Blog of the Society for Menstrual Cycle Research

Midlife Muddle — Own the Power of Naming

May 17th, 2012 by Elizabeth Kissling

Guest Post by Jerilynn Prior, M.D. — Centre for Menstrual Cycle and Ovulation Research

By “midlife muddle” I don’t mean the trouble concentrating or remembering names that sometimes occurs for all of us (but more frequently if we’ve wakened with night sweats and not gotten back to sleep). I mean the condoned and official confusion about naming of women’s reproductive aging. Let me show you why I am upset.

 

STRAW+10 staging system for reproductive aging in women

Stages of Reproductive Aging Workshop (STRAW) held a 10-year anniversary last summer. (As someone frustrated by not being “heard” at the original conference, I still think that the “W” in STRAW should stand for Women!) Despite that, STRAW+10 has made progress because at least some of the classification is now supported by population-based prospective data rather than based on what experts believe. The names that are now politically correct are summarized in the STRAW+10 Executive Summary1 and the diagram1 at right.

 

We in the Society for Menstrual Cycle Research have also had our say about nomenclature: “Naming Women’s Midlife Reproductive Transition”.  I wrote this (with revision and refinement by collective effort of SMCR members) because women keep getting left out of this naming business. For example:

  • a regularly menstruating woman with night sweats, heavy flow, and increased cramps could learn to call herself perimenopausal2 (not STRAW+10 Late Reproductive Phase -3b?!).
  • a woman who just finished her period can say, I’m in late perimenopause and have at least a year without further flow before I’ll be menopausal. Based on STRAW+10 she could be told that specific menstruation was her final menstrual period (nickname “FMP”) and the next day, according to STRAW+10 be told that she is now “postmenopausal”!!
  • a woman with sore breasts, irregular periods, and heavy flow could say, I’m in perimenopause. However, she may instead be told she is in the “Early Menopausal Transition.” Because she has heavy flow she is also likely to be prescribed the birth control pill (as is currently and commonly recommended). Usually she will not be told that The Pill will make her perimenopausal irregular flow worse—she may well start spotting in the middle of her cycle.3

This new and improved STRAW+10 still centers all of women’s reproduction on that mythical FMP. But to call the FMP “menopause”, as many women’s health experts do, is just unscientific. It takes at least a year without another menstruation in those of us over age 45 before nine out of ten of us will not get another period4. But one (out of ten) of us will get a further, normal period even though we’ve been that whole year without any4. We can tell that new flow is normal (in other words, does not need investigation for endometrial cancer) if we had cramps or bloating or sore breasts or moodiness—or all of these—that told us our period was coming.

 

So our new Naming position statement says don’t call it “menopause” until you’ve not had a period for a year. And do call it “perimenopause” if things are variable and changing even if you are still having regular flow2.  Three of nine changes can confirm for you that you are perimenopausal even if your flow is still regular:2

  1. Shorter cycles (25 days or less);
  2. Increased cramps;
  3. Heavier flow;
  4. Increased trouble sleeping—especially waking up in the middle of sleep;
  5. New or increased migraine headaches;
  6. Night sweats—especially if they tend to occur before or during flow;
  7. An increase in or new premenstrual mood swings;

It’s National Women’s Health Week — Celebrate and Reminisce with the FDA

May 15th, 2012 by Elizabeth Kissling

I admit, I didn’t know that this is National Women’s Health Week until I received a reminder in my inbox from a U.S. FDA mailing list, letting me know about the Food & Drug Administration’s role in promoting Women’s Health. They’ve published a brochure (available in both HTML and PDF versions) commemorating 100 Years of Protecting and Promoting Women’s Health.

Image Source: Public Domain

Society for Menstrual Cycle Research members and other women’s health advocates and activists will want to look through the list of the accomplishments the FDA claims responsibility for and lists as unequivocal improvements in women’s health.

For instance, we’ve had many discussions at re:Cycling about the FDA approval of the pill in 1960 as one holding mixed benefits for women, and not always the best choice for women’s health. The brochure also asserts that in 1970, “FDA initiated the first package insert written for consumers to explain to women the benefits and potential risks of oral contraceptives.” That happened in 1970, but Barbara Seaman, Alice Wolfson, and the other founding mothers of the National Women’s Health Network had more to do with its initiation than the FDA.

And here’s another inspiring quote from the FDA brochure:

1980: Making Tampon Use Safer

Problem: In 1980, there were 814 confirmed cases of menstrual related Toxic Shock Syndrome (TSS) and 38 deaths from the disease.
Response: FDA began requiring all tampon packages to include package inserts educating women about the risk of TSS and how to prevent it. In 1997, there were only five confirmed menstrually-related TSS cases and no deaths. The tampon package inserts with TSS information continue to be used today.

Sure, the FDA is proud of those safety rules now, but in 1982 the agency asked the industry to come up with their own voluntary standards because they did NOT want to regulate tampon safety. After years of pressure and organizing from Boston Women’s Health Collective members Esther Rome and Judy Norsigian, activist Jill Wolhander, researcher Nancy Reame, and others to standardize tampon absorbency ratings, the FDA finally enacted regulations in 1989, by court order. Nine years after 38 women died from a tampon-related illness.

Just last year, the FDA could have made another decision that would almost certainly save women’s lives, by removing birth control pills containing the synthetic progesterone drospirenone from the market, but instead the advisory panel voted by a four-person margin that the drugs’ benefit outweighed the risks.

You know what else isn’t on the list? Emergency contraception, a.k.a. the Morning After Pill and Plan B. The agency hemmed and hawed and delayed unconscionably for years, until finally approving it for limited over-the-counter availability in 2006 — a year after Susan Wood walked out of the FDA Office of Women’s Health for good over what she believed to be “willful disregard of scientific evidence showing Plan B to be safe.”

Celebrating organizational achievements that advance and protect women’s health is a fine thing. I’m glad Frances Kelsey withheld approval of Thalidomide in 1960, and for the most part, I’m glad the FDA is on the job. But while we’re celebrating women’s health and reminding everyone to be active, eat healthy, and get preventive health care (if they are so fortunate to have access to health care), let’s also celebrate the activists and advocates that keep agencies like the FDA in line.

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Man boobs, Teen Sexuality, a Drug to Prevent HIV, and More Weekend Links

May 12th, 2012 by Elizabeth Kissling

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The Medically Unnecessary Transvaginal Ultrasound and other Weekend Links

April 28th, 2012 by Elizabeth Kissling

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Marilyn Monroe’s Ovaries, Crazy Things Gynecologists Say, and other Weekend Links

April 21st, 2012 by Elizabeth Kissling

 

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“Lives will be saved” – the FDA decision not to ban Bayer’s birth control pill

April 18th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall

 

Photo by Monik Markus // CC 2.0

How many of us read the inserts included in a packet of pills? How many decide not to take the pills on the basis of the information enclosed?  The rapidly reeled-off list of side effects stated at the end of a televised advert for a new drug has more comedic value than serious consequence to most. If we do have doubts, many of us will rely on the reassurance of a doctor, and then take the pill anyway.

I recently wrote a piece for Ms. Magazine Blog outlining the FDA reappraisal of top-selling oral contraceptives Yaz and Yasmin. It was discovered that drugs such as these containing drospirenone held a significantly higher risk of causing blood clots. Research by the FDA and other bodies suggested this conclusion was definite, while research funded by the pharmaceutical company behind these billion-dollar products, Bayer, suggested the opposite conclusion to be true: that there was no increased risk evident. A team of experts, some of which had financial ties to the company, voted against having the pills taken off the market when presented with the question of whether the risks of taking these pills outweighed the benefits.

Bayer is facing 11,300 lawsuits from women who have been seriously injured and family members of women who have died after taking one of the company’s bestselling hormonal contraceptives. They have settled the first 500 addressed with a total of $110 million in payouts. When discussing this process with a lawyer representing many of the women I was told that Bayer would do anything to avoid a trial wherein the full spectrum of their marketing strategies would be revealed.

The FDA came to the decision to add into the insert included with these drugs a statement of the discovery of “conflicting” research that suggested the pills had a higher risk of causing blood clots  (up to three times higher) – acknowledging the discrepancy of the research funded by Bayer and giving it equal standing as that performed by other bodies including the FDA itself.

Prior to this decision being announced a number of women’s health groups got together to write a letter to the FDA asking that they look again at the question put to the board of experts. They argued that the correct comparison for the board to consider would be between drospirenone-containing contraceptives and other oral contraceptives, and not between Bayer’s drugs and unwanted pregnancy. In the final sentence, they remarked that they believed that “lives will be saved” if the pills were no longer on the market. They met with the FDA and one representative asked that the FDA strongly reassess its acceptance of Bayer-funded research. Another asked that the drugs no longer be prescribed and that the FDA “get back to the arc of history and progress that protects women while supporting their contraceptive needs.”

The new labeling will state the “conflicting” findings and advise that women speak to their doctor if concerned. The official statement on this decision, relayed through the media coverage, reminded women that when compared to pregnancy the risk of development of a blood clot was insignificant. They also asked that women currently taking the drugs not stop doing so. Despite the FDA studies suggesting the blood clot risk is particularly high for women under 30, the statement compounded the understanding that the issue is only relevant to those over 35,  those overweight, those that smoke, and those with relevant medical history.

Sync Your Cycle, Bleach Your Vulva, Lose Your Virginity, and More Weekend Links

April 14th, 2012 by Elizabeth Kissling

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Fear of Childbirth, Gaining Weight While Pregnant, Period-TV and other Weekend Links

April 7th, 2012 by Elizabeth Kissling

via RH Reality Check, Tumblr edition

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It’s My Period and I’ll Have a Party If I Want To

April 6th, 2012 by Elizabeth Kissling

Today’s post was created using the web tool Storify, and may take an extra moment to load in some browsers. If the page fails to load, please use your refresh/reload button

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Menstrual Art, Quitting Depo-Provera, Moldy Tampons, and other Weekend Links

March 31st, 2012 by Elizabeth Kissling

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Period Parties, Endometriosis Awareness Month, Theme Songs, and More Weekend Links

March 24th, 2012 by Elizabeth Kissling

Via Buzzfeed, March 21, 2012

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Mammogram Tutorial, Ladybusiness Legislation, and other Weekend Links

March 17th, 2012 by Elizabeth Kissling

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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.