Blog of the Society for Menstrual Cycle Research

Marketing Menopause: Economic Forecast

August 30th, 2010 by Elizabeth Kissling

Longtime readers may recall that late last year, the New York Times published an essay about how hard Big Pharma has worked to market menopause as an estrogen deficiency disease. Despite that exposé and others of the well-documented risks and limited benefits of hormone therapy, plus thousands of lawsuits pending over the role of HT in breast cancer,  there’s apparently still quite a large potential market for pharmaceutical treatments for menopause (and other women’s health concerns).

To find out exactly how to mine that market, you can purchase the research report titled Women’s Health Therapeutics Market to 2016 – High Unmet Need will Drive the Uptake of Novel Drugs in Menopause and Osteoporosis from GBI Research. The report promises the following:

  • Analysis of the women’s health market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain and Japan.
  • Market characterization of the women’s health market, including market size, annual cost of therapy, sales volume and treatment usage patterns.
  • Key drivers and barriers that have a significant impact on the market.

This will better allow you to “align your product portfolio to the markets with high growth potential” and “develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth”. Not to mention the ability to “reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with more efficiency and better safety”.

It all looks very useful. Too bad I don’t have an extra $3500 in my back pocket.


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Hot Flash—Progesterone is an Effective Alternative to Estrogen

July 19th, 2010 by Elizabeth Kissling

Guest post by Jerilynn Prior, Centre for Menstrual Cycle and Ovulation Research

hot flash hellIt’s been two weeks since Chris Hitchcock and I returned from San Diego’s recent Endocrine Society meetings. We are feeling incredibly happy with the success of our protracted, intense commitments to a controlled trial of oral micronized progesterone (marketed in the USA and Canada as Prometrium®) for night sweats and hot flushes/flashes. At the Endocrine Society we presented the first-ever trial showing that the molecularly identical progesterone by mouth is effective treatment for vasomotor symptoms (VMS = hot flushes/flashes and night sweats)(1). We were also invited to present our data at an Endocrine Society-sponsored press conference.

Why did a scientific study require so much from us? First, this trial started in 2003 as the initial scientific venture of the newly founded Centre for Menstrual Cycle and Ovulation Research–thus CeMCOR’s reputation became tied to this trial. Second, despite concerted efforts, we were never able to obtain peer reviewed funding for this study—we successfully supported it with individual private donations. Finally, because of the “estrogen myth” and its corollary negatives about progesterone, I wanted to gain additional accurate information about how Prometrium® works in women’s cardiovascular system from this same study. For that reason we decided to enroll only very healthy women who were within 1-10 years since their final flow—they had to be non-smokers, without obesity, diabetes, or high blood pressure, and further to have normal measured waist circumference, blood pressure, cholesterol, and fasting blood sugar levels. Therefore many women were interested but few were eligible.

Teens and the IUD

July 8th, 2010 by Elizabeth Kissling


Art by Flickr user Buhny | CC 2.0

Art by Flickr user Buhny | CC 2.0

A new study published in the Journal of Obstetrics and Gynecology has found that adolescents are usually able to tolerate the Mirena® IUD rather well. The mean age of girls in this British study was 15.3 years, and they were prescribed the Mirena® for painful and/or heavy periods that did not respond to oral medications. 93.4% of girls in the study (45 young women) reported “significant improvement” within four months. The researchers conclude “that Mirena is a well tolerated and effective alternative for heavy periods±dysmenorrhoea in adolescents who do not respond to oral therapy.”


So will this finding make it easier for young women to obtain an IUD if they’d like it for birth control, now that there is evidence that it is well tolerated?

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Latest News on Hormone Therapy

June 23rd, 2010 by Elizabeth Kissling
Wellcome Library, London // CC 2.0

Wellcome Library, London // CC 2.0

The Endocrine Society has released a new, peer-reviewed statement on the risks and benefits of hormone therapy for menopausal women. The upshot is that risks and benefits vary depending on the age of the patient and the length of time since menopause:

One interesting finding . . . was that women who start hormone therapy within 10 years of menopause have a 30% to 40% reduction in total mortality.

In addition, in the 50 to 55 age group the task force concluded that hormone therapy reduced hot flashes and overactive bladder and that vaginal estrogen reduced recurrent urinary tract infections. The evidence also showed that hormone therapy reduced pain on intercourse and improved quality of life.

Given that there are thousands of lawsuits pending over the role of HT in breast cancer, I was especially interested in this nugget of new information:

“Our conclusion is that [the estrogen/progestin hormone combination] didn’t cause breast cancer — it caused preexisting tumors to grow to a size where they became detectable.”


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Pill Protests – It’s About the Environment

May 25th, 2010 by Elizabeth Kissling
Empty birth control pill packet in the street

Photo by Gnarls Monkey // CC by 2.0

A whole bunch of anti-choice political organizations are co-sponsoring a national protest against birth control pills, but they say it’s not about killing babies or controlling women; it’s all about the environment!

The following is released by the American Life League and the following groups:

WHO: American Life League , Human Life International, Pro-Life Wisconsin, Pharmacists for Life International, Archdiocese of Mobile Respect Life, Operation Rescue, Jill Stanek, Generation Life/Brandi Swindell, Life Education Ministry, Pro-Life Unity, Movement for a Better America, AMEN (Abortion Must End Now), Pro-Life Action of Oregon, Children of God for Life, Expectant Mother Care/Chris Slattery, Mother and Unborn Baby Care, Defenders of the Unborn, California Right to Life Education Fund, Delaware Pro-Life Coalition, Life Guard, Homeschoolers for Life, Focus Pregnancy Center, Central Texas Voices for Life and Dubuque County Right to Life

WHAT: Protest the Pill Day 2010: The Pill Kills the Environment

This year, birth control advocates are celebrating 50 years of decriminalized hormonal contraceptives. American Life League and our co-sponsors don’t think half a century of contaminating our waterways is something to celebrate. Study after study has shown that hormonal estrogen in the water has severely damaged the ecosystem and our health.

Join American Life League and co-sponsors as they launch the largest nationwide protest against the birth control pill.

You know what, American Life League? ALL prescription drugs, not just birth control pills, contaminate our waterways, both through human excretion and production waste. And some of that “hormonal estrogen” is from the hormone supplements taken by middle-aged women. Are you protesting hormone “replacement” therapy, too?

[via Miriam at Feministing]

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How the Pill Gave Birth to the Women’s Health Movement

May 25th, 2010 by Elizabeth Kissling
Photo from http://www.flickr.com/photos/blmurch/486046904/  // CC BY 2.0

Photo from http://www.flickr.com/photos/blmurch/486046904/ // CC BY 2.0

Only a latter-day Rip Van Winkle could avoid knowing that this month marks the 50th anniversary of the FDA’s approval of Enovid, the world’s first birth control pill. Hundreds of newspaper and magazine articles have marked this anniversary.

Many incorrectly credit the pill with giving birth to feminism. As Elaine Tyler May notes in the current issue of Ms., the pill didn’t start the feminist movement but was in the right place at the right time:

The timing could not have been better. The feminist movement gained momentum just as the Pill became available. With the ability to control their fertility, women could take full advantage of new opportunities for education, careers and participation in public life.

But in the midst of all this celebrating, we’ve neglected another anniversary: 2010 marks the 40th anniversary of U.S.  Senator Gaylord Nelson’s congressional hearings about the pill’s safety profile, which arguably did launch the women’s health movement.

SMCR Bloggers Respond to ACOG’s Homage to the Pill

May 20th, 2010 by Laura Wershler

MenstruationResearch.org – Today, during an email exchange among the Society for Menstrual Cycle Research blogging team, research-advocacy experts on the menstrual cycle spoke out in response to the unbridled passion for the pill expressed by members of the American College of Obstetricians and Gynecologists at their 58th Annual Clinical Meeting. Amidst the hoopla surrounding the 50th anniversary of the pill, it must be noted that not all experts believe the pill to be an unequivocally positive contribution to women’s health and well-being that those quoted in the ACOG media release purport it to be.



“The pill has literally changed the world, and it was a primary stimulus to the women’s movement of the 60s. It has done far more for women’s rights than any legislation that has been passed and should be recognized as the great emancipator of women.”


Mark S. DeFrancesco, MD, MBA, Cheshire, CT
Secretary Elect, The American College of Obstetricians and Gynecologists

“When the pill first came out, young unmarried women had to fight for the right to take it. Now, they have to fight for the right NOT to take it. Overhyped as medicine’s gift to women’s health, by mostly male gynecologists who have never taken the drug, the pill has become an almost forced right of passage – the “standard of care” treatment for being a girl. Emancipation or subjugation? Ask the young women who face coercion and control by their doctors when they ask for support to use non-hormonal methods of birth control.”

Laura Wershler, Sexual Health and Reproductive Rights Advocate,
Executive Director, Sexual Health Access Alberta


“Birth control pills provide women with many non-contraceptive benefits, including cycle control, cancer prevention, and pain relief. They have been an integral part of women’s health.”

Scott D. Hayword, MD
Mt. Kisco, NY
Chair, District II, The American College of Obstetricians and Gynecologists

“Birth control pills provide women with many risks in exchange for contraception, including blood clots, stroke, breast, cervical, and liver cancers, diminished libido, and mood disorders. They have been instrumental in activating the women’s health movement, as feminists
demanded responses to these risks.”

Elizabeth Kissling, Ph.D.
President, Society for Menstrual Cycle Research


“I have often thought that the birth control pill should be called a hormone regulation pill because its use and impact have been so much broader than contraception alone. The pill has certainly improved reproductive control, but the impact on menstrual regulation has been very important for women, from adolescence to menopause.”


Jeanne A. Conry, MD, PhD
Roseville, CA
Chair, District IX, The American College of Obstetricians and Gynecologists

“I’m so happy to have The Pill called “a hormone regulation pill” because that is the way it is currently used by many physicians, and some women. It is used to cover up the far-apart cycles of anovulatory androgen excess (also known as PCOS) but doesn’t promote ovulation. The Pill is used to treat heavy bleeding in teenagers, but doesn’t restore her own balance of estrogen and progesterone. It is used for menstrual cramps when ibuprofen or other non-steroidal is more effective and has no suppressive effect. It is used to treat premenopausal osteoporosis when the evidence suggests it causes rather than prevents subsequent fragility fractures.

In short–the Pill has become the major non-surgical tool of gynecology.”

Jerilynn C. Prior, MD, FRCPC
Professor of Endocrinology / Department of Medicine
Centre for Menstrual Cycle and Ovulation Research
University of British Columbia

“The introduction and rapidly accepted, widespread adoption of oral contraceptives among women of reproductive age drastically reduced women’s fear of unplanned pregnancy in ways their mothers and grandmothers never knew. The pill has allowed women to take different roles in all aspects of their lives—career, education, travel, and a host of other beneficial ways.”

J. Craig Strafford, MD, MPH,
Gallipolis, OH
Vice President, The American College of Obstetricians and Gynecologists

“Women realize their full potential when they are supported in making informed decisions in all aspects of their lives. Indeed, oral contraception has enabled women to avoid unplanned pregnancies, but it has never been a risk-free option. While providers are eager to prescribe the pill, they are less eager to fully explain how hormonal contraception works and the side effects it carries. Until women have access to a full range of safe, affordable and accessible options, their freedom is compromised.”

Chris Bobel, Ph.D.
Chair and Associate Professor of Women’s Studies, University of Massachusetts-Boston

“The pill has revolutionized women’s health care. Obviously, the contraceptive benefits are paramount, but I have become a huge advocate for all of the non-contraceptive reproductive health benefits that the pill offers. Another advantage is that the pill has enjoyed incredible safety over its 50-year history.”

Douglas H. Kirkpatrick, MD, Denver, CO
Immediate Past President, The American College of Obstetricians and Gynecologists

“The Pill has its roots in a time much farther back than fifty years.
Historically the female body has been feared and the release of the
Pill fitted very easily into this history. Victorian doctors removed
women’s ovaries in response to many perceived female problems, and today doctors prescribe the Pill, shutting down ovulation. The Pill is not only prescribed for birth control – it is handed out to women with acne, PMS, irregular periods, heavy periods. Even light, regular periods are now considered enough of an inconvenience to warrant a long-term drug dependency. The Pill has developed into a medication for the disease of being female. In place of changing society, society decided to fix women. At a time when we are more concerned about what we eat, what we wear, what we use to clean the toilet than ever before, we are still celebrating millions of otherwise healthy women taking a powerful medication every day, for years.”

Holly Grigg-Spall, Journalist

“The advent of effective contraception was revolutionary, transforming, empowering, and a tremendous boost to women’s health. It continues to play a major role in the effort to achieve responsible reproductive health and choice for all women—a goal of every child being a wanted child delivered into a supportive and secure environment.”

James N. Martin, MD, Jackson, MS Secretary, The American College of Obstetricians and Gynecologists

“If the pill was as revolutionary, transforming and empowering as is suggested, then all women should be taking it from menarche to menopause, except when we are ready to have the “wanted child.” But we aren’t. Today, young women are ditching the pill in favor of non-hormonal methods, and still managing to achieve responsible reproductive health choices. As for the pill being ”a tremendous boost to women’s health” – I think not. Troublesome side effects, serious health concerns, and a growing interest in holistic approaches to health care are putting the pill in its proper place. One contraceptive choice that works for some women, some of the time.”

Laura Wershler, Sexual Health and Reproductive Rights Advocate,
Executive Director, Sexual Health Access Alberta


“The pill is probably the single biggest contribution to women’s health in our lifetime. Not only has it given women more control over their fertility, it has been successfully used to treat many gynecologic conditions such as dysmenorrhea, menometrohaggia, PMS, acne, PCOS, and endometriosis, enabling women to have a better quality of life.”


James A. Macer, MD, Pasadena, CA

Assistant Secretary Elect, The American College of Obstetricians and Gynecologists


“Long term safety data on the current patterns of use of the pill do not exist, and are not being collected. When first approved, the pill was available to married women, most of whom had children, and allowed them to space their families. Currently, the pill is most commonly used by childless young women, often during the teen years, and can extend for decades. The consequences of pharmaceutical suppression of the developing endocrine system (during the 12 years following the first period) have, to my knowledge, not been explored. For example, taking the pill interferes with bone acquisition, compromises the accumulation of bone density, and may compromise peak bone mass. Peak bone mass sets the bar for lifelong bone health. In a cohort expected to live into their 80’s, casual and enthusiastic use of the pill may be something society regrets half a century from now. There is a tendency to blame side effects on the bad old days, and to say that things are better now. But a recent large study confirmed blood clot risks with today’s “modern” formulations, and, more worryingly, these risks are amplified by obesity and smoking, both of which are more prevalent in modern populations.”


Christine L Hitchcock, PhD, Research Associate, Centre for Menstrual Cycle and Ovulation Research, and Clinical Assistant Professor, School of Population and Public Health, University of British Columbia

This ACOG statement furthers a broader message to young women that they should trust pharmaceutical menstrual rhythms over that of their own bodies and that they should trust clinical authority over their own authority. In and of itself, ceding their bodily authority, ownership and stewardship to medicine causes harm to women.

###

The Society for Menstrual Cycle Research is a nonprofit, interdisciplinary research organization. Our membership includes researchers in the social and health sciences, humanities scholars, health care providers, policy makers, health activists, and students with interests in the role of the menstrual cycle in women’s health and well-being.

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Ultrasound Man:Birth Control Superhero

May 17th, 2010 by Laura Wershler

superheroYou know how most superheros become superheros because of exposure to some weird, intensified chemical or element? Take Peter Parker’s spider bite for example.

According to a story reported in various media, including International Planned Parenthood Federation’s website, if science can perfect the contraceptive effect of ultasound on men’s testicles, then we may be in for a new breed of superhero.  Ultrasound Man: able to bear the burden of pregnancy prevention for women everywhere. 

I joke, but for decades women have yearned for gender equality when it comes to bearing the burden of birth control. Could the promise of six months of ultrasound induced, reversible infertility in men be the answer? Well, to date, we only know it works in rats. There is a long way to go before we send the men for a bi-annual ultrasound “zap test”.

This isn’t the first male method touted over the last decade. In 2003, news out of the UK about a birth control pill for men had women nodding their heads with approval. I was immediately dubious and dashed off a commentary for the Calgary Herald that began thus:

Truth in Advertising . . .

May 14th, 2010 by Elizabeth Kissling

…might look something like this parody by Jena Friedman:

[via Salon.com's Broadsheet]

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How to overcome resistance to Cycle-Stopping Contraception (a physician’s guide)

May 12th, 2010 by Chris Hitchcock

If you’re wondering why your doctor might not take you seriously when you question taking the pill to abolish your periods, you might want to look at this piece of advice.

I had a look at the Clinical Advisor magazine information – it looks like they pay for articles, help to massage them into shape, but as far as I can tell the articles are not peer-reviewed, and the editorial staff do not have any credentials after their names, so they look like non-medical people. But it is freely available on the web, and apparently gets sent to many practicing physicians and nurses. And it’s a lot more readable than other sources of medical education.

The article is framed as a doctor-to-doctor question:

What can I do to overcome patient resistance to continuous use of oral contraceptives (OCs)? So many women say it’s not natural.—SHERRY HILL, ARNP, Bothell, Wash.

And, the answer? Explain the physiology, explain that there is no build up of old blood, that menstrual flow doesn’t have any effect on infections or toxins. And, for talking points, use the educational materials about cycle-stopping contraceptives on the Association of Reproductive Health Professionals web page (coincidentally funded with unrestricted educational funds from companies who happen to make cycle-stopping contraceptive products). And use Malcolm Gladwell’s 2000 article, John Rock’s Error, to reframe monthly menstrual flow as a historic anomaly (”you don’t need that old-fashioned thing”) and help women to see their regular menstrual flow as unnatural, so that the synthetic drugs you are suggesting will seem less unnatural by comparison.

But, ultimately, “if a patient feels that a monthly withdrawal bleed suits her best, many OCs containing 21 active pills and seven inert pills are available.”

I guess the option of using non-hormonal contraception just won’t come up.

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“Why I’ll never take the pill again”

May 11th, 2010 by Chris Hitchcock

In an article in today’s Independent, Holly Grigg-Spall presents an alternative to the current celebrations of the pill. It’s an important message to add to the collective contemplation of what the pill has meant to women and to women’s lives, and interesting reading. The pill prevents pregnancy, but not everyone likes how they feel when they take it, and women’s experiences are often not heard or dismissed. In a world where proponents of the pill see it as a cure for all things menstrual, and recommend it as therapy for the painful cramping that the majority of teenagers experience, it is important to also say that there are significant side effects for some women that affect quality of life.

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Estrogen is the New Ritalin. NOT.

May 10th, 2010 by Elizabeth Kissling

Guest Post by Barbara Sommer, University of California-Davis

Ritalin bottle with tabletsWhy is it that assertions about hormones and behavior lead us to readily suspend our capacity for critical thought? It seems like folks will accept just about any assertion with regard to the power of estrogen and the fluctuation of the menstrual cycle.

My observations over several decades (I am nearly forty years post-doctorate) have been reassuring. I have not seen women crushed in the working and professional worlds by the demands of their physiology. In fact it looks like women might be moving towards running the world, at least in those areas where they have access to education. Nevertheless, it rankles when a journal of some credibility makes assertions based on scanty evidence.

It is difficult to evaluate the quality of the research underlying the claims of the article “Is Estrogen The New Ritalin?” in the current issue of Scientific American: Mind. The title is cute. A writer for the New Yorker recently claimed that “White is the New Black.” Do we believe it? The article was provocative, and did not pretend to be a scientific piece of work. In contrast, the estrogen piece, by appearing under the prestigious banner of the Scientific American, carries an imprint of scientific credibility. The first paragraph claims the menstrual cycle might affect the brain as much as caffeine, methamphetamines, and Ritalin. Nowhere in the study is there any indication that estrogen levels or even menstrual fluctuation effects were actually compared with the above substances. The author also claims that this study is “the first to show that cognition is tied to estrogen levels in people” – perhaps the first because no one else has done a good job of it, but certainly not for a failing to try. There are many published studies claiming that estrogen affects cognitive function.

The central problem with this report is that the scientific community has not vetted the research. There is nothing to suggest that it was subject to review. It has not been published – at least nowhere that could be found by this writer with access to a university library. I don’t expect a popular version of scientific research to include information about whether there were adequate controls for subject selection, for practice effects on the task performance, or that the claim of population dopamine levels was accurate, and whatever measure was used to estimate estrogen levels was reliable. But someone needs to have looked at those aspects of the research. Without that, we end up with questionable conclusions at best, and junk science at worst.

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Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.