nelson pill hearings Archives

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

Published on November 2, 2023

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nelson pill hearings - birth control side effects

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

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

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

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

A Massive Experiment

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

They Knew: Pill Induced Stroke

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

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

So seeing an increase in these should tell us something…

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

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

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

These symptoms are almost identical to mine.

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

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

Expletives and Indignation

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

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

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

We Need Your Help

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

Yes, I would like to support Hormones Matter.

This article was published originally on April 18, 2016.

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

by Chandler Marrs, PhD

Published on August 31, 2023

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

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

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

The History of Birth Control Induced Side Effects

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

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

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

Politics and Money Rewrite History

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

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

Beyond Thrombosis: System Wide Side Effects

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

Metabolic Disturbances

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

“There are more than 50 ways in which the metabolic functions of the body are modified, and to say therefore that normal physiological function has been demonstrated in the years of oral contraception is to overlook a very large amount of information (Dr. Victor Wynn, NPH page 6311).”
“When I say these changes occur, I mean they occur in everybody, more in some than in others, but no person entirely escapes from the metabolic influence of these compounds. It is merely that some manifest the changes more obviously than others (Dr. Victor Wynn, NPH page 6303).”

And yet another said:

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

Impaired Reproductive Capacity

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

“…completely incompatible with live birth…”

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

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

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

Cancer

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

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

Liver

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

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

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

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

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

Disturbed Immune Function

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

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

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

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

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

Psychiatric Illness

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

“There is considerable incidence of mild to moderate psychiatric morbidity [disease] associated with the use of combination oral contraceptive agents… In three of the four studies, there seems to be agreement that those who have required psychiatric care in the past will be more at risk for the development of morbidity, including psychosis. One study also suggests that there may be some increase in the depth of illness the longer the medication is taken (Dr. Francis Kane, NPH page 6457).”
“The emotional or psychiatric problems are the complications which seem to me to have the most serious potential danger. Three patients have stated that they were desperately afraid that they were going to kill themselves… After the pills were omitted, the depression and suicidal fears of the three patients disappeared, as did the depression of the other patients (Dr. John McCain, NPH page 6473).”
“It is disturbing to consider the patients on the pills whose depression may have ended in suicide and/or homicide with no recognition of any association with the contraceptive pills… Personality changes could be a factor in other conditions such as automobile accidents and divorces (Dr. John McCain, NPH page 6473).”

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

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

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

Hormonal Contraceptives Today

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

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

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

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

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

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If you have a birth control story, please consider sharing it on Hormones Matter.

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.

Image created in Craiyon.com

This article was published originally in June 2017.

The Spin Doctor’s Prescription for Birth Control

by Mike Gaskins

Published on November 9, 2021

4249 views

The term ‘Spin Doctor’ wouldn’t be coined until much later, but it was already clear by the time of the Nelson Pill Hearings that some prominent physicians were willing to twist statistics, incorporate doublespeak, and create confusion in any way they could to defend hormonal birth control. They were Spin Doctors in the truest sense. Fortunately, within the context of Senate Hearings, their ‘spin’ was frequently challenged.

Let the Spin Begin

Dr. Robert Kistner from Harvard couldn’t find a bad thing to say about The Pill if his daughter’s life depended on it. However, simple challenges to his testimony made several of his statements seem comical. Consider this exchange with Ben Gordon from Senator Nelson’s staff, when Dr. Kistner compared pill deaths with those of cigarettes:

Dr. Kistner: For every pill-induced death in Britain there are at least 1,500 cigarette induced deaths; based on the total sales of the two products during 1967 one cigarette is three time as dangerous to life as one pill.
Mr. Gordon: Dr. Kistner, may I interrupt for just one moment? Since you compared the risks of smoking with that of the pill, do you know of any cases where smoking three packages of cigarettes has caused either serious illness or death? Three packages?
Dr. Kistner: Smoking three packages?
Mr. Gordon: Right.
Dr. Kistner: Obviously the answer to that question is no.
Mr. Gordon: I have here the proceedings of a conference held… at the headquarters of the American Medical Association… there are case reports, several reports where people have either died or have become seriously injured taking the pill for only 3 months, in other words, three packages of pills.
Dr. Kistner: Is there a cause and effect relationship demonstrated or proved?
Mr. Gordon: Well, it just says “Case reports: Thrombosis and embolism in patients taking the pill.”
Dr. Kistner: There is no cause and effect relationship so far as I can understand.
Mr. Gordon: They said the same thing about tobacco.

Then, there’s this exchange when Senator McIntyre tries to clear up which side effects Dr. Kistner thinks should be shared with women:

Sen. McIntyre: Well, Doctor, there is one thing that occurs to me, could you distinguish for me the difference between a side effect and a complication?
Dr. Kistner: Yes. A side effect of a drug is one that is generally accepted as occurring in some individuals as an undesirable effect other than that for which the drug is given. If one takes estrogen, one frequently becomes nauseated, estrogen “pulls in” sodium and some women don’t excrete the excess fluid and they become edematous and “blow up.” These are side effects: but if a woman takes estrogen and gets a blood clot and dies that is a complication.
Sen. McIntyre: That is more than a complication.
[Laughter]
Dr. Kistner: Well, that is the difference. I think if you asked me to explain the difference, I did.

Today, the spin is just as silly, but the humor is missing. No longer are the distortions challenged. What used to be a laughable punch line is now presented as a valid counterpoint.

Strokes Linked to Hormonal Birth Control

In 2012, the New England Journal of Medicine published the results of an extensive Danish study showing that women on birth control pills or other hormonal contraceptives are up to twice as likely to have a stroke or heart attack than non-users, but a funny thing happened to the story on its way to the press. Industry experts analyzed, mitigated, and diluted it beyond recognition.

ABC News offered the most balanced report. Their story begins with a young woman, a ‘former smoker and birth control pill user’ who suffered a stroke. However, after sharing some of the details of the study, they downplayed the results with the aid of a Spin Doctor, a gynecologist, to be exact, who said, “…pregnancy is far more likely to cause an MI or stroke than hormonal contraception.” Whenever someone dismisses a comprehensive 15-year, peer-reviewed study with a statement like this, they should be required to provide supporting evidence at least as comprehensive as the study itself. In this case, the doctor is repeating an old fallacy – a misinterpretation of statistics that has been around since the beginning of birth control.

Don’t Question Birth Control

One could argue that it is good journalism to seek out a dissenting voice – to effectively present both sides of the story. In this case, I disagree. It’s dangerous. And I have to admit, reading the responses from ‘expert’ physicians frequently brings out my snarky side. Consider the dissenting voices from these spin doctors in articles related to the same Danish study:

Huffington Post interviewed Dr. Diana Petitti, who told them:

“The amount of attention paid to these miniscule risks…detracts attention from more salient issues, like preventing unwanted pregnancy.”

Miniscule risks?! I’m not sure, but I think Dr. Petitti is saying she would rather double her daughter’s chance of having a stroke than risk her getting pregnant.

Later in the same article, Dr. Kathy Hoeger explained:

“The risk might be as much as two times greater, but when you know that the rates are 1 in 10,000, you’re just bringing it up to 2 to 4 in 10,000.”

Those numbers sound so cute, but when you think about an estimated 18 million women in the U.S. currently use hormonal birth control; we could be subjecting an additional 5,400 women per year to strokes and heart attacks.

My favorite may be Dr. Isaac Schiff, who told Boston.com:

“I would say in many ways, this is a good news story. This is a lengthy, large study that helps to confirm that the birth control pill is relatively safe, recognizing that no drug is 100 percent safe.”

He’s ecstatic that hormonal birth control only doubles the risk! He probably turned somersaults when he read that women on The Pill also have a 30% higher risk of developing Multiple Sclerosis, a 50% higher risk of developing Lupus, and could triple their chances of having Crohn’s Disease! (I will talk more about The Pill and the rise of Autoimmune Disease in future posts.)

Dissenting Voices

So, why is it dangerous to present these dissenting voices? Imagine you’re a young woman who’s just been diagnosed with a chronic disease. You begin puzzling the pieces together, and recall that your first symptoms appeared within weeks or months of starting The Pill. You take your suspicions to Google, and stumble upon an article that confirms your fears… or does it?

So, you click on another article. For example, this lupus article that tells you, “The risk was greatest during the first three months after starting “the Pill” — when there was a 2.5-fold increased risk.” You think you’re on to something, but then a prominent doctor from Johns Hopkins is quoted, “One shouldn’t oversell this. Women taking oral contraceptives need to weigh the risk/benefit of unexpected pregnancy versus a very small increase in lupus.” We can’t blame the reader for concluding her diagnosis probably didn’t have to do with The Pill after all.

The Risks versus The Optical Illusions

Optical Illusion - birth control spin

You probably saw this image floating around the internet not too long ago. It reveals a lot about how our brains process information. Our eyes take in all the curves, lighting, and shadows that define Blocks A and B, allowing our brains to analyze the difference in colors. However, when you cover the middle of the image, you discover the blocks are actually the exact same shade.

Only by covering the embellishment do you see the reality.

Media reports on epidemiological studies associated with The Pill often work like this illusion in reverse. They first give us the reality of the image – sharing some of the alarming facts or statistics from the new study. Just as the reader grows concerned that The Pill may be too dangerous, the author bevels the edges, moves the light source, and casts a different shadow.

As laypeople, we tend to assume they know more than us. They minimize the importance of the findings, and we — well, we start to look at it in an entirely different light. We walk away thinking it must not have been as bad as it originally sounded.

We can no longer afford to let reality be obscured by these tactics. Rather than having blind faith in a doctor quoted in some article, we need to consider that we could be dealing with a Spin Doctor. We’ve seen examples of some of these above, but here are five red flags that should make you think twice about the motivation of the speaker:

1) “Those Statistics Aren’t Really That Bad”

Pill proponents will attempt to re-frame numbers so that they seem insignificant. We saw a stereotypical example earlier in this article – “…you’re just bringing it up to 2 to 4 in 10,000.”

Another form of statistical acrobatics seen less frequently today is the attempt to convince us that nature is more dangerous than The Pill. You will recall the gynecologist mentioned early in this article: “…pregnancy is far more likely to cause an MI or stroke than hormonal contraception.”

I believe this method has lost some steam over the years because the mathematical contortions are so easily untangled. Consider this historical example: in his testimony at the Nelson Pill Hearings, Dr. Alan Guttmacher, President of Planned Parenthood/World Population, gave statistics suggesting pregnancy was more dangerous than The Pill (Competitive Problems in the Drug Industry, Ninety-First Congress, Second Session, Page 6565). This was a common argument at the time, but it was refuted beautifully by world-renowned neurologist, Dr. David Clark, speaking to the American Academy of Neurology,

“The woman who takes oral contraceptives is, in effect, pregnant and delivering every month. In the normal course of her life, the average American woman has 3.6 pregnancies. She is fertile for approximately 30 years. If she takes oral contraceptives, she will be pregnant and delivering 360 times in that span of time. Expressed differently, she has 90 times more chance of showing the complications of pregnancy.” (Barbara Seaman, A Doctors’ Case Against the Pill, Page 26)

2) “Old Smokers Beware”

Media reports frequently stress that the risk is greatest for women who smoke or are over 35. This is a true statement, but the slight-of-hand comes in the implied message, ‘If you’re young and don’t smoke, you have nothing to worry about,’ which couldn’t be further from the truth.

Sure, they may try to convince you that you have better odds of winning the Publisher’s Clearinghouse than developing a deadly disease, but you don’t want to be on the backside of this one, saying, “That’s what I used to think.”

3) “There is No Proof of an Association”

The US tobacco industry played the ‘Proof versus Evidence’ game masterfully for decades. In 1954, they responded to early lung cancer studies by releasing the ‘Frank Statement to Cigarette Smokers.’ In part, it said:

“Distinguished authorities point out…that there is no proof that cigarette smoking is one of the causes.”

As recently as 1998, John Carlisle of the Tobacco Manufacturers Association said:

“There is no such thing as conclusive evidence when you are talking about such a vast subject.”

The subsequent public release of internal communications from the tobacco industry revealed exactly what they knew, and how they strategized to maintain credibility while continuing to deny the overwhelming evidence. While we can’t assume Big Pharma has been consciously playing the same game, there are signs dating back to the early days of The Pill that eerily parallel the tobacco industry’s stance:

Complete denial of the association to cancer and strokes
Maintain credibility by admitting danger to a ‘small number’ of consumers
Agree to include a warning of the dangers with the product

By 1965, Morton Mintz, in the Columbia Journalism Review, expressed dismay at the ‘significant volume of reporting’ in medical journals that attempted to cast doubt on studies by using the argument that The Pill had not been proven unsafe. This was a 180-degree paradigm shift. The FDA had never been required to prove a drug unsafe. The onus was/is on the manufacturer to prove the drug safe. Clearly irritated by the ‘parroting’ in the press, Mintz wrote:

“…there was no acknowledgement that more was required – a disclosure as to specifically what weight of evidence of harm, in the eyes of the advocates, would add up to proof. Also missing was a recognition that for scientists there is no proof in the black-and-white sense, that all that can be had is evidence in one or another shade of gray.”

4) “It Could Have Been Something Else”

This is essentially a nebulous tangent of the ‘Proof vs. Evidence’ game. Despite the fact that criteria for publishing a study are extremely stringent, naysayers will attempt to cast doubt by questioning other variables that could have influenced the study. I recall one doctor actually asking, “How do we know it wasn’t the breakfast cereal the women had been eating that was causing these strokes?”

I suggest to you very few studies get published if they don’t eliminate Cocoa Puffs as a variable.

5) “The Benefits Still Outweigh the Risks”

Then there is the ubiquitous, “The benefits still outweigh the risks.” This phrase, more than any other, makes my head want to explode.

What kind of scale are they using to measure the benefits and risks? Are they looking at the isolated risk in a vacuum, and forgetting about all of the other associated risks? How do you compare a decreased chance of pregnancy with an increased risk of a deadly disease, regardless of percentages on either side, and determine that the benefits outweigh the risks?

Even if there were no other fertility control options available, I cannot grasp the idea of a healthcare professional saying, “Take this pill. It will greatly reduce the likelihood of you getting pregnant, but it doubles your risk of having a stroke…Did I mention that it will help clear your skin?”

Take Your Thumb Off the Scale

Clearly, when weighing the benefits to risks, someone has their thumb on the scale. The result is that there are many prominent physicians willing to perpetuate a pattern of denial and obfuscation anytime a new study is published. We have already seen how medical dogma can trump scientific evidence. So, whenever you read about a new study linking birth control to a deadly disease, remember that the media has run it through a decades-old filter of dogma and distortion. Isolate the Spin Doctor quotes, and take them with a grain of salt. Then, focus on the findings of the study itself. In other words, remove the embellishments and see the reality.

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The FDA approved The Pill despite it not being proven safe. Today, it has been linked to everything from blood clots and cancer to lupus and Crohn’s disease — and still has not been proven safe.
This book explores the medical and historical disconnects that brought us to this point.

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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 on September 13, 2016.

Birth Control’s Most Important Forgotten Anniversary

by Mike Gaskins

Published on January 27, 2020

3592 views

Fifty years ago this month, a vibrant group of young women put on their best dresses and placed themselves strategically around the senate gallery. They were eager to disrupt and ready to make some noise but had no idea the impact they were about to make on the course of history. They were attending the opening statements of a controversial look at hormonal birth control that would later became known as the Nelson Pill Hearings.

In 1970, hormonal birth control had been on the market for almost a decade. Although 8.5 million women were already taking The Pill, serious questions about its safety were just coming to the surface. Senator Gaylord Nelson chaired an explosive Congressional committee that set out to answer two simple questions:

Has the safety of hormonal contraceptives been established?
Are women being given sufficient information about the verified risks?

Questioning Birth Control

The hearings remain relevant today because much of the testimony about potential consequences has proven prophetic, and many of the questions raised about side effects continue to be unresolved.

This dive into the subject of oral contraceptives lasted a few months and represented only a small sample of the overall hearings entitled Competitive Problems in the Drug Industry. By the time they concluded, this comprehensive investigation would become the longest running hearings in Congressional history. The committee examined a vast range of issues in the drug industry (most of which are ripe for revisiting today), including questionable pricing practices, deceptive advertising, safety and efficacy of over-the-counter products, generics versus name brands, and a lack of regulation on medical devices. Ultimately, the hearings would fill thirty-three volumes in the Congressional Library. However, nothing in the ten-plus years of hearings came close to matching the energy and excitement of those first few months in 1970.

It all began when feminist writer, Barbara Seaman released her book, The Doctors’ Case Against the Pill. She had expected the book to spark a national outrage but was disappointed by the lack of attention it received. Aware of the drug industry hearings, she saw the symbiotic possibilities and penned a six-page letter to Sen. Nelson outlining some of her gravest concerns.

She had more in common with the senator than she imagined. They both believed they had uncovered some seriously unscrupulous problems with the pharmaceutical industry, and that these critical discoveries had gone largely unnoticed by the public. Sen. Nelson knew he needed a hot-button topic if his hearings were going to generate appropriate publicity, and Ms. Seaman’s letter seemed to deliver exactly what he needed.

Sen. Nelson passed the letter along to his lead staffer, Ben Gordon, and asked him to look into making it part of their hearings. Mr. Gordon worked on Capitol Hill for ten years before joining Sen. Nelson’s staff, and the senator trusted him implicitly. While most Congressional Hearings are coordinated and managed by a large team, Mr. Gordon had a staff of one. He did all the extensive behind-the-scenes legwork on the drug hearings himself. He assembled the roster of experts to testify, wrote the opening statements, and throughout the proceedings, sat next to Chairman Nelson, frequently chiming in with questions and comments of his own. Consequently, it may have been every bit as important that the letter resonate with Mr. Gordon as it had with the senator. It did, and Mr. Gordon eagerly set up a meeting with Ms. Seaman.

Mr. Gordon passed away last July at the age of 105. I was fortunate enough to become friends with him over the last few years of his life and was amazed by his lucidity until the end. He told me that he had first thought he would call Ms. Seaman to testify but, after reading her book, decided to call on the expert physicians she had interviewed. He said he always avoided indirect testimony because it was too easily picked apart. With this decision, Mr. Gordon may have inadvertently set into motion the events that would propel the hearings to headline status above the fold in most of the nation’s major newspapers.

Boston Tea Party for Women’s Health

January 14, 1970, the first day of The Pill hearings, was a typically cold winter morning in Washington D.C. As Sen. Nelson and Mr. Gordon walked to Capitol Hill, they were confronted by protesters. Groups of women walked alongside them yelling their disapproval. Their breath rose visibly through the air, creating the impression they were literally venting steam, but this was only the beginning. A progressive group of young feminists known as D.C. Women’s Liberation, led by Alice Wolfson, had heard that an all-male committee of senators was going to be hearing testimony from all-male doctors about women’s reproductive health. Unbeknownst to the senators, a small group of these women sat waiting in the gallery.

Those in attendance heard the results of new British studies that left Pill proponents in a panic, but they weren’t the only ones growing uncomfortable. Testimony linked The Pill to alarming side effects like breast cancer, depression, heart attacks, and strokes. Fear and uncertainty spread across the women in the senate chambers and would soon blanket the country. Ms. Wolfson and her companions had heard enough. The first of many interruptions came during the testimony of Dr. Philip Corfman from the National Institutes of Health (NIH). The nightly news eagerly covered their outrage as the women jumped up and shouted questions like ‘Why isn’t there a pill for men?’ and ‘Why are no women testifying?’ With these outbursts, Ms. Wolfson soon became the face of the hearings.

Mr. Gordon later recalled that most of the early protesters were upset because they felt the senators might have a hidden agenda for going after birth control. However, as the hearings progressed and leading physicians shared their concerns about The Pill’s safety, the outcry from protesters shifted. Suddenly, they began to question why they were being used as guinea pigs by the drug companies in some sort of mass population experiment.

Reflecting upon the events, Ms. Seaman wrote that the Nelson Pill Hearings brought the ‘uptown’ and ‘downtown’ feminists together on the issue of women’s health. Ms. Wolfson and she met for the first time at the hearings and began a lifelong friendship. They went on to co-found the National Women’s Health Network along with three other women. Surprisingly, Dr. Corfman and his wife, Eunice, also became lifelong allies to their cause. Ultimately, the actions and alliances born out of this brief exploration into birth control safety would lead to the hearings later being dubbed “The Boston Tea Party of the Women’s Health Movement.”

Birth Control Hearings Still Relevant

The committee answered a lot of the questions surrounding hormonal contraceptives. Probably the most notable result of the hearings was that The Pill became the first drug ever required to have an information pamphlet in each package, not for doctors, but for the patient. Unfortunately, those pamphlets are clunky, verbose, incomprehensible, and astoundingly incomplete. Their glaring omissions raise new questions about informed consent, as do the deaths of many young women from birth control related blood clots.

Proof that the hearings aren’t merely ancient history to be forgotten came in 2011, when the FDA commissioned a study and found that new, fourth generation formulations, which include bestsellers Yaz and Yasmin, doubled the risk of blood clots over the already elevated risk found with other hormonal contraceptives. They assembled an advisory panel of 26 experts to discuss possible action. After much debate, 15 of the experts voted that the benefits still outweighed the risks. However, 21 of the 26 voted that these formulations should contain stronger warnings for patients.

As of January 2016, the drug companies had paid out over $2 billion to settle more than 10,000 blood clot lawsuits brought against these newest formulations, and the number of injuries, deaths, and lawsuits continues to rise.

On this 50^th anniversary of the Nelson Pill Hearings, perhaps the greatest lesson we can take away is that the battle has just begun. Our country’s independence wasn’t won in 1773 at The Boston Tea Party. Rather, it was the start of a movement. It is incumbent upon all of us who care about women’s health to take up the torch of those protesters from the hearings fifty years ago. We need to demand answers. And, it all begins with two simple questions:

Has the safety of hormonal contraceptives been established?
Are women being given sufficient information about the verified risks?

Thank you

Alice Wolfson is now a retired attorney living in San Francisco. That’s her featured in the photo above. You can see actual footage from the protests here. I would like to thank her for taking the time to visit with me and for offering her guidance and perspective on this article. Alice, your energy is infectious. May it continue to inspire those of us devoted to women’s health.

For more information about the history of hormonal birth control:

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In the Name of The Pill*

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The FDA approved The Pill despite it not being proven safe. Today, it has been linked to everything from blood clots and cancer to lupus and Crohn’s disease — and still has not been proven safe.
This book explores the medical and historical disconnects that brought us to this point.

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The Next Step in Birth Control Activism

by Mike Gaskins

Published on May 9, 2019

2462 views

Birth Control Activism and Women's Health

In recent hearings on Capitol Hill, freshman Representative Lauren Underwood challenged Labor Secretary Alex Acosta on his Cabinet department’s efforts to allow insurance exemptions to employers who wish not to cover birth control for religious reasons. She told him, “Women’s lives and their health depend on their ability to access contraceptives.” Then, citing the many women who take contraceptives to treat polycystic ovarian syndrome, endometriosis, and anemia, she continued, “Your actions, sir, are denying science and putting American women at risk.”

Can we put the religious debate aside and talk honestly about the science and the risks to women for a moment?

Caring About Women’s Health

Women’s health care has grown into something very different than caring about women’s health. If we actually cared about their health, we would want women to know the truth about their options. We would want their informed consent to be informed.

I get that hormonal birth control is frequently prescribed off-label, not to prevent pregnancy, but in response to some underlying issue. Sometimes it’s a serious condition, like those mentioned by Rep. Underwood, and sometimes it’s a not-so-serious condition, like acne or slightly irregular periods.

When I’ve spoken with women about the dangers of birth control, a surprising number of them have told me that off-label issues caused them to go on The Pill. I think of one young lady in particular who told me she really didn’t want to go on birth control, but her periods were too heavy. She literally had a period that lasted 30 days, making her terribly weak. She said The Pill helped regulate her periods.

In instances like this, the problem is that The Pill really isn’t regulating the period, nor is it treating anything. It’s only masking the underlying medical issue. We wouldn’t put a band-aid on a patient who appears to have a flesh-eating bacteria and think we’ve done our job, but that’s essentially what we do with these hormonal ‘treatments.’

There has to be a better option, an actual treatment, for women like this young lady. I’m not a medical professional so I don’t know what it would be, but I’ve taken this stance regarding the multitude of off-label prescriptions: I may not have all the answers, but that doesn’t mean I’m obliged to accept the doctors’ answers – and neither are the women suffering these conditions.

A recent conversation I had with an Ob/Gyn validated that position. She explained why Ob/Gyns are hesitant to consider cutting back on birth control prescriptions:

“Providing contraception represents one-third of an Ob-Gyn’s practice, and in the back of their minds they think [reducing birth control prescriptions] will hurt the number of patients coming to see them. However, even for medical problems often treated with hormonal contraceptives, there is always a better, safer way to manage the problem that gets to the cause rather than acting as a cover-up.”

Women Deserve Better

In my new book, In the Name of The Pill, I tell the story of Anthony, a father emboldened by the death of his 20-year-old daughter, Alex, after only 8 months on The Pill. Anthony reached out to me when he read my article on Hormones Matter, which posted the very day his daughter died. In it, I discussed the many young women we have lost to birth control, and my hopes that one of these stories might trigger a chain reaction that would inspire women to stop taking The Pill.

Anthony is determined to prevent other families from experiencing the pain his family will endure for the rest of their days. I admire his tenacity. Every day, he posts informative stories and articles on social media with the frequent hashtag – #womendeservebetter.

He strikes up conversations with women about their birth control and attempts to alert them to the dangers. He told me that women are often outraged when he tells them about the Nelson Pill Hearings because they can’t believe that the vast multitude of risks have been known for over 50 years. That is the crux of the problem.

How many young women even know that The Pill has been linked to cancer, depression, and autoimmune disease? The answer is “not enough.”

The History of Birth Control Risks

If you’ve read any of my previous articles, you may know I’m slightly obsessed with the Nelson Pill Hearings. Held in 1970, these Congressional hearings featured leading physicians who exposed the diverse complications just beginning to be associated with The Pill. These warnings were largely ignored, but the reason the hearings are still relevant today is because the drug industry continues to act surprised when new studies connect hormonal birth control to the very same complications.

Imagine you’re a young woman who visited the doctor this morning and were diagnosed with lupus. You question the timing because you just started birth control weeks ago, and suspect it may have something to do with your diagnosis. When you find out that doctors 50 years ago recognized the increased risk of developing lupus among birth control users, you’re likely to become more than a little angry – and justifiably so. This is important information that should have been shared with you before you began taking The Pill.

And, it isn’t just lupus. Anthony’s daughter died from blood clots in her lungs. He said he had no idea how dangerous birth control was until after it was too late for Alex, and he’s sure she hadn’t been sufficiently warned either. He told me, “It’s easy to find articles about how The Pill helps your acne or menstrual pain, but to learn how dangerous these things are you really have to dig and know what you’re looking for.”

We have to do more to bring the dangers to light. I believe this calls for a new level of activism, but once again, I don’t have all the answers. I just know I want to do something more. I write these articles. I’ve written a book. I talk about birth control with nearly every young woman I meet, but I WANT TO DO MORE. I know there are many of us who have awoken to the dangers of this potent drug, and we all want to do more.

What more can we do? And, how can we collectively organize our efforts? Next year marks the 50^th anniversary of the Nelson Pill Hearings, and many of the topics discussed at the hearings deserve further investigation. I think we should band together and demand that Congress revisit the hearings. We should ask them to simply address the same two questions Senator Gaylord Nelson attempted to answer in 1970:

Whether The Pill (and all other hormonal contraceptives) have been proven safe
Whether women are being given sufficient information about the possible dangers.

I’d like your suggestions on how we can make this push. Please share any ideas you have in the comments section below.

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Books

In the Name of The Pill*

by Mike Gaskins

The FDA approved The Pill despite it not being proven safe. Today, it has been linked to everything from blood clots and cancer to lupus and Crohn’s disease — and still has not been proven safe.
This book explores the medical and historical disconnects that brought us to this point.

Price: $ 17.95

Buy now at Amazon*

Price incl. VAT., Excl. Shipping

Last updated on October 21, 2023 at 9:38 pm – Image source: Amazon Affiliate Program. All statements without guarantee.

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More Side Effects From Birth Control- The Liver and the Gallbladder

by Kerry Gretchen

Published on December 3, 2018

14385 views

birth control liver and gallbladder damage

This time of year, the holiday season, can be a time of overindulgence for many of us. And how can we talk about overindulgence without taking a look at the liver? To say the liver is important is an understatement. It is the body’s largest gland and while estimates of the number of functions of the liver vary, many textbooks generally cite around 500. Nearly everything we ingest, from drugs and alcohol to vitamins and nutrients, is metabolized by the liver. The vital role it plays in the functioning of our bodies makes the testimony from the 1970 Nelson Pill Hearings about the effects of oral contraceptives on the liver that much scarier.

Research Presented at the Nelson Pill Hearings

Dr. Victor Wynn was one of the first physicians to testify about the effects of hormonal birth control on the liver.

On page 6341 he states, “if you will take cells out of the liver and examine them under the electromicroscope of women taking oral contraceptive medication, you will find some extraordinary changes.” Of these and other changes caused by the pill, he says: “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.”

Later to testify was Dr. William Spellacy who was specifically called upon to speak about the metabolic effects on the liver. His testimony about the liver begins, “The biochemical effects of the sex hormones on the liver are legion.” Below is a list of liver functions that, based on the research presented in Dr. Spellacy’s testimony, are altered or impaired (NPH 6427):

Lowering of total plasma protein level
Decrease in the albumin and gamma globulin and increases in other fractions
Tests may be abnormal in women on oral contraceptives without disease being present
Estrogen (including that in oral contraceptives) interferes with liver function and varies with dosage
Some women taking oral contraceptives have abnormally high blood bilirubin levels
1/3 of women who have jaundice on oral contraceptives will get it when pregnant
Discontinuation of oral contraceptives “cures” jaundice

He summed up his thoughts on the liver damage caused by hormonal birth control:

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

The honorary Chairman of the Population Crisis Committee, a “pro-pill” organization focused on population control added his two cents about the effects of oral contraceptives on the women using them. “While metabolic alterations affecting the liver and other organs do result from use of the pill, there is no evidence at this time that they pose serious hazards to health;” General William Draper, Page 6705.

Of course, we shouldn’t assume that just because a medication causes a “legion” of biochemical effects on the livers of otherwise healthy women that there will be any lasting problems, right?

Research Since the Hearings

“Women more commonly present with acute liver failure, autoimmune hepatitis, benign liver lesions, primary biliary cirrhosis, and toxin-mediated hepatotoxicity,” according to a 2013 article in Gastroenterology and Hepatology.

Like I mentioned in my piece about rheumatoid arthritis, whenever a health issue affects women disproportionately, there is often a connection with hormonal birth control. While this study doesn’t specifically mention that, it does call for further studies assess the role of sex hormones and other behaviors on liver problems in women.

These connections were well-documented at the 1970 Nelson Pill Hearings but the subsequent research gets more confusing.

Timeline of Liver Research

1980: Lancet published an article showing the connection between malignant liver tumors and women using oral contraceptives.

1989: The British Journal of Cancer found “confirmation in this population of the association between oral contraceptives and hepatocellular carcinoma” and “the relative risk was significantly elevated in long-term users [of oral contraceptives].”

1992: “This study, the largest to date, adds to the number of investigations demonstrating an increased risk of primary liver cancer with use, particularly long-term use, of oral contraceptives.”

2006: “Long-term use of oral contraceptives (OCs) and anabolic androgenic steroids (AASs) can induce both benign (hemangioma, adenoma, and focal nodular hyperplasia [FNH]) and malignant (hepatocellular carcinoma [HCC]) hepatocellular tumors.”

Yet a 2015 meta-analysis concluded that “oral contraceptive use was not positively associated with the risk of liver cancer.” However, the analysis also conceded that “a linear relationship between oral contraceptives use and liver cancer risk was found.” And the authors noted the need for further research into specific formulations of oral contraceptives and the duration of usage.

It makes you wonder how we went from pretty convincing and highly damning connections between oral contraceptives and liver cancer to no positive association at all. Did all the scientists from the 1960s to 2006 get it wrong? Or is something else going on here?

What About the Gallbladder?

Perhaps we can look at the liver’s little buddy, the gallbladder, for some more information. The two are intimately connected in that the liver is constantly making bile and sending it to the gallbladder for storage and dispensation. Like problems with the liver, women are more likely to develop gallstones than men. According to the National Institute of Diabetes and Digestive and Kidney Diseases, “Extra estrogen can increase cholesterol levels in bile and decrease gallbladder contractions, which may cause gallstones to form. Women may have extra estrogen due to pregnancy, hormone replacement therapy, or birth control pills.”

This was proven shortly after the Nelson Pill Hearings. According to the revised edition of The Doctors’ Case Against The Pill by Barbara Seaman:

“The Pill also has serious adverse effects on the gallbladder, and women who take the Pill face an increased risk of someday facing surgery for gallstones. Pill use causes higher levels of cholesterol saturation in the bile, according to a study reported in the New England Journal of Medicine in 1976. This high level of fate in the bile is considered ‘an early chemical stage of gallstone disease,” according to Dr. Donald Small of the Boston University School of Medicine… The risk of gallbladder disease rises with the length of time a woman has been on the Pill… In some studies, Pill users are two and a half times as likely to suffer from gallstones as comparable women.”

A meta-analysis conducted in 1993 found “Oral contraceptive use is associated with a slightly and transiently increased rate of gallbladder disease” and “Considering…the rapidly changing formulas of oral contraceptives, the authors suggest that the safety of new oral contraceptives be evaluated by studying bile saturation and biliary function rather than by waiting for gallbladder disease to develop.”

A much more recent study (2011) found that there was even more risk of gallbladder disease with the newer formulations:

Long-term use of an oral contraceptive is associated with an increased risk of gallbladder disease compared with no use
There was a small, statistically significant increase in the risk of gallbladder disease associated with the use of desogestrel, drospirenone and norethindrone compared with levonorgestrel
Both estrogen and progesterone have been shown to increase the risk of gallstones
Estrogen has been shown to increase cholesterol production in the liver, with excess amounts precipitating in bile and leading to the formation of gallstones
Progesterone has been shown to decrease gall-bladder motility, which impedes bile flow and leads to gallstone formation

The gallbladder shows us that these hormones are damaging the body.

What Now?

So what do you do when you have a gallbladder that’s not functioning properly? The current practice is to take it out! Of course, removing the gallbladder is not the quick fix many think it is and often leads to other health complications like irritable bowel syndrome, acid reflux, and Sphincter of Oddi Dysfunction.

What about when your liver isn’t functioning properly? That’s not as simple. You can’t just take a liver out. How can the gallbladder, an organ so fundamentally connected to the liver, experience drastic and dangerous changes from hormonal birth control but the liver is supposedly unaffected? Have we researched ourselves out of that problem by declaring that it isn’t a problem? Has there been some spin-doctoring going on when it comes to the liver?

As Dr. Wynn said at the hearings, “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.”

I think a very large amount of information has indeed been overlooked.

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.

Laboratoires Servier, CC BY-SA 3.0, via Wikimedia Commons

This article was first published December 15, 2016.

It’s Not All In Your Head: Mental Health and Hormonal Birth Control

by Kerry Gretchen

Published on August 22, 2017

5686 views

Once upon a time, a 26-year-old woman went to her doctor and asked to be put on the new birth control pill that allowed women to only have four periods a year. She had seen it advertised on television. Four months later, 15 pounds heavier and suffering from mild depression, she returned to the doctor feeling miserable. The doctor told her the weight gain and depression were not from the pill because those were not side effects of hormonal birth control. Wait, does this sound familiar? It’s the same story I told in my article about hormonal birth control and weight gain. Only this time, I’m talking about mental health.

The truth is that I gave my mood changes and my mild depression very little thought. Once the doctor told me they were not a symptom of my new birth control pills, I figured it was my fault I was sad and not dealing with things very well.

What They Knew in 1970

I remembered the connection between my birth control pills and that bout of depression when I began reading the Nelson Pill Hearings. One of the first doctors to testify pointed out that there had been a suicide during the original pill trials in Puerto Rico. Neither the suicide, nor the other three sudden deaths (of five total deaths during the experiments) were investigated. But what really got my attention was that the page after the mention of the suicide was the only one missing in the nearly 1500 pages of testimony. I have since been able to get a copy of that page and while the testimony doesn’t seem that damning given the laundry lists of risks, concerns, and dangers with hormonal contraceptives that are examined at the hearings, it does bring up an interesting point.

Doctor Edmond Kassouf’s testimony answers questions from Mr. James Duffy, minority counsel at the hearings (page 6112):

Mr. Duffy: One of the five deaths was suicide.
Dr. Kassouf: Yes.
Mr. Duffy: So what I would like to understand is how does one take a suicide and link the case of death to the pill?
Dr. Kassouf: Very simply. It has been of current concern. Many physicians and psychiatrists are concerned about depression and the pill. If this is true, suicide may well be the end result of that combination and, therefore, a reasonable suspect, a reasonable link.

Suicide Attempts While on the Pill

“I’ve really got to look into this more,” I thought. Well, I had to look no further than page 6447 and the testimony of Dr. Francis Kane, Jr., Associate Professor of Psychiatry at the University of North Carolina. To sum up his testimony about the studies conducted with regard to mental health and oral contraceptives, he says this (page 6457):

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

Dr. Kane describes a study conducted in England of 50 women on oral contraceptives who were compared to a control group of 50 women who had not used hormonal contraception. There were no differences in socioeconomic status, age, or history of past depressive episodes. But in the group taking the pill, 14 women “had depression of mild to moderate proportions, while only three of the control group reported this.” The pill users also reported greater depression as well as particularly high scores for “guilt, self-absorption, and loss of energy.”

He goes on to say, “Two suicidal attempts in the pill sample were found, which had not been disclosed to the general practitioner. Since completing the study, another depressed pill-taker had made a serious suicidal attempt.” Three suicide attempts in a study of 50 women? That seems incredibly high to me. Ludicrously high. Especially given that there are other methods of contraception.

But Wait, There’s More!

But that’s just one doctor testifying about a few studies, right? Sure. But the next person to testify was Dr. John McCain (not the senator). One of the first things the doctor points out is (page 6471):

“The contraceptive pills are potent steroid hormones. Alterations of the anterior pituitary function are produced by them… the potential endocrine and systemic disturbances are almost unlimited. The effects produced through the anterior pituitary may be so indirect that years may elapse before a correlation is established between the abnormality and the administration of the contraceptive pills.”

You know what else is a hormonal medicine? Anabolic steroids. “Roid rage” is pretty well documented. Is it really such a leap to think that hormones in birth control can also cause changes in mental health?

Dr. McCain spent years documenting the patients in his practice who suffered serious side effects from hormonal contraception. In that time, he recorded episodes from 52 patients. And per his own testimony, his largest concern was mental health (page 6473).

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

He also points out (page 6473):

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

Is it really so much of stretch to think that a potent steroid could cause personality changes that could lead to the damaging of personal relationships that are beyond repair? Plenty of other potent substances can and do.

What They Say Now

Dr. Kane and Dr. McCain, as well as every other expert who testified at the Nelson Pill Hearings, agreed on one thing. More research was needed.

So what does the research say now?

Medscape published an article from the American Journal of Epidemiology with the claim that “Hormonal contraception may reduce levels of depressive symptoms among young women.” Yet when you read further into their conclusions, they say that nearly one-third of women discontinue hormonal contraceptives within the first year, many because of mood changes, and those women are unlikely to restart hormones. Therefore, “hormonal contraceptive users at any time point may be overselected for less depression than nonusers.”

The study also points out that:

“Existing literature on hormonal contraception and depression has been primarily confined to small, unrepresentative samples. Among these smaller studies, few cohesive findings have emerged.”

And:

“Little research has examined the role of exogenous hormone use in suicidality, and existing research has focused on mortality from suicide rather than suicide attempts.”

And according to WebMD, there are a laundry list of medications that can cause depression. What is not included on this list? Birth control pills. The only hormonal contraception included is Norplant. Interestingly enough, the active ingredient in Norplant is levonorgestrel, a progestin found in many birth control pills as well as hormonal IUDs. So am I supposed to believe that when injected into my arm, synthetic hormones can cause me depression but when taken daily as a pill or sitting in my uterus for 5 years, they won’t? Does that make any sense at all?

It doesn’t make sense to Dr. Kelly Brogan. That’s why when she has patients that complain of depression, anxiety, low libido, mood changes, weight gain, etc. she recommends they stop using hormonal contraception.

What Have We Learned?

Hormonal contraceptives can cause mental health issues
Women who suffer from mental health issues are much more likely to suffer from increased symptoms when on hormonal contraception
Often the longer hormonal contraception is used, the greater the symptoms
Discontinuation of hormonal contraception can usually alleviate mental health symptoms
The research promised from the Nelson Pill Hearings has never materialized

Why, if they knew in 1970 that hormonal contraception was deeply connected not only to depression but also to suicide, has it not been further researched? It’s been nearly 50 years since Dr. Philip Ball (page 6493), a specialist in internal medicine, testified before congress. Which makes what he says all the more chilling.

“It is not considered reasonable that there be any mortality or morbidity in a pill used purely for contraception purposes. Medical research has got to offer something better than this. Physicians will probably look back on the contraceptive pill era of the past 5 years with some embarrassment.”

Exactly.

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This post was published originally on Hormones Matter on June 22, 2016.

A Joint Problem: Rheumatoid Arthritis and Hormonal Birth Control

by Kerry Gretchen

Published on November 17, 2016

23946 views

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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