Saturday, February 9, 2008

The Morning After Pill: What you Might Not Know


Introduction to Emergency Contraception

Emergency contraception (EC) also known as the “morning-after-pill” is a little known method of pregnancy prevention that has proved safe and effective through numerous medical reports and case studies. One survey conducted revealed that only six percent of women 18-44 have ever used emergency contraception (Weismiller, 2004). EC may be administered after failure of contraception or unprotected intercourse, including sexual assault. The primary method of EC requires that the first dose be taken within 72 hours following unprotected intercourse (Weismiller, 2004). While some feel that EC should be made more easily accessible by being available over-the-counter (OTC), others feel that it should be limited in availability. I feel OTC availability is a crucial issue to both American woman and men alike because the Food and Drug’s Administration’s (FDA) decision on OTC status could alter their methods to pregnancy prevention. It is important for college-aged individuals between the ages of 17-23 to know the benefits of OTC emergency contraception because they hold a high tendency to incur an unplanned pregnancy. In addition the FDA strictly requires, “if a medication can be offered over-the-counter status, it must be.” Cleary in the issue of emergency contraception, the FDA is not following its own rules.

The Problem

There are many problems surrounding the switching of emergency contraception to over the counter status. These issues range from the FDA requirements on over the counter medications to the time frame in which the medication must be administered to the lack of involvement by the Bush administration. According to the FDA’s requirements for a medication to attain over the counter status, emergency contraception should attain such a status. However the FDA denied OTC status citing that emergency contraception needed to be researched more for young persons. They further argued that making EC available over the counter could alter sexual behavior, especially in woman 15-24 (Science overruled, 2004). The FDA’s decision to deny emergency contraception over the counter (OTC) status is unsubstantiated by medical evidence.

The FDA has strict requirements for a medication to be switched to over-the-counter status and in the case of emergency contraception; there are definite discrepancies in the FDA’s evaluation. First and foremost the FDA requires two studies before granting a medication arrival of OTC status. They first test the comprehensibility of the contraception labeling information then conduct an actual study of the OTC usage (Grimes, 2002). Medical analysis reveals that emergency contraception met the FDA’s labeling requirement (Grimes, 2002). In fact, seven of the eleven labels tested were understood by more than 85% of woman (Grimes, 2002). An actual study of OTC emergency contraception is unnecessary. The drug has already been approved for prescription use and it is impossible for a consumer to overdose.

As for the claim that OTC availability is linked to a change in sexual behavior; this statement is scientifically untrue. A case study conducted by four San Francisco area clinics found that EC does not alter sexual behavior. The case involved 2,117 women ages 15 to 24, participants were each given access to emergency contraception in three forms, at pharmacies, at clinics and in packs of “morning after” pills. The study found that about 55% of those who received “morning after” pills didn’t use them after unprotected sex (Morning after, 2005). In addition the study analyzed their contraception use, their condom use and the number of sexual partners. The findings indicated that there was no increase in risk-taking (Morning after, 2005). This study reveals that if EC were made easily accessible, women would not alter there current procedures for pregnancy prevention.

The second problem stemming from the FDA’s denial of OTC status is that taking EC within the 72 hour period following unprotected intercourse is crucial to the effectiveness of the medication. One randomized controlled study found that the sooner the first dose was taken after intercourse, the greater the effectiveness. The study also concluded that the failure rate at 72 hours after hormonal emergency contraception is approximately 4 percent; this rate increase to 10 percent at five days (Weismiller, 2004). If EC were available OTC, it would be much more accessible within the 72 hour time period. Pharmacies that are open 24 hours would be able to administer the medication without a consultation with a physician. In fact there is little evidence linking a consultation with a physician to the effectiveness of the medication.

Amidst all the controversy concerning OTC status for EC, there has been little acknowledgement by the Bush administration. The Bush administration that is highly non-abortion has made little to no assertions on the matter. Medical physicians recognize that emergency contraception is not abortion because implantation marks the beginning of pregnancy, and emergency contraception works after fertilization but before implantation (Grimes, 2002). The Bush administration appointed the FDA members, and they are rumored to have placed pressure on the FDA’s decision in the case of emergency contraception. These rumors are fueled by the fact that the Joint Advisory Committee to the FDA voted of 23-4 in favor of making Plan B, a form of emergency contraception available over the counter in combination with the FDA’s persistent rejection (Stanley, 2004). In the past the Bush administration has also been linked to discrediting the effectiveness of condoms and erroneously asserting that abortion causes breast cancer (Stanley, 2004). In both case it is evident that the far right ideologies of the Bush administration far outweigh scientific evidence. Nonetheless, the Bush administration has surly done little to support the switch to over the counter, and is publicly withdrawn from the scientific advancement.