involves an assumption of independence among the test groups. What I mean by that is the research design assumes that women who use contraceptives, who are pregnant/postpartum, or using HRT are independent groups with different risk profiles. In reality, however, a woman contemplating hormonal contraception, will likely consider pregnancy at some point in her life and she may also consider HRT later in life. If she has a clotting disorder, it will impact her health across her lifespan. Testing and identifying those clotting disorders when a woman contemplates hormonal contraceptives not only reduces the risk of clots induced by the contraceptives, but allows her and her physician the means to prevent or at least manage clotting during pregnancy and postpartum and should inform her decision regarding HRT and other medications/procedures/surgeries where clotting is a factor. From a cost/benefit rationale, the number of clotting events potentially prevented would be much higher if we recognized that a woman with a clotting disorder is in fact, a woman with clotting disorder across her entire lifespan. Test once. Prevent events across the lifespan.

And the List Goes On

Some of the other errors in the research include:

  1. Only ever evaluating clots induced by oral contraceptives and ignoring those induced by the NuvaRing, which seems to have a higher incidence of induced clots. Also ignored, hormonal IUDs, the injectable depo-provera or the implant. Admittedly, the incidence of clotting is lower with these forms, but not absent entirely.
  2. Using hypothetical populations and risk assessments versus actual incidents and actual costs. (A study from Italy did look at actual hospital costs but suffered from other issues). An interesting tidbit, one study looking a clots identified by autopsy versus those identified clinically, argued those identified by autopsy over-estimated the incidence of blood clots while those identified clinically underestimated. My question, how is that the actual, verifiable incidence of clots is an over-estimation?
  3. Addressing hospital and immediate care costs only. Not only are there typical 2-3 primary care and/or hospital visits prior to the diagnosis of blood clots, there are post-hospital care costs medical and rehabilitation costs, as well as, long-term health issues and additional risks associated with surviving a DVT, PE, and especially a stroke. Without fully addressing cost of care across time, the cost and benefits of preventing clotting events cannot be calculated accurately.
  4. Squishy math. To this point, I can find none of the hard costs used in these models, particularly in the US. It is not clear what it cost to test one woman for clotting disorders or treat one woman for either a DVT or PE. The models reviewed offer what I can only describe as a type of ‘unit calculation’ based on a variety of factors that I have yet to fully understand.

How Expensive is Thrombophilia Testing Versus the Cost of Thrombosis Care?

The only study I could find with sufficient information to calculate the cost of saving a woman’s life by testing prior to prescribing hormonal contraceptives suffered from all of the methodological flaws outlined above. In addition, it was conducted from the perspective of the UK National Health Service in 2002, and thus, estimates were made in British pounds and converted to US dollars. As part of this project, we will be looking closely at testing costs in the US. For now though, let’s use the UK figures converted to US dollars.

Based upon a hypothetical population of 10,000 women, testing for thrombophilia before prescribing oral contraceptives would cost approximately $9,150,809.09 or about $915 per test per person. The researchers estimated this would save 7 lives at a cost of $1.3 million per life saved. The study looked at only DVTs and PEs and only oral contraceptives. It did not include other types of clotting events, the cost of care for these women leading to fatalities, the cost of care in women who developed clots and survived, the cost of complications or medical management, short-term or long term, and of course, it considered the cost of saving a woman before prescribing contraceptives, independent of and different from the cost of preventing clotting events across other life phases like pregnancy/postpartum. Nevertheless, based upon these numbers the value of a woman’s life can be viewed either the $915 that it costs to administer the tests per person or the aggregated cost of $1.3 million to save each of the 7 women whose deaths would be prevented. Does it really cost $915 for one test panel? Who knows. That number was derived simply by dividing the total cost offered above by the hypothetical study population. No actual testing costs were provided.

Even more difficult to ascertain are the hospital costs themselves, as this study and the other studies did not provide an actual or estimated dollar amount for caring for one woman who develops a clot, whether it is a DVT or PE. Instead, each study uses calculated unit value that represents a sort of ‘units saved’ if the clot were prevented. To be honest, I have yet to fully understand how these ‘units’ are derived. Sure, the methods sections indicate they captured certain costs associated with care, but I have not been able to translate those factors into dollars. So while, these studies are quick to point out the expense of testing and dismiss the value of these tests based upon economics, the actual economics are ambiguous at best.

What Is a Woman’s Life Worth?

Not much, it appears. If we take the estimate above, the cost of saving one life by testing women for clotting disorders prior to prescribing hormonal contraceptives, the value accorded to the life of a woman is $1.3 million. It sounds like a lot, but when we consider how other federal agencies value human life, it is quite low. Federal agencies that estimate the value of human life in order to calculate the value of programs that reduce fatalities and illness suggest that an American life is worth between approximately $7-10 million. In contrast, the federal agency tasked with valuing and then paying for lives lost on 9/11 determined that the worth of a human life was far less in some instances, but far more in others. That is because the value was calculated based upon one’s income at the time of death and potential income across the lifespan. This begs the question, by what metrics do we determine the value of a life, particularly in a girl or young woman who has yet to reach her income status?

What is a woman’s life worth? Is the value of her life accounted for only by what it costs an institution, a hospital or insurer, to care for her during a discrete period of time?  Why isn’t there a cost associated with the ramifications of the loss of her health or her life – ramifications which affect her family across a lifespan? Blood clots are not simple one and done health events. Provided she survives, the risk of lifelong disability is very real, particularly with stroke, but even so with DVT and the occurrence of post-thrombotic syndromes. Why are those costs not calculated against the cost/benefit of testing?  Why is her potential loss of income not calculated? And why is it acceptable to justify and ultimately dismiss what are entirely preventable injuries and deaths with squishy economic calculations?  I don’t have answers to these questions. As the project progresses, we’ll explore the economics and ethics more fully. For the time being, however, I cannot help but be disappointed in how little value a woman’s life is accorded.

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 on June 6, 2017.

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A Pain in the Leg: Blood Clots on Birth Control

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My experience with blood clots started in 1980 as a 16 year old after Family Planning recommended the pill to me. At the time, I played sport – sailing and ice-hockey, was lean and fit, didn’t drink alcohol nor smoke. I grew up eating mostly home-cooked meals; no junk food or soft drinks.

Within 6 months of going on the pill the only obvious side-effects were weight gain and possibly the migraine headaches that I would sometimes get. Then, at some point, I had leg pain that felt like muscle cramping. I didn’t think or know that this was a side-effect of the pill. I don’t remember being advised about this as a known problem with the pill.

Calf Cramp or Blood Clots?

My right calf muscle would seize with pain and feel very tender. I couldn’t flex my ankle and it became difficult to walk up and down stairs. The pain grew worse over the following few weeks, so mum and I went to the hospital. The doctors in the ER insisted I had pulled a muscle, even though I was certain I had not. At the same time the doctors suggested I return if I felt tingling or if my foot felt cold.

I returned the next day with a cold foot. Again, the doctors measured my calf muscles with no difference between the painful leg and the other leg. A student doctor suspected deep vein thrombosis and after much debate with other doctors, ordered a venogram for the next morning. I was admitted to the hospital. The result was positive and I was bed-bound in hospital for twelve days while taking heparin and warfarin.

While I was in hospital, another teenage girl arrived in my ward. She was flown to Sydney by helicopter from Mudgee with the clots under her upper arm.

Six years later in 1986, after trying several other contraceptive devices, like the diaphragm which popped out of place when I moved, family planning suggested that I go on the ‘mini pill’ as it was a very low dose. After some time, I don’t remember how long, I had the same leg pain, in the same calf muscle.

I knew what it was. After two weeks of hoping it would go away, I went to the hospital ER closest to where I lived. The registrar there would have none of it, even with my history, and refused to check using venogram. Again, there were no visual signs of a blood clot. Just the pain.

So, I traveled over an hour on a train to go to the hospital where I was previously treated. They admitted me straight away and performed a venogram the next morning. The treatment was the same as before.

I’ve not used chemical contraceptives since then. I found naturopath Francesca Naish and followed her natural fertility management program for the rest of my fertile life. I have never had any further issues with blood clotting, even with two pregnancies.

Because of this history, the obstetricians tried to label me as a high-risk pregnancy when I was pregnant, prohibiting me from a natural birth in the birthing centre. After I strongly insisted, they signed me off. I agreed to take a shot of anticoagulant when my baby was born. I had no sign of clots during either of my two pregnancies and delivered both naturally, without pain medication.

I realize I was a very lucky woman.

Real Risk Study: Birth Control and Blood Clots

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

We need your help.

Hormones Matter needs funding now. Our research funding was cut recently and because of our commitment to independent health research and journalism unbiased by commercial interests, we allow minimal advertising on the site. That means all funding must come from you, our readers. Don’t let Hormones Matter die.

Yes, I’d like to support Hormones Matter.

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Birth Control and the Fifth Vital Sign

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From March 2nd to May 30th of this year, we drove 15,000 miles across the US, from New York to California, on a reproductive health education tour. We offered 60 free classes in 43 states in order to share accurate, fair information about the menstrual cycle and hormonal health. We dubbed the project The Fifth Vital Sign, because we consider the menstrual cycle to be a vital sign, as indicative of our health status as blood pressure, heart rate, respiratory rate, and temperature, with the potential to give us information about thyroid issues, endometriosis, PCOS, infections, cancers, fertility and infertility, pregnancy, miscarriage, menopause and more.

By sharing information about how our bodies work, we hope people are better equipped to make fully informed choices about their health care and contraception in particular. If we’re not aware of the benefits of ovulation and menstruation, can we really make an informed choice about hormonal birth control, which prevents ovulation and menstruation? Beyond body literacy, without knowing or being presented with all of our contraceptive options, and the risks and side effects of each, how can we make an informed decision, which is our right, about our preferred method?

Informed choice in the context of contraception is one of our favorite parts of The Fifth Vital Sign curriculum, because we realize how critical it is. We were able to initiate our project, thanks in large part to a generous donation from Informed Choice for Amerika. Karen Langhart founded the organization after her daughter, Erika, died at the age of 24 from a double pulmonary embolism as a result of the NuvaRing. From then on, it became Karen’s life’s mission to catalyze research and communications that lead to informed contraceptive decisions for women. She didn’t want anyone else to lose their lives because they didn’t know the third generation progestin in NuvaRing is associated with a higher risk of blood clotting (between 3 and 12 women using combined hormonal contraception out of out of 10,000 will develop a serious blood clot, according to the NuvaRing website).

Body Literacy and Hormonal Contraception

So, how can you make an informed choice about contraception, both hormonal and non-hormonal? We always preface this section of our class by saying: our opinions do not belong in this space, and we are here to provide you with information so that you can make the best decision for your body, which you are the authority on.

We wrote about how body literacy is an important part of making an informed choice. Our recommended resources for menstrual cycle knowledge are listed on our website, but it’s a long list! A good place to start menstrual cycle 101 is Appleseed Fertility’s blog.

Know your rights. When you are speaking with your health care provider, you have the right to say no; the right to ask more questions because you have the right to informed consent; and the right to a second opinion. Depending on where you live and your personal, financial situation, a second opinion is not always available or accessible. If this is the case, know that you can always bring a patient advocate with you to an appointment, a trusted friend or support person who can help you advocate for yourself. Bring as much information with you to the appointment as possible. We will share some of our go-to resources for contraceptive information below. Also, request a long appointment time, so that you don’t feel rushed, and write down any questions you have.

Know why you want birth control. Ask yourself what’s important to you about contraception: STI protection, price, convenience, pregnancy prevention, inconspicuousness? Making what you want and need in contraception clear to yourself will help direct your choice. If you’re considering hormonal contraception for reasons other than contra-conceiving, like acne, decreased menstrual cramps or flow, be aware that hormonal contraception is not a treatment for these issues but a temporary relief. In Women’s Bodies, Women’s Wisdom, Christine Northrup compares taking hormonal contraception for these reasons to putting a piece of duct tape over the check engine light in your car and continuing to drive. There’s still a problem under the hood, but for the moment, you’re not aware of it. These issues can be indicative of hormonal imbalances, and treatment may be found in diet and lifestyle changes. This is one of our favorite questions to ask in order to make a fully informed choice: what are the alternatives to X option? In other words, if I’ve been on the pill for six years to decrease my acne, and I’ve just come off the pill and my acne is back, what are alternative treatments? Some of our favorite diet and lifestyle resources for hormonal balance and health are Nicole Jardim’s blog, Alisa Vitti’s Flo Living and Woman Code, Lara Briden’s blog and Period Repair Manual, other members of our health care team, including abdominal massage therapists, and of course the Hormones Matter blog! Also, if your cycle is irregular, hormonal contraception won’t regulate your natural cycle; instead, the synthetic hormones will induce an artificial one. An irregular cycle may signify hormonal imbalances, or it could just be your normal.

Research and ask for a comprehensive list of contraceptives. We use a combination of Scarleteen, Bedsider, Planned Parenthood, and ACOG to learn about contraceptive options prior to speaking with our health care providers. Once you’ve narrowed down your options, we also recommend looking at the pharmaceutical companies’ websites for more information. To facilitate an effective conversation with your health care provider, ask them three main questions about each option: what are the benefits, risks, and side effects?

Know your health history and your family’s history. Communicate this information to your provider. For example, does your family have a history of blood clotting disorders? Risks of combined hormonal contraceptives include blood clots.

Make sure you understand the instructions for how to use the contraceptive. Repeat what you understand back to the health care provider in order to verify your understanding.

Be sure to know what your insurance will and won’t cover. For example, some insurance companies will cover the insertion of the implant but will not cover the cost of the removal.

 

Real Risk Study: Birth Control and Blood Clots

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

 

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Help Us Crowdsource: Birth Control and Blood Clots Study

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A few months ago we began the Real Risk: Birth Control and Blood Clots study. The goal is to determine the real risk of birth control induced blood clots in real women, with real lives, and complicated health histories. The project, like each of our others, relies heavily on patient stories and the patient’s (or patient’s family’s) recollection of health issues preceding the blood clot crisis. This type of self-reporting is messy, complicated, and in many cases, carries with it inherent flaws. For all the difficulties, however, I believe crowdsourced research offers the opportunity for unheralded discoveries, not just because in women’s healthcare medication safety and efficacy evidence is, and has always been, sorely lacking, but also, because I believe in women. I believe in the wisdom of their voices. For too long, women’s voices have been silenced, even where our own bodies are concerned. We aim to change that, one story and study at a time.

Not unexpectedly, however, we have been chided and our efforts blocked by more traditional researchers and patient advocacy groups (especially those sponsored by industry). It is not the kind of research ‘real’ scientists do, we are told. Real research is filtered through the lens of the medical-pharmaceutical establishment. Real research is hierarchical and highly controlled. Real research eliminates as many confounding variables as possible; variables like medication and lifestyle interactions, the very real-life variables we embrace. Most importantly, real research is sanctioned, either by academia or industry. For if it is not, it cannot be real, and it certainly is not valid, no matter the rigor.

What Constitutes Real Research?

One might surprised to find what constitutes real research. Did you know that fewer than 50% of all pharmaceutical treatments have any data supporting efficacy. Of that evidence, much could be suspect given the rampant payments from pharmaceutical and device companies to physicians and other decision-makers, plus the well-documented publishing bias and even fraud plaguing the scientific publishing industry. Real research, conducted by the real scientists and sanctioned appropriately, may be no better than flipping a coin.

In women’s healthcare, matters are even worse. Not only are evidenced-based, clinical practice guidelines nearly non-existent in gynecology (only 30% of practice guidelines based on data), and women still not included in early stage clinical trials in sufficient numbers, but regulatory agencies do not mandate analytics to determine sex-based differences in medication safety or efficacy. The result, post-market adverse events – think death and disabling injury – are more common in women than men. When superimposed upon a deep-seated medical mistrust of women’s symptoms, is it any wonder women’s healthcare is dangerous to women? Again, however, this is the real research that experts speak of so highly.

Women Are Different than Men

Digging a little deeper, it becomes abundantly clear why women’s healthcare is so dangerous for women. Most medications reach the market without having ever done the appropriate testing or analytics to distinguish why women might respond to said medications differently than men. Indeed, prior to 1998, women of childbearing potential were prohibited from participating in clinical trials. So every medication that came to market before these regulations, was not tested on women.

Even in the lab, male rodents are used about 90% of the time, because dealing with the rodent estrus cycle is considered too expensive and too complex. It was only a few years ago that the National Institutes of Health (NIH), the major funding agency for most early stage research, began mandating that female animals be used in all basic research — 2014!!! This was only after a large, media driven, public embarrassment (see Leslie Stahl’s reporting on 60 minutes).  It remains to be seen if the differences between male and female animals will be analyzed, or if, like the continuously eroding 1998 regulations, researchers have only to check a box assuring the presence of female animals in the study design.

Medications for Women Only

What about medications developed specifically for women – like hormonal birth control? Certainly, these types of medications included females?  While it is true, the development of hormonal birth control used female test subjects, the study was small, hugely flawed and completely unethical – women were forced to stay on the pill despite experiencing serious side-effects, including death by blood clot, but also, by suicide. Almost a fifth of the participants suffered serious side effects, side effects that were discussed in the Nelson Pill Hearings but ultimately dismissed and ignored. And now, decades later, we are only just beginning to revisit those side effects.

For the newer formulations of hormonal contraception, only efficacy is ever tested. Safety is largely ignored. As a result, with each change in formulation and administration route (cervical rings, IUDs, patches, etc.), the side effects appear to increase not decrease. The newer generations of birth control are several-fold more clot-inducing than their predecessors, despite marketing admonitions to the contrary.

I think it is important that hormonal contraceptives prevent pregnancy, but it is equally important that they don’t cause blood clots, stroke, heart attack or cancer. And if blood clots, stroke, heart attack or cancer are deemed acceptable risks for birth control (and I don’t think they are), then shouldn’t we know which forms are the most dangerous and which women are most at risk?

One cannot manage, what one does not measure and we don’t measure critical components of women’s health. We also don’t track adverse events or side-effects very well. Question: have you ever reported a side-effect to a doctor? Do you know if he/she reported it to the FDA, the CDC or any other adverse events registry?  Probably not, and that is the problem.

If you knew you had a 20 times higher risk of stroke or heart attack for one medication versus another, would you choose differently? I bet you would, but as medical consumers, we don’t have that information. In many cases, those data don’t exist. We’re collecting those data and we need your help. If you are a woman, please consider taking the birth control and blood clots survey. There are four arms to the survey. It is likely that you fit into one.

Who is Eligible to Participate in the Birth Control and Blood Clots Survey?

  • Women who have experienced a blood clot(s) while using hormonal birth control: take survey now
  • A family member or partner of a woman who has suffered from deadly or disabling birth control induced blood clots: take survey now
  • Women who are currently using hormonal birth control, have used hormonal birth control for at least 1 year, and have not had a blood clot: take survey now
  • Women who have never used hormonal birth control or synthetic hormones of any kind: take survey now

Chances are you know someone who has experienced ill-effects, perhaps even blood clots, from hormonal birth control. Please share on social media.

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The Real Risk Birth Control Study: Take Charge, Find Answers

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I recently read an article about how fewer women are taking birth control pills now. The article claimed:

“The reasons behind the shift are hard to pin down. Study after study has shown the pill is generally safe for most women, and is 99 per cent effective with perfect use. The pill’s safety has only improved since it was introduced in 1960. It is perceptions that are changing.”

This is completely untrue. It wasn’t safe in 1960 and it certainly isn’t any safer now. It’s also not true that study after study has shown it to be safe. At the Nelson Pill Hearings, the 1970 congressional hearings on the safety of the birth control pill, every doctor that testified agreed that more research was necessary. Yet, every modern study I have found (from research on depressionweight gaindiabetes and more) has said that even more research is necessary to make any conclusions. So in the 46 years since, we still don’t adequately understand the risks with hormonal contraceptives. Dr. Paul Meier, who testified at the hearings, spoke about the challenges of conducting said research:

“Of far greater concern to me is the failure of our governmental agencies to exercise their responsibilities in seeing to it that appropriate studies were carried out… Frankly, the required research, although important, is not especially appealing to scientists. It is not fundamental and it is not exciting. It is difficult, it is expensive, and it is fraught with the risk of attack from all sides.

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.”

We can see that what Dr. Meier warned against is exactly what has happened. Experts testified in 1970 that the pill was linked to depression and possibly suicide. They warned that the pill should not be given to women with a history of depression. Yet, in 2004 when I was depressed after switching my brand of pill, my doctor told me that wasn’t a side effect. It wasn’t until last month that a European study on hormonal contraception said what no American study has dared. The pill is irrefutably linked to depression.

Unfortunately, depression is only ONE of the side effects of hormonal birth control. Obviously, blood clots are one of the most dangerous and why we are looking at them with this research study. Other side effects that were warned about at the Nelson Pill Hearings but for which the current research claims even more research is necessary include: diabetes, weight gain, cancer, loss of libido, urinary tract and yeast infections, lupus, infertility, hypertension. So no, studies do not actually show that “the pill is generally safe.” What studies show is that there STILL needs to be more research. Well, if they haven’t done it in the past 46 years, when are they going to do it?

As for the pill’s safety improving, just look the increased risk with newer formulations. Third and fourth generation pills have significantly higher risk for deadly blood clots.

“The problems with Yaz and its sister pills stem from drospirenone, a fourth-generation progestin.

After years of blood clot reports, the U.S. Food and Drug Administration (FDA), reviewed studies on oral contraceptives and found that an estimated 10 in 10,000 women on newer pills will experience a blood clot versus 6 in 10,000 with older pills.

Another study conducted by the French National Agency for the Safety of Drugs and Health Products (ANSM) found that birth control pills were linked to more than 2,500 cases of blood clots annually between 2000 and 2011. But third- and fourth-generation pills were responsible for twice as many deaths as earlier pills.

Two studies appeared in the British Medical Journal in 2011 and indicated newer pills were two to three times more likely to cause blood clots.

Why would the pharmaceutical industry make newer birth control pills that are less safe? Maybe because once the patent runs out on medication they don’t make as much profit. So they change the formula and market it as a new and better pill. As history has shown though, there never seems to be enough research done before these products are approved. And women are paying the price. Dr. Ball warned of this at the Nelson Pill Hearings when he said (page 6500):

“Each time we change the dose or the chemical, you have a whole new ball game statistically, and then a long period of time has to go by for evaluation. Again, is it going to be just this unscientific, hand-out-the-pills-and-see-who-gets-sick business, which I say is wrong and which has been done. Each time there is a new pill, there is a new problem.”

Alas, that’s exactly the business that’s been taking place. Throw in the fact that doctors often dismiss the complaints from women as psychosomatic and you have a recipe for a completely misrepresented medication.

I don’t know about you but I’m tired of being a rube for the pharmaceutical industry. If we want to know what’s really going on with hormonal contraception, we’re going to have to start looking at it ourselves. We can’t wait for the government or the pharmaceutical industry to provide us with perfectly funded, unbiased research. They haven’t done that in the near 50 years since the Nelson Pill Hearings and there’s little indication they are going to start now. That’s why we’re conducting this research ourselves. We need information to help women assess what their REAL RISK is for taking a medication. Not what their doctors are telling them based on studies conducted by the pharmaceutical industry. The aim of this study is not to take away contraceptive options but to provide more accurate information about which women may have more risk for serious side effects like blood clots and which forms of hormonal contraception may be more dangerous than others.

It’s time to take charge of our health and find our own answers. That’s exactly what this research hopes to do but we need your help to do it. Please participate. And please share our study with those you know who might be willing to help. Thank you.

Take Charge: Participate in the Birth Control and Blood Clots Study

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

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