hormonal contraceptives - Page 2

Matters of the Heart and Birth Control

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Dr. Ernst Rietzschel described his findings as ‘startling.’ His fellow cardiologists buzzed in agreement after he presented the findings at the American Heart Association 2007 annual meeting. His Ghent University lab in Belgium had discovered that women taking hormonal birth control and those who ever took them for more than a year have an increased risk of atherosclerosis, plaque build-up in their arteries. And, the risk goes up with the duration of use – up to a 42% increased risk with each decade.

This was different from the clotting issues most doctors associated with The Pill. They viewed clotting as a short-term side effect that receded after a woman stopped taking synthetic hormones. However, plaque build-up continues long after a woman stops taking birth control and could ultimately lead to deadly consequences like a stroke or heart attack.

Building Blocks

Ideally, medical research is like a set of building blocks. Each new study builds on the foundation of past experiments. While taking us to a new level of understanding, the new study also provides the foundation for the next layer of discovery that lies ahead.

Dr. Rietzschel’s study contained its own internal set of building blocks. The team initially discovered that women taking hormonal contraceptives had a threefold increase in C-Reactive Protein (CRP) levels. The liver typically increases CRP production in correlation to inflammation levels in the body. Consequently, high CRP levels can act as a marker to indicate the presence of other diseases or conditions.

Dr. Rietzschel explained how this dramatic rise in CRP levels led to discovering the increased risk of atherosclerosis.

“This is the first time that this has been documented. It was an accidental finding. We were stunned by the large elevations in CRP that you see in women taking the pill, so we then performed a safety analysis to see whether there was a link between past pill use and atherosclerosis measured by echo in both the carotid and femoral arteries.”

Single Layer Research

Rietzchel’s results were groundbreaking, but in many ways, his study exemplifies everything that is wrong in medical research related to hormonal birth control. The ideal building-block metaphor has never really materialized. Rather than resembling a pyramid, the blocks making up birth control research look more like someone let their rambunctious four-year old brother into the room. These blocks, scattered in disarray, rarely stack to even a second level.

The investigator accurately described his findings as startling, but even more disturbing is that they were discovered entirely by accident. If CRP levels in the subjects hadn’t been so ridiculously elevated, the researchers might never have considered the link between The Pill and atherosclerosis – despite the fact that the foundation had been laid decades earlier.

With any half-hearted Google search, you can discover that some of the leading factors contributing to atherosclerosis include: high blood pressure, high blood sugar levels, diabetes, and high cholesterol levels. The birth control pill’s contribution to each of these conditions was discussed in depth at the Nelson Pill Hearings in 1970.

Birth Control and High Blood Pressure

Dr. Laragh testified at the hearing that his discovery of the relationship between oral contraceptives and high blood pressure came by chance.

“We observed a woman who we knew had normal blood pressure develop rather severe and impressive hypertension several months after starting an oral contraceptive medication.”

He confirmed this behavior in several other patients and found that, in most cases, the blood pressure returned to normal after stopping The Pill. After they normalized, two patients who had no previous history of high blood pressure requested to continue with birth control pills. In both cases, their hypertension reappeared, and then disappeared upon terminating the medication.

Dr. Laragh stressed that his trial size was too small to have statistical significance, but this ‘rechallenge experiment’ convinced him of a cause and effect relationship. Having also observed that some women ‘swell up and accumulate salt and water,’ he deduced a probable mechanism that could be triggering high blood pressure in birth control patients.

To test his theory, he began measuring certain components of the kidney hormonal system and found that women on birth control experienced enormous increases in renin substrate levels. Renin substrate circulates through the blood and has the capacity to release angiotensin. Dr. Laragh described angiotensin as ‘the hormone which is the most powerful of all hormones in its capacity to raise the blood pressure.’

His suspicions seemed to be confirmed by a 2011 study (40 years later), which found that birth control so significantly elevated angiotensin levels that it could cause false-positive results for aldosteronism.

Another block on the floor…

While addressing the big picture, Dr. Laragh offered a couple of important caveats for the medical industry. First, he strongly recommended that any patient on birth control be seen by the doctor every 2 to 3 months to monitor her blood pressure.

When questioned about such frequent follow-ups, he warned, “We have a responsibility when we have powerful drugs like this; our responsibility is to learn about them, and the second responsibility is to apply the information. Otherwise, we do not have any right to have them on the market.”

Blood Sugar Levels and Diabetes

Further evidence of oral contraceptives’ causal relationship with high blood pressure came in Dr. Philip Corfman’s testimony, when he matter-of-factly stated, “It is known that steroids alter the diameter of veins and other blood vessels. These effects are also related to the changes in blood pressure observed in some users of oral contraceptives. Several reports of hypertension have appeared and there is an increasing body of evidence that there may be a positive relationship.”

Dr. Corfman had previously headed a task for at the National Institutes of Health. His team combed through nearly 4,000 journal articles and sorted the concerns into more than 20 categories that they felt needed further attention. Much of his testimony focused on birth control’s metabolic effects on the body, particularly how the synthetic hormones modified carbohydrate metabolism.

“Recent investigations show that a significant proportion of normal women on these agents appear to handle sugar in an abnormal way.” He continued, “Another biologic change of increasing concern is the effect on the way the body handles fat. This effect is closely related to changes in sugar metabolism since fat synthesis is related to insulin levels. The changes which have been observed in fat metabolism simulate levels seen in older individuals and raise concern over the possibility that these alterations may be related to heart disease.”

And this was no rare event, Dr. Victor Wynn testified that nearly 1-in-5 young women taking The Pill developed an abnormal glucose tolerance that he named “chemical diabetes.”

The Pill and High Cholesterol

Recognizing that there were also abnormalities in the fats circulating in the blood of birth control patients, Dr. Wynn decided to measure triglycerides against a control group. He discovered that “at least one-third of the users had triglyceride values higher than the highest value we found in our control subjects.” Let that sink in – the woman with the very highest triglyceride values from the control group had numbers lower than one-third of the women on The Pill.

In his beautiful British accent, Dr. Wynn slyly added, “I am sure that there is no need for me to tell an American audience the significance of having your cholesterol levels elevated, since there is so much propaganda in the press, medical, and lay, indicating the importance of having your cholesterol lower, if you can possibly achieve it.”

In order to demonstrate the domino effect of these complications, Dr. Wynn submitted a summary of over 70 references taken from medical literature over the previous 3 years.

“It is by no means exhaustive. But the references are to the association between abnormal glucose metabolism, abnormal insulin levels, and abnormal blood lipid or blood fat levels, and the accelerated development of atherosclerosis.”

More blocks on the floor…

Don’t Discount Clotting

World-renowned neurosurgeon, Dr. David Clark testified that the strokes young women on birth control encountered were different than those seen in older patients. The Pill seemed to trigger a different mechanism, as ‘alterations in the normal clotting behavior are certainly present.’

“There is some reason also to believe that there may be changes in the vascular wall itself. It is known that estrogens have an effect on the caliber of veins. In some of the stroke victims who have been studied, there is a peculiar beaded appearance to the walls of the arteries -– not occlusion, but irregularity of outline that suggests there may be edema or other changes in the outer wall of the artery.”

Dr. Wynn added, “When you see the abnormalities, these are associated in some curious way with increased incidence of clotting, so that putting the two together, I think it is a reasonable case, but it cannot be proved, and this underlines the great difficulty we have with the contraceptives, that what harm they may do may never in fact be proved.”

At the rate we’re going, it will certainly never be proved.

Second Level Stuff

However, there is a seed of hope on at least one front.

Some practicing cardiologists have noticed the long term effects of birth control on their patients and they’ve begun to talk about it.

After his study that uncovered the startling link to atherosclerosis, Dr. Rietzschel told Medscape:

“I’m certainly not advocating stopping use of the pill,” he noted. First, the findings need to be replicated, “that’s really important,” he said, “and then we need more research. It’s staggering that for a drug that is being used by 80% of women, there is so little information about the long-term safety. That’s really incredible.”

It is very common for the lead investigator of a negative study to make statements like “This doesn’t mean women should stop taking The Pill” and “Certainly more research needs to be done,” I suppose in an attempt to appease pharmaceutical companies. But Dr. Rietzchel’s statements were different. You could sense his genuine dismay that so little has been done to understand the safety of hormonal contraceptives.

This prompted me to contact Dr. Rietzschel to see if he was aware of any subsequent studies building on his atherosclerosis findings (10 years have lapsed since its publication). It turns out, his team is in the final stages of a longitudinal study, and he expects the analysis to be published within the next year.

This is a promising development. Let’s just hope no one let’s their four-year old brother into the room.

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A Joint Problem: Rheumatoid Arthritis and Hormonal Birth Control

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Rheumatoid arthritis is an autoimmune disorder which causes the body’s immune system to attack the joints, resulting in pain and swelling. About 1.3 million people in the United States have rheumatoid arthritis, and of these, nearly 75 percent are women. “In fact, 1–3 percent of women may get rheumatoid arthritis in their lifetime. The disease most often begins between the fourth and sixth decades of life, however, RA can start at any age.”

At this point in my research into hormonal contraceptives, any disease that affects women so much more drastically than men I find suspicious. While reading the Nelson Pill Hearings (NPH), the testimony of Dr. Giles Boles, a professor of internal medicine, caught my attention. He was discussing oral contraceptives and rheumatoid arthritis. Like diabetes, this is another connection I had never heard about before.

At the hearings, Boles describes a 24-year-old woman who was experiencing mild rheumatic symptoms. After running some tests, she showed three abnormalities commonly associated with lupus. She had been taking oral contraceptives for 8 months and was on no other medication. “She was advised to discontinue her oral contraceptive therapy and within 6 weeks all of her laboratory abnormalities had disappeared.” Doctors continued to monitor her for over 2 years and she remained disease-free.

He also spoke about a two-year study published in 1969 that showed rheumatoid arthritis in women taking oral contraceptives increased more than 50 percent. Another study from the same year reported that 22 women with rheumatic symptoms had their symptoms diminish or disappear after discontinuing the pill (NPH page 6089).

That study, which was originally published in the British medical journal Lancet, was also discussed in Barbara Seaman’s book The Doctors’ Case Against the Pill (page 122):

“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 researching the connection further, my first stop was the Centers for Disease Control. On their page for rheumatoid arthritis under “Risk Factors” is the following:

Oral Contraceptives (OC): Early studies found that women who had taken OCs had a modest to moderate decrease in risk of RA. However, most recent studies have not found a decreased risk. The estrogen concentration of contemporary OCs is typically 80%-90% lower than the first OCs introduced in the 1960s. This may account for the lack of associations in recent studies.

This seems very odd to me for a few reasons. First of all, if oral contraceptives decrease the risk of rheumatoid arthritis, why put it under “Risk Factors?” Secondly, though the “early studies” being cited are from 1993 and 1989, they point to the higher concentration of estrogen from pills in the 1960s as a reason for the conflicting information. Yet in 1970, Dr. Boles testifies about a very real connection between rheumatoid arthritis and the use of oral contraceptives.

Rheumatoid Arthritis on the Rise

A 2010 study from researchers at the Mayo Clinic showed that after four decades of decline, rheumatoid arthritis was on the rise among women. They cited oral contraceptives as one of the culprits:
“The incidence of rheumatoid arthritis (RA) in women has risen during the period of 1995 to 2007, according to a newly published study by researchers from the Mayo Clinic. This rise in RA follows a 4-decade period of decline and study authors speculate environmental factors such as cigarette smoking, vitamin D deficiency, and lower dose synthetic estrogens in oral contraceptives may be the source of the increase.”

Yet this WebMD article discusses a small German study that showed that oral contraceptive use could ease some symptoms of RA. Incidentally, the article also points out, “certain patients with inflammatory arthritis may increase their risk of blood clots by going on oral contraceptives.” This statement makes it seem that only some women are at an increased risk for blood clots when using oral contraceptives. That’s untrue. ALL women who use hormonal contraceptives are at an increased risk for blood clots.

While the German study was small and focused on symptoms, a meta-analysis of 17 studies showed no “protective effect of oral contraceptives on the risk for RA in women.”

Perhaps even more strange are the findings presented at the American College of Rheumatology Annual Meeting in Boston in 2014. The study presented there showed that choice of contraception may influence rheumatoid arthritis autoimmunity risk, with the biggest risk coming from IUDs (intrauterine device), though the research findings don’t specify whether patients used a copper IUD or a hormonal IUD.

According a meta-analysis by Hazes and van Zeben the overall unsatisfactory state of studies relating RA to the contraceptive pill suggest

“that oral contraceptive use may in fact be a marker for some other causal factor.”

Another article by William H. James from the Annals of Rheumatic Disease describes the problem with determining the connection between oral contraceptive use and rheumatoid arthritis:

“Over the last decade a dozen large scale studies have offered strikingly dissimilar conclusions on this possibility. An international workshop was held in Leiden in 1989 in an attempt to reach a consensus. It is not unfair to comment that consensus proved evasive.”

Is Rheumatoid Arthritis Connected to Hormonal Contraceptives or Not?

In 1970, the research clearly showed a connection between rheumatoid arthritis and hormonal contraceptives. Further research confirmed that. Then other studies attempted to demonstrate that the pill mitigated symptoms, while a meta-analysis showed no protective effect. Yet recent findings show an increased risk for women who use IUDs. In all of the recent research, the only consensus seems to be that there is no consensus.

The bottom line is that evidence about the connection between rheumatoid arthritis and hormonal birth control is inconclusive at best, incoherent at worst, and sometimes downright contradictory. Once again, I have to ask why. Why were there not conclusive studies conducted immediately after the 1970 Congressional hearings? Who gains by there still being confusion about this issue? Who loses? That one I can answer; women lose.

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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Blinded By Side Effects: Vision and Hormonal Birth Control

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I don’t know about you but my vision is pretty important to me. I’m using it right now to type this article. I use it all the time, every waking hour of the day (except maybe when I’m meditating). So when I read the Nelson Pill Hearings and I came across the testimony of Dr. Guttmacher, I was shocked.

“Now, in addition to the danger from thromboembolism which has been described to this committee on several occasions by several witnesses, I think that there are other dangers for the pill… such as high blood pressure, headache, depression, interference with vision, and so on.” (page 6566)

Wait… the birth control pill affects your vision??? How can that be? And how could he just say that in passing? Why did no one on the Senate committee stop him and make him explain that that statement? It turns out, just like diabetes, yeast infections and UTIs, depression, weight gain, and so many other side effects, no one had told me that my vision could be affected by using hormonal birth control.

How Hormonal Birth Control Affects Vision

Hormones affect every system of the body so perhaps it should come as no surprise that they can greatly impact your vision. In fact, it is the fluctuation in hormones that is the primary reason for worsening eyesight with age. So of course, manipulating the body’s natural chemistry by using hormonal birth control can cause a variety of vision problems.

Dry Eye

According to the National Eye Institute (NEI), “Dry eye occurs when the eye does not produce tears properly, or when the tears are not of the correct consistency and evaporate too quickly.” While usually more uncomfortable than dangerous, if dry eye is left untreated it can cause pain, ulcers, scars on the cornea, and in rare cases, some loss of vision.

The NEI also states that it can be temporary or chronic and that one of the causes of dry eye is medications such as birth control. Unfortunately, that means dry eye is often overlooked in young women and teen girls using the pill. As Dr. Reiser of the Cornea Institute at the Children’s Hospital of Los Angeles points out, doctors “may not even think of it, but these drugs are frequently prescribed to treat skin problems and dysmenorrhea. Some [ocular] symptoms can mimic what you see in menopausal women.”

We also see dry eyes as a side effect of women who’ve had hysterectomies. Robin Karr details her experience with it here. It’s obvious that eye health is linked to hormones but the vision problems associated with hormonal birth control don’t stop there. Dry eyes may be the least of our worries.

Glaucoma

Dry eye may be uncomfortable and inconvenient but glaucoma, another eye condition linked to hormonal birth control, can be much more dangerous. Glaucoma causes damage to the optic nerve and can lead to permanent loss of vision. Perhaps the scariest thing about glaucoma is that most patients have no symptoms and are only diagnosed when having an eye exam. A researcher and ophthalmologist from the University of San Francisco found that use of birth control pills for three years or longer doubles the risk of glaucoma.

The fact that glaucoma is the second leading cause of blindness and that there is no cure  is very disturbing. The American Optometric Association downplays the findings of this study and calls for more research. Yet, that seems to be the response to all of the research about the dangerous side effects of hormonal contraception. How much more research do we need to show that these medications are dangerous and dangerously over-prescribed? A woman could literally go blind from a medication she’s been prescribed to treat acne.

Retinal Occlusion

As someone who had a stroke while using hormonal birth control, this risk probably shouldn’t have come as a surprise to me. Retinal occlusion is a stroke of the eye caused by a blockage in the blood vessels of your retina. These blockages can be caused by blood clots, a well-researched and documented side effect of hormonal contraception. Like with a stroke of the brain, recovery isn’t guaranteed. Some people who suffer these retinal occlusions will never see again.

In fact, the risk with oral contraceptive use is so substantiated that you can find it in the “Practicing Ophthalmologists Curriculum Core Ophthalmic Knowledge” on the American Academy of Ophthalmologists website.

It should also be said that many of our Real Risk: Birth Control and Blood Clots study participants experienced vision changes before and during their blood clots. This was the case not just in the women who had had strokes but surprisingly also in the women who suffered pulmonary embolisms.

Seeing Clearly

I used birth control pills for 10 years and I never once had a healthcare professional- not my gynecologist, not my general practitioner, not my ophthalmologist- tell me that vision problems were a side effect. That Dr. Guttmacher mentioned it in passing at Nelson Pill Hearings seemed to indicate that the risk was well-known, even back in 1970. Current research supports that hormonal contraceptives adversely affect vision. Where does that leave us? What would you be willing to give up for a medication? Your physical health? Your mental health? Your libido? Your vision? Your life?

What else do we need in order to see that hormonal contraception is not worth it?

Real Risk Study: Birth Control and Blood Clots

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

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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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Deconstructing Contraceptives: What Do We Really Know?

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Over the last several weeks, I have been preparing a report regarding our research on birth control and blood clots. In doing so, I have been reviewing past work and stumbled upon my notes for the presentation that landed the grant allowing this research to begin. The talk was filmed, but the video is behind a paywall. So, I decided to post the notes and the presentation. Enjoy.

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

As I considered how to put this presentation together, I struggled with where to begin, what to leave in, what to leave out. There is so much that needs to be understood about contraceptives that we could fill a week of lectures and discussions. What I kept coming back to, however, is the notion that if I can teach you how to think about contraceptives, or for that matter, any medical treatment, if I can teach you how to question and evaluate the research, how to find the answers that you need; if I can give you a foundation and a framework for understanding the science, the economics and the politics of this medication, then each of you can find your own answers, and perhaps, if you are so inclined, contribute back to the knowledge base, so that we all have a better understanding of these issues. And so it is from that perspective that I have decided to approach this discussion. I want to give you a foundation and a framework from which to build your own house of knowledge. Sounds a little corny, doesn’t it, but bear with me, learning how to think critically about medical science might just save your life or the life of a loved one.

The Framework of Knowledge

I have a background and a natural inclination towards philosophy. In other words, I tend to think about things a bit more deeply than perhaps I should. This gets me into trouble sometimes.

One of the questions that plague my thinking is ‘how we know what we think we know’. I find that more often not, pondering from where and from whom the knowledge, the science, the politics, even the historical interpretations come from, tells us a lot about what it is we know exactly and what we really have no business claiming knowledge of.

With hormonal contraceptives, and indeed, the entirety of women’s health, when we deconstruct what is known and detach it from how we know it, or at least how we think we know it, it becomes very clear, very quickly, that our knowledge is severely limited.

For example, did you know that most of the science on contraceptives was developed over 50 years ago before the thalidomide tragedies changed FDA regulations regarding women’s health? Did you know that after thalidomide, research involving women of childbearing potential was all but prohibited until the late 1990s?

The post-thalidomide regulations, when combined with the political quagmire that is female reproduction, all but eliminated research and development on hormonal contraceptives, with the large pharmaceutical industries preferring to make only slight changes to dosage or delivery method and focus almost entirely market saturation over all else.

Probably not, unless you study this stuff. But knowing this, understanding how we know what we know about hormonal contraceptives can tell us a lot about these products, even if you don’t know the science.

So, hormonal contraceptives didn’t get the safety research they deserved. Indeed, they did not and continue not to because of the perceived economic and political costs associated with contraceptive science is greater than the perceived benefits.

Why fund new science, when the old science is already approved and the market is mature, in the sense that women and physicians alike consider hormonal contraceptives safe, but more importantly, a necessary component of reproductive health?

The Objectivity Bias

Back to the topic of how we know what we know, not only do we have to consider the science behind these drugs, but we also must consider in what context the science emerged and whether and how that context introduces a bias that impedes our understanding.

I would argue that bias is inevitable, even fundamental to the scientific endeavor, even though we claim objectivity. Consider, for example, the process of research design. What questions are asked and not asked are dependent entirely on the researcher’s individual constructs about what the problem is. Defining the problem, or even whether there is a problem to be investigated, is informed by education, culture, society, advertising, marketing, and in more modern times, by research funding availability. In many ways, bias permeates every aspect of the scientific endeavor. And yet, we hold tightly to this notion that delineating science from every other pursuit of knowledge, is its objectivity, its lack of bias.

In science, in particular, we have exalted the notion of objectivity above all else. The experiments we do are meant to eliminate subjectivity, to eliminate chance and the variables that might confound our data so that we can say with some confidence that this or that treatment is safe and effective.

While these are laudable goals that have contributed largely to the great advancements we have in all fields of science and technology, I think, in some ways, we have taken this reliance on objectivity too far, so much so that we have lost the humanity, and indeed, the humility in our scientific endeavors. This fealty to what I would argue is a contrived reliance of objectivity, to controlled but abstracted data calculations, not only severely limits the scope of our understanding but also poses real risks to human and organismal health. We see evidence of this every day, when human illness mediated by a particular drug or environmental toxicant is viewed only in terms of averages. That is, when a drug evokes a reaction in only small fraction of those who use the medication, but appears not evoke that reaction in others (though I would argue that it evokes other reactions that we are simply not recognizing), then those reactions, those costs, are viewed as inconsequential. They are not statistically significant and because we forget that statistical significance is different that clinical significance, because supplant statistical significance, a mathematical abstraction for clinical and human significance, we fail to recognize the dangers of a particular medication.

And so when I approach medical science, or really anything, it is always with those two things in mind – how we know what we think we know, and how biases, mine and others, influence that knowledge. It is from that perspective, we’ll take our foray into the contraceptive conundrum.

My Biases

Because I believe biases are so important – let’s begin with my biases. We’ll then look at the biases in modern medicine and statistics and how those biases have informed how we know what we know about hormonal contraceptives. Finally, we’ll tackle what is known and what is not known about what hormonal contraceptives do and do not do to the body.

You already know a little about me from the bio I submitted and from the brief introduction. But let me insert myself into the research, give you some idea of the lens through which I understand medical research in general, and hormonal contraceptives, in particular. I stand here today as a woman who has used oral contraceptives and experienced side effects from them (but at the time had no clue about the connections between my health issues and the contraceptives, nor did any of the physicians I sought help from).

I am mom of 21 year old twins, a wife of 26 years and a lifelong jock (even at the ripe old age).

I am as a research scientist. I love figuring out how things work, and to me, figuring out how things work means not only going to down to the smallest possible unit of function – the molecule, the chemical pathways, but mapping the systems involved, not just of the target organ but across the entire body. I think I was an engineer in a former life.

I am writer, as I mentioned, with philosophical tendencies.

I am business owner, whose business involves understanding women’s health and healthcare.

Finally, I am fierce women’s health advocate. For too long, questions about women’s health have been ignored. I want to change that.

I should also mention, as someone who is involved in medication adverse events research, listening to patient stories, seeing the devastation that some of these medications can evoke, and then investigating the mechanisms by which these reactions can occur, I have become increasingly wary of pharmaceutical promises. Admittedly, in that regard, I am probably more biased than others. It is difficult not to be.

So it is this totality of experiences that color, not only my interpretation of data, but I think more importantly, the questions I ask about any given medication. When I look at the safety and efficacy of a drug, I want to know in real terms what the benefits versus the risks are to an individual.

Unfortunately, we don’t have that information for majority of medications on the market, especially for women, and most especially for hormonal contraceptives.

With that long introduction, let’s dig into the topic at hand.

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

Add Your Experience to the Conversation

As a result of this presentation, we were awarded a grant to investigate the health risks associated with hormonal contraceptives. Some of the early results of the pilot study can be found here and here. You can help us delineate those risks further by adding your experiences to our growing database by taking part in the Real Risk Study and, if you are so inclined, sharing your health story on Hormones Matter.

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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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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Diabetes: Another Problem with Hormonal Birth Control

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Diabetes is the 7th leading cause of death in the United States according to the American Diabetes Association. Tens of millions of people have diabetes and are at increased risk for a whole host of other problems because of it. The estimated economic cost of diabetes is nearly $245 billion each year. BILLION! So shouldn’t we take a look at how to decrease these risks, lessen this economic burden, save lives?

I’ve done a lot of research on birth control pills, their side effects, and how those risks are communicated to women. My interest in the topic is both personal (I suffered a stroke from hormonal birth control at age 28) and professional. I’ve been reviewing the Nelson Pill hearings and what I’ve found is shocking. Beyond the obvious correlation between blood clots and hormonal birth control, even back in 1970 doctors and scientists knew that these medications affected, contributed to, and caused a myriad of health problems from weight gain to stroke. One of the most surprising to me, because I hadn’t come across it in any of my previous research, was the link between synthetic hormones and diabetes. Dr. Hugh J. Davis, the first doctor to testify at the Nelson Pill Hearings said the following (page 5930):

“A woman, for example, who has a history of diabetes or even a woman with a strong family history of diabetes is not an ideal candidate for using oral contraceptives… [they] produce changes in carbohydrate metabolism which tends to aggravate existing diabetes and can make it difficult to manage.”

Hormonal birth control elevates blood glucose levels, can increase blood pressure, increases triglycerides and cholesterol, and accelerates the hardening of the arteries, among other things. They knew this in 1970. But what about the research now? Well, if you’ve read any of my other articles it probably won’t surprise you that the current research is… wait for it… you guessed it… INCONCLUSIVE! Here’s a look at what I’ve found:

“Cardiovascular disease is a major concern, and for women with diabetes who have macrovascular or microvascular complications, nonhormonal methods are recommended. There is little evidence of best practice for the follow-up of women with diabetes prescribed hormonal contraception. It is generally agreed that blood pressure, weight, and body mass index measurements should be ascertained, and blood glucose levels and baseline lipid profiles assessed as relevant. Research on hormonal contraception has been carried out in healthy populations; more studies are needed in women with diabetes and women who have increased risks of cardiovascular disease.

 

And:

“The four included randomised controlled trials in this systematic review provided insufficient evidence to assess whether progestogen-only and combined contraceptives differ from non-hormonal contraceptives in diabetes control, lipid metabolism and complications. Three of the four studies were of limited methodological quality, sponsored by pharmaceutical companies and described surrogate outcomes. Ideally, an adequately reported, high-quality randomised controlled trial analysing both intermediate outcomes (i.e. glucose and lipid metabolism) and true clinical endpoints (micro- and macrovascular disease) in users of combined, progestogen-only and non-hormonal contraceptives should be conducted.

 

Not enough evidence is available to prove that hormonal contraceptives do not influence glucose and fat metabolism in women with diabetes mellitus.”

For women with polycystic ovarian syndrome (PCOS), this is particularly troubling. They are already at an increased risk for diabetes. “Researchers in Australia collected data from 6,000 women and found that those who had PCOS were three to five times more likely to develop type 2 diabetes than women who didn’t.” Yet the first treatment doctors usually prescribe for PCOS is birth control pills. It’s unclear whether the PCOS alone increases a woman’s risk or just that most women with PCOS are treated with hormones that make her more likely to develop diabetes.

It begs the question, why are we treating a woman for a condition that increases her risk for diabetes with a drug that increases her risk for diabetes?

Even if you don’t have PCOS, you are still at risk. A recent study showed that “women who used hormonal methods of birth control had higher odds for gestational diabetes than did women who used no contraception.” So using hormonal birth control may prevent you from getting pregnant but at the cost of making a future pregnancy more dangerous? It’s not just dangerous for pregnant women, however. Hormonal contraceptives seem to predispose women to diabetes across the lifespan. For example, another study found:

“The prevalence of diabetes was significantly higher in post-menopausal participants who had taken OCs (oral contraceptives) for more than 6 months than in those who had never taken OCs. The duration of OC use was also positively associated with the prevalence of diabetes. Furthermore, taking OCs for more than 6 months led to a significant increase in fasting insulin levels and HOMA-IR in nondiabetic participants. Past use of OCs for more than 6 months led to a significant increase in the prevalence of diabetes in post-menopausal women, and increased IR in nondiabetic participants. These results suggested that the prolonged use of OCs at reproductive age may be an important risk factor for developing diabetes in post-menopausal women.”

This is further proof that taking hormonal birth control affects women for much longer than the duration they take it. A correlation between synthetic hormones and diabetes was evident to doctors and researchers back in 1970 and we’re still trying to understand those effects today. Dr. Hugh Davis testified (pg 5928) about hormonal birth control:

“While you are accomplishing your contraceptive objective you are producing very, very widespread and generalized changes.”

I’m starting to feel like a broken record here, but at what point are these risks not acceptable? And why do we still not fully understand these risks? The goal of the Nelson Pill Hearings was to determine if these medications were safe and they are clearly not. Over and over, experts testified and said the pill should not be taken off the market but that it should be studied more and replaced by something better as soon as possible. As we can see, that hasn’t happened. Women are still having to make the choice between convenient contraception and their health and safety. The risks involved with hormonal contraceptives are still being downplayed, skewed, and hidden. If a serious and potentially life-threatening condition like diabetes is not too high a price to pay to avoid pregnancy, what is? How about loss of libido? Mental health? Weight gain? Blood clots? Stroke? Loss of life? Dr. Davis also said (pg 5925):

“In using these agents (hormonal contraceptives), we are in fact embarked on a massive endocrinologic experiment with millions of healthy women.”

I couldn’t agree more. And the experiment continues.

 

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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Hormonal Birth Control 46 Years Later- Why Has Nothing Changed?

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Over the last several months I have been reading and writing about the Nelson Pill Hearings. I was hired by the late Karen Langhart to dig through 1500+ pages of congressional hearing transcripts. Her daughter, Erika, died of blood clots caused by hormonal birth control and Karen wanted to know what the researchers, the FDA, and Congress knew about the risks associated with these hormones back then. This matter is close to my heart because I suffered a stroke at the age of 28 caused by the pill. Could Karen’s daughter’s life, and the lives of so many other young women, have been spared had Congress and the FDA heeded the warnings of the researchers at these hearings? What was the result of all this government time and money? What was the point and what did the hearings lead to? Karen believed that if women and their doctors today fully understood what doctors back in 70s understood, fewer women would choose hormonal birth control and if they did, the risks would be understood and the side effects could be recognized and treated earlier.

Based on my personal experience, and the experience of many of the women helping with our research, doctors don’t understand the risks involved with hormonal birth control. And I think we need to ask why. The testimony given by both industry and non-industry physicians and researchers is pretty damning. The fact that the information presented at the hearings has been largely ignored is infuriating. Why did my ER doctors send me home from the hospital twice when I presented with the exact stroke symptoms testified about at the hearings? Why, over 45 years later, do we still have doctors doubting the dangers of hormonal birth control and misdiagnosing women or worse, dismissing them completely? Why do women continue to suffer from side effects ranging from mood swings to death? And why after all these years are there no better and safer options?

This is by no means a complete account, but below I’ve compiled some of the most interesting, and sometimes shocking, testimony from the Nelson Pill hearings.

What Are the Nelson Pill Hearings?

Senator Gaylord Nelson scheduled these congressional 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.

In his own words (page 5923):

The aim of these hearings: First, whether they [birth control pills] are dangerous for the human body and, second, whether patients taking them have sufficient information about possible dangers in order to make an intelligent judgement whether they wish to assume the risks.

I should note that it was the feminists who demanded the hearings, expressly because of the safety issues. Consider whether that would happen today?

Who Testified?

Doctors, scientists, and officials from the Food and Drug Administration testified over the course of two months. After the first few days of testimony, Senator Bob Dole implied that the hearings were biased against the pill, to which Senator Nelson responded (page 6021-6022):

These hearings will permit a presentation of all viewpoints respecting the pill, in the best balanced fashion that I know how… Every single company is invited, and if they want to have 5 days or 10 days, 8 hours a day, to present their case, I will give it to them if they want to come.

Members of the D.C. Women’s Liberation, led by Alice Wolfson, interrupted the hearings to ask repeatedly (until dragged away by guards) ”Why isn’t there a Pill for men?” and ”Why are 10 million women being used as guinea pigs?”

To this 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.”

Senator McIntyre in defense of the activists said (page 6018):

I would like to say, Mr. Chairman, a few words in behalf of the young ladies who spoke up from the audience. The scientists we just heard this morning speak of side effects and drugs and so many reactions on so many thousands or hundreds of thousands of patients. However, I Think we should bear in mind, Mr. Chairman, the fact that for an individual who experiences a serious adverse reaction to the drug, her incidence is 100 percent. So, for this reason, Mr. Chairman, I hope we can arrange for at least one of these young ladies to be heard.

Even Dr. Louis Hellman, a doctor who had worked on projects funded by the pharmaceutical companies felt that the women should be heard. (page 6189):

Women use these drugs and it is important that they be presented in any decision-making body.

Yet the feminists were escorted from the hearings by security. None of them were allowed to give testimony. The only two women to testify at the hearings were doctors who championed the pill. So at these “fair and balanced” hearings, they heard from no one who had actually experienced side effects of the pill.

The Effects of the Pill

I’ve written about several of the side effects of the pill and included expert testimony and current research from stroke to weight gain to depression to loss of libido. But perhaps Dr. Victor Wynn put it most succinctly during his testimony (page 6311):

“All the disadvantages of this medication stem from the metabolic changes, whether they be changes in personality, whether they be changes in putting on weight, whether they be changes in skin pigmentation or what have you, high blood pressure… 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.”

What our research from the Birth Control and Blood Clots study has found so far is that it is not simply a matter of if a patient will experience these side effects, but when. I had been using hormonal birth control for 10 years before I had a stroke. And I was told that was rare. It turns out that it’s not so rare. And Dr. Victor Wynn agreed (page 6303):

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.

Which makes what Dr. Joseph Goldzieher said all the more chilling (page 6353):

What is an acceptable risk of death from a pill? There is no simple answer to this question.”

I disagree. The risk of death is not an acceptable tradeoff for birth control.

Communicating Risk: Researchers, Doctors, Patients

As Senator Nelson said, one of the roles of the hearings was to determine if women were being given sufficient warning information about the dangers of the pill so that they might make an educated decision about whether to use it. You can read more about how risk is communicated with regard to hormonal birth control here. 

Communication by Researchers

Edmond Kassouf gave some of the most interesting and alarming testimony of any of the doctors at the hearings. On page 6114 and 6115 he says:

On September 30, 1968, the lead article in the JAMA was “Oral contraceptives and thromboembolic disease.” It was written by Dr. Victor Drill and David Calhoun of the G.D. Searle Co. They concluded that U.S. data did not reveal a clotting or death risk. This paper is unique, being in effect, a major policy statement by the manufacturer on the safety of their own drug, which is in contention.

Dr. Kassouf makes an excellent yet disturbing point. For the first time, the pharmaceutical company is making the judgment call about whether their own product is safe. Here we see the very company that stands to profit from downplaying the risks of using hormonal contraceptives doing just that. And I dare say, they’ve been doing it ever since.

Communication to Doctors

Not only is the pharmaceutical industry doing the research, drawing the conclusions, and publishing the results, but they are also marketing directly to doctors. Dr. J. Harold Williams (page 6261) testified about these advertising materials.

A photograph of a beautiful child on the left hand side, and on the right hand side in big bold letters ‘Just what the doctor ordered.’ Now, how God-like can you get, gentlemen? In smaller print, ‘And spaced just right in the family plan, worked out years before by the physician,’ and oh yes, ‘The baby’s parents.’ I find it disgusting that this kind of appeal has to be made to American physicians to wheedle them into prescribing the pill for millions of women. If the pill is as good as they say it is, and if it is as safe as they say it is, that kind of advertising would not be necessary.

Nelson Pill Hearing Ad

Communication to Patients

After much of the testimony, you can almost hear the frustration in Senator Nelson’s voice as he points out how women are being misled. Senator Nelson to Dr. Guttmacher (page 6610):

The literature that is going out is inaccurate. It is misleading 8,500,000 women in this country and it had been doing it for 10 years. It has not been corrected by the Food and Drug Administration, it has not been corrected by the medical profession; it has not been refuted by anybody. Here it stands. You refute it; I reject it. You would not use this in your clinics. Yet it is being passed to women all over the country. At what stage do you consider the women’s rights?

False Promises- The Results of The Nelson Pill Hearings

So what was the result of these hearings?

Senator Nelson (page 6486):

My own view is that, as a result of these hearings, we are going to see a substantial increase in the research moneys allocated for the improvement of oral contraceptives, and research into other methods of contraception.

 

I think all those I have talked to who have been working in the field would agree that the oral contraceptive now on the market is a sort of crude, first generation contraceptive and that we have not done enough research… So I am hopeful that out of all this, we will get a substantial increase, as I think we will, in research funds.

But what happened to all of that funding? Do we have better research now? If you’ve read any of my other articles about the side effects of hormonal birth control, you will find a similar theme. Every time I’ve looked into a health problem associated with hormonal contraception, the most recent studies still call for more research. How is it that we’ve been needing more research on this medication for nearly 50 years and we can still draw no conclusions? Perhaps Dr. Paul Meier illuminated part of the problem in his testimony (page 6553-6554):

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.

So where is all this promised research that was called for at these hearings? One of the only things nearly every expert that testified agreed upon was that there needed to be more and better research. And that the birth control pill would and should be replaced by something better. Dr. Guttmacher (page 6616):

I think the two methods, the pill and the intrauterine device, have been significant contributions. I think we are still in the horse and buggy day of effective contraception. I am optimistic in feeling that in 5 years, we shall have methods that are infinitely superior and safer than either.

Where are these methods? Surely, it’s not the ring nor the patch which have proven to be even more dangerous than the pill? Or the shot which is also used as chemical castration for sex offenders? Or the implant which comes with all of the side effects of the pill but also pain, swelling, scarring, bruising at the area where it is placed? What happened to the promised funding? What happened to the requested research? What happened to communicating more effectively to patients? What happened to protecting women?

What Now?

So many women have lost their lives because of these medications. I was nearly one of them. The promises of these hearings—better communication, more conclusive research, safer alternatives—have never materialized. We cannot rely on research conducted by the pharmaceutical companies or policies developed by politicians paid by the pharmaceutical industry. They have made it clear time and time again that they are not in the business of protecting people. They continue to demonstrate that profit takes precedent over human life. So, now it’s up to us. We need to do the research, spread the awareness, and speak out. We need to demand safer alternatives. Fighting for reproductive freedom should not come at the expense of our health and safety. It should not come at the expense of our lives. Women were literally dying from the pill back then. The feminists of the 1970s knew they had to speak out. Women are STILL dying from hormonal birth control. Why are the feminists not speaking out now?

Why have we relinquished our health and safety for convenience?

 

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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