Under fire for the approval of drugs like Vioxx, Oxycontin, and Palladone, the FDA appeared to be carefully considering its decision to make the morning after pill (Plan B) available over the counter (OTC), without a doctor's prescription. The FDA announced last week that further information needed to be gathered before the drug would be safe without a prescription required for minors.
In response, Susan F. Wood, assistant FDA commissioner for women's health and director of the Office of Women's Health, said she was leaving her position after five years as she could "no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
Pro-abortion activists, like NARAL, have rushed to support her, explaining that the FDA had succumbed to political pressure, presumably from social conservatives.
But if Wood is so committed to not playing politics, why is she being represented by the activist PR firm DDB Issues & Advocacy? Go back to her press release. Contact information is given for her "press availability," an unusual element for someone who isn't into politicking. The press release gives an individual's name and contact number. The number happens to belong to DDB whose clients include NARAL, Emergency Contraception, and Safe Motherhood -- all abortion-related projects. DDB's portfolio further establishes its activist credentials.
Meanwhile, these same activist groups fail to mention the real facts about Plan B. They continue to state that the morning after pill is just contraception, that it doesn't cause an abortion even though they say that Plan B works by "inhibiting implantation."
Eggs don't implant. Sperm don't implant. But embryos do. The linguistic loophole they've created suggests that pregnancy doesn't begin until the embryo has implanted. Basic biology, on the other hand, confirms that a unique living human organism exists from the moment of conception. Abortion means ending a pregnancy with the specific intention of destroying an unborn life, no matter how young it may be.
Now, if groups like NARAL and Planned Parenthood are truly concerned about choice, they'd think women are smart enough to handle the facts, all of them. Instead they mask them and deny that this drug can work as an abortifacient.
Perhaps this should come as no surprise since a review of the Plan B label revealed that the drug's labeling left 22 percent of the review's high literacy group unclear on the fact that it is not a form of regular contraception. That rate shot up to 54 percent in the low literacy group. So much for truth in advertising.
Simply put, Plan B is an increased dosage of hormonal birth control pills. According to Planned Parenthood, the two-pill dosage is equivalent to anywhere from a double dose of Ovral taken twice to twenty pills of Ovrette taken in one dose, followed by another twenty twelve hours later. The dosage depends on the type of birth control pill used. Planned Parenthood offers its own conversion chart (scroll down) just in case you don't have access to the morning after pill.
If we follow the politics-versus-science angle that DDB clients, including Susan Wood, tout, it would make sense that the morning after pill would follow a similar, if not more intense, distribution protocol than that of regular birth control bills which generally require a doctor's prescription and a yearly gynecological exam.
The protocol for hormonal contraception recognizes that the drugs can be harmful to some women. These same women would have no knowledge of the potential danger if the drug were available over the counter. It's fair to assume that young women would be particularly at risk since they often are not well informed or are not informing their parents of their actions. Jenny Bacon, a British mother, opposed the OTC availability of the morning after pill because she knows first hand what happens when parents aren't involved in their minor children's decisions. Her 15-year old daughter died from a stroke and coma caused by hormonal birth control.
Plan B's own "Very Important Safety Information" doesn't even list that the drug should not be used as regular birth control. For that matter, it doesn't even talk about the frequency with which the drug should or should not be taken.
The prescribing information provided by Plan B explains that ectopic pregnancies account for two percent of all pregnancies. Immediately after this explanation, the prescribing information relates, "Up to 10% of pregnancies in clinical studies of routine use of progestin-only contraception are ectopic. A history of ectopic pregnancy need not be considered a contraindication to use of this emergency contraception."
Plan B is a progestin-only drug; so the prescribing information should explain why there's no correlation between Plan B and ectopic pregnancy, especially when the normal rate of ectopic pregnancy is only 2%. If anything, the prescribing information suggests that there might in fact be a link and a serious concern. After all, they claim it's just another form of birth control...
Maybe some of the explanations we're looking for could be found in the course Wood taught at Rutgers. In the course intro, she claimed that the course would "provide a background on women's health policy and politics in the United States, focusing primarily on the federal level." It definitely looks like she has the credentials to teach the policy and politics. Perhaps now, we can get down to the science and health aspects.
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