Archive for the ‘Menopause’ Category

February 20, 2008

Outrage Over FDA Crackdown on Biodentical Hormones? Not So Fast, says National Women’s Health Network

The Washington Post last week reported on an ad campaign protesting the FDA’s crackdown on pharmacies that manufacture and market biodentical hormones to treat symptoms of menopause. Sandra J. Boodman writes:

Last week the HOME (Hands Off My Estrogens!) Coalition, a group based in tiny Edinburg, Va., placed a full-page ad in five newspapers, including USA Today and the Wall Street Journal, accusing regulators of being hostile to “natural” hormonal medicines made according to a doctor’s prescription by a compounding pharmacy.

The ads urge women and their physicians to e-mail the White House and members of Congress asking them to protect patients’ access to medications they claim are “bio-identical” to those found in the body.

Hold the outrage. There is no scientific evidence that bioidentical hormones are safer than conventional hormone therapy drugs — and marketing claims that such drugs can restore youth and prevent or treat serious conditions such as cancer have long irked many in the medical community. As the Post story notes, “A key ingredient in these made-to-order drugs is estriol, a form of estrogen that the coalition claims is safe and protects against breast cancer — but that the FDA says is unapproved.”

Last month, the FDA sent letters to seven pharmacy operations that compound biodentical hormones, warning them that their claims about the safety and effectiveness of bioidentical hormone replacement therapy “are unsupported by medical evidence, and are considered false and misleading.”

While this upset the HOME Coalition, the National Women’s Health Network, along with physician groups such as the Endocrine Society, applauded the enforcement. The NWHN has long been concerned about the oversight of natural hormones — here’s a handy fact sheet on the subject — and two years ago the NWHN petitioned the FDA to stop companies from marketing estrogen-and-testosterone combination pills.

Marian Sadler of the NWHN critiques the Home ad over at Prescription Access Legislation. Sadler writes that the ad attempts to “make you feel that the HOME Coalition is looking out for women’s health and women’s rights, defending natural care from hostile attacks by drug companies and the FDA, and ‘speaking the truth,’” but it’s basically just a sales pitch for natural hormones. She continues:

Like hormones that are synthesized in a lab and sold by drug companies, natural hormones are powerful chemicals that affect many parts of the body. It is very important to understand that products are not necessarily safe just because they’re natural. The same questions we ask about drugs need to be answered for alternative therapies too.

Just as pharmaceutical companies promote drugs, there is a large industry that produces and sells alternative health care products. Whether they are recommended by a doctor, a nurse practitioner, a naturopath or the cashier at the health food store, women should be skeptical of products that claim they will extend life, reverse aging, restore youth or prevent disease without causing any adverse effects.

Plus: The “Our Bodies Ourselves: Menopause” features a section specifically on “Natural Products: Phytoestrogens and Bioidentical Hormones.”


January 13, 2008

Double Dose: A Modest Proposal for Pregnant Teens; C-Section Stats Under Review; Googling Your Health; New Info on Medicare and Health Insurance Coverage

A Modest Proposal: “Pregnant students in a Denver high school are asking for at least four weeks of maternity leave so they can heal, bond with their newborns and not be penalized with unexcused absences,” reports the Denver Post, which notes that Denver Public Schools has no districtwide policy, meaning it’s left up to schools to “to work out plans for students to continue their education.”

What that means is some schools have set a policy whereby girls who don’t show up for school the day after they give birth are charged with unexcused absences. Many of the comments on this story argue against “special treatment.”

Florida Considers Proposal to Teach “Abstinence Plus”: “The bill would still require that schools teach abstinence as ‘the only certain way to avoid pregnancy or sexually transmitted diseases,’” reports the AP. “But, the measure would require that starting in the 6th grade, sex education classes provide information about the health benefits and side effects of contraceptives.”

Iowa Gets Funding to Reduce Unintended Pregnancies: Former Iowa first lady Christie Vilsack launched a statewide project called “Iowa Initiative to Reduce Unintended Pregnancies” that will focus on women ages 18 to 30. “As a woman, as a teacher, as a mother, I believe we have a responsibility to give all women in our state the knowledge and the means to prevent unintended pregnancies,” she said. From the Des Moines Register:

Half of all pregnancies in Iowa in 2006 were unintended, Vilsack said, citing state Department of Public Health statistics. Of those, 14 percent ended in terminations, she said, citing Iowa Barriers to Prenatal Care Project statistics.

Iowa ranks 48th in the nation in making family planning services available and 39th in its public funding for those efforts. More than half of Iowa’s counties do not have family planning centers, Vilsack said.

C-Section Statistics Under Review: “In 2006, 31.1% of U.S. births were by C-section, a 50% increase over the previous decade,” notes USA Today in a story that examines the debate over safety of elective c-sections.

For more information, check out this earlier post on c-sections and the rise of maternal mortality, as well as Rachel’s post on c-section rates by hospital.

FDA Takes Action on Biodentical Hormones: “The Food and Drug Administration is cracking down on pharmacies that sell customized hormone mixtures as antidotes for menopause symptoms such as hot flashes, saying they are being promoted with false claims about their benefits and contain an ingredient the agency hadn’t approved,” reports the Wall St. Journal.

Here’s more from Well, where an interesting discussion follows, and the FDA press release.

Do You Google Your Health?: Rahul K. Parikh, M.D. doesn’t mind if you do and suggests websites that provide accurate, up-to-date medical information. Don’t forget Rachel’s great post on online health research — it includes questions to ask when evaluating the reliability of websites.

Medicare and Health Insurance Coverage: The Kaiser Family Foundation this week released a new issue brief providing an overview of Medicare’s financing and the fiscal challenges the program faces in the coming decades.

KFF also released two updated fact sheets that provide the most current information and data on health insurance coverage for women ages 18-64. The first, Women’s Health Insurance Coverage, provides new statistics on health coverage, describes the major sources of health insurance, summarizes the major policy challenges facing women in obtaining health coverage, and provides data on the more than 17 million women who are uninsured.

The second fact sheet, Health Insurance Coverage of Women by State, provides state-by-state data on the uninsured rate, as well as rates of private insurance and Medicaid coverage.


June 27, 2007

Good Bones: Prevention and Treatment for All Ages

Our Bodies Ourselves Executive Director Judy Norsigian and Managing Editor Heather Stephenson recently wrote about the potential side effects associated with some medications for post-menopausal osteoporosis, and they offered smart tips to help navigate the pharmaceutical hype.

Writing in the Washington Post, Nancy J. Nelson personalizes the challenge of determining one’s risk for bone fractures and making informed decisions about treatment options:

I share an anxiety with several women friends in their 50s and 60s. We’ve all been told that because our bone mineral density is low — though not low enough to meet the definition of the brittle-bone disease osteoporosis — we need to take medication to reduce our chance of fractures. This means primarily hormones or Fosamax, the top-selling osteoporosis drug, for which doctors wrote more than 20 million prescriptions last year, nearly $2 billion worth. Knowing the associated risks — heart disease, stroke and breast cancer for hormones; ulcers of the esophagus and stomach, and jaw decay for Fosamax — none of us is eager to follow our doctors’ orders. [...]

I also suspect my friends and I are a lot less at risk than someone in my parents’ generation. My mom and three of her pals have all fallen and had fractures; no one I know in my generation has done either.

My search of the scientific literature suggests we are right to be wary of over-medication.

Low bone density is only one of several well-established risk factors for bone fractures. Age and fracture history are just as important, according to Michael R. McClung, director of the Oregon Osteoporosis Center and a member of the council of scientific advisers for the International Osteoporosis Foundation. None of these factors alone is very good at predicting fracture risk. But some doctors don’t appear to have gotten the message.

“Many younger women whose bone density is borderline low are getting treated, although their risk of fracture in the next five to 10 years is fairly low,” said Nelson B. Watts, director of the University of Cincinnati Bone Health and Osteoporosis Center and chairman of the Food and Drug Administration’s Advisory Committee for Endocrine and Metabolic Drugs. “And many patients who have had fractures are not being evaluated or treated, even though their risk of a second fracture in the next five to 10 years is fairly high.”

Nelson reports on a new fracture-risk tool that may be published later this year by the World Health Organization. The tool, which will combine bone density with other risk factors, could end up altering osteoporosis treatment guidelines.

And it’s still important to remember the basics when it comes to good bone health: quitting smoking, limiting alcohol consumption to two drinks per day, exercising (particularly weight-bearing exercises like running or tennis) and making sure you get enough calcium and vitamin D.

Plus: It’s never too early to start educating girls about good bone health, note Newsweek columnists Barbara Kantrowitz and Pat Wingert:

Getting that message across is the focus of a new public service educational campaign sponsored by the American Academy of Orthopedic Surgeons (AAOS) and the National Institute for Child Health and Human Development (NICHD). The campaign ads feature a young girl with the headline “Almost Past Her Prime.” “This is a prevention campaign,” says Dr. James H. Beaty, AAOS president and a pediatric orthopedic surgeon at the Campbell Clinic in Memphis. “We’re trying to prevent future problems rather than treat them when the kids become adults.”


December 16, 2006

Friday Double Dose on Saturday: Breast Cancer Drop, New Military Health Clinic and Healthiest Places for Women to Live

Breast Cancer Drop Linked to HRT: Rates of the most common form of breast cancer dropped15 percent from August 2002 to December 2003, while rates for all breast cancer dropped by 7 percent, according to researchers. “The reason, they believe, may be because during that time, millions of women abandoned hormone treatment for the symptoms of menopause after a large national study concluded that the hormones slightly increased breast cancer risk,” reports The New York Times.

See also: the National Cancer Institute website about menopausal hormone use and the Women’s Health Initiative study, which included nearly 17,000 women. It was halted prematurely when slight increases in breast cancer, heart attacks, blood clots and strokes were discovered.

Replacing One Male-Dominated Culture With Another: “The United States military has long prided itself on molding raw recruits into hardened soldiers. Perhaps none have undergone a transformation quite like that of Ms. Hamdan,” writes Andrea Elliott in The New York Times. Fadwa Hamdan’s story is nothing short of remarkable:

Forbidden by her husband to work, she raised five children behind the drawn curtains of their home in Saudi Arabia. She was not allowed to drive. On the rare occasions when she set foot outside, she wore a full-face veil.

Then her world unraveled. Separated from her husband, who had taken a second wife, and torn from her children, she moved to Queens to start over. Struggling to survive on her own, she answered a recruiting advertisement for the Army and enlisted in May.

Ms. Hamdan’s passage through the military is a remarkable act of reinvention. It required courage and sacrifice. She had to remove her hijab, a sacred symbol of the faith she holds deeply. She had to embrace, at the age of 39, an arduous and unfamiliar life.

Continue reading the story here.

Military Opens Women’s Health Clinic: The U.S. military has opened a new women’s health clinic on a military site in Germany, and it’s the first of its kind, reports Stars & Stripes.

“Although women’s health clinics are fairly common at civilian hospitals, the concept is relatively new in the military,” writes Scott Schonauer. “The new building will have nine exam rooms decorated with the type of color and style not often seen at most drab hospital wards. Exam tables will an extra feature: They’ll be heated. The center also will include a sex-assault suite that will offer 24-hour care for victims. The room will be stocked with testing kits and provide a more comfortable alternative to going to the emergency room.”

Still, U.S. law prohibits military facilities from performing abortions, even when privately funded to avoid using taxpayer funds. Such regulations put the health of women serving overseas at risk every day.

Hospitals in Violation: “Some Massachusetts facilities violate the year-old state law requiring hospitals to offer emergency contraception to rape victims by imposing “serious restrictions” on the treatment, according to a survey by NARAL Pro-Choice Massachusetts,” reports the Boston Globe. According to the survey, “officials at 7 percent of the hospitals with emergency rooms contend the provision for emergency contraception may be left to the doctor’s discretion. Another 7 percent indicated that such provisions were contingent upon the woman undergoing a rape exam.”

Male Circumcision Cuts HIV Transmission: News that men who are circumcised are about 50 percent less likely to contract HIV, based on studies in Uganda and Kenya, sparked this response from Broadsheet’s Tracy Clark-Flory, who looks at arguments for and against circumcision. See also Carol Lloyd’s post on female infanticide in India.

The Skinny on Thin: Jessica Clark of In These Times on “Thin,” a documentary by Lauren Greenfield about patients at a residential center for eating disorders. “[The recovery] process can be circuitous and frustrating, with many false starts,” writes Clark. “Anorexia is the most deadly mental disorder; up to 20 percent of sufferers die from related complications. Some even court it: ‘I just want to be thin,’ says Alisa ‘If it takes dying to get there, so be it.’”

Suspected Prostitutes Paraded Through City Streets in China: “For people who saw the event on television earlier this month, the scene was like a chilling blast from a past that is 30 years distant: social outcasts and supposed criminals — in this case 100 or so prostitutes and a few pimps — paraded in front of a jeering crowd, their names revealed, and then driven away to jail without trial,” reports The New York Times. But the public effect wasn’t what officials hoped for, and an “angry nationwide backlash” has ensued.

Healthiest Places for Women: What do Honolulu, Portland, Maine; Nassau-Suffolk counties in New York; Orange County, Calif.; and Burlington, Vt. have in common? They’re the healthiest cities for women, according to Self magazine. Honolulu came in at no. 1. (Having lived in Burlington, I’m up for a site-test challenge.)


October 11, 2006

A Quiz from Our Bodies Ourselves

If you’re procrastinating working by blog surfing, stay an extra minute and test your menopause knowledge … Answers follow below, but no cheating!


September 18, 2006

Popular Drug to Treat Menopause Symptoms Lacks Approval

“In the first half of 2006, women in the USA spent nearly $90 million on unapproved estrogen-plus-testosterone pills, says IMS Health, a pharmaceutical information company. Estratest, made by Solvay Pharmaceuticals, represented 75% of the market,” writes Rita Rubin in USA Today.

Would it surprise you to learn that Estratest, a combination of estrogen and testosterone, has never received FDA approval?

Last month, the National Women’s Health Network petitioned the FDA to stop marketing estrogen-and-testosterone combination pills such as Estratest and Syntest (a generic version of the same drug). From the NWHN’s Aug. 28 health alert:

Both products carry a label indicating that they should be used for treatment of moderate to severe vasomotor symptoms, such as hot flashes, that don’t respond to estrogen alone. But the NWHN has filed a citizen’s petition with the FDA demanding that it stop the manufacturers from marketing these products due to lack of evidence of effectiveness and concerns about serious health risks to women.

“This is an outrageous example of drug companies manipulating the FDA regulatory process for their own benefit at the expense of women’s health,” says Cynthia Pearson, NWHN Executive Director. “The FDA determined several years ago that there’s no evidence that combination estrogen/testosterone products are effective for this use, yet Estratest still remains on the market years later.”

[...] The NWHN is not just concerned about the use of a product that hasn’t been proven to work; it also points out that there’s evidence that estrogen/testosterone combinations may pose a serious threat to women’s health. Recent findings from the Nurses’ Health Study show that Estratest significantly increases a woman’s risk for invasive breast cancer. [1] In addition, there are other serious health risks associated with testosterone use by women, and an FDA advisory committee recommended against approval of a testosterone product for women in 2004 due in part to concerns about the safety of long-term exposure to testosterone.

The NWNH’s citizen petition on Estratest and Syntest is available here (PDF). The footnote cited above refers to a study published in July in the Archives of Internal Medicine: Combined Estrogen and Testosterone Use and Risk of Breast Cancer in Postmenopausal Women.

According to USA Today, Solvay spokesman Neil Hirsch sent an e-mail to the newspaper in which he stated the company “stands behind the safety and efficacy of Estratest brand products. After more than 40 years of patient use and 39-plus million prescriptions written for the product, Estratest continues to serve as an important therapeutic alternative.”

Rubin adds, “Yet, in April 2003, the FDA stated in the Federal Register that it no longer believed there was ‘substantial evidence’ of the hormone combination’s effectiveness. The FDA invited manufacturers to ask for a hearing if they disagreed. Solvay and Breckenridge, maker of Syntest, quickly did so. The hearing has yet to be held, so the makers can keep selling their products.”