hormonal contraceptives blood clots

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, here, here, 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.

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Image by 652234 from Pixabay.

This article was first published on June 6, 2017.

Related posts:

Why Aren’t Women Tested for Factor V Leiden and Other Clotting Disorders? Eosinophilic Esophagitis May Be a Sugar Sensitive Disease Birth Control Induced Pulmonary Emboli: Sudden and Slow Hormonal Contraceptives: Do We Really Know What We Think We Know?