Monday, August 30, 2010

Irish Examiner: Pharmacists call for 'morning-after pill' to be available over the counter

Monday, August 30, 2010 - 05:06 PM

Pharmacists are renewing calls for the 'morning-after pill' to be available over the counter.

At present, women who wish to take emergency hormonal contraception require a prescription from a doctor.

The Irish Pharmacy Union (IPU) said its members have the skills to dispense such drugs and provide appropriate advice and counselling to patients.

"It is important that patients get timely access to emergency hormonal contraception and many often find it difficult to get a prescription at the weekend," said spokesperson Kathy Maher, a pharmacist in Co Meath.

"Pharmacists should be able to provide such a service and this could be done with appropriate advice, counselling and within agreed protocols."

Ms Maher emphasised that the morning-after pill "should never be the only form of contraception used" and said pharmacists could also refer patients back to their GP where appropriate.

The IPU represents around 1,800 community pharmacists across the country.


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Saturday, August 14, 2010

NYTimes: F.D.A. Approves 5-Day Emergency Contraception

August 13, 2010

WASHINGTON — Federal drug regulators on Friday approved a new form of emergency contraceptive pill that prevents pregnancies if taken as many as five days after unprotected intercourse.

The pill, called ella, will be available by prescription only. Developed in government laboratories, it is more effective than Plan B, the morning-after pill now available over the counter to women 17 and older.

That pill gradually loses efficacy and can be taken at most three days after sex. Ella, by contrast, works just as well on the fifth day as the first after sex.

Women who have unprotected intercourse have about 1 chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take ella would cut that risk to about 1 in 50, regulators say. Studies show that ella is less effective in obese women.

The decision was greeted with enthusiasm by abortion rights groups and denounced by anti-abortion activists. But in recent years both sides have treated the emergency contraceptive pills as a side issue in the wider debate over abortion.

Studies have found that many women fail to realize they are at risk for an unplanned pregnancy after unprotected sex. So they tend not to use the emergency contraceptives even when they receive them free.

“Emergency contraception has no effect on pregnancy rates or abortion rates,” said Dr. James Trussell, director of the Office of Population Research at Princeton, who has consulted without charge for ella’s maker. “Women just don’t use them enough to make an impact.”

Still, the decision by the Food and Drug Administration to approve ella, less than two months after a federal advisory committee voted unanimously to recommend approval, marks a decided shift for the agency.

Under President George W. Bush, White House political advisers overruled united F.D.A. scientists, delaying the decision to make Plan B available over the counter and barring such distribution to women under 18.

Some advocates said Friday that the agency’s relatively rapid adoption of its scientists’ advice meant that its traditional separation from political considerations had returned.

“It’s really important the F.D.A. made a decision that’s based on the scientific evidence and not on the political controversy,” said Diana Zuckerman, president of the National Research Center for Women and Families.

But Wendy Wright, president of Concerned Women for America, which opposes abortion, said that political considerations were still at work inside the agency.

“The fact that the F.D.A. waited until late on a Friday night in August to release this when they hoped nobody was paying attention underscores that this is a political decision,” she said.

Ms. Wright warned that men might slip ella to unsuspecting women, and she said testing so far was not adequate to establish whether it was safe.

In studies, the most common side effects associated with ella’s use were mild to moderate headache, nausea, abdominal pain, painful menstrual cramps, fatigue and dizziness.

Ella’s approval may also intensify a long-simmering controversy about whether pharmacists and doctors can refuse to prescribe or fill prescriptions for birth control measures they find personally objectionable.

Much of the debate over the drug springs from an argument over how it works, which despite considerable research remains something of a mystery. It blocks the effects of progesterone, a female hormone that spurs ovulation. It is, however, a chemical relative to RU-486, the abortion pill, and there is some evidence that ella makes the womb less hospitable to a fertilized egg by reducing the lining of the uterus.

To the scientists on the advisory committee, whether the pill works by preventing ovulation or implantation was mostly immaterial to the decision about whether it is safe and effective. But to religious groups, the distinction is crucial, since they consider that preventing implantation of a fertilized egg is akin to abortion.

Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently from RU-486.

Ella, which was approved in Europe last fall, is manufactured by HRA Pharma, a small French drug maker. In the United States it will be distributed by Watson Pharmaceuticals, a company based in California and New Jersey, which plans to introduce it by the end of the year.

The pill was originally developed by the National Institute of Child Health and Human Development, part of the National Institutes of Health and now named after Eunice Kennedy Shriver. It decided in 2002 to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive.

Studies have shown that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and that more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended.


Wednesday, August 11, 2010

Reuters: Economic crisis rekindles Irish debate on abortion

August 11, 2010
By Marie-Louise Gumuchian

DUBLIN (Reuters) - Minutes after the test revealed she was pregnant, Amy saw only one option -- to leave Ireland and have an abortion in Britain.

Her architect partner had lost his job in Ireland's property crash and she was worried about hers, so the 29 year-old office assistant felt she had no choice.

"We found it hard enough to finance the abortion," said Amy, who declined to give her full name because of the sensitive subject. "So how could we effectively support a child?"

Women's activists say Ireland's deep economic crisis may have driven more women to consider an abortion. But a growing number cannot afford to travel to Britain for the procedure and may be forced into the hands of underground abortionists.

A year later, Amy has not told her parents. Growing up in mainly Roman Catholic Ireland, abortion was taboo and she recalls how women rumored to have had one were shamed.

"Abortion was a no-no then, and still is now," she said.

Terminating a pregnancy has long been a fraught issue in Ireland, where one of the strictest abortion laws in Europe allows it only when the mother's life is in danger.

Women who have an abortion still face a maximum sentence of life imprisonment, driving thousands abroad each year, mainly to Britain. Even that is a little more liberal than before a 1992 referendum which gave women the freedom to receive abortion information and travel abroad to terminate pregnancies.

Today, following the former 'Celtic Tiger's' slide from boom to bust, Amy is not alone in seeking that route, although statistical evidence is hard to find.

Last year, 15 percent of the 1,300 women who visited the Dublin Well Women Center cited financial problems as the main reason for seeking information on terminating a pregnancy.

"Financial pressure might have always affected a women's decision around whether she continued with her pregnancy but in the last year there was some sort of shift in the priorities," Alison Begas, chief executive of the center, said.

"She would say she had lost her job, or her salary had been cut or even those for whom the guy has lost his job."

Ireland crawled out of the longest recession of any euro zone country in the first quarter of this year, but sustained economic recovery is some way off.

Ann Rossiter, a London-based Irish author who for years helped Irish women seek terminations in Britain, has warned that the credit crunch could bring a return to illegal abortions.

Abortions in UK clinics start from 350 pounds ($551). There are also travel costs. "I see no reason why we wouldn't have a return to the backstreet or self-induced abortions," she said.

Between 1980 and end-2009, at least 142,060 women traveled for abortion services in England and Wales, according to the Irish Family Planning Association (IFPA).

Last year, 4,422 women providing Irish addresses had terminations in England and Wales, British figures show, down 178 on 2008. Numbers have fallen since 2001.

But IFPA says the figures are an underestimate as not everyone wants to provide their address for confidentiality reasons, and women also travel to the Netherlands.

"I think what makes it tougher is the stigma," said Mara Clarke, of the UK-based Abortion Support Network. "(Abortion) is one of the most commonly performed medical procedures."

Women in Catholic Poland also face strict laws. Official statistics show several hundred abortions performed annually but pro-choice campaigners estimate hundreds of thousands are performed underground or abroad, sometimes in poor conditions.

Traditionally Catholic Spain has changed its law making it easier for women to have a termination but some conservative-led regions have refused to allow their hospitals to perform them.

In decades of debate in Ireland both pro-choice and pro-life campaigners have had their victories.

A March YouGov poll for British sexual health consultants Marie Stopes showed 78 percent of those questioned supported abortion if the pregnancy endangers a woman's health or is the result of sexual abuse, rape or incest.

A month later, a poll for the Pro-Life Campaign showed support for a continued ban, with 70 percent in favor of constitutional protection for the unborn child.

"People in Ireland just don't want abortion to be introduced, and that's very clear from the polls," Cora Sherlock of the Pro-Life Campaign, said. "It's not really an issue, because people are happy with the status quo."

Ireland is defending its abortion law at the European Court of Human Rights, countering a legal challenge by three women who said it endangered their health and violated their rights. The two Irishwomen and a Lithuanian living in Ireland went to Britain for abortions.

"I think it could be the case that gets the political system really focused on trying to resolve the issue," said Niall Behan, chief executive of IFPA, which supports the women.

While the court is unlikely to rule on the substance of Ireland's abortion law, it could say it is deficient in respecting the right to private life of those concerned, said Adam McAuley, a law lecturer at Dublin City University.

But he sees no immediate change. "The state will probably dilly-dally, I can't see it being quick," he said.

"The reality is (politicians) can just see votes being lost on this rather than being gained."

Rossiter knows it will take more than a court case for change. She has performed a one-woman-show, "Making a Holy Show of Myself, An Abortion Monologue", to select Irish audiences.

"I got weary of the usual format of presenting talks on the abysmal state of Irish women's reproductive rights," she says in a flyer for her show. "But I am not hanging up my spurs to retire to one of God's waiting rooms just yet."

(Additional reporting by Alice Tozer in Madrid and Gabriela Baczynska in Warsaw; editing by Paul Taylor)


NYTimes: Argentina Faulted for Reproductive Policies

August 10, 2010

RIO DE JANEIRO — The government of Argentina’s president, Cristina Fernández de Kirchner, has reversed steps toward protecting women’s health and reproductive rights, and backtracked on its intention to guarantee access to legal abortions, according to a Human Rights Watch report released Tuesday.

Despite what seems to be a liberal social wave sweeping through Argentina — including Congress’s approval last month of a national law authorizing same-sex marriages, the first in Latin America — the Human Rights Watch report offered a scathing assessment of the reproductive rights policies under Mrs. Kirchner, who took over from her husband, Néstor Kirchner, as president in late 2007.

Women continue to struggle to obtain birth control, despite a 2002 law ensuring access to it, and doctors shy away from offering legal abortions in the predominantly Roman Catholic country, the report said. Argentine law strictly limits abortions, with exceptions that include physical or mental risk to the patient and pregnancies resulting from rape.

Researchers found that unsafe abortions continued to be a leading cause of maternal mortalities in Argentina. In 2008, more than 20 percent of deaths recorded as a result of obstetric emergencies were caused by unsafe abortions, according to government figures cited in the report.

The group said an estimated 40 percent of pregnancies in 2005 ended in abortions, most of them illegal and unsafe. “Little has changed for the women and girls who depend on the public health system,” the organization said.

The report’s author, Marianne Mollmann, wrote that anti-abortion voices continued to carry significant political weight, as in many Latin American countries. Last month, the Health Ministry “backtracked on its declared intention to guarantee access to legal abortion” under wilting questioning by the Argentine press, Human Rights Watch said.

A spokesman for Health Minister Juan Luis Manzur declined to comment on the report on Tuesday. Neither the minister nor Mrs. Kirchner addressed the issue publicly.

At an event on July 30, Dr. Manzur declared that the government was “against abortion,” noting that the president felt the same way.

Earlier in July, though, a ministry official said Dr. Manzur had signed a resolution backing a guide to legal abortion services. The guide would allow doctors to carry out abortions for rape victims without securing a police report. But a day later, the minister issued a statement saying he had not signed the resolution, and Argentine news outlets suggested that Mrs. Kirchner had ordered him to halt the effort.

In 2002, Argentina’s Congress dismantled an 11-year ban on the use and sale of contraceptives when it enacted the National Law on Sexual Health and Responsible Procreation. The law focused on providing universal access to contraceptives and information on reproductive health.

But researchers from Human Rights Watch have found that, in practice, women in Argentina have encountered barriers to making independent decisions about reproduction, obstacles that include lack of information, domestic and sexual violence, and economic restraints that the government had not adequately addressed. The group also found that public officials were not being penalized for failing to uphold the laws on the books.

Ginés González García, the health minister under Mr. Kirchner, installed guidelines and clearer laws, including a sex-education law, but the government’s efforts were undermined by “erratic implementation,” Human Rights Watch said.

When Mrs. Kirchner took over in 2007, the stigmatization of abortion increased, the group said. The president’s first health minister, Graciela Ocaña, declared abortion to be a matter of criminal law and repudiated the guide on legal abortion. It finally appeared on the ministry’s Web site in March 2010 after Dr. Manzur replaced Ms. Ocaña.

But in July, after republishing the guide, the ministry seesawed on the issue, eventually removing Web references to the resolution the ministry said a day later had not been signed by the minister.

Charles Newbery contributed reporting from Buenos Aires.


RHReality Check: IUDs: Now for Emergencies?

By Amie Newman
Created Aug 9 2010 - 1:22pm

According to the results of a study undertaken in China by the National Research Institute for Family Planning, the Copper IUD (sold under the name ParaGard in the United States) can be an excellent emergency contraceptive if inserted within five days of unprotected sex.

Researchers followed 2000 women who came to eighteen different clinics around the country for emergency contraception, within the five day window, and then were implanted with the Copper IUD. Women returned for follow-up visits, according to the study published in BJOG [1](an international journal of obstetrics and gynecology), at 1, 3 and 12 months post-insertion. Prior to or at the first follow-up visit, not one woman (all but 70 women returned) had become pregnant.

Women involved in the study did report some side effects: increased menstrual bleeding and menstrual disturbances (however vague that might be). Twenty-nine women "experienced a difficult IUD insertion process, requiring local anaesthesia or prophylactic antibiotics," notes the study.

It's an interesting find.

The old kid on the block, Plan B, the brand name for the emergency contraceptive (EC) pills sold in the United States, is effective at preventing pregnancy in 1 out of 100 pregnancies. Women have been encouraged to keep them "on hand" or in their medicine cabinet so, if there comes a time when they do need them, they do not need to struggle with finding a pharmacy open and available as soon as possible or finding a pharmacy that won't judge or refuse to sell the pills to you [2]. A recent study concluded that though women who keep EC on hand are not as likely to use the pills as previously thought, it is still an important option for women to have.

But how likely is it that a woman who is in immediate need of emergency contraception would actually choose to undergo insertion of an IUD into her uterus, have access to a health provider in a timely manner or be able to afford the "option," in order to make use of this successful form of emergency contraception?

From a Reuters [3] article on the study:

"...despite the benefits of Copper T, it's not easy to get for many women seeking emergency contraception in the United States. One deterrent is that while women 17 and over can buy Plan B over-the-counter at a pharmacy, Copper T must be inserted by a doctor - an extra step for women who only have a window of time when emergency contraception can work.

"The issue," Godfrey said, "is immediate access. In the U.S. it's easier just to go to a pharmacy."

And while Plan B runs for about $50 off the shelf, Godfrey said that depending on her insurance a woman could pay more than $500 to have Copper T inserted. "Cost could certainly be prohibitive," she said."

There are two different IUDs sold in the United States, currently. The hormonal IUD, sold under the brand name Mirena continually releases hormones into your body for up to five years; and the Copper IUD. Both work to prevent fertilization of an egg or to create an inhospitable environment for a fertilized egg to attach to the uterine wall.

The IUD is a more permanent form of birth control so if you use have one inserted, it's a one-time only occurrence (or at least a one-time every 5-10 years occurrence). While these sorts of studies are important from an efficacy perspective, they don't take into account the reality of women's lives. What are the real benefits of a study such as this one if most women cannot ultimately make use of the results?

Dr. James Trussell, a long-time proponent for emergency contraception, and head of the Office of Population Research at Princeton University was quoted as saying,

"It's too bad it's [Copper IUD] not used more often...If there were many, many more IUD insertions rather than emergency contraception pills (used), it certainly would have an impact on lowering pregnancy rates and abortion."

And while I cannot argue with his logic, it's the realistic implementation in women's lives with which I take issue. It seems to me that if we look at women's lives first and see how we can best address unplanned pregnancy rates given, well, the givens then we can "impact" said rates much more effectively.

I'm sorry if I'm short sighted here but the IUD, while effective at preventing pregnancy, is not the right method of birth control for every woman. Here's a basic run-down, from Planned Parenthood [4], on when you shouldn't use the IUD:

You should not use an IUD if you:

have had a pelvic infection following either childbirth or an abortion in the past three months
have or may have a sexually transmitted infection [5] or other pelvic infection
think you might be pregnant
have cervical cancer that hasn't been treated
have cancer of the uterus
have unexplained bleeding in your vagina
have pelvic tuberculosis [6]
have a uterine perforation during IUD insertion

There's a lot of room between thinking "you may have" an STI and finding out for sure. Would a doctor insert an "emergency" IUD in that case? What about not knowing if you have cervical cancer or not? Would a woman be honest about her symptoms if she were so intent on preventing pregnancy and getting an IUD put in place? This is a long list of "ifs" to me. I'm not discounting the IUD as a form of EC but I'm not sure this study would be enough to persuade me that inserting an IUD so swiftly is a bright idea, unless the woman has already done her research and was planning on having one inserted anyway.


Sunday, August 1, 2010

NYTimes: Another Pill That Could Cause a Revolution

July 31, 2010

Could the decades-long global impasse over abortion worldwide be overcome — by little white pills costing less than $1 each?

That seems possible, for these pills are beginning to revolutionize abortion around the world, especially in poor countries. One result may be tens of thousands of women’s lives saved each year.

Five-sixths of abortions take place in developing countries, where poor sterilization and training often make the procedure dangerous. Up to 70,000 women die a year from complications of abortions, according to the World Health Organization.

But researchers are finding an alternative that is safe, cheap and very difficult for governments to restrict — misoprostol, a medication originally intended to prevent stomach ulcers.

“I feel like people must have felt when they discovered the nuclear bomb,” says Dr. Beverly Winikoff, president of Gynuity Health Projects, a nonprofit research institution on reproductive health. “This technology is world-shaking.”

This pharmaceutical approach is called “medical abortion.” In the United States and Europe it typically consists of two sets of “M” pills. The first is mifepristone, formerly known as RU-486, and then a day or two later the misoprostol.

Using the drugs in combination produces a miscarriage more than 95 percent of the time in early pregnancy. But mifepristone is difficult to obtain in much of the world, because it is used only to induce abortions. In contrast, misoprostol is very widely available and can’t easily be banned because it is also used for ulcers and can save lives of women with postpartum hemorrhages. Whatever one thinks of misoprostol for abortions, it also is a potential lifesaver for women who hemorrhage after childbirth.

Researchers are finding that if women take misoprostol alone, effectiveness drops to 80 to 85 percent. That may sound low, but it’s typically far better and safer than alternatives that women turn to, Dr. Winikoff noted.

“Medical abortion represents a revolution in women’s reproductive health,” said Dana Hovig, the chief executive of Marie Stopes International, an aid group that provides women’s reproductive health services in 43 countries around the world. “It saves women’s lives and has enormous potential to increase access to safe abortion at minimal cost.”

Medical abortion causes a miscarriage that is indistinguishable from a natural one. That’s important for women in countries where they risk arrest if they seek help in a hospital after a botched abortion. The risks to a woman seem no greater than with a natural miscarriage, and there’s no known harm to a woman who turns out not to have been pregnant after all. One serious downside is that misoprostol is suspected of causing birth defects, perhaps 1 percent of the time, but only if it fails and the pregnancy continues to term.

In the United States, only about one abortion in eight is done with pills. Partly that’s because by law, mifepristone must be taken in a clinic. But worldwide, the number of medical abortions is surging, accounting for nearly 70 percent of all abortions in Scotland, according to Marie Stopes International.

It’s not clear how late in pregnancy medical abortion is feasible. “It sounds like a simple question, but it’s not,” Dr. Winikoff said. In some form and strength, medical abortion seems to work “from Day 1 to the end of pregnancy,” she said — but the effectiveness and safety of later-stage abortions still need to be worked out.

In the United States, the pills can be taken up to nine weeks’ gestation. In Britain, inpatient use of the pills is permitted up to 24 weeks.

What do these pills mean for the political battles over abortion? To firm opponents of abortion, the means of ending a pregnancy doesn’t matter. But my hunch is that, for those in the middle, taking pills at home may seem a more natural process than a surgical abortion, and the result may be a tad more acceptance.

In any case, it would be tough to carry out a ban on medical abortion. Indian companies are producing mifepristone and misoprostol in a big way, and blister packs with the combination of drugs can be purchased for less than $5 — and then shipped anywhere.

In addition, misoprostol on its own can be found all over the world, from Internet sites to over-the-counter pharmacies in Delhi. In India, misoprostol costs just pennies per pill.

Misoprostol is likely to become even more widely available, because last year the World Health Organization expanded its uses as an “essential medicine” to include treatment of miscarriages and incomplete abortions.

Brazil and some other countries have tried to tighten access to misoprostol because of its use for abortion. But curbing access to misoprostol would mean that more women would die of hemorrhages.

As word spreads among women worldwide about what a few pills can do, it’s hard to see how politicians can stop this gynecological revolution.

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