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  • 2
    days
    ago

    Court strikes down Arizona 20-week abortion ban

    By Paul Elias, The Associated Press

    SAN FRANCISCO -- A federal court in San Francisco Tuesday struck down Arizona's ban on abortions after 20 weeks of pregnancy.

    The 9th U.S. Circuit Court of Appeals ruled that the law violates a string of U.S. Supreme Court rulings starting with Roe v. Wade that guarantees a woman's right to an abortion before a fetus is able to survive outside the womb. That's generally considered to be about 24 weeks. Normal pregnancies run about 40 weeks

    Several states have enacted similar bans starting at 20 weeks. But the 9th Circuit's ruling is binding only in the nine Western states under the court's jurisdiction. Idaho is the only other state in the region covered by the 9th Circuit with a similar ban.

    A trial judge had ruled that the ban could take effect. U.S. District Judge James Teilborg ruled it was constitutional, partly because of concerns about the health of women and possible pain for fetuses.

    But abortion-rights groups appealed that decision, saying the 20-week ban would not give some women time to carefully decide whether to abort problem pregnancies.

    The ban included an exception for medical emergencies.

     

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  • 5
    days
    ago

    'Why would we wait?': 3 sisters face Jolie's cancer dilemma

    John Makely / NBC News

    Sisters Cathy Balsamo, left, Patti Broccoli, center, and Cindy Lepore, right, have all tested positive for the BRCA1 genetic mutation that raises the risk of breast and ovarian cancer. All three sisters have had preventive surgery to have their breasts and ovaries removed. Two weeks after her surgery, Broccoli was diagnosed with breast cancer.

    By JoNel Aleccia, Senior Writer, NBC News

    Actress Angelina Jolie’s revelation this week that she’d had both breasts removed to lower her elevated risk of cancer came as a bombshell to many -- but not to three sisters from Berkeley Heights, N.J.

    The women -- Cathy Balsamo, Cindy Lepore and Patti Broccoli -- have spent most of the past year grappling with the very dilemma that Jolie faced: What to do when a genetic mutation means you’ve got a sky-high chance of breast or ovarian cancer?

    “Rich, poor, famous, not famous -- it’s the same decision,” said Balsamo, 46, who was the first to learn last spring that she had a mutation of the BRCA1 gene, which boosts the risk of both kinds of cancer.

    “It doesn’t make it easier or harder.”

    The family -- which includes the three sisters and a brother, Joseph Zichichi, 48 -- offers an extreme example of the issues now illuminated by Jolie’s spotlight. 

    Like Jolie, all three women opted for preventive double mastectomies. Unlike Jolie, who’s 37, the 40-something sisters also all had concurrent operations to remove their ovaries. Jolie wrote in the New York Times that she plans to have that surgery later.

    “The option of waiting and watching was never an option,” said Broccoli, a 49-year-old nurse. “Why would we wait for cancer?”

    Though their mother, Patricia Zichichi, had always warned of a family history rife with cancer -- a grandmother and two great-aunts died young of what was then called “women’s cancer” -- the sisters didn’t know about their actual genetic risk until Balsamo asked her doctor to perform the BRCA test in April 2012.

    “He was just so upset and said ‘I hate to have to tell you this,’” recalled Balsamo, who is an activity director at a nursing home. “Immediately, when he said BRCA1, breast and ovarian, I said, ‘I’m getting a double mastectomy and a hysterectomy.”

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    Within weeks, her sisters had the same test -- with the same results. It’s not surprising that all three women would turn up positive for BRCA mutations, said Dr. Larissa Korde, a breast cancer specialist at the Seattle Cancer Care Alliance in Washington. If one parent carries the defective gene, there’s 50 percent chance any child will get it.

    “Sometimes you see it in families where everybody’s got it,” Korde said. “It’s just chance.”

    A woman with a harmful BRCA1 or BRCA2 mutation has a 60 percent chance of developing breast cancer during her lifetime, about five times higher than the overall rate of 12 percent, cancer experts say. She has a 15 percent to 40 percent lifetime chance of getting ovarian cancer, compared with about 1.4 percent in the general population.

    With those odds, the sisters opted for surgery within months of each other. Lepore, 42, a respiratory therapist who has type 1 diabetes, had her initial and reconstruction surgeries last October. Broccoli had her surgery in January and Balsamo followed in February.

    Ironically, Broccoli’s preventive surgery actually may have saved her life. Two weeks after her double mastectomy in January, she was diagnosed with breast cancer -- but at such an early stage her chance of cure is very good. A mammogram and two MRIs before surgery had suggested strongly she was cancer-free, but doctors detected ductal disease after Broccoli's operation. 

    “I consider it a blessing,” said Broccoli, who lost her hair to three rounds of chemotherapy. “I know what could have happened if it hadn’t been caught early.”

    Rates of women opting for preventive mastectomies have risen by as much as 50 percent in recent years, cancer experts estimate. That's despite the small chance of getting cancer anyway, the risk of major surgery and the fact that there are alternatives, including drugs and careful monitoring. 

    Still, some women who learn of BRCA mutations are devastated by the information -- and by the dilemma of whether to have surgery, Korde said. “I’ve definitely had women who were through childbearing and who feel emotionally conflicted about losing their breasts.”

    But the New Jersey sisters aren’t among them. “For me, it was a no-brainer,” Balsamo said. “The good of it outweighed the bad. So I don’t have terrific boobs. I’ll never have nipples. I didn’t have that emotional thing.”

    John Makely / NBC News

    The sisters all live within a mile of each other in Berkeley Heights, N.J. They say they've supported each other through the ordeal.

    What does make them emotional, the sisters said, is what the genetic legacy might mean for the rest of the family. Joe Zichichi is scheduled to be tested for BRCA mutations soon, too, the women said.

    The results could have implications for him in the form of an increased risk of pancreatic, prostate or other cancers, doctors say.

    “There’s more to BRCA genes than breast and ovary cancer,” said Dr. Eileen O’Reilly, a gastrointestinal cancer specialist at Memorial Sloan Kettering Cancer Center in New York. “As much as 5 percent of pancreatic cancer risk might be related to BRCA mutations.”

    But the family is especially concerned about possible future effects on their children. They all live within a mile of each other; there are 13 grandchildren in the family, including Joe Zichichi’s four daughters.

    Two of the granddaughters are in their early 20s. The U.S. Preventive Services Task Force recommends BRCA testing only for women with a strong family history of cancer, about 2 percent of all women in the U.S. But for those with that high risk, testing can be done at age 25.

    Whether such young women choose to be tested -- and what action they’ll take afterward -- is something serious to ponder, the sisters said. 

    “We have a good four years to figure this out,” said Balsamo. “God willing there will be something in that period of time that helps our daughters deal with it.”

    It’s not clear when Jolie learned of her genetic risk or how long it took to decide that surgery was the best option. Her decision has prompted a flood of calls and inquiries to cancer centers nationwide, including Korde’s, and to geneticists, said Dr. Michael Watson, executive director of the American College of Medical Genetics and Genomics.

    The New Jersey sisters said they’re grateful for the awareness that Jolie’s decision brings to an issue that has become central to their daily lives.

    “I was actually very happy,” said Lepore. “In this world, it takes someone like Angelina Jolie to get recognition of important things.”

    What choice would you make if you had a BRCA mutation, dramatically raising your cancer risk? Talk about it on Facebook.

    Related stories: 

    • More women opting for preventive mastectomy -- but should they be?
    • Angelina Jolie: I had a double mastectomy because of high breast cancer risk
    • Doctors detail Angelina Jolie's breast cancer surgery
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  • 6
    days
    ago

    New IVF method uses time-lapse snapshots to boost live births

    The EmbryoScope is helping doctors best determine which embryos offer the best chance at becoming healthy babies, and new research indicates this process could raise live birthrates by 50 percent or more. NBC's Dr. Nancy Snyderman reports.

     

    By Kate Kelland, Reuters

    LONDON -- British fertility experts have devised a new IVF technique that takes thousands of snapshots of a developing embryo that they say can help doctors pick those most likely to implant successfully and develop into healthy babies.

    At a briefing in London before publishing their results, the researchers said they are already using the technique to select "low risk" embryos that are the least likely to have chromosomal abnormalities that could hamper their development.

    In their study, published in the journal Reproductive BioMedicine Online, the team's chances of producing a successful live birth after in-vitro fertilization (IVF) were increased by 56 percent using the new technique compared to the standard method of selecting embryos that look best through a microscope.

    "In the 35 years I have been in this field, this is probably the most exciting and significant development that can be of value to all patients seeking IVF," said Simon Fishel, a leading fertility doctor and director at the IVF clinic operator CARE Fertility where the technique is being developed.

    Independent scientists not involved in the work welcomed it as a significant advance but said full randomized controlled trials - the gold standard in medicine - should be conducted before it is adopted as mainstream practice.

    "This paper is interesting because we really do need to make advances in selecting the best embryos created during IVF," said Allan Pacey of Sheffield University, chair of the British Fertility Society.

    "The idea of monitoring embryo development more closely is being used increasingly in clinics around the world and so it is good to see the science involved submitted to peer review and publication," he added. "All too often, developments in IVF are trumpeted as advances when they remain unproven."

    Experts say that today, as many as 1 to 2 percent of babies in the Western world are conceived through IVF. The standard methods of selecting embryos are based largely on what they look like through a microscope, and many IVF cycles fail because the embryo chosen and transferred to the womb fails to develop.

    The scientists who led this study said that using time-lapse images, they had found that developmental delays in the embryo at crucial stages are good indicators of likely chromosomal abnormalities that could result in a failed pregnancy.

    "In conventional IVF laboratories, embryo development will be checked up to six times over a 5-day period," said Alison Campbell, Care Fertility's embryology director and the lead researcher on the study being published.

    "With time-lapse we have the ability to view more than 5,000 images over the same time period to observe and measure more closely each stage of division and growth."

    Using this new knowledge, the team developed what they call morphokinetic algorithms to predict success (MAPS). By applying these MAPS to the selection of embryos, they predict they could reach a live birth rate for patients undergoing IVF of 78 percent - about three times the national average.

    Fishel, whose CARE Fertility clinics are Britain's largest independent provider of assisted conception cycles, with around 3,500 a year, said he is charging around 750 pounds ($1,100) for IVF using the MAPS technique - compared to several thousand pounds for a standard IVF cycle.

    But Sue Avery, head of the Women's Fertility Centre in Birmingham, said it was too soon for all clinics to adopt it.

    "Until the new technique is compared to current practice we cannot know whether different embryos are being chosen," she said. "The IVF community needs a prospective randomized controlled trial to prove that the new approach delivers better results before it can be recommended to patients."

    Copyright 2013 Thomson Reuters. Click for restrictions.

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  • 6
    May
    2013
    2:17pm, EDT

    FDA warns pregnant women of migraine drug risk

    By AP staff

    WASHINGTON - U.S. health regulators are warning doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant.

    The Food and Drug Administration says the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches.

    The pills, which contain valproate sodium, already carry a warning about the risk of birth defects. But the FDA said it is adding new warnings to the drugs' labeling after a study showed they decreased IQ scores in children whose mothers took them while pregnant.

    Depakote and similar drugs are also used to treat bipolar disorder and seizures. The FDA said pregnant women should only take the drugs for those uses as a last resort. 

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  • 29
    Apr
    2013
    7:50pm, EDT

    Estrogen-blocking drugs may lower breast cancer risk

    By Karen Rowan, MyHealthNewsDaily

    Drugs that block estrogen may lower women's risk of breast cancer for 10 years, according to a new review of studies.

    Postmenopausal women in the studies who took drugs called selective estrogen receptor modulators (SERMs), such as tamoxifen, were 38 percent less likely to develop any type of breast cancer over a 10-year period, compared with women who weren’t taking SERMs. The studies also involved the SERMs raloxifene, arzoxifene and lasofoxifene.

    The review shows that "each of these drugs will prevent breast cancer in populations of women," said Dr. V. Craig Jordan, scientific director of oncology at the Lombardi Comprehensive Cancer Center at Georgetown University.

    The review "places into perspective the 40-year journey" of SERM research, said Jordan, whose studies in the 1970s showed that tamoxifen prevented mammary cancer in rats. He was not involved in the new study.

    Only tamoxifen and raloxifene are approved by the Food and Drug Administration for the prevention of breast cancer, and only tamoxifen is approved for use in premenopausal women who are at high risk for breast cancer. The other drugs in the studies are currently being studied as treatments for osteoporosis, but they also lower the risk of breast cancer, Jordan said.

    The drugs come with side effects that have made women reluctant to take them, he said. The common side effects are similar to symptoms of menopause, including hot flashes and vaginal dryness.

    "There is the belief that the gains do not exceed the discomfort," Jordan said. "I think it is now time for women to seriously consider taking advantage" of the drugs' effects. Women should talk with their doctors about their options, he noted.

    In the new review, researchers looked at nine studies involving more than 83,000 women. Eight of the studies compared taking a SERM with taking a placebo, while one study compared raloxifene to tamoxifen.

    Researchers found that 4.2 percent of women taking a SERM developed breast cancer, while 6.3 percent of women in the control groups developed breast cancer.

    The reduction in risk was primarily seen with estrogen-receptor positive breast cancers, which are fueled by estrogen, according to the study.

    Jordan said that in one "pivotal" trial included in the review, researchers found that both raloxifene and tamoxifen reduced women's risk of breast cancer by 50 percent while they were taking the drugs, but only the women who took tamoxifen continued to see a reduced risk after they stopped taking the drug.

    The new study also showed that only tamoxifen reduced the risk of ductal carcinoma in situ, a precancerous condition. "The other ones don't tend to do that. One of the mysteries has been why only tamoxifen really reduces DCS. "We still don’t know why," Jordan said.

    The more serious side but less common effects of SERMs include an increased of endometrial cancer, or cancer of the uterine lining. Among women in the studies, endometrial cancer was indeed more common in those taking SERMs, although a small number — 168 women — in the studies developed endometrial cancer.

    The drugs also increase the risk deep-vein thrombosis.

    The study did not look at whether the drugs might help women live longer. To get data on mortality rates, more time is needed, Jordan said. The drugs have not been used for long enough for an effect on mortality rates to be seen.

    The study is published online Tuesday (April 30) in the journal Lancet. 

    More from MyHealthNewsDaily:

    • 5 Key Nutrients Women Need As They Age
    • 6 Things Women Can Do to Lower Breast Cancer Risk
    • 7 Cancers You Can Ward Off with Exercise 

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  • 9
    Apr
    2013
    4:50pm, EDT

    IUDs are safe, effective for teens, study finds

    By Genevra Pittman, Reuters

    NEW YORK - Intrauterine devices are safe for teenagers, according to a new analysis of more than 90,000 women who used the long-term contraceptives. 

    Researchers found less than 1 percent of all women developed serious complications from the devices, such as pelvic inflammatory disease, regardless of their age.

    And teens were only slightly more likely than older women to lose their periods or become pregnant while using an intrauterine device (IUD), according to findings published in Obstetrics & Gynecology.

    "It shows exactly what many of us have thought all along, that IUDs are great options for teens," said James Trussell, who studies birth control methods at Princeton University in New Jersey.

    IUDs include the hormone-releasing Mirena, which can prevent pregnancy for five years, and a copper version, sold as ParaGard, which is effective for 10 years. The devices cost a few hundred dollars each, not including doctors' charges for inserting them.

    Evidence has been mounting that new IUDs are safe and effective in preventing pregnancy. But some doctors have been difficult to convince since an older and badly-designed version of the IUD, the Dalkon Shield, caused serious infections and even deaths in the 1970s.

    In guidelines published last year, the American College of Obstetricians and Gynecologists said IUDs and contraceptive implants should now be considered one of the best birth control options for teens because they are reliable and reversible (see Reuters Health story of September 24, 2012 here:).

    To get more evidence on how they work, researchers led by Dr. Abbey Berenson from the University of Texas Medical Branch in Galveston used private health insurance claims to study 90,489 women, age 15 to 44, who had an IUD inserted between 2002 and 2009.

    Between 2 and 6 percent of women reported pain during menstruation or absence of periods while using an IUD. Both symptoms were 30 to 40 percent more common among teens than older women.

    Teenagers were also more likely to become pregnant while using an IUD, but both younger and older women had similar rates of stopping IUD use - between 11 and 13 percent. And serious complications were rare across the board, Berenson and her colleagues found.

    "The very serious concerns that physicians had with the older IUDs just really are not appearing to be concerns with the newer IUDs," Berenson told Reuters Health.

    The hormone-releasing IUD was tied to fewer complications and discontinuations than the copper version, her team found.

    Trussell said the slight increase in side effects among teens wasn't concerning. Some, such as not having periods, might actually be seen as a good thing among young women and save them money on products like tampons, he pointed out.

    He said he would recommend an IUD to any sexually-active teenager.

    "The point is that it's just so very, very effective," Trussell, who was not involved in the new research, told Reuters Health.

    "Either that or the implant would make excellent options for teens who don't want to get pregnant."

    Berenson said young women who are interested in IUDs should discuss the possible side effects with their doctors.

    She said the best candidates are teens who want a long-acting form of contraception and are not at high risk of sexually transmitted infections.

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  • 5
    Apr
    2013
    8:47am, EDT

    Judge: Make 'morning-after pill' available to all girls without prescription

    A federal judge ruled that the Plan B emergency contraception products must be made available for purchase over the counter without any age restrictions. NBC's Stephanie Gosk reports.

    By JoNel Aleccia, Senior Writer, NBC News

    A federal judge on Friday reversed a contentious Food and Drug Administration ruling and ordered the agency to make the so-called "morning-after pill" available without a prescription to all girls of reproductive age, including those younger than 17.

    The ruling by U.S. District Judge Edward Korman in Brooklyn, New York, comes in a lawsuit brought by reproductive-rights groups that had sought to remove age and other restrictions on emergency contraception.

    Currently, only women aged 17 and or older can obtain emergency contraception without a prescription. For those women, the medication is available only at health clinics or pharmacies and they're required to show identification to obtain it.

    The rule requiring girls younger than 17 to obtain a doctor's prescription was confirmed in December 2011, when Health and Human Services Secretary Kathleen Sebelius overruled an FDA recommendation -- and Commissioner Margaret Hamburg -- to force the agency to limit access to emergency contraception for young girls.

    In her decision, Sebelius said she wasn't convinced that drug makers had proven that access should be broadened and she expressed concern that girls who reached reproductive maturity at ages as young as 11 could have access to the medication. 

    At the time, that decision drew intense criticism from medical and women's rights groups, who said that denying access defied strong scientific data that showed that emergency contraception is safe and effective for girls and women of all ages. Sebelius' action was widely seen as a move to protect President Barack Obama's administration from the appearance of encouraging sexual activity in such young girls.

    Korman said the FDA's rejection of requests to remove age restrictions to obtain the pill had been "arbitrary, capricious and unreasonable." The 59-page ruling says that Sebelius' actions were "politically motivated, scientifically unjustified and contrary to agency precedent."

    The ruling orders the FDA to make levonorgestrel-based emergency contraception available without age or so-called "point of sale" restrictions within 30 days. It appears to apply to all brands of the morning-after pill, although Korman gave FDA the option of limiting the expanded access to the Plan B One-Step single-pill product if the agency "actually believes there is any significant difference between the one- and two-pill products."

    Nancy Northup, president of the Center for Reproductive Rights, hailed the ruling. "Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception," she said.

    The group was among those that brought the lawsuit, the culmination of more than a decade of political and legal wrangling. 

    "Today's court order has swept away all the FDA stalling, all the interference and all the gamesmanship," Northup told reporters in a conference call. 

    Anti-abortion activists reacted swiftly to the ruling, saying it provided access for vulnerable young girls to drugs that the groups believe induce abortions.

    “Teen girls need parents, not unfettered access to abortion-inducing drugs,” said Marjorie Dannenfelser, president of the Susan B. Anthony List. “Judge Korman’s decision is reckless and denies girls the protection that comes along with the involvement of parents and doctors."

    The U.S. Conference of Catholic Bishops also opposed the change, saying the court acted "irresponsibly" by making powerful hormonal drugs available without prescription to minors. 

    "Plan B does not prevent or treat any disease, but makes young adolescent girls more available to sexual predators," said Deirdre McQuade, spokeswoman for the conference, in a statement. "The court's action undermines parents' ability to protect their daughters from such exploitation and from the adverse effects of the drug itself." 

    A new ruling from a federal judge is ordering that the morning-after pill be available for over-the-counter purchases to girls of all ages, not just to those over the age of 17, as previously ruled.

    Meanwhile, news of the ruling was applauded by a range of medical, women's rights and reproductive rights groups. 

    Dr. Cora Collette Breuner, a Seattle pediatrician and professor of adolescent medicine, said the American Academy of Pediatrics regards the ruling as a victory of science over politics.

    "Finally, my children and their children will have access to a product they didn't have before," she said. 

    Cecile Richards, president of the Planned Parenthood Federation of America, also praised the move. 

    “Lifting the age restrictions on over-the-counter emergency contraception is a significant and long-overdue step forward for women’s health that will benefit women of all ages," she said in a statement. 

    The ruling would particularly benefit immigrant women by removing requirements to show identification to buy the drugs, and also by making them available in a wide range of settings, advocates said.

    "It's getting EC right on the store shelves, right next to the condoms and the cough medicines, where it belongs," said Kimberly Inez McGuire of the National Latina Institute for Reproductive Health.

    FDA spokeswoman Erica Jefferson declined to comment on the ruling, saying it was an ongoing legal matter.

    It wasn't immediately clear if the U.S. Department of Justice would appeal the judge's ruling. Allison Price, a department spokeswoman, told NBC News the agency was reviewing the opinion.

    In the past, druggists and store owners who regarded the morning-after pill as a form of abortion had refused to dispense or sell the products. It's not yet clear whether some stores would refuse to stock the drugs, or whether they would keep them behind locked counters to dissuade shoplifting. The drugs typically sell for about $50 a package. 

    Emergency contraception uses high doses of the same hormones used in birth control to prevent pregnancy when taken within 72 hours of unprotected sexual intercourse. Taken in one- or two-pill doses, the product can prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg into the lining of the uterus. It does not cause miscarriages or abortions and would have no effect if a woman were already pregnant, medical experts say. 

    Related: 

    • Plan B won't be available OTC to younger teens, HHS says
    • Bioethicist: It's high time for 'morning-after pill' ruling

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  • 12
    Mar
    2013
    3:31pm, EDT

    233 million women may need contraception by 2015

    By Tanya Lewis, LiveScience

    More women are using birth control worldwide, but an unmet need for contraception persists, a new study shows.

    Researchers estimated the contraceptive use and unmet contraceptive need among married or cohabiting women of reproductive age for 194 countries between 1990 and 2010. The researchers defined an unmet need as the proportion of women who would like to delay or stop childbearing but who are not using any method of contraception to prevent pregnancy.

    Global use of contraceptives by these women increased from 55 percent to 63 percent over the period from 1990 to 2010, while unmet need decreased from 15 percent to 12 percent, the results showed. Despite this, the researchers project that 233 million women will have an unmet need for modern birth control by 2015.

    "The changes over time that we see — in terms of increases in contraceptive prevalence and reductions in need — are in the right direction," study leader Ann Biddlecom, a fertility and family planning researcher in the United Nations Department for Economic and Social Affairs, told LiveScience. "But there are still parts of the world where there remains a high level of unmet need for family planning."

    The biggest surge in contraceptive use between 1990 and 2010 occurred in southern Asia and eastern, northern and southern Africa. Birth control usage was also high in developed countries, but decreased slightly in Western Europe, Australia and New Zealand.

    Other areas showed a very low rate of contraceptive use. In central and western Africa fewer than 1 in 5 married women of reproductive age used any kind of birth control as of 2010.

    The study shows the discrepancies of access to contraception in different subregions of Africa, Biddlecom said. Eastern and central Africa had similar rates of contraceptive use in 1990, but by 2010, the rate of use had grown twice as much in eastern Africa.

    Most of the rise was in modern methods of contraception (such as condoms or hormonal forms of birth control), as opposed to traditional methods such as withdrawal before ejaculation or the rhythm method. Worldwide, 9 out of 10 married women using birth control were using a modern form in 2010. [ Birth Control Quiz: Test Your Contraception Knowledge ]

    As contraceptive use has grown, the unmet need for family planning has fallen. Even so, about 146 million married women of reproductive age still had unmet need for birth control in 2010, the researchers estimated, or 221 million women if those using traditional methods are included. More than 20 percent of married women in eastern, central and western Africa had an unmet need for family planning in 2010.

    "Things have gotten somewhat better, but the reality is we have a ways to go," obstetrician/gynecologist Ronald Burkman of Tufts University School of Medicine, who was not involved in the study, told LiveScience.

    Where there were gaps in the data on contraceptive use, the researchers used data from nearby countries to model the missing information. The study only looked at married or cohabiting women, but unmarried women tend to have even higher contraceptive needs, according to the researchers. In order to meet the worldwide need for contraceptive methods, increased investment will be necessary, they say.

    The findings were detailed today (March 11) in the journal The Lancet.

    More from LiveScience:

    • 7 Surprising Facts about The Pill
    • The Sex Quiz: Myths, Taboos and Bizarre Facts
    • 5 Myths About Fertility Treatments 

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  • 5
    Mar
    2013
    3:50pm, EST

    FDA panel warns of cancer risk from osteoporosis drug

    By AP staff
    WASHINGTON - A panel of federal health experts says a long-established bone strengthening drug should no longer be used by women because there is little evidence it works and it may actually increase the risk of cancer.

    The Food and Drug Administration panel voted 12-9 that the risks of the inhalable osteoporosis drug outweigh its benefits for postmenopausal women with brittle bones.

    The drug, known chemically as calcitonin salmon, has been prescribed for osteoporosis in postmenopausal women since the 1980s. Currently the drug is sold in nasal spray form by Novartis and Upsher-Smith.

    But the health authorities around the world have been reviewing the drug's safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. 

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  • 1
    Mar
    2013
    11:04am, EST

    FDA warns of cancer risk from osteoporosis drug ingredient

    By Toni Clarke, Reuters

    Staff reviewers for the U.S. Food and Drug Administration said that a potential increased risk of cancer with drugs containing calcitonin salmon appears plausible.

    In briefing documents released on Friday, the reviewers said the risk raises concerns about the overall risk versus benefit of calcitonin products to treat osteoporosis in postmenopausal women.

    Calcitonin products include Novartis AG's Miacalcin injection and nasal spray and Unigene Laboratories Inc's nasal spray. Privately held Upsher Smith Laboratories Inc. distributes Unigene's product in the United States. Generic calcitonin products are also available.
    Calcitonin salmon is a man-made version of the hormone calcitonin that is found in salmon.

    The reviewers said significant questions remain about calcitonin salmon's effectiveness in reducing fractures in the treatment of postmenopausal osteoporosis.

    An advisory panel to the FDA is scheduled to discuss the products on March 5 and will make a recommendation to the agency on whether to allow the continued marketing of these products for that use.

    Last July European regulators recommended that long-term use of calcitonin be curtailed after a review found evidence of a small increased risk of cancer with long-term use of the drugs.

    They recommended that they should only be authorized for short-term use in Paget's disease, a bone disorder; for acute bone loss due to sudden immobilization; and for excess calcium in the blood caused by cancer. They ruled that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.

    Unigene officials declined to comment on the FDA staff review as they do not distribute a calcitonin product in the United States. Upsher Smith officials were not immediately available for comment. Novartis said in a statement that it "places the highest priority on patient safety and the appropriate use of its medicines and is looking forward to the opportunity to engage in the discussion at the upcoming meeting."

    Related:

    Vitamin D may not protect older women's bones
    Even a drink a day may boost cancer risk
    Lung cancer death risk rising in women smokers

    Copyright 2013 Thomson Reuters. Click for restrictions.

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  • 26
    Feb
    2013
    2:30pm, EST

    FDA approves drug for painful sex in women

    By Reuters

    WASHINGTON - U.S. health regulators said on Tuesday they have approved a drug made by Japan's Shionogi & Co to treat women experiencing pain during sexual intercourse. 

    The U.S. Food and Drug Administration approved the drug, Osphena, for a type of pain known as dyspareunia, which is a symptom of vulvar and vaginal atrophy due to menopause.

    Dyspareunia is associated with declining levels of estrogen hormones during menopause. Osphena, known chemically as ospemifene, is a pill that acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in pain associated with intercourse.

    The drug's label includes a boxed warning, the most severe available, alerting patients to an increased risk of strokes and deep vein thrombosis. Common side effects include hot flashes, vaginal discharge, muscle spasms and excessive sweating.  

     

     

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  • 25
    Feb
    2013
    6:24pm, EST

    Vitamin D, calcium may not curb older women's risk for broken bones

    By Andrew M. Seaman, Reuters

    NEW YORK - Older women shouldn't take vitamin D and calcium supplements to prevent broken bones, and there's not enough evidence to say whether it would help anyone else either, says a U.S. government-backed panel.

    Based on two reviews of past research, the U.S. Preventive Services Task Force waded into the debate over the two vitamins that are thought to strengthen bones to prevent against breaks.

    "Calcium and vitamin D are important in general health and bone health. For this recommendation, we review data on whether supplements of vitamin D and calcium can prevent fractures in addition to dietary intake," said Dr. Jessica Herzstein, a member of the Task Force.

    Approximately 1.5 million Americans suffer from breaks that are tied to brittle bones each year. And about half of all women over 50 years old will end up with a break that's linked to the bone-weakening disease osteoporosis.

    That's a major concern, according to the Task Force, because broken bones are linked to chronic pain, disability and increased risk of sickness and early death.

    Based on the reviews, the panel found there were no benefits but some risk for post-menopausal women taking low-dose vitamin D and calcium supplements - below 400 international units and 1,000 milligrams, respectively.

    Specifically, taking low-dose supplements didn't change the older women's risk for broken bones, but was tied to a small increase in the risk of kidney stones.

    They also found that there is not enough evidence to suggest higher doses of the vitamins would be effective or safer in older women, or that taking any dose of the supplements would help men or younger women.

    For men and younger women, "We're not saying don't take it, we're just saying we don't know enough right now," said Herzstein, who is in charge of employee health at Air Products in Allentown, Pennsylvania.

    She added that these recommendations do not apply to people who already have a diagnosis of osteoporosis, a history of fractures or are living in an assisted-living community.

    Herzstein said it's important for people to talk with their doctors about the supplements.

    Cara Welch, senior vice president of scientific and regulatory affairs for the Natural Product Association in Washington, D.C., told Reuters Health she agreed that people should talk to their doctors, but said the group disagrees with the new recommendation.

    "We believe this recommendation is out of step with current research, and it really should not affect consumers who are trying to supplement their calcium and vitamin D intake with supplements," Welch said.

    According to the most recent data from a national survey of Americans, 56 percent of women over 60 years old take vitamin D supplements, and 60 percent take calcium supplements.

    The two vitamins are often sold together and are relatively inexpensive.

    The Task Force already recommends women older than 65 years old be screened for the bone-weakening disease osteoporosis, and younger women who have a higher risk of broken bones.

    The panel also recommends senior citizens with a history of falls and vitamin D deficiency take supplements to help strengthen muscles and help with balance.

    Vitamin D has also been researched as a preventive measure against dementia, heart disease and cancer, but with mixed results. Herzstein said the panel will soon be issuing recommendations about the vitamin for some of those diseases.

    Marion Nestle, a nutrition researcher from New York University who coauthored a commentary published alongside the recommendations in the Annals of Internal Medicine, said that good studies on vitamin D are hard to do, and any end to the debate over whether to take supplements or not is a long way off.

    "These studies are so difficult to do and to interpret that scientific consensus seems impossible to achieve, especially in situations where entire organizations are devoted to convincing people to take high-dose vitamin D," she wrote in an email to Reuters Health.

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