CONTRIBUTE to Humor,
Words and expressions about
menstruation and Would
you stop menstruating if you could?
|
Continued to next earlier News & NotesNEW this month (news & letters BELOW, 15 Feb. 2006):How Modess and the
CLASSIEST sanitary napkin ads began
|
Read about the new edition (pdf). Take a quiz about women's health (pdf). Buy the books through the books' home pages for the English and Spanish editions. |
Click on the covers to go to the books' Web sites, where you can learn more about them and get 'em for yourself! |
Barr Pharmaceuticals makes Seasonale, a hormone drug that allows women to have only four periods a year - at least that was the plan. But read on . . . .
"FDA Warns Barr Over Seasonale Commercial
"Fri Dec 31, 2:49 PM ET Health - Reuters
"WASHINGTON (Reuters) - A television commercial for Barr Pharmaceuticals Inc.'s Seasonale misleads consumers by excluding risk information to make the birth control pill seem safer, U.S. health regulators warned in a letter released on Thursday.
"The commercial suggests use of the oral contraceptive leads to only four menstrual periods a year but fails to mention frequent and sometimes substantial bleeding, the FDA (news - web sites) said in the Dec. 29 letter.
"Barr's advertisement plays down the risk of irregular menstrual bleeding that can be as heavy as a regular period by suggesting it would subside with continued use of the pill, the letter said.
"The FDA posted the letter Thursday on its web site at www.fda.gov/cder/warn" (a pdf from December 2004)
Christine L. Hitchcock, Ph.D., Research Associate, Centre for Menstrual Cycle and Ovulation Research (CeMCOR), Endocrinology, Dept. of Medicine, University of British Columbia, Vancouver, BC, Canada (URL: http://www.cemcor.ubc.ca/), sent this to members of the The Society for Menstrual Cycle Research (which includes me).
Here is the first article from the Phase III trial of the higher dose extended schedule pill (Seasonale).
In Contraception. 2003 Aug;68(2):89-96.
A multicenter, randomized study of an extended cycle oral contraceptive.
Anderson FD, Hait H.
The Jones Institute for Reproductive Medicine, Eastern Virginia Medical
School, Norfolk, VA 23501, USA. [email protected]
OBJECTIVE: To assess the efficacy and safety of Seasonale, 91-day extended cycle oral contraceptive (OC). METHODS: A parallel, randomized, multicenter open-label, 1-year study of the OC Seasonale [30 microg ethinyl estradiol (EE)/150 microg levonorgestrel (LNG), and Nordette-28 (30 microg EE/150 microg LNG)] in sexually active, adult women (18-40 years) of childbearing potential. Patients received either four 91-day cycles of extended cycle regimen OC, or 13 cycles of the conventional 28-day OC with daily monitoring of compliance and bleeding via electronic diaries. RESULTS: When taken daily for 84 days followed by 7 days of placebo, the extended cycle regimen was effective in preventing pregnancy and had a safety profile that was comparable to that observed with the 28-day OC regimen that served as the control. While unscheduled (breakthrough) bleeding was reported among patients treated with the extended cycle regimen, it decreased with each successive cycle of therapy and was comparable to that reported by patients who received the conventional OF regimen by the fourth extended cycle. CONCLUSION: This study demonstrated that Seasonale, 91-day extended cycle OC containing 84 days of 30 microg EE/150 microg LNG followed by 7 days of placebo, was effective, safe and well tolerated.
PMID: 12954519
Press release from the maker of Seasonale, Barr Laboratories
(Kathleen O'Grady, of the Canadian Women's Health Network, kindly sent this to The Society for Menstrual Cycle Research members)
WOODCLIFF LAKE, N.J., Nov. 18 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. (NYSE:BRL) today announced that it has begun promoting SEASONALE(R) (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets directly to physicians and other healthcare providers. SEASONALE is the first and only FDA-approved extended-cycle oral contraceptive indicated for the prevention of pregnancy and designed to reduce periods from 13 to 4 per year. The Company has initiated physician detailing and promotional activities using the 250-person Duramed Pharmaceuticals, Inc. Women's Healthcare Sales Force. Duramed is a wholly owned subsidiary of Barr Laboratories, Inc.
The Company began shipping SEASONALE in mid-October. Promotional Programs directed to physicians include a variety of patient education initiatives, various medical education programs and a publication plan that includes journal advertising. Women and healthcare professionals who would like to learn more about SEASONALE, including full prescribing information, should visit http://www.seasonale.com/ or call the toll-free number 800-719-FOUR (3687).
"We are excited to begin marketing this new choice in oral contraception to healthcare providers and patients through extensive promotional activities and an education campaign," Bruce L. Downey, Barr's Chairman and CEO said. "Our market research indicates that the extended-cycle regimen represents a substantial opportunity with patients and we believe that the already high awareness of SEASONALE will be even higher among target physicians and patients following the launch of our promotional activities and detailing by our Women's Healthcare Sales Force."
"SEASONALE is a 91-day regimen taken daily as 84 active tablets of 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol, followed by 7 inactive tablets and is designed to reduce the number of periods from 13 to 4 per year," explained Dr. Carole S. Ben-Maimon, President and Chief Operating Officer of Barr Research. "With SEASONALE, women now have an FDA-approved, safe and effective alternative to the traditional 28-day oral contraceptive regimen."
Clinical Data
The clinical data supporting FDA approval of the SEASONALE (levonorgestrel and ethinyl estradiol) 0.15 mg/0.03 mg tablets product resulted from a randomized, open-label, multi-center trial that ended in March 2002 and an extension to that trial. In the trials, SEASONALE was found to prevent pregnancy and had a comparable safety profile to a more traditional oral contraceptive.
In the trial, the most reported adverse events were nasopharyngitis, headache and intermenstrual bleeding or spotting.
SEASONALE(R) has been formulated using well-established components, long recognized as safe and effective when used in a 28-day regimen. SEASONALE offers 4 periods per year as compared to 13 per year with traditional oral contraceptives. When prescribing SEASONALE, the convenience of fewer planned menses (4 per year instead of 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting.
Important Information About Oral Contraceptives
It is estimated that more than 16 million women currently take oral contraceptives in the United States. Oral contraceptives are not for every woman. Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years. Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Use of SEASONALE provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins (an additional 9 weeks per year). While this added exposure may pose an additional risk of thrombotic and thromboembolic disease, studies to date with SEASONALE have not suggested an increased risk of these disorders. The convenience of fewer menses (4 vs. 13 per year) should be weighed against the inconvenience of increased intermenstrual bleeding/spotting.
Barr Laboratories, Inc. is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Forward-Looking Statements
The following sections contain a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission.
Source: Barr Laboratories, Inc.
CONTACT: Carol A. Cox, Barr Laboratories, Inc., +1-201-930-3720, [email protected]
To mark the one-year anniversary of the Women's Health Initiative Study, which highlighted possible health risks associated with long-term hormone therapy use for menopausal women, the Canadian Women's Health Network has now made the following documents available online and free of charge:
Frequently Asked Questions, answered in plain language:
What is Menopause?
What is Hormone Therapy (HT)?
What are the Alternatives to Hormone Therapy?
Menopause and Heart Disease; What are my Risks?
How do I Stop Taking Hormone Therapy?
In-depth articles:
*The Pros and Cons of Hormone Therapy: Making An Informed Decision
*Health Protection Measures from the Women's Health Initiative
*The Medicalization of Menopause
*HRT in the News: The Women's Health Initiative
*Challenges of Change: Midlife, Menopause and Disability
*Natural Hormones - Are They a Safe Alternative?
*Perimenopause Naturally: An Integrative Medicine Approach
*Thinking Straight: Oestrogen and Cognitive Function at Midlife
*The Truth About Hormone Replacement Therapy
*Menopause Home Test: Save Your $$$
*Recent Studies on Menopause and Pain
*What The Experts are Saying Now: A Round-Up of International Opinion
*Women and Healthy Aging
... and many more!
Check us out at www.cwhn.ca
The Canadian Women's Health Network
Women's Health Information You Can TrustMany thanks to the Women's Health Clinic, Winnipeg,
http://www.womenshealthclinic.org/ and A Friend Indeed newsletter, www.afriendindeed.ca for making many of these documents available to the general public.============================================
Kathleen O'Grady, Director of Communications
Canadian Women's Health Network/Le R�seau canadien pour la sant� des femmes
Suite 203, 419 Graham Ave.
Winnipeg MB R3C 0M3
Tel (204) 942-5500, ext. 20E-mail [email protected]
www.cwhn.ca
Book about periods needs your input, MEN!
Kaylee Powers-Monteros is writing a book about women's periods called "Bloody Rites."
"I consider a woman's period her rite of passage. . . . My book is focusing on the language we use about periods and how that impacts our perceptions of it," she writes.
She has a chapter about men's first learning about menstruation and would like to hear from men in response to the question, "When was the first time you ever heard anything about a period and what was it?" I already sent her mine: when I was in sixth grade the kid next door said his sister had started bleeding from you-know-where. I didn't know anything about you-know-where, actually, having grown up in a prudish military household with two bothers, no sisters and a mother who must have felt very alone.
E-mail her at [email protected]
Women's Universal Health Initiative
Women's Universal Health Initiative
Women's Universal Health Initiative is by women for women - if you have ideas, events, information, or comments to share, send them to [email protected]
In these difficult times, all advocacy groups are struggling financially. WUHI is no exception. Please consider becoming a member to support the continuation of the web site and our work on universal health care.
You become a member of WUHI with a tax-deductible donation of any amount. Go to the WUHI website to join online, or send your donation to WUHI, Box 623, Boston, MA 02120.
Health Care Reform: a Women's Issue
Anne Kasper
Anne Kasper, a long time women's health activist, discusses why health care reform is a women's issue. Anne is an editor, with Susan J. Ferguson of Breast Cancer: Society Shapes an Epidemic, a powerful and informative book on the politics of breast cancer.
To read the complete article: http://www.wuhi.org/pages/articles.html <http://www.wuhi.org/pages/articles.html%A0>
Health care reform has long been a women's issue. Since the beginnings of the Women's Health Movement in the late 1960s, women have known that the health care system does not work in the best interests of women's health. When we think of the health care system and its component parts � doctors, hospitals, clinics, and prescription drugs, for instance � we are increasingly aware that the current system is not designed to promote and maintain our personal health or the health of others. Instead, we are aware of a medical system that delivers sporadic, interventionist, hi-tech, and curative care when what we need most often is continuous, primary, low-tech, and preventive care. Women are the majority of the uninsured and the under insured as well as the majority of health care providers. We are experts on our health, the health of our families, and the health of our communities. We know that we need a health care system that must be a part of changes in other social spheres -- such as wage work, housing, poverty, inequality, and education -- since good health care results from more than access to medical services.
Featured Site
UHCAN - Universal Health Care Action Network
http://www.uhcan.org/
UHCAN is a nationwide network of individuals and organizations, committed to achieving health care for all. It provides a national resource center, facilitates information sharing and the development of strategies for health care justice. UHCAN was formed to bring together diverse groups and activists working for comprehensive health care in state and national campaigns across the country.
Their annual conference, planned for October 24-26, 2003 in Baltimore, MD, is one of the best grass-roots action conferences available. They consider universal health care justice from many perspectives.
Visit UHCAN's website for resources, analyses of health reform issues, and more information on their campaigns for health care justice.
Proposals, Policies, Pending Legislation
Health Care Access Campaign - the Health Care Access Resolution
http://www.uhcan.org/HCAR/
Health care in America is unjust and inefficient. It costs too much, covers too little, and excludes too many. As the economy deteriorates, it is rapidly getting worse.
One in seven Americans, 80% of whom are from working families, lack health insurance and consequently suffer unnecessary illness and premature death. Tens of millions more are under insured, unable to afford needed services, particularly medications. Health care costs are a leading cause of personal bankruptcy. Communities of color endure major disparities in access and treatment. Double-digit medical inflation undermines employment-based insurance, as employers drop coverage or ask their employees to pay more for less. State budgets are in their worst shape in half a century. Medicare and Medicaid are caught between increases in need and a financial restraints.
In the 108th Congress, the Congressional Universal Health Care Task Force will introduce the Health Care Access Resolution, directing Congress to enact legislation by 2005 that provides access to comprehensive health care for all Americans. Legislators, reacting to the urgency for health care reform, will likely introduce several proposals in this Congress.
Check out the link to learn more about the resolution and how you can contribute to it.
Proposed Health Insurance Tax Credits Could Shortchange Women
http://www.cmwf.org/programs/insurance/collins_creditswomen_589.pdf
Commonwealth Fund report, reviews federal policies designed to help low-income adults buy health insurance, which have focused on tax credits for purchasing coverage in the individual insurance market. This analysis of premium and benefit quotes for individual health plans offered in 25 cities finds that tax credits at the level of those in recent proposals would not be enough to make health insurance affordable to women with low incomes.
Time for Change: the Hidden Cost of a Fragmented Health Insurance System
http://www.cmwf.org/programs/insurance/davis_
An excellent overview by Karen Davis, President of The Commonwealth Fund, of factors in the US health care system that lead to it being the most expensive health system in the world.
A Place at the Table: Women's Needs and Medicare Reform
By Marilyn Moon and Pamela Herd
http://www.tcf.org/Publications/Order.asp?ItemID=199
This book, published by the Century Foundation, shows that women have different retirement needs as a group than men. Women are more likely to require long-term care services because they live longer and are more likely to suffer from chronic diseases. Suggests guidelines that would make Medicare reforms work for women, including how to deal with comprehensiveness, affordability, access to quality care, and the availability of information.
Women in the Health Care System: Health Status, Insurance, and Access to Care
http://www.meps.ahrq.gov/PrintProducts/PrintProd_Detail.asp?ID=78
Report from the Agency for Healthcare Research and Quality (AHRQ) focuses on women in the United States in 1996. Health insurance status is examined in terms of whether women are publicly insured, privately insured, or uninsured, and whether insured women are policyholders or dependents.
Health Insurance Coverage in America: 2001 Data Update
http://www.kff.org/content/2003/4070/
Although not specific to women, this resource contains valuable information about women and health insurance coverage and provides valuable information and facts for general presentations on universal health care. The chart book provides year 2001 data on health insurance coverage, with special attention to the uninsured. It includes trends and major shifts in coverage and a profile of the uninsured population.
Resources
Health Care Links
http://www.pnhp.org/links/
Links to state, national and international organizations working for single payer health care and universal health care. A resource of Physicians for a National Health Program - check out the site for many other resources and excellent factual information on a single payer health care system [ http://www.pnhp.org/links/ <http://www.pnhp.org/links/> ].
Universal Health Care Organizations in Your State
http://www.everybodyinnobodyout.org/index.htm#regnl
A list of state organizations working for universal health care. Resource of Everybody In, Nobody Out [EINO: http://www.everybodyinnobodyout.org ]. Not all states represented.
Families USA New Online Service
http://fusa.convio.net/site/R?i=6d26XZDs_24DRYvcWDDmjg .
Families USA online service to provide registered users with the following benefits:
Free bimonthly newsletters with articles on health policy issue.
Announcements about organization events.
Discounts on publications
Kaiser Network for Health Policy - Publications and Reports
http://www.kaisernetwork.org/health_cast/hcast_index.cfm?display=links&hc=806&linkcat=61 <http://www.kaisernetwork.org/health_cast/hcast_index.cfm?display=links&hc=806&linkcat=61>
Reports and publications on health policy, access, uninsured and insurance. Supported by the Kaiser Family Foundation. Good source of information.
Calendar
May 8 - 9 2003
Health Policy and the Underserved
http://www.jcpr.org/conferences/event_description.cfm?conid=124
Sponsored by the Joint Center for Poverty Research, looks a social, economic, and outcomes of policies for the underserved.
May 14-16, 2003
2003 Managed Care Law Conference
Colorado Springs, CO
http://www.healthlawyers.org/programs/prog_03mc.cfm
Co-sponsored by American Health Lawyers Association and American Association of Health Plans. Presents legal issues facing health plans and providers.
October 24-26, 2003
National Universal Health Care Action Network [UHCAN] Conference
Baltimore, MD
http://www.uhcan.org/
One of the best grass-roots action conferences available. Considers universal health care from all its perspectives. Check out their website for an overview of their orientation.
November 15, 2003
Physicians for a National Health Program Fall Meeting
http://www.pnhp.org/action/?go=events
San Francisco, CA
November 15 - 19, 2003
American Public Health Association Annual Meeting
San Francisco, CA
http://www.apha.org/meetings/
Meeting of professionals in public health. Has many sessions on health care reform and women's health, including universal health care.
January 22-23, 2004
National Health Policy Conference
Washington, DC
http://www.academyhealth.org/nhpc/
Wide-ranging discussions of health policy, including health care reform and universal health care.
Women's Universal Health Initiative
PO Box 623
Boston, MA 02120-2822
617-739-2923 Ext 3
www.wuhi.org <http://www.wuhi.org>
here.]
Read more about it - it includes this museum (when it was in my house) and many interesting people associated publically with menstruation. Individual Americans can buy the video by contacting
Films for the Humanities
P.O. Box 2053
Princeton, NJ 08543-2053Tel: 609-275-1400
Fax: 609-275-3767
Toll free order line: 1-800-257-5126Canadians purchase it through the National Film Board of Canada.
If so, Lana Thompson wants to hear from you.
if I die before establishing the Museum of Menstruation and Women's Health as a permanent public display in the United States (read more of my plans here). I have had coronary angioplasty; I have heart disease related to that which killed all six of my parents and grandparents (some when young), according to the foremost Johns Hopkins lipids specialist. The professor told me I would be a "very sick person" if I were not a vegetarian since I cannot tolerate any of the medications available. Almost two years ago I debated the concept of the museum on American national television ("Moral Court," Fox Network) and MUM board member Miki Walsh (see the board), who was in the audience at Warner Brothers studios in Hollywood, said I looked like a zombie - it was the insomnia-inducing effect of the cholesterol medication.
And almost two years ago Megan Hicks, curator of medicine at Australia's Powerhouse Museum, the country's largest, in Sydney, visited MUM (see her and read about the visit). She described her creation of an exhibit about the history of contraception that traveled Australia; because of the subject many people had objected to it before it started and predicted its failure. But it was a great success!
The museum would have a good home.
I'm trying to establish myself as a painter (see some of my paintings) in order to retire from my present job to give myself the time to get this museum into a public place and on display permanently (at least much of it); it's impossible to do now because of the time my present job requires.
An Australian e-mailed me about this:
Wow, the response to the museum, if it were set up in Australia, would be so varied. You'd have some people rejoicing about it and others totally opposing it (we have some yobbos here who think menstruation is "dirty" and all that other rubbish). I reckon it would be great to have it here. Imagine all the school projects! It might make a lot of younger women happier about menstruating, too. I'd go check it out (and take my boyfriend too) :)
Hey, are you related to Karen Finley, the performance artist?? [Not that I know of, and she hasn't claimed me!]
Don't eliminate the ten Regional Offices of the Women's Bureau of the Department of Labor
The Bush Administration is planning to propose, in next year's budget, to eliminate the ten Regional Offices of the Women's Bureau of the Department of Labor. This decision signals the Administration's intent to dismantle the only federal agency specifically mandated to represent the needs of women in the paid work force.
Established in 1920, the Women's Bureau plays a critical function in helping women become aware of their legal rights in the workplace and guiding them to appropriate enforcement agencies for help. The Regional Offices take the lead on the issues that working women care about the most - training for higher paying jobs and non-traditional employment, enforcing laws against pay discrimination, and helping businesses create successful child-care and other family-friendly policies, to name only a few initiatives.
The Regional Offices have achieved real results for wage-earning women for eighty-one years, especially for those who have low incomes or language barriers. The one-on-one assistance provided at the Regional Offices cannot be replaced by a Web site or an electronic voice mail system maintained in Washington.
You can take action on this issue today! Go to http://capwiz.com/nwlc/home/ to write to Secretary of Labor Elaine Chao and tell her you care about keeping the Regional Offices of the Women's Bureau in operation. You can also let E. Mitchell Daniels, Jr., Director of the Office of Management and Budget, know how you feel about this. You can write a letter of your own or use one we've prepared for you.
If you find this information useful, be sure to forward this alert to your friends and colleagues and encourage them to sign up to receive Email Action Alerts from the National Women's Law Center at www.nwlc.org/email.
Thank you!
Book about menstruation published in Spain
The Spanish journalist who contributed some words for menstruation to this site last year and wrote about this museum (MUM) in the Madrid newspaper "El Pa�s" just co-authored with her daughter a book about menstruation (cover at left).
She writes, in part,
Dear Harry Finley,
As I told you, my daughter (Clara de Cominges) and I have written a book (called "El tab�") about menstruation, which is the first one to be published in Spain about that subject. The book - it talks about the MUM - is coming out at the end of March and I just said to the publisher, Editorial Planeta, to contact you and send you some pages from it and the cover as well. I'm sure that it will be interesting to you to have some information about the book that I hope has enough sense of humour to be understood anywhere. Thank you for your interest and help.
If you need anything else, please let me know.
Best wishes,
Margarita Rivi�re
Belen Lopez, the editor of nonfiction at Planeta, adds that "Margarita, more than 50 years old, and Clara, 20, expose their own experiences about menstruation with a sensational sense of humour." (publisher's site)
My guess is that Spaniards will regard the cover as risqu�, as many Americans would. And the book, too. But, let's celebrate!
I earlier mentioned that Procter & Gamble was trying to change attitudes in the Spanish-speaking Americas to get more women to use tampons, specifically Tampax - a hard sell.
Compare this cover with the box cover for the Canadian television video about menstruation, Under Wraps, and the second The Curse.
An American network is now developing a program about menstruation for a popular cable channel; some folks from the network visited me recently to borrow material.
And this museum lent historical tampons and ads for a television program in Spain last year.
Now, if I could only read Spanish! (I'm a former German teacher.)
Irregular menses identify women at high risk for polycystic ovary syndrome (PCOS), which exists in 6-10% of women of reproductive age. PCOS is a major cause of infertility and is linked to diabetes.
How Modess and the CLASSIEST
sanitary napkin ads began
Determine what kind of brain you have!
(The test helps explain why I started this museum.)
Too much hair: Hypertrichosis,
Hirsutism and Androgenic Manifestations in Women
Religi�n y menstruaci�n (Religion
and Menstruation page in Spanish; English
version)
Douching with
Lysol and Zonite: DON'T! -
See new Stop menstruation mail and new words, below.
Humor
SCROLL UP FOR THE NEWS AND LETTERS TO YOUR MUM