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Senate approves state-funded birth control

February 28, 2007

The Senate endorsed a bill Tuesday that would allow a state-funded health insurance program to buy birth control for children.

The Children’s Health Insurance Program, which insures about 13,000 Montana children up to age 19 who live below 150 percent of the federal poverty line, is currently banned from paying for contraceptives.

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The bill’s sponsor, Sen. Christine Kaufmann, D-Helena, said lifting the ban is good social policy.
“By preventing children from having children we can address many vexing problems,” Kaufmann said.

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But Sen. Jerry O’Neil, R-Kalispell, said the bill would be costly and encourage risky behavior by teens.

“If people think that sex is safe they are more likely to do it,” O’Neil said.

Others said the state had no business buying birth control.

“This is going to take general fund dollars and put it in a program that to some portion of our society is against their religion,” said Sen. Roy Brown, R-Billings.

The Senate voted 25-24 in favor of the bill. The vote was split mostly along party lines, with Democrats favoring the bill and Republicans opposing it. The bill faces a final vote in the Senate before moving to the House.

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Safe not to go with the flow?

February 27, 2007

Trying to remember to take an oral contraceptive at the same time each day can be annoying. Perhaps the only thing more annoying about this form of birth control is the one week each month a woman doesn’t have to take the pill. Menstrual periods can be inconvenient, but most women accept them as a fact of life - until now.

New extended oral contraceptive regimens are letting women experience fewer periods a year by offering more active pills in each pack. Seasonale, one such regimen, features 84 active pills (compared to 21 in most birth control pill packs) followed by seven placebo pills (which cause a period). As a result, women experience only four periods each year. Seasonale was approved by the FDA in early Sept. 2003, and has steadily gained popularity.

“Four times a year is great for me,� said fourth year UNLV student Brandy Guhlke. “I would consider doing it.�

So is skipping a period (or two or three) safe? According to Anne Hartig, a pharmacist at the UNLV Student Health Center, the answer is “definitely.�

“Usually (skipping a period) doesn’t cause any harm at all,� Hartig said.

Hartig also added that athletes and dancers have been using traditional birth control pills to control when they get periods for years.

Not getting a period can also benefit non-athletes during an important event. Seasonale’s website offers a “Personal Planner� that allows the user to plan events based on inactive pill dates, giving examples of “romantic encounters and family reunions.�

In theory, women experience freedom from menstrual periods for three months at a time. In practice, however, the results are a bit different. Clinical trials showed that women using Seasonale are more likely to experience “unplanned bleeding and spotting� than women using a traditional birth control pill, according to the FDA. Seasonale’s own Web site announces that this bleeding can vary from very “slight spotting to a flow much like a regular period� and is more common during the first year of use. This break through bleeding is supposed to decrease over time. Seasonale.com also adds that “during the first year, total bleeding days are similar to a traditional pill.�

While Seasonale offers the benefit of fewer periods, many hormonal contraceptive methods can offer the same results. Skipping the placebo pills in regular birth control packs and/or using a contraceptive device such as the Nuvaring continuously (switching rings after three weeks without waiting a week in between) can also cause a woman to cease menstruation. Another method of birth control, Depo-Provera (which is given via injection), allows women to have less frequent periods.

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While on hormonal contraceptives, such as the pill, a woman is not actually ovulating, so any menstruation is not caused by an egg being released, but instead by a withdrawal of hormones.

Although causing the body to cease menstruation for a few months may be safe and convenient, not everyone thinks it is such a good idea.

Cristina Crofts, a senior business management major, said she wouldn’t feel safe using an oral contraceptive like Seasonale to skip periods.

“I like to get it every month as reassurance,� Crofts said. “I wouldn’t feel natural not getting it every month.�

And it’s not just females who feel that playing around with menstrual cycles is unnatural. Senior Curt Andersen, a criminal justice major, thinks women who take Seasonale to skip periods are taking contraceptives for the wrong reasons.

“If they are taking it to stop a period then that is stupid,� Andersen said. “Birth control should not be used for any reason other than to prevent pregnancy. Periods in women are part of the normal human cycle.�

Other issues surrounding extended oral contraceptive regimens have been raised as well. On Jan. 23, the FDA issued a statement refuting stories about a meeting of the FDA Reproductive Health Drugs Advisory Committee. These stories claimed, according to the FDA’s memo, that new hormonal contraceptives are not as effective as pills that have been around for years.

Articles claiming that the committee met to discuss the need for higher standards for new contraception methods are also false, the FDA said. The real purpose of the meeting was to “discuss clinical trial designs that reflect the diversity of users of hormonal contraceptives, expectations for efficacy and safety, and user acceptability of the newer generation products, including cycle control.�

The next step for birth control seems to be a pill that eliminates menstruation altogether. Last summer Wyeth Pharmaceuticals announced that they had received an “approvable letter� from the FDA for their pill, Lybrel, a low-dose continuous non-cyclic combination oral contraceptive.

Guhlke said that while she is fine with skipping some periods, she would not want to eliminate them all together.

“I don’t like getting one, but not getting it at all is weird.�

“I am not sure how I feel stopping them all together,� Andersen agreed. “Doesn’t it all need to come out at some point?�

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FDA Weighs Birth Control Drug Standards

February 21, 2007

The government is considering setting higher standards for birth control drugs used by millions, saying that newer pills appear to be less effective at preventing pregnancy than those approved decades ago.

The Food and Drug Administration asked a panel of experts Tuesday whether it should require new contraceptive drugs to meet a standard of effectiveness before they are approved for the market. The panel meets again Wednesday.

More than 60 percent of U.S. women between the ages of 15 and 44 use some sort of contraception, with 11.6 million choosing birth control pills, according to a 2005 survey by the Guttmacher Institute, a nonprofit research group. The global market for hormonal contraceptives was $5 billion in 2005, according to an estimate by U.K. research firm Piribo.

In briefing documents posted to its Web site, the FDA says newer contraceptives appear to be less effective - at times, with twice the failure rate - than previous products, most likely because manufacturers have started using lower doses of hormones that stop ovulation.

“The very first pills were very high dose and carried risks of blood clots and cardiovascular problems that would be unacceptable to most women,” said Amy Allina, program director of the National Women’s Health Network. “Today most birth control pills are very safe for the vast majority of women.”

The original birth control pills approved in the 1960s allowed less than one pregnancy when taken by 100 women for at least a year, the FDA said. But in the last decade, the government has approved pills allowing more than two pregnancies for every 100 woman-years of use.

The FDA asked 14 members of its reproductive drugs panel whether that difference in performance is large enough for concern. The panel is chiefly made up of gynecologists and obstetricians, but it also includes a statistician and a neurologist.

After Tuesday’s discussions, an FDA spokeswoman said the agency does not believe the effectiveness of different contraceptive drugs can be compared due to the way their clinical trials are designed. Moreover, spokeswoman Karen Riley said the FDA considers all contraceptives it approves to be safe and effective.

Separately, FDA is looking at requiring manufacturers to include a more representative mix of women in the clinical trials for their new products.

Companies often exclude women who smoke, are overweight or have a history of heart problems from their trials. The FDA says this makes it difficult for scientists to judge the safety and efficacy of the drugs in the real world.

Heather Boonstra, a policy analyst for Guttmacher Institute, said the FDA is likely holding its two-day meeting now to stay abreast of a number of innovative contraceptive products that are now in development.

One such product is Wyeth Pharmaceuticals’ Lybrel, which is designed to be the first birth control pill for continuous use, 365 days a year. The drug is pending approval in the U.S. and in Europe. A Wyeth representative said the company would attend the meeting but did not plan to make a presentation.

Other recent innovative products have proved problematic for the agency. In September, for example, the FDA warned women that Johnson & Johnson’s birth control patch Ortho Evra could raise their chances of developing blood clots in the legs and lungs. Johnson & Johnson markets a number of traditional contraceptives, including its top-selling birth control pill, Ortho Tri-Cyclen.

The FDA also weathered heavy criticism over its handling of Barr Pharmaceutical Inc.’s controversial “morning after pill,” Plan B, which was only approved for over-the counter sales after two years of wrangling between politicians and consumer advocates.

Barr also markets the more traditional pill Seasonale.

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Old reliable IUD is safe, effective

February 19, 2007

Birth control is a tough issue for many couples. If it’s not the Pill, with all of its well-known side effects, it’s the desensitizing condom. The joys of sex are heavily balanced by the lack of good contraceptive choices.

I say we bring back the IUD!

Short for intrauterine device, the IUD is short on side effects and long on benefits.

The IUD was popular back in the 1970s, but was removed from the market because of an increased risk of pelvic infections. Unfortunately, the reputation persists today — even though the IUD has been perfected and regulated. The IUD is as safe as any other method out there. In fact, it may be safer.

The IUD is a hormone-free form of birth control. The benefits of this fact cannot be underestimated in a time of hormone mass confusion. The IUD is a great option for women who simply can’t tolerate the Pill or for women who are wary of anything hormonal. The T-shaped copper device works by blocking sperm from reaching the fallopian tubes and altering the lining of the uterus so it is uninhabitable for a fertilized egg.

The IUD also offers extraordinary convenience. For anyone who’s ever had to scramble for birth control in the heat of the moment, or freaked out because they forgot to take the Pill — in other words, all of us — the IUD is a great option. Your doctor inserts it during a regular office visit. A little cramping is normal, but it’s a quick procedure. The IUD stays put for 10 years.

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That’s it! A birth control dream come true. You and your partner won’t know what to do with yourselves. (I can think of something!)

Speaking of which, this brings up an important caveat: IUDs are only recommended for women in monogamous relationships. If you contract a sexually transmitted infection while on an IUD, it may increase the severity of infection and lead to all sorts of terrible things, like infertility. Fidelity is a requirement.

Like any birth-control method, side effects vary for every woman. Some women find that their periods get heavier on the IUD. Anemia is a risk. Fortunately, there is also a hormonally supported version called Mirena that minimizes menstrual bleeding, so much so that up to 20 percent of women using Mirena will cease to have menstrual periods within a year — a welcome “extra” for many women. Mirena uses a synthetic version of the hormone progesterone to thin the uterine lining and help prevent pregnancy, which means women with a history of breast cancer can’t use it.

Fertility returns to normal quickly after an IUD is removed (also by your doctor). Women who still plan to have children can safely use the IUD until they are ready.

Let’s face it, women often bear the brunt of contraceptive responsibility in their relationships, both financially and logistically. An IUD is cost-effective (if you have insurance) and convenient. You don’t have to worry about birth control. You can reap the benefits of spontaneous, barrier-free sex in a committed relationship.

Isn’t it time to check out the IUD?

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Local doctors argue that the risks are low

February 14, 2007

The public interest organization Public Citizens sent a petition in early February urging the Food and Drug Administration to ban the third-generation low-dose birth control pills. They claim that these new contraceptive pills double the risk of potentially fatal blood clots, or thrombosis, in comparison to other pills.

According to Dr. Sidney Wolfe, director of Public Citizens’ research group, the new type of birth control uses a specific type of progesterone, desogestrel, which increases the risk of fatal blood clots. In every 100,000 women who take low-estrogen birth control pills, 30 develop blood clots — compared to 15 out of 100,000 women who take the regular-dose birth control pills.

While second-generation pills that do not contain desogestrel are still prescribed more often than those that do, approximately 7.5 million prescriptions of these new birth control pills are filled every year.

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“We estimate that hundreds of women are affected each year,” Wolfe said.

He said since sending the petition last week, Public Citizens’ research group has received calls from three women who developed blood clots and suffered subsequent health problems when taking birth control pills — two of them specifically used the third-generation pills.

“One said that after taking the pills for six months, she developed pain in the chest and rushed to the hospital. She said she was minutes away from dying because [the clot] went into her lungs,” Wolfe said. “She said she wouldn’t have taken the pills if she knew about the increased risk.”

He said the organization urges women to visit the Public Citizens website to learn more and sign the petition. So far, approximately 1,000 women have signed the petition.

Dr. Clara Paik, assistant professor in the department of obstetrics and genecology at the UC Davis Medical Center, said the estrogen within the pills also increases risks of deep-vein thrombosis or pulmonary embolus, which may lead to stroke or heart attacks

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ASA: Stroke Risk With Migraine Aura Makes Birth Control Pill Problematic

February 13, 2007

SAN FRANCISCO, Feb. 12 — Women under age 35 who suffer migraine with aura should consider avoiding oral hormonal contraception because of their elevated risk of a stroke.
Action Points

* Explain to interested patients about the combined risk of stroke due to migraine with aura and oral contraception.

* This study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

So concluded Dulka Manawadu, M.B., of the University of Alberta in Edmonton, and colleagues, after conducting a risk analysis based on a literature review.

Aura, the neurological symptoms that precede other migraine symptoms among about one-third of migraine patients, is associated with an elevated stroke risk as is oral contraception.

“Uncertainty exists as to the best advice for females under the age of 35 with migraine plus aura regarding use of the oral contraceptive pill,” they said at the American Stroke Association meeting.

In the literature review, they found that women with migraine plus aura are at elevated stroke risk when on oral hormonal contraception (30 versus 19 per 100,000 annually), a risk that is especially high for women who smoke (102 on-pill versus 44 off-pill per 100,000 annually).

However, this risk has to be balanced with that of unwanted pregnancy. The stroke risk in pregnancy is also elevated (22 per 100,000 pregnancies) with further elevation for smokers (44 per 100,000 pregnancies).

So the researchers then performed a cost-effectiveness-style analysis that allows comparisons of health outcomes. In the utility analysis, a utility of 0 represents immediate death whereas a utility of 1 represents a perfect state of health.

The analysis was done for a hypothetical patient younger than 35 who was already taking oral contraception but suffered from migraine with aura. The results supported:

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* Discontinuing oral contraception in favor of barrier methods for nonsmokers (0.999901 versus 0.999847 for continuing), and
n assumptions for annual failure rates of oral contraception were varied from 1% up to 8%. Likewise, varying the assumption for barrier method failure rates from 5% to 14% did not alter the conclusions.

The researchers noted that there are no published utility data for unwanted pregnancy, so they assumed a value corresponding to perfect health. If the true utility is 0.99 or less, then the results actually favor continuing oral contraceptives for smokers and nonsmokers, they said.

“If unwanted pregnancy is considered to be even a mildly undesirable state of health then the decision analysis supports continuation of the oral contraceptive pill,” they added.

However, physicians should treat other stroke risk factors such as helping women quit smoking before they start weighing the switch to other contraceptive methods, said Harold Adams, M.D., of the University of Iowa, in Iowa City, who commented on the study.

Then, physicians should discuss with these women how they rank the importance of not becoming pregnant, he said.

He cautioned that this study is likely not the final word and that further study will be needed, particularly in evaluating whether the stroke risk is lower for modern, lower dose estrogen contraceptive pills.

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Seasonale Oral Contraceptive

February 8, 2007

Woman has many options these days. There are number of contraceptive methods available to women today than ever, and technology has improved the effectiveness of those options.

Woman has many options these days. There are number of contraceptive methods available to women today than ever, and technology has improved the effectiveness of those options.
The new oral contraceptive pill, called Seasonale, work in the same manner as the other oral contraceptive, but it is taken in a 12-week regimen rather than three weeks at a time. The result is having only four periods a year.

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Seasonale oral contraceptive is available in the market by prescription, 98-99 percent effective and, like all oral contraceptive, must be taken on a daily schedule regardless of sexual activity. Innovation has taken birth control past physically ingesting hormones through the mouth. Ortho Evra, the patch, is a self-adhesive patch for the skin worn on the upper body, lower abdomen or even the butt.
In theory, women experience freedom from menstrual periods for three months at a time. In practice, however, the results are a bit different. Clinical trials showed that women using Seasonale are more likely to experience “unplanned bleeding and spotting” than women using a traditional birth control pill, according to the Food and Drug Administration. Seasonale adds that “during the first year, total bleeding days are similar to a traditional pill.”
Try to remember to take an oral contraceptive at the same time each day cab be annoying. Perhaps the only thing more annoying about this form of birth control is the one week each month a woman does not have to take the pill.
More than 60 per cent of the 62 million U.S. women between ages 15 and 44 use some sort of contraception, with 11.6 (about 30 per cent) of them choosing birth control pills, according to a 2005 survey by the medical institute, a non-profit research group. The global market for hormonal contraceptive was $ 5 billion US in 2005, according to an estimate by U.K. research firm.

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Pill to patch: all about birth control

February 5, 2007

Women these days have options. There are more contraceptive methods available to women today than ever, and technology has helped improve the effectiveness of those options.

The first oral contraceptive, commonly known as “the pill,” was approved by the Food and Drug Administration in 1960, and is widely used today. Taken daily, it suppresses ovulation with a combination of the hormones estrogen and progestin. A chewable form of the pill was approved in 2003. Both forms are 98 to 99 percent effective at preventing pregnancy.

The “mini-pill” contains lower levels of progestin and no amount of estrogen. It is 98 percent effective as a contraceptive.

A newer contraceptive pill, called Seasonale, works in the same way as the others, but is taken in a 12-week regimen rather than three weeks at a time. The result is only having four menstrual periods a year. It is available by prescription, 98-99 percent effective and, like all oral contraceptives, must be taken on a daily schedule regardless of sexual activity.

Innovation has taken birth control past physically ingesting hormones through the mouth. Ortho Evra, the patch, is a self-adhesive patch for the skin worn on the upper body, lower abdomen or even the butt.

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The patch releases progestin and estrogen, the same hormones used in the pill form, into the bloodstream. A new patch must be applied once a week for three weeks, and then the woman goes patch-less for the week of her menstrual period. The patch was FDA approved in 2001. It is 98-99 percent effective, but less successful when used by women weighing more than 198 lbs.

The newest to the market is the NuvaRing, approved in 2001. It is a flexible ring that a woman places in the vagina and the ring releases hormones into the body. One ring is left in for three weeks, and then removed for one week. The ring is 98-99 percent effective at preventing pregnancy.

Both the patch and the contraceptive ring are available by prescription only.

The FDA approved post-coital contraceptives, such as Plan B, in 1999. Taken within 72 hours after unprotected sex, the pills reduce the risk of pregnancy by 80 percent. The pills are not designed to be a regular method of pregnancy prevention but are available by prescription. Go2planb.com says that Plan B is not an “abortion” pill, but pro-life groups have hit the day-after pill with some criticism. Plan B will not work if a woman is already pregnant.

No pills, patches or rings protect against HIV or sexually transmitted infections. The male condom is still the most effective method, other than abstinence, in protecting against STDs. The condom is between 89 to 98 percent effective at preventing pregnancy. All forms of birth control are most effective when used consistently and correctly.

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Today’s birth control: Does it work?

February 2, 2007

The Associated Press sparked controversy last week by suggesting that birth control pills are less effective than the original contraceptives of the 1960s.

Andrew Bridges, an AP writer, said the Federal Drug and Administration, concerned about the increasing failure of new birth control forms, consulted a board of health advisors to decide whether these new drugs should be granted federal approval.

According to Bridges, the outside panel recommended that the FDA keep an open mind in approving the “less effective pills” because of their ability to reduce the occurrence of blood clots and stroke among women taking contraceptives.

In an affronted response made on Jan. 23, the FDA said the wire service stories had created misperceptions as to the effectiveness of modern hormonal contraceptives, “The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago. In fact, the newer generation products are highly effective in preventing pregnancy.”

So what is the truth?

According to Kate Horle, Vice President of Public Affairs for Planned Parenthood, newer generation pills do have lower levels of hormones than those of decades past. However, lower hormones do not mean lower success rates.

“Low level hormone pills are much easier and more comfortable to take. They minimize the side effects that we saw with earlier forms of the pill, [side effects] such as nausea, vomiting, headaches, etc.” Horle said.

Moreover, according to Molly Fortuna, manager of the Women’s Health Clinic at Wardenburg, it is not the composition of the contraceptive that causes it to fail, but rather the mistakes made on the user’s behalf.

“There’s what’s called typical use and perfect use. The typical use with birth control pills has an 8 percent failure rate. The perfect use of birth control pills has a 0.3 percent failure rate. So it really depends on a person using it correctly,” Fortuna said.

The statement released by the FDA went on to accuse the AP of misconstruing the purpose of the meeting with the health consultants held on Jan. 23.

“The stories mistakenly state that FDA called the meeting to discuss the need for higher standards of efficacy for the newer products,” the statement read.

Instead, the FDA claimed that the major purpose of the meeting was to discuss clinical trials designs that better reflect the diversity of users of contraceptives.

Currently, clinical trials exclude women who smoke and women with cardiovascular disease or cancer because hormonal contraceptives are considered dangerous for these women. However, this does not stop many women from continuing to take the pill.

Horle argues that women at risk should not be included in hormonal contraceptive trials because there are alternative forms of birth control available to women, for whom, hormones, or a combination of hormones, carry dangerous effects.

“Some women don’t like the side effects of hormones. So a non-hormonal contraceptive is appropriate for those women. That includes women who are smokers, who have a history of hypertension, heart attack, liver disease or other kinds of cancers or who are any of those things and over the age of 35,” Horle said.

The Copper IUD, also known as ParaGard, is one hormone-free alternative.

ParaGard works by surgically inserting a t-shaped copper coil into the uterus. The copper then serves to kill sperm.

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Jentry Lee, a senior at CU, opted for the copper insert after experiencing headaches while taking the pill. Now with fewer headaches, a potentially dangerous side effect of hormonal contraceptives, Lee is happy with her decision.

“I feel like my body is naturally doing its thing,” said Lee.

Despite patterns or trends, both Horle and Fortuna believe that the best birth control method depends on a person’s specific health conditions, history, and preferences.

“It really depends on a variety of risk factors. It would depend on age, blood pressure and family history. There is a lot that would go into that decision,” Fortuna said.

The type of birth control that is best may also depend on the number of partners a women has.

“With IUDs, if a woman has multiple partners, it’s less of a good idea for her to have an IUD because of the risk of infection. But if a woman is in a monogamous relationship, or serial monogamy, then an IUD may be a very good choice,” Fortuna said.

Certainly choice and variety are positive differences from contraceptives of the 1960s. Today, alternatives to the standard combined hormonal pill include mini-pills, progesterone-only pills, ParaGard, Mirena (IUD with progesterone), Depo-Provera shot, NuvaRing, the implant (the insertion of a rod under the arm), and the patch.

One downfall of modern birth control may be the variety of options available to women, as compared to the narrow options available to men.

Although there have been talks of new birth control forms designed for male use, “the only approved option for men right now is the condom, [but] there are several other pill-based methods that are in clinical trials,” Horle said

Perhaps the lack of a pill comes as a relief to the male-half of society.

“If it came down to me or her [taking the pill], I would look to other options, such as the condom,” Andy Gerk, a senior political science major said.

Irregardless, there are ways men can take some of the burden off of women, one of which is support.

Lee felt she had the backing she needed when taking on the IUD: “I talked to my boyfriend a lot about [my decision]. He offered to pay for half of it and he did. He knew it was his responsibility too.”

For males and females alike, the world of contraceptives is increasingly expanding, but as for now the FDA is saying breathe easy: birth control is effective.

Such confidence seems to reflect the feelings of the millions who rely on the pill for pregnancy prevention everyday.

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