January 20th, 2012 by Laura Wershler
Is there a woman over the age of 18 anywhere who doesn’t know that taking the birth control pill can make her periods lighter and less painful? Most women know this, but not many know why. The news stories swirling around a new study about the pill and period pain will not enlighten them.
Photo credit: Ceridwen, Creative Commons 2.0
A 30-year longitudinal Swedish study has finally proved the worth of what is accepted practice in North America and Europe: the prescribing of combined oral contraceptives (COCs), or birth control pills with synthetic estrogen and progestin, to treat painful periods known clinically as dysmenorrhea.
Of course, pharmaceutical companies that manufacture COCs are probably eager for this research, as prescribing the pill for dysmenorrhea is still an off-label use in the U.S. (unlicensed use in the U.K.). Pill manufacturers may be able to use this finding to lobby the FDA (or equivalent agencies in other nations) to approve the pill as treatment for menstrual pain, leading to increased sales and insurance coverage. Perhaps that’s why news media have been treating this discovery as breaking news.
Take this headline: Yes, the Pill CAN ease the agony of period pain: Scientists confirm what millions of women already know, or this one: The pill ‘does ease period pain’, or this one: Combination oral contraception pills cut menstruation pain, or, really, any of these.
You can read the abstract of the study by Swedish researchers Ingela Lindh, Agneta Andersson Ellström and Ian Milsom, published this week in the journal Human Reproduction, here: The effect of combined oral contraceptives and age on dysmenorrhoea: an epidemiological study. The conclusions are simple: “COC use and increasing age, independent of each other, reduced the severity of dysmenorrhoea. COC use reduced the severity of dysmenorrhea more than increasing age and childbirth.”
Forget the age factor for the purposes of this discussion. The fact that COC use reduces the severity of dysmenorrhea is not astounding. This is old news. So says Dr. Steven Goldstein, an obstetrician/gynecologist at NYU Langone Medical Center in New York City, quoted in a USA Today story:
“The study results are not surprising. It’s gratifying to see researchers documenting scientifically what practitioners have been seeing for a very long time. The amount of discomfort from a woman’s period with a combination birth control pill is a fraction of what it is without the Pill. There is a diminution of pain from the Pill.”
What is astounding is what Dr. Goldstein, and other OBGYNs, didn’t say in responding to the study. That the reason the pill reduces menstrual pain is because the synthetic hormones in the pill shut down a woman’s own menstrual cycle. The “period” women experience when on the pill is technically known as a “withdrawal bleed,” brought on by seven days of placebo pills. While it feels like a period to menstruators, it is not the same physiologically as the period they experience when NOT on the pill. That’s why it doesn’t hurt as much.
The point is, the pill is too often credited with regulating the menstrual cycle. It does no such thing. The pill does not regulate any woman’s menstrual cycle; it supercedes it. This research, and the many news stories that reported it, once again ascribe power to the pill – this time the power to cut menstrual pain. This is an incomplete truth.
Tags: Activism, big pharma, Birth Control, birth control pill, drugs, Dysmenorrhea, estrogen, hormones, menstrual suppression, Menstruation, oral contraceptive pills, pain
Posted in Birth Control, Communication, Dysmenorrhea, Health Care, Menstruation, New Research, Pharmaceutical | 6 Comments »
January 12th, 2012 by Elizabeth Kissling
Guest Post by Holly Grigg-Spall
“Less stressed, thinner and more interested in sex.” – but not buying magazines.
In a recent issue of the UK’s Stylist magazine — a weekly women’s glossy that is available for free at tube stations and selected clothing stores — there was an article headlined ‘What does 10 Years On The Pill Do To You?‘ As a result of my on-going blog, Sweetening the Pill, which documents my experience of coming off the contraceptive pill, I was contacted by the writer to provide some quotes for this piece. Unfortunately, I was edited out. As a journalist myself, I understood this situation has little to do with the writer’s choice of content and more to do with the magazine editor’s final say on what was most fitting for the feature. Yet the title question is the very crux of my blog: having taken the Pill for 10 years, stopping as a result of discovering the answer to this very question.
Photo Credit: Anthony Easton // CC 2.0
According to the Stylist piece the answer is that the Pill changes your memory skills, lowers your libido, makes you attracted to the wrong kinds of men for you, changes weight distribution, prevents you building muscles, make you retain water, make you depressed and jealous…and how can you tell if this all is just you or the Pill? You can’t and you shouldn’t try to find out, is the message here. We are advised to not take a break from the Pill, not even for a week, and if you are concerned, just ask for a different brand from your doctor. There is no discussion of non-hormonal alternatives. There is also no discussion of the benefits of not taking the Pill, of allowing your body to ovulate once a month.
My answer to this question was: “The Pill has a whole body impact. Taking the Pill shuts down a woman’s hormone cycle — and the ovulation and menstruation that is an essential part of this cycle — and replaces it with a low stream of synthetic hormones. This has an affect on every organ in the body — the impact is wide-reaching and crudely administered. The peaks, troughs, and plateaus of a woman’s ‘natural’ cycle are wiped out. The monthly hormone cycle is integral to many of the body’s central functions, including the metabolic, immune, and endocrine systems. This changes everything — from your sense of smell to your libido to your ability to absorb vitamins from your food.
Many women have said to me that coming off the Pill was ‘life-changing’ and, as someone now two years off the Pill after ten years on, I have to agree with the description. The life-threatening potential effects of the Pill get publicity — the blood clots and strokes — but the quality of life-threatening and the emotional and mental effects are barely discussed. Fatigue, muscle loss, urinary tract infections, bleeding gums, stomach disorders, flu-like symptoms, hair loss — relatively minor physical issues caused by the Pill that together can make life very hard. Depression, anxiety, panic attacks, rage, paranoia — all issues brought on by the Pill, due to a combination of switching off the hormone cycle and vitamin B deficiency. I experienced the whole package and when I wasn’t bordering on nervous breakdown I was flatlining, barely able to feel anything at all.”
Continue reading...
Tags: advertising, big pharma, birth control pill, guest post, hormones, ladymags, magazines, menstrual cycle, quitting the pill, side effects, side effects of the pill
Posted in Birth Control, Health Care, magazines, Pharmaceutical | 1 Comment »
January 11th, 2012 by Laura Wershler
The Internet abounds with articles, posts and forum discussions about coming off the birth control pill. Women are looking for information and advice. Many are trying to get pregnant, others are just done with hormonal contraception.
It’s a topic that interests many of us connected to the Society for Menstrual Cycle Research (SMCR) because of
Created at an a menstrual arts and crafts event, Andrea, 25, said this piece depicts the multiple emotions she feels around menstruation. Photo by Laura Wershler
how the pill and other forms of hormonal contraception impact the menstrual cycles of the women who take these medications. Some of us are experts in menstrual cycle function and dysfunction, most are advocates for healthy, positive menstrual cycle experiences from menarche to menopause.
A recent blog post at nomoredirtylooks.com on the topic of quitting the pill caught our members’ attention. Re: Cycling blogger Elizabeth Kissling included the post in Weekend Links on November 19.
A young woman in Paris was looking for advice and comments from other blog readers about how to manage the effects of coming off the pill. Siobhan O’Connor, the blog co-editor, shared Paris girl’s story with a graceful, inclusive invitation to readers:
There’s no judgment—implicit or explicit—on anyone who is on or has been on birth control pills. Some people love them, some people have to take them for medical reasons, some people abhor them. Here, we want to talk candidly about what happens when you go off them. Because, whoa. That can be hectic.
The post drew over 80 comments, with a few coming from SMCR members. What struck me was how many women:
1) had already ditched the pill or were planning to
2) expressed a desire for the return of regular, normal menstrual cycles
3) were concerned about their skin (it often breaks out after quitting the pill).
SMCR member, endocrinologist and guest blogger Dr. Jerilynn Prior answered the concerns about acne and bad cramps in a comment posted on November 22, and included a link to Centre for Menstrual Cycle and Ovulation Research website where readers can find information about all things related to menstrual cycle health.
Holistic Reproductive Health Practitioner Geraldine Matus, another member, commented on November 26 that it was concerns and experiences like those expressed by posters that prompted her and colleague Megan Lalonde to write the guide: Coming Off the Pill, the Patch, the Shot and Other Hormonal Contraception.
I invited No More Dirty Looks readers to visit this blog to learn more about the menstrual cycle and the issues raised by their online discussion.
Regular visitors to re: Cycling know that we cover a broad range of topics, but bloggers frequently address hormonal contraception as it relates to women’s health issues.
Check out this sampling from the re: cycling archive:
Several of the women who responded to the Paris girl post at nomoredirtylooks.com expressed eagerness to reclaim healthy, ovulatory menstruation and a willingness to learn how to manage their fertility without the aid of hormonal contraception. Continue reading...
Tags: advertising, Birth Control, birth control pill, blogging, blogs, blood, drugs, hormones, Menstruation, oral contraceptive pills
Posted in Birth Control, Health Care, Menarche, Menopause, Menstruation, ovulation | 6 Comments »
November 16th, 2011 by Laura Wershler
Of the growing list of reasons why women might want to reconsider using birth control pills, this could well be the strangest.
Researchers at Princess Margaret Hospital in Toronto published a study on Nov. 15 in the BMJ Open Journal in which they found a “strong correlation” between the use of birth control pills and the incidence of prostate cancer worldwide.
One of the possible explanations of how the two are related is the potential impact of the estrogen compound – ethinyloestradiol – that women using the pill secrete in their urine. It has been speculated elsewhere that these endocrine-disrupting substances could end up in our drinking water or get into the food chain.
The Pill, introduced in the 60’s, has been widely used for decades. The study suggests that exposure to these substances over 20 to 30 years could have a clinically significant effect. Researchers said further study of this link is needed.
In 2010 the media was full of stories marking the 50th anniversary of the birth control pill. The Pill at 50: Sex, Freedom and Paradox, rang the headline of a Time Magazine article by Nancy Gibbs. Could rising rates of prostate cancer be part of this paradox?
Tags: Birth Control, birth control pill, boys/men, drugs, estrogen, hormones, oral contraceptive pills, prostate cancer
Posted in Birth Control, Health Care, Men, New Research | 3 Comments »
September 23rd, 2011 by Elizabeth Kissling
Roseanne’s Nuts was one of the delights of summer 2011, especially for those of us who have missed the comedic talents of Roseanne Barr. If you don’t watch television (or are outside the US), Roseanne’s Nuts is Roseanne Barr’s return to episodic television, this time in the form of a reality show set on the star’s 40-acre macadamia nut farm in Hawaii. When her eponymous sitcom ended in 1997, she made a couple of attempts at talk show hosting, then left L.A. and the limelight to raise her youngest son and macadamias in Hawaii. He’s now a teenager, and the nuts are ready to harvest.
An ongoing thread of the show is Roseanne’s plan to harvest and distribute her nuts as a low-cost protein source for impoverished people. Each episode also has its own self-contained, seemingly unscripted plotline. Unlike many of today’s popular reality shows, however, there are no manipulated showdowns or drunken feuds. Much of the time, Roseanne and her family seem like everyone else’s family — if only the rest of us could live off sitcom residuals and were followed around by a camera crew. There is laughter and teasing, and some conflict underpinned with genuine affection, but everything isn’t always tidily resolved in 22 minutes.
In the Episode #15 (original air date September 10), 58-year-old Roseanne copes with continuing symptoms of menopause. It’s handled so honestly (for the most part) that I’m going to overlook the fact that the episode was titled “Menopause for Dummies”.* The episode opens with Johnny Argent, Roseanne’s manpanion**, sharing a list of menopause symptoms he has found on the internet. Roseanne acknowledges having them all, except for tingling in her extremities, and decides to visit her friend, Dr. Allen, and to investigate whether she should receive hormone treatments. (The full episode can be watched online at Lifetime.com until Oct. 11; preview a short clip at right.)
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Roseanne visits Dr. Allen — on camera, of course — this is a reality show — and explains her concerns. He asks about her libido and her sex life, and she replies, “It’s like an old person’s”. She responds forthrightly to his suggestion that dryness may be the cause of her ‘feminine itching’: “that’s all dried up like a sonofabitch”. Dr. Allen wants to measure Roseanne’s hormone levels with a 24-hour urine test, as he believes that will provide more precise information than any blood test. Roseanne is horrified by his description of her contribution to the procedure (“You pee in a bucket for 24 hours”), but even more horrified by his other recommendation: she needs to exercise.
Roseanne tells the camera — the proxy for us, the audience at home — that she doesn’t know if she’ll go on hormones or not. Her women friends recommend red wine, saying it’s bad for menopause (“because it makes you sweat”) but good for the libido. Her eldest son Jake is delighted to hear that his mom is considering hormones, telling the camera, “After eight years of being batshit crazy, I think she’s finally ready. I’m so happy — once she gets hormones, my life’s gonna be a lot easier.”
Some of my SMCR colleagues who study menopause may cringe at these scenes, but I think they’re representative of the kind of communication many women experience around menopause; that is, well-meaning, if ill-informed, advice from friends and family. It feels like the kinds of conversations lots of us have in our own living rooms and front porches. It is this feeling of unscripted authenticity that draws viewers to Roseanne’s Nuts. I also note the special irony of menopause; after 20 or 30 years of our hormones being blamed for erratic and irritable behavior, we’re now advised to consume hormones to rein in our erratic and irritable “batshit crazy” behavior. Continue reading...
Tags: family relationships, hormone therapy, hormones, macadamia nuts, menopausal hormone therapy, Menopause, menopause advice, menopause symptoms, Roseanne Barr, television
Posted in Celebrities, Media, Menopause, Television | 2 Comments »
November 24th, 2010 by Elizabeth Kissling
So there’s a surge today in news stories about how hormone treatment for menopause (popularly known as ‘hormone replacement therapy’ or HRT) benefits the brain, apparently based on publicity over this study published in Hormones and Behavior. In media interviews, the researchers suggest that HT enhances the communication between left and right sides of the brain, making the older women’s brains more similar to those of younger women. The researchers had the women perform tasks designed to demonstrate fine motor coordination, such as tapping buttons with different fingers. Of the 62 women in the study, the 36 on hormone treatments showed higher levels of motor coordination, leading the researchers to conclude that hormone treatments, especially estrogen, “exert positive effects on the motor system thereby counteracting an age-related reorganization.”
Admittedly, I have not read the entire study, just the abstract and press summaries, but would you consider me too cynical if I suggested that the publicity this research report is receiving is more about promoting the use the hormones among menopausal women than the significance of the research findings?
Tags: big pharma, brain, estrogen, hormone therapy, hormones, menopausal hormone therapy, Menopause
Posted in Menopause, New Research | 3 Comments »
October 27th, 2010 by Elizabeth Kissling
Guest Post by Kitty Holman
Yves Saint Laurent Satin Peep-Toe Shoes
Make no mistake, there are some women who absolutely love to shop. And why not? Shopping has long been described as being a therapeutic activity because it has the uncanny ability to lift the spirit. After all, bringing home a new pair of sassy shoes can do wonders for a foul mood. But shopping can also be a detrimental hobby for women who are carefully monitoring their funds. This is especially true during the week right before menstruation. New research by Karen J. Pine and Ben C. Fletcher at the University of Hertfordshrine’s School of Psychology has shown that women tend to spend more money when they are later into their menstruation cycle than during any other time of the month. Their paper, “Women’s spending behaviour is menstrual-cycle sensitive,” appears in the January, 2011, issue of Personality and Individual Differences.
Menstruation affects women in an almost primal way. At peak ovulation, which is when the female body is the most fertile and therefore the most likely to become pregnant, women may find themselves unconsciously adapting their behavior to attract men, or potential mates. Many women change their dress style during this time in an effort to impress potential partners, which has been dubbed the “ornamentation effect,” according to researchers . The ornamentation effect typically occurs a week before menstruation, coinciding with Pine and Fletcher’s findings that women tend to make more indulgent and reckless expenditures during this time than any other time of the month. The research suggests that the two are connected, as women may make more self-indulgent purchases, typically of clothing or other “preening” items, because they are unconsciously driven to adapt their physical appearance to attract a mate. In fact, the researchers surveyed 443 women, all menstruating and between the ages of 18 and 50, and found that 48 percent of the women who admitted to impulsive and excessive spending did so when they were premenstrual, as opposed to the 34 percent who were menstrual or post-menstrual and the mere 18 percent who were in mid-cycle.
Another factor driving women to overspend a week before menstruation can be attributed to hormones. Immediately before menstruation, the female body is barraged with different signals in addition to the desire to attract a potential partner. Hormonal triggers can bring on mood swings and other irritability symptoms associated with premenstrual syndrome, also known as PMS. These symptoms and the stress that they bring on can dampen a woman’s capacity for self-control, which can further explain why women tend to spend more during the luteal phase, the only time during the menstrual cycle when PMS occurs. If the unawareness of self-control is not one of the driving causes behind overspending during the luteal phase, then it is likely that justification is. Women may feel that they deserve to spend more during this time of the month as they are generally feeling uncomfortable and irritable, even if they understand that the expenditure is extravagant.
Whether excessive spending is caused by an unconscious need to preen, a lack of self-control in the face of PMS-related stress, or a simple license to indulge in shopping caused by luteal phase anxiety, otherwise money-smart women can find themselves more susceptible to making impulse purchases the later they are into their menstrual cycle. Those who wish to watch their spending and protect their funds from reckless behavior can simply avoid the mall during that particular time of the month.
This guest post is contributed by Kitty Holman, who writes on the topics of nursing schools. She welcomes your comments at her email address kitty.holman20@gmail.com Continue reading...
Tags: guest post, hormones, Menstruation, money, stereotypes
Posted in Menstruation, New Research | 3 Comments »
October 21st, 2010 by Heather Dillaway
Yes, the hormone therapies prescribed for women in perimenopause and beyond have already been suspect. Especially after the initial Women’s Health Initiative (WHI) trial results in 2002 (but even before that), researchers documented the health risks associated with the use of hormones during menopause, especially combination hormone therapies (therapies including estrogen plus progesterone, such as Prempro). SMCR’s Jerilynn Prior has done plenty of work on this as has SMCR’s Paula Derry, and WHI researchers and spokespeople have had to come out about many of the health risks as well. Now, this week, we find out that not only is there an increased risk of breast cancer for women who use these hormone therapies but that, according to a New York Times article published on Tuesday, “Women who took hormones and developed breast cancer were more likely to have cancerous lymph nodes, a sign of more advanced disease, and were more likely to die from the disease than were breast cancer patients who had never taken hormones.” According to this New York Times article, this report is the first to reveal WHI death rates.
After the dust settled from the original WHI reports about the risks of hormone therapies, researchers and doctors often made claims that it was still okay for women to be on hormone therapies for an extended period of time. Instances of death (instead of just disease/illness) are now causing some researchers and doctors to come forward and say that it is no longer safe for women to be on hormone therapies for this amount of time. Dr. Chleblowski, an author of the latest study about women’s mortality, is quoted in the New York Times article as saying that women should not stay on Prempro for more than a year or two.
Bottom line, these drugs are dangerous for women. The older we get, the more we realize that illness, disease, and death are a normal part of life. I find myself realizing this more and more each day as I watch people around me get sick, die, or have to deal with the loss of loved ones. But illness, disease, and death caused by prescriptions and indirectly by doctor’s care (what is often termed iatrogenic illness or death) is just not okay – especially when more caution could be used. Sure, it’s happened all throughout history. Plenty of people died so we could have Aspirin, Viagra, epidurals, Coumadin, birth control pills, safe abortions, hysterectomies, and pacemakers, just to name a few. But, as a doctor quoted in the New York Times article says, “The fallback is that doctors and patients should be deciding this on a one-to-one basis, weighing risks and benefits,” [but] “How do you do that when you don’t know what the risks are?”
We know that doctors are left in a precarious position, as are female patients, as they contemplate the use of hormone therapies….but what these articles and reports aren’t saying outright is that it is probably better NOT to use these drugs unless we absolutely have to. I was listening to Detroit’s NPR station driving home from work yesterday and heard even Dr. Susan Hendrix, a Detroit-based WHI researcher and doctor say, “maybe we can now just laugh at hot flashes,” instead of rely on combination hormone therapies to help us. At least that’s what she was inferring. We don’t completely understand all of the risks of combination hormone therapies but we know they include possible cancer and death, and delayed diagnosis of cancer as well (which means further death). Since yesterday was “Love Your Body Day,” I think perhaps we need to love our bodies more by remembering that some of the signs and symptoms we experience (such as hot flashes and irregular bleeding in menopause, no matter how hard to deal with) are not life-threatening, are completely normal, and can be dealt with without drugs — because the alternative is not so benign. Why should women continue to worry about whether they’ll die by Prempro? It seems WHI results are beginning to get even clearer, and I’ll be interested to see whether rates of prescription decrease after this last report. I also wonder what the makers of Hot Flash Havoc might think of this. Continue reading...
Tags: big pharma, estrogen, Health Care, hormones, Menopause, WHI
Posted in Menopause, New Research, Newspapers, Pharmaceutical | Comments Off
October 19th, 2010 by Elizabeth Kissling
This morning, ladymag The Stir posted an article titled, “5 Weird Things Our Menstrual Cycles Make Us Do”. Over the weekend, science site Live Science featured an article about the recent surge in ovulation-related research (with the unfortunate title, “Booty Call: How to Spot a Fertile Woman”). As a quick perusal of re:Cycling archives will reveal, these are only the most recent mass media reports of research on how ovulation and female hormones purportedly determine women’s behavior. Recent research has linked hormones and/or ovulation to women’s preferences for masculine faces, why there are so few women sushi chefs, fluctuating cholesterol levels, chocolate cravings, and competitive bidding in online auctions.
I find myself increasingly weary of such stories, especially when they’re uncritically accepted and advanced. I’m not so naïve as to argue that there aren’t any biological differences between women and men,* but in isolation, hormones explain very little about human behavior. Ovulation is part of a complex endocrine system, which is part of an even more complex body, which exists in a social world with complicated, byzantine, ever-evolving norms, rules, and consequences for our choices. Why are overly simple explanations so popular? Is the current embrace of biological determinism a marker of a new backlash?
*I will argue, however, that most of those differences aren’t as important as they’ve been made out to be.
Tags: backlash, critical thinking, hormones, Media, ovulation
Posted in anatomy, Media, New Research | Comments Off
September 8th, 2010 by Chris Hitchcock
An open-access article published in PLOS Medicine yesterday, Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, presents an article describing the ways in which the pharmaceutical industry used a medical education & communication company to produce ghostwritten articles that inserted marketing messages into articles published in medical journals.
This article is the first academic analysis of the 1500 documents unsealed in recent litigation against the pharmaceutical giant Wyeth (now part of Pfizer). It reveals the ways in which pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that were used to promote unproven benefits and downplay harms of Prempro—a brand of menopausal hormone therapy (HT)—and to cast competing therapies in a negative light. These articles were widely circulated to drug reps and doctors to disseminate the company’s marketing messages. The analysis appears in this week’s PLoS Medicine.
Wyeth used a medical education & communication company, DesignWrite, to produce ghostwritten articles in order to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular ‘‘benefits’’ of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles, writes Fugh-Berman.
The analysis revealed that DesignWrite was paid US$25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on the HOPE trials of low-dose Prempro. DesignWrite was also assigned to write 20 review articles about the drug, for which they were paid US$20,000 each.
The analysis concludes that “Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.”
In July 2009, PLoS Medicine, represented by the public interest law firm Public Justice, and The New York Times acted as intervenors in litigation against menopausal hormone manufacturers by 14,000 plaintiffs whose claims related to the development of breast cancer while taking the hormone therapy Prempro (conjugated equine estrogens). This resulted in a US federal court decision to release approximately 1500 documents to the public. The Wyeth Ghostwriting Archive is available at http://www.plosmedicine.org/static/ghostwriting.action or through the UCSF Drug Information Document Archive at http://dida.library.ucsf.edu/documents.jsp
Funding: The author received no specific funding for this article.
Competing Interests: Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper. She was not paid for any part of researching or writing this paper. Dr. Fugh-Berman directs PharmedOut, a Georgetown University-based project founded with public money from the Attorney General Consumer and Prescriber Grant program and currently supported by individual donations.
Citation: Fugh-Berman AJ (2010) The Haunting of Medical Journals: How Ghostwriting Sold ‘‘HRT’’. PLoS Med 7(9): e1000335. doi:10.1371/journal.pmed.1000335
(This blog largely lifted from the article press-release).
Tags: big pharma, drugs, estrogen, ghostwriting, hormones, lawsuit, menopausal hormone therapy, Menopause, Prempro
Posted in Menstruation | Comments Off
August 11th, 2010 by Elizabeth Kissling
Fascinating new research from the National Institutes of Health finds that women’s cholesterol levels correspond with cyclic changes in estrogen levels. Total cholesterol levels can vary by as much as 19% over the course of the cycle.
The researchers found that as the level of estrogen rises, high-density lipoprotein (HDL) cholesterol also rises, peaking at the time of ovulation.
In a typical cycle, estrogen levels steadily increase as the egg cell matures, peaking just before ovulation. Previous studies have shown that taking formulations which contain estrogen — oral contraceptives or menopausal hormone therapy — can affect cholesterol levels. However, the results of studies examining the effects of naturally occurring hormone levels on cholesterol have not been conclusive. According to the NIH’s National Heart, Lung and Blood Institute, high blood cholesterol levels raise the risk for heart disease.
. . . .
In contrast, total cholesterol and low-density lipoprotein (LDL) cholesterol levels — as well as another form of blood fat known as triglycerides — declined as estrogen levels rose. The decline was not immediate, beginning a couple of days after the estrogen peak at ovulation.
These findings provide another reason for girls and women to learn to track their cycles, so their blood tests can be interpreted more precisely.
It also gives more weight to the frequent assertion of members of the Society for Menstrual Cycle Research that menstruation matters — and is worthy of our study — in part because it is not an event isolated in the uterus and vagina, but a complex part of the endocrine system that has effects on health and well-being throughout a woman’s body.
Tags: cholesterol, endocrine system, estrogen, hormones, menstrual cycle, ovulation
Posted in Health Care, Menstruation, New Research, ovulation | 1 Comment »
July 19th, 2010 by Elizabeth Kissling
It’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.
Late last fall when we broke to code on this study, we were ecstatic to discover that our trial was highly successful. After only three months’ therapy with Prometrium® (300 mg at bedtime daily) the 127 (of 133 randomized) women’s vasomotor symptoms score (VMS Score, combination of number of flushes times their intensity during the day and during sleep) was decreased by about 60% on progesterone compared to less than 30% decrease on placebo.
In early June we learned the answer to another important question: Does progesterone effectively treat intense VMS? The answer is yes! Although less than half all the treatment-seeking women in our study met the FDA’s criteria for more than 50 moderate-intense VMS/week, the 30 women who did who were randomized to Prometrium® showed significantly more improvement in hot flushes than did women on placebo.
What were the reactions to this news? Some local doctors said they already knew that progesterone was good for VMS! Others people were curious, or skeptical but many realized the importance of providing women with an effective alternative to estrogen for VMS. Other reactions were predictable—many questions about whether this couldn’t really be explained, somehow, by estrogen (Prometrium® is converted into estrogen—not!). And there were several questions about side effects and alleged serious health risks from progesterone (wrongly attributed because of confusion of progesterone with synthetic progestins). Happily I was able to respond that participants had no serious negative effects—more placebo-treated than Prometrium®-treated women dropped out before completion. And it is likely that in estrogen-treated women progesterone decreases breast cancer risk rather than increasing it as medroxyprogesterone does (2). Because of Prometrium®’s significant sleep benefit (3), some women who entered the trial sleep-deprived experienced short-lived morning drowsiness. But the estrogen myth-related mood, bloating, weight gain, migraine headaches, and breast tenderness did not occur.
An epic journey for me, Chris, and CeMCOR ends in triumph. Now that the dust has settled, I am so grateful that CeMCOR’s many researchers over the last six years dedicated themselves to a world class trial, that local donors made the trial possible, and that the Prometrium® and placebo were provided by Schering Canada (for the first two years) and subsequently by the world-wide manufacturer, Besins Healthcare of Belgium. Continue reading...
Tags: CeMCOR, clinical trial, estrogen, guest post, hormones, hot flashes/flushes, Menopause, progesterone
Posted in Menopause, New Research, Pharmaceutical | 1 Comment »
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.
