MEDICATIONS: THE ABCS OF ORAL CONTRACEPTIVES

Oct. 5, 2006 — Despite its proven track record, the Pill is still dogged by myths and misconceptions about its safety and efficacy, according to The American College of Obstetricians and Gynecologists (ACOG), which convened experts in the field to address these concerns at a news conference today.

"The Pill works; it's safe; it's easy to use; and it even provides noncontraceptive health benefits," said ACOG President Douglas W. Laube, M.D., M.Ed. "Our goal is to reach women with the basics — the ABCs of OCs. When it comes to birth control, the Pill might very well be a woman's best friend." The Pill leads the way as the most popular method of reversible birth control and is used today by more than 11 million women in the United States, he added.

Speakers answered top consumer questions about oral contraceptives (OCs) and provided updates on the various brands available, hormonal contraception for women with special health concerns, attempts to limit women's access to contraception, how to choose birth control over a woman's lifespan, and newer methods of hormonal contraceptives. Highlights included the following:

Societal Impact

"The Centers for Disease Control and Prevention has recognized family planning as one of the 10 most important public health developments of the 20th century in the United States," noted Anita L. Nelson, M.D., professor of ob-gyn, the University of California Los Angeles' David Geffen School of Medicine, and medical director of women's health care programs, Harbor-UCLA Medical Center in Torrance. "And the Pill has played a key role in enhancing the health and lives of millions of women.

"The contributions that the Pill has made to the quality of life and the economic and professional potential of women cannot fully be appreciated until we remember what life for women was like before the Pill," explained Dr. Nelson. "Most women had to rely on their partners and contraceptive methods such as the condom, withdrawal, periodic abstinence, the diaphragm, or spermicide to protect them from pregnancy. Pregnancy rates for these methods range from 15 percent to 40 percent, which is in sharp contrast to the protection afforded by early high-dose pills. And on a practical level, women often had to rearrange their lives, including their work schedules, because of the unpredictability of their menstrual cycles," she added.

"I'd be remiss if I didn't talk about emergency contraception (EC) and its impact on women's health," said Dr. Nelson. EC, also called the morning-after pill, is highly effective in reducing a woman's chance of pregnancy after a contraceptive failure or unprotected sex. "Nearly half (49 percent) of the more than six million pregnancies that occur each year are unintended. I'm saddened that logistical and political barriers continue to restrict women's access to EC. All women need to be made aware of EC and be able to get it when they need it," she added.

Emergency contraception pills are specific combinations of birth control pills in higher doses. In addition to Plan B®, the only dedicated FDA-approved EC product on the market today, there are 21 brands of oral contraceptives that can be used as EC in the United States. If taken correctly and without delay, EC can reduce a woman's risk of getting pregnant by up to 89 percent.

Safety

"Women want reliability from their contraception. And without question, the Pill delivers that to women. They can depend on it to be highly effective in preventing pregnancy, and they can trust that it is safe — backed by decades of research," noted Paula J. Adams Hillard, M.D., director of gynecology at Cincinnati Children's Hospital Medical Center and professor of ob-gyn and pediatrics at the University of Cincinnati College of Medicine in Ohio.

Although a majority of women have used the combined pill (estrogen and progestin) at some point in their lives, many women still question its safety and remain confused about its associated risks and side effects. But according to Dr. Hillard, more research has been done on the Pill than on any other medication in history. The bottom line: over 40 years of data has shown that oral contraceptives are a safe and appropriate option for most women.

"Teens may be reluctant to take the Pill because they fear that it causes weight gain," said Dr. Hillard. "But, placebo-controlled studies that compare birth control users to those taking an inactive pill have found that Pill users do not gain more weight than do those who take the inactive pills. And, adolescence is a time when we expect healthy young women to be gaining some weight."

Dr. Hillard explained that while some women experience irregular bleeding in the first few months after starting oral contraceptives, most women quickly establish regular, predictable, light periods, with few or no menstrual cramps. Experts agree that the benefits of oral contraceptives generally outweigh the risks in most healthy women. Side effects, such as nausea, headache, and breast tenderness, are minor and often go away after a few months of use.

"To combat the misinformation that exists about the Pill, our mission as ob-gyns is to assist women in making informed decisions on contraception based on science," said Andrew M. Kaunitz, M.D., professor and assistant chair of ob-gyn at the University of Florida College of Medicine and director of menopause and gynecologic services at the University of Florida Southside Women's Health Specialists in Jacksonville.

For example, many women with a history of benign breast conditions or a positive family history of breast cancer have rejected oral contraceptives for fear that their use will increase the risk of breast cancer. But according to Dr. Kaunitz, "That reasoning is based on conventional wisdom, not scientific fact. In reality, the Pill may be a viable option for women with these circumstances. First and foremost, physicians and their patients should let the scientific evidence guide them when making decisions about birth control."

Some women, especially those with uncontrolled high blood pressure or a history of blood clots, stroke or other disease of the blood vessels, should not use birth control pills, according to ACOG, and for women who are older than 35 and who smoke or are obese, OCs should be prescribed with caution, if ever. Because the Pill does not protect against sexually transmitted diseases (STDs), women at risk for STDs should use condoms for protection.

Because informed patients tend to have better outcomes, experts advise revisiting the issue of contraception at least on an annual basis and at times when a woman's contraceptive needs may change, such as postpartum and perimenopause. According to ACOG, women with underlying medical problems should work closely with their ob-gyn to determine what contraceptive methods are right for them.

Another concern of young women is whether or not the Pill will have an effect on their future ability to become pregnant. "The conception-contraception connection should not be a major concern for women using OCs because there is no evidence that the Pill causes infertility," said Dr. Nelson. "Although many women may conceive very easily after going off the Pill, for others it may take significantly longer. It all depends on the individual, her lifestyle, which oral contraceptive she was on, and how long she took it."

Benefits

"Not only is the Pill 99 percent effective in preventing pregnancy when taken correctly, but it also provides many health benefits beyond contraception," said Dr. Hillard. The combination pill reduces the risk of a number of health problems, including cancers of the uterus and ovary; ovarian cysts; pelvic inflammatory disease; bone loss; benign breast disease; symptoms of polycystic ovary syndrome; ectopic pregnancy; and anemia (iron-poor blood). "Another perk of the Pill is that certain brands help balance hormone levels, which control acne," added Dr. Hillard.

"Menstrual suppression — taking a birth control pill each day of the month to stop a woman's monthly period — has become increasingly popular among women. For some women it's a matter of convenience, and for others, menstrual suppression provides significant relief from migraines or painful periods. The other value-added benefit of menstrual suppression is a reduced risk of ovarian cancer," noted Dr. Nelson.

Also, according to Dr. Kaunitz, healthy, nonsmoking, perimenopausal women who may be good candidates for the Pill may experience additional noncontraceptive benefits such as increased bone density; treatment of irregular perimenopausal bleeding, heavy flow, and/or painful cramps; reduction of hot flashes; and prevention of ovarian, uterine, and possibly colon cancers.

40 Pill Varieties

"When it comes to the Pill, one size doesn't fit all, and it doesn't need to. With over 40 brands currently on the market, women have options," said Carolyn L. Westhoff, M.D., professor of ob-gyn and epidemiology, population, and public health at Columbia University's College of Physicians and Surgeons and attending physician and medical director of family planning at Columbia Presbyterian Medical Center in New York.

"I encourage my patients to experiment with different versions to find one that is medically right for them and that fits their needs and lifestyles," noted Dr. Westhoff. "While most women do well with the first Pill that they try, if they do experience bothersome side effects, other Pill formulations are available."

According to Dr. Westhoff, several of today's newer versions shorten the duration of the menstrual period — providing 24 days of active hormones and four days of placebo rather than the traditional 21 days of active pills and seven days of placebo.

Other Hormonal Delivery Systems

"Of course, the Pill is not for every woman, and no one contraceptive method will meet every woman's needs," noted Vanessa E. Cullins, M.D., M.P.H., M.B.A., vice president for medical affairs for Planned Parenthood® Federation of America in New York. "As versatile as the Pill is, it may not suit some women to have to take it every day. If that's the case, women can choose from several other methods of hormonal delivery, such as injections, the vaginal ring, and the skin patch."

Dr. Cullins also assessed the impact of the contraceptive most recently approved by the U.S. Food and Drug Administration (FDA) in July 2006: ImplanonT, a matchstick-like rod inserted into the upper arm by a health care provider that is up to 99 percent effective in preventing pregnancy. It works for up to three years by releasing a continuous low dose of progestin in a woman's body, blocking ovulation and thickening cervical mucus so sperm cannot enter.

ImplanonT is the only implantable birth control method available in the United States. It has been used by about 2.5 million women in more than 30 countries since 1998 and is expected to be widely available throughout the United States by early next year. "We welcome this newest addition to the world of contraception — more choices give women greater ability to control their reproductive lives," said Dr. Cullins.

Access

"Yes, women today have more contraceptive options available to them than ever before, but exactly how do they get them?" asked Rebekah E. Gee, M.D., M.P.H., a Robert Wood Johnson Clinical Scholar at the University of Pennsylvania in Philadelphia. "The answer may seem obvious, but take note — there are often hurdles that make obtaining contraception extremely difficult.

"Emergency contraception is a prime example of the battle that looms over the fundamental right of women to make decisions about their own bodies, including using contraception," said Dr. Gee. "Even though Plan B® is expected to be available over the counter for some women by the first of the year, the FDA ruling is complicated and hardly encompassing.

"We know EC is safe for over-the-counter use by women of all ages. However, women under 18 will still need a prescription for EC, and pharmacists may still refuse to fill it based on moral or religious objections. For women over 18, the behind-the-counter status may bring additional stigma to using EC," said Dr. Gee. "EC works, and it is safe, but what good is it if women can't get it?" added Dr. Gee.

"Many women are confused about the mechanism of EC," noted Dr. Gee. "EC is just that — contraception; it prevents pregnancy. It is not, and cannot cause, an abortion. Getting this message out to women is equally important."

Dr. Gee also discussed how her role as a plaintiff in a lawsuit against Wal-Mart eventually led the nation's largest retailer to stock Plan B® in all of its pharmacies.

Insurance Coverage

"Conscience clauses are not the only contraceptive hurdle facing women," noted Dr. Laube. "Women are at a disadvantage because significant gaps still remain in insurance coverage of birth control pills and other prescription contraceptives."

According to a 2002 study by the Alan Guttmacher Institute, despite advances in contraceptive insurance coverage over the past decade, half of all U.S. women live in the 30 states that do not require health plans to cover contraceptives, and plans designed for these states offer inferior coverage compared with plans designed for mandate states. Differences in insurance coverage and concerns over out-of-pocket costs may lead some women to delay contraceptive use or to select less appropriate or effective contraceptive methods.

"It's fundamentally wrong for health insurance plans to continue to exclude contraceptives from the list of prescription medications they cover. If you recall, when Viagra was approved some eight years ago, it immediately made the list of covered drugs. That says to me — gender discrimination," said Dr. Laube. "Women should have access to affordable contraception, and they should be offered the full range of contraceptive methods.

"Birth control is basic health care; it's not a 'frill.' A woman needs contraception to protect both her health and quality of life," noted Dr. Laube. "It's a medical necessity for women during 30 years of their lifespan. To ignore the health benefits of contraception is to say that the alternative of 12 to 15 pregnancies during a woman's lifetime is medically acceptable.

"If this country is truly committed to preventing unintended pregnancies and reducing the number of abortions, we must all become more aggressive advocates for women to ensure that contraception is there when they need it," noted Dr. Laube.