Note: this didn't happen yet, they had some bad data when writing the article, but the rest is good

CULTURE & COSMOS

April 27, 2004 Volume 1, Number 38

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."

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