FDA Approval of Morning-After Pill Based on Inconclusive Data, Charges Group

According to a charges leveled by the Population Research Institute (PRI), the FDA decision to grant the morning after pill (MAP) over the counter status was based on inconclusive data on the effects and efficacy of the drug. The status is currently scheduled for the change in May. Dr. Carole Ben-Maimon, president and chief operating officer of Barr Research, the producers of the drug, has reportedly said MAP is "an additional contraceptive option" that will provide a "significant public health service to American women."

When testifying in front of the FDA in December, proponents of the drug relied primarily on estimates by the Allen Guttenmacher Institute (AGI), the research arm of abortion provider Planned Parenthood. The main Guttmacher study on contraceptive use relied on just a single medical study done in 1999, the data from which determined the morning-after pill's efficacy rate to be 65%. The overall calculated estimate used by proponents of the drug during the hearing was 75%, but Dr. Chris Kahlenborn admitted that this "rate could be artificially inflated."

Critics explain that the danger of attaching higher efficacy rates could create an even greater use of the MAP as a contraceptive. MAP producers have run advertising making these claims and at least one received a warning letter from the FDA for radio and print ads that "overstate efficacy, fail to convey important limitations on use, and minimize important information about risks associated" with the drug.

While producers exaggerate the efficacy of the drug, they also downplay the health risks. Last week USA Today reported, "The pill prevents 89% of pregnancies" and "does not pose health risks in other nations." Yet, concerns have been raised by experiences in other countries, notably the UK, where MAP has already been widely available to girls. Sir Liam Donaldson, the UK government's chief medical officer, posted an urgent notice to all doctors in 2002, that among other potential risks, MAP causes an increased risk of ectopic pregnancies.

Critics also charge that the drug is marketed without letting women and girls know that is can cause an abortion. Producers and proponents now make the claim that pregnancy starts at implantation and therefore any interruption prior to implantation could not be considered an abortion. This contradicts what is presented in all medical textbooks that place pregnancy starting at conception.

Critics also wonder if young people will know how to use the drug.

A label comprehension study provided to the FDA showed some age groups answered incorrectly 60% of the time. Even the FDA admitted “participants did not clearly understand” the schedule to take the drug. PRI says that approving the morning after pill amounts to inflicting "upon our nation's youth a great medical and social experiment" because "the use/abuse of Plan B by adolescents has not been adequately studied."

 CULTURE & COSMOS
April 27, 2004    Volume 1, Number 38
Copyright---Culture of Life Foundation.
Permission granted for unlimited use. Credit required.

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RARTL Updated May 2004