Dr. Tina Raine

(WOMENSENEWS)–Giving women packets of Plan B, a form of emergency contraception also known as the “morning after pill,” did not lead to an increase in unprotected sex, an increase in pregnancy rates or cause women to forgo regular contraception, according to a study published today in the Journal of the American Medical Association.

The study revealed women with the greatest access to emergency contraception were more likely to use it, but that greater access did not lead to changes in sexual behavior that were statistically different from subjects whose access was more restricted.

The findings–released just two weeks before the Food and Drug Administration is expected to make a decision about whether Plan B should be made available over-the-counter for only women 16 and older–enter a heated public debate over whether to make emergency contraception available in drugstores. Currently, emergency contraception is only available through a physician’s prescription in 44 states. Six states–California, New Mexico, Hawaii, Alaska, Maine and Washington–allow women to leapfrog the doctor and get emergency contraception directly from a pharmacist.

“Policymakers are afraid that if you have easy access, women are going to overuse it and misuse it,” lead researcher Dr. Tina Raine and assistant clinical professor of obstetrics and gynecology at the University of California at San Francisco, told Women’s eNews. “But in our study we found that wasn’t the case, so that’s an important finding.”

Study Arrives Before New FDA Decision on Access

Plan B’s manufacturer Barr Pharmaceuticals in Woodcliff Lake, N.J., resubmitted its application for over-the-counter approval after the FDA rejected its initial application last year saying the company lacked data showing the drug could be taken safely by women under age 16. The new application seeks over-the-counter access for women over 16. Plan B is one of the most popular and well-known emergency contraception in use, but there are several types of emergency contraception pills.

Raine and other investigators at the University of California at San Francisco tracked 2,117 women ages 15 to 24 for six months who attended four California clinics.

The women went to the clinics for various reasons; such as obtaining birth control or routine Pap-smear checkups. None of the women wanted to become pregnant. Women were given questionnaires at the beginning of the study that asked about their contraceptive choices and uses, their sex life, how many partners they had, their previous use of emergency contraception and any history of pregnancies or sexually transmitted infections.

The subjects were split into three groups. Women in one group were given three free packets of Plan B. Those in another were given contact information for 13 pharmacies that provided emergency contraception. Women in the third group were told that they needed to come back to the clinic if they had unprotected sex and required the morning-after pill. Researchers defined this final group as the study’s control group because this is parallels the standard way most women around the country obtain emergency contraception.

Six months later, the 1,950 women who returned and answered a second follow-up questionnaire with many of the same questions. Researchers also administered pregnancy tests and screening for Chlamydia and herpes.

“There was no increase risk taking in women who had emergency contraception access,” said Raine. “There were no changes in sexual behaviors or contraceptive behavior.”

Unprotected intercourse rates were similar among the women who had received advanced packets of emergency contraception (39.8 percent) and those who were told they could only come to the clinic (41 percent).

A total of 29.3 percent of the entire study group used emergency contraception. Researchers report that 46.7 percent of participants who received the advance packets and who had unprotected intercourse used emergency contraception during the study period.

The findings uphold similar results by a different research team from the University of California at San Francisco that was reported in the journal Obstetrics and Gynecology in July 2003. Those results found that women given advanced provision of emergency contraception were four times more likely to use it than women who did not have such access. Planned Parenthood, which was not affiliated with this older University of California at San Francisco study, states emergency contraception could prevent up to 1.7 million unintended pregnancies and 800,000 abortions each year in the United States.

In the most recent study, 8 percent of the entire study group became pregnant and 12 percent developed a sexually transmitted infection, but the rates of pregnancy and infection did not differ among the three groups.

Only 24.2 percent of the group given pharmacy contact information used emergency contraception compared to 21 percent for the group told to come to the clinic. However, 37.4 percent of the women given advance packets used their emergency contraception, indicating even women who obtained free packets in advance did not end up always needing them.

Researchers Say Access Does Not Affect Behavior

Raine said the study clearly indicates “giving increased access is not affecting behavior.” “I think the FDA’s decision not to make emergency contraception an over-the-counter medication wasn’t driven by the available data. There is definitely a conservative ideology that education will promote sexual activity.”

“Concerns that people would use emergency contraception as a form of contraception was shot down by the study,” said Dr. Yvonne S. Thornton, vice chair of the department of obstetrics and gynecology at Jamaica Hospital Medical Center in New York. Emergency contraception, Thornton said, is necessary when “condoms break and diaphragms fall out.”

Increased availability of emergency contraception has widespread support from numerous groups, such as Planned Parenthood Federation of America, the National Family Planning and Reproduction Health Association and NARAL Pro-Choice America as well as leading physicians.

But many people do not want to see emergency contraception sitting next to cough syrup and cold medicine on drug store shelves.

“Studies like this give new meaning to political science,” said Wendy Wright, senior policy director for Concerned Women for America, a Washington, D.C.-based public policy advocacy organization. She said the researchers behind studies like Raine’s have their own agenda. “They’ve politicized science.”

Wright said self-reporting questionnaires are “skewed” and not a reliable method of conducting research. (The researchers counter that they did pregnancy and STD tests at follow-ups and did not rely solely on self-reported questionnaires.)

Wright said research from Jamaica indicates that increasing access to emergency contraception resulted in more school-age girls coming in to ask for it and, in Thailand, there’s evidence that men would purchase emergency contraception for young girls. Wright said there’s also research out of the United Kingdom, indicating wider accessibility of emergency contraception led to more sexually transmitted diseases.

“STD rates go up and the number of abortions does not go down,” she said. “They either stay the same in some areas or they go up in other areas (of the world.)”

Raine countered that the same argument was made against making condoms more widely available in vending machines and at college campuses. “People make decisions about sexual behavior based on social parameters, not because they can get more medication,” Raine said. “That evidence is very clear, so there’s really no reason to limit access.”

The morning-after pill was deemed safe for over-the-counter use by an advisory panel to the FDA by a vote of 23-4 in December 2003, but the FDA, which is not bound to its panel’s recommendations, rejected Barr Pharmaceutical’s application.

The pill contains high doses of progestin, also found in oral contraceptives, and can work by either blocking the release of an egg, inhibiting sperm from reaching an egg or preventing a fertilized egg from implanting to the uterine wall, the stage many health care professional consider the start of pregnancy since a fertilized egg cannot progress until it has implanted.

It must be used within 72 hours of unprotected intercourse to be effective. Emergency contraception does not end an established pregnancy and should not be confused with RU-486, another hormone-based medication that is designed to end pregnancies.

When contacted, the FDA said it had no comment on the issue.

Katrina Woznicki is a freelance journalist in Edgewater, N.J., and writes frequently about women’s health.

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