Politics and Women's Health: RU-486 Deaths Result in Renewed Calls to Ban Drug
Saturday March 18, 2006
Headlines trumpet two more deaths related to probable off-label use of RU-486 (Mifepristone), known as the abortion pill or morning-after pill, and three politicians immediately renewed calls for legislation ending its sale in the United States.
The reporter fails to put death risk in context; the politicians are grandstanding to core constituencies. The FDA, prudently, reminds practitioners of approved dosing regimes.
From the AP story: More than 1.5 million women have taken the pill in Europe; no deaths reported. Planned Parenthood estimates that RU-486 has been used in the US 560,000 times since 2000.
Four California women had died prior to these latest deaths. That yields a death rate of 1.07 in 100,000. The death risk from a legal abortion is <1 in 100,000.
However, the risk of the mother dying in childbirth, according to the CDC, is 12.1 per 100,000 live births. In other words, although both risks are low, the death risk due to carrying to term is 12 times as great as from taking RU-486. So, shall we outlaw pregnancy? Thought not. [Note: the AP article - near the end - attributes to unnamed FDA officials a risk "similar" to childbirth.]
Proposed Federal Legislation
A few facts about relative risks didn't stop Rep. Roscoe Bartlett (R-MD), Sen. Jim DeMint (R-SC) or Sen. Tom Coburn (R-OK) from renewing calls for legislation to "suspend" sales while the GAO reviews the FDA approval process.
Bartlett has introduced HR 1079 and wants to "pull this dangerous abortion drug from the U.S. market." DeMint has introduced a companion bill, S. 511: "This drug should never have been approved, and it must be suspended immediately."
History
In 2000, the FDA approved RU-486 for terminating pregnancy up to 49 days after the beginning of the latest menstrual cycle. Both bills call for a review of the FDA process, but neither has had a hearing; both were referred to respective committees in March 2005. The legislation is known as "Holly's Law" - named for California woman Holly Patterson, 18, who died after taking RU-486 in 2003.
The Australian goverment says this about RU-486 (even though the drug is not yet available there): it "offers a safe, reliable and non-surgical means of abortion [and] is available in about 33 countries, mainly in Europe."
The pill was approved for use in Europe in the 1980s but was opposed by the Reagan and Bush Administrations. In 1989, Bush banned the importation of the drug; in 1991, the American Association for the Advancement of Science (AAAS) called for testing. Then in 1992, the Supreme Court approved "confiscation of pills brought in from England by Leona Benton."
The reporter fails to put death risk in context; the politicians are grandstanding to core constituencies. The FDA, prudently, reminds practitioners of approved dosing regimes.
From the AP story: More than 1.5 million women have taken the pill in Europe; no deaths reported. Planned Parenthood estimates that RU-486 has been used in the US 560,000 times since 2000.
Four California women had died prior to these latest deaths. That yields a death rate of 1.07 in 100,000. The death risk from a legal abortion is <1 in 100,000.
However, the risk of the mother dying in childbirth, according to the CDC, is 12.1 per 100,000 live births. In other words, although both risks are low, the death risk due to carrying to term is 12 times as great as from taking RU-486. So, shall we outlaw pregnancy? Thought not. [Note: the AP article - near the end - attributes to unnamed FDA officials a risk "similar" to childbirth.]
Proposed Federal Legislation
A few facts about relative risks didn't stop Rep. Roscoe Bartlett (R-MD), Sen. Jim DeMint (R-SC) or Sen. Tom Coburn (R-OK) from renewing calls for legislation to "suspend" sales while the GAO reviews the FDA approval process.
Bartlett has introduced HR 1079 and wants to "pull this dangerous abortion drug from the U.S. market." DeMint has introduced a companion bill, S. 511: "This drug should never have been approved, and it must be suspended immediately."
History
In 2000, the FDA approved RU-486 for terminating pregnancy up to 49 days after the beginning of the latest menstrual cycle. Both bills call for a review of the FDA process, but neither has had a hearing; both were referred to respective committees in March 2005. The legislation is known as "Holly's Law" - named for California woman Holly Patterson, 18, who died after taking RU-486 in 2003.
The Australian goverment says this about RU-486 (even though the drug is not yet available there): it "offers a safe, reliable and non-surgical means of abortion [and] is available in about 33 countries, mainly in Europe."
The pill was approved for use in Europe in the 1980s but was opposed by the Reagan and Bush Administrations. In 1989, Bush banned the importation of the drug; in 1991, the American Association for the Advancement of Science (AAAS) called for testing. Then in 1992, the Supreme Court approved "confiscation of pills brought in from England by Leona Benton."
Editorial cartoons from Cagle.
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