WASHINGTON (BP)–Critics of RU 486 again are calling for its removal from the market after two previously unreported deaths were disclosed by the abortion drug’s manufacturer.
Danco Laboratories in New York revealed July 18 that women in California had died in 2004 and in 2005 after using the two-step drug regimen to abort their unborn children. Danco has acknowledged two other California users of RU 486 died in 2003 and a Canadian woman died after its use in 2001. Other reports have cited additional deaths by RU 486 users — three in Europe, one in the Philippines and another in the United States.
Danco announced it would update the safety information on the label for Mifeprex, the American brand name for RU 486, which is also known as mifepristone. The label already contains a “boxed warning,” the Food and Drug Administration’s highest level of warning on a federally approved drug. The deaths were from bacterial infection and sepsis, according to Danco. Sepsis is a systemic reaction to infection that can result in organ failure and death.
The FDA issued a public health advisory regarding off-label use of the drug the day after Danco’s announcement and said it would begin an investigation.
Those steps were not sufficient for critics of RU 486 inside and outside Congress.
Rep. Roscoe Bartlett, R.-Md., urged his fellow representatives to support his RU 486 Suspension and Review Act, H.R. 1079, which would halt sale of the drug while FDA approval of RU 486 is reviewed. The bill is known as Holly’s Law in memory of Holly Patterson, 18, who died of a systemic infection in 2003 after obtaining RU 486 from a Planned Parenthood clinic in Hayward, Calif.
“Clearly, warning labels and letters to doctors are not protecting the life and safety of young American women from this dangerous drug,” Bartlett said in a written statement. “I hope there will be no more deaths reported before Congress approves Holly’s Law.”
David Stevens, executive director of the Christian Medical Association, said in a written release, “With every death of another woman due to RU 486, the FDA’s mandate grows clearer –- to pull this drug for an objective safety review.”
Bartlett’s bill has 73 cosponsors, while a Senate version, S. 511, has only nine cosponsors. Sen. Jim DeMint, R.-S.C., is the sponsor of S. 511.
RU 486, or mifepristone, is used as the first part of a process normally occurring in the first seven weeks of pregnancy. That initial action causes the lining of the uterus to release the embryonic child. A second drug, known as misoprostol, is taken two days after mifepristone and causes the uterus to contract, expelling the baby. Misoprostol normally is used to treat ulcers.
Pro-life organizations, including the Southern Baptist Ethics & Religious Liberty Commission, fought introduction of RU 486 into this country for more than a decade before the drug was approved by the FDA in 2000, the final year of President Clinton’s second administration.
ROMNEY V. ROE — Massachusetts Gov. Mitt Romney not only vetoed legislation expanding access to the “morning-after” pill because it has abortifacient qualities, but he also took a shot at the 1973 Supreme Court decision legalizing abortion.
In a July 26 commentary for The Boston Globe, Romney said he opposes abortion with exceptions for rape, incest and danger to the mother’s life. The Republican governor said in the opinion piece, which was published a day after his veto, he believes “states, through the democratic process, should determine their own abortion laws and not have them dictated by judicial mandate.”
The 1973 Roe v. Wade ruling, coupled with the Doe v. Bolton companion decision, struck down all state bans on abortion and had the effect of legalizing the procedure for any reason throughout all stages of pregnancy.
When he was campaigning for governor in 2002, Romney said in a response to a Planned Parenthood questionnaire he endorsed “the substance of the Supreme Court decision in Roe v. Wade,” The Globe reported.
Romney said in the commentary his “convictions have evolved and deepened” since he became governor in 2003. “In considering the issue of embryo cloning and embryo farming, I saw where the harsh logic of abortion can lead -– to the view of innocent new life as nothing more than research material or a commodity to be exploited,” Romney wrote.
Some observers, especially pro-choice critics of Romney, have said the governor is shifting his position to gain support from social conservatives in the Republican Party in hopes of a run for the White House in 2008.
The bill Romney vetoed would permit pharmacists to provide the “morning-after” pill, also referred to as “emergency contraception,” without a prescription and would mandate that hospitals offer it to rape victims, according to The Globe.
If the “morning-after” pill were only contraceptive in nature, he would not have vetoed the bill, Romney said. “The drug it authorizes would also terminate life after conception,” he wrote. Romney also said the measure does not require parental consent for underage girls. He said signing the bill would have broken a promise he made to voters not to change the law either to limit or promote abortion.
The “morning-after” pill works by restricting ovulation in a woman, but it also can work after conception, blocking implantation of a tiny embryo in the uterine wall, Romney and pro-lifers contend. In such a case, an abortion occurs, pro-lifers point out.
In spite of Romney’s action, the bill is expected to become law. Both houses of the Massachusetts legislature passed the measure with veto-proof majorities.
The “morning-after” pill is basically a heavier dose of birth control pills. Under the regimen, a woman takes two pills within 72 hours of sexual intercourse and another dose 12 hours later. The U.S. Food and Drug Administration has approved prescription use of two brands, Preven and Plan B. The FDA will announce by Sept. 1 whether it will permit over-the-counter sale of Plan B without a prescription to women 16 years of age and older.
NOT BINDING — Neither Supreme Court nominee John Roberts, if he is confirmed, nor any other justice would be obligated to uphold Roe v. Wade, Attorney General Alberto Gonzales told the Associated Press.
In a July 26 interview with AP, Gonzales said Roberts’ comments during a 2003 Senate hearing on his nomination to a federal appeals court would not be binding on him if he were to become a Supreme Court justice. During the hearing, Roberts described the 1973 opinion legalizing abortion as “settled law.” He told senators, “There’s nothing in my personal views that would prevent me from fully and faithfully applying that precedent.”
Gonzales told AP, “If you’re asking a circuit court judge, like Judge Roberts was asked, yes, it is settled law because you’re bound by the precedent. If you’re a Supreme Court justice, that’s a different question, because a Supreme Court justice is not obliged to follow precedent if you believe it’s wrong.”
President Bush nominated Roberts, a District of Columbia Circuit Court of Appeals judge, to replace Sandra Day O’Connor. Though Roberts has yet to address the abortion issue as an appellate judge, most abortion rights organizations are seeking to prevent his confirmation.
Gonzales was considered one of the contenders for the high court nomination that went to Roberts.
According to The Hill, a Capitol Hill newspaper, Senate Majority Leader Bill Frist and Republican members of the Judiciary Committee would like to begin hearings on Roberts in August, when Congress is in recess. Judiciary Committee Chairman Arlen Specter of Pennsylvania, however, would prefer to start the hearings when the Senate reconvenes Sept. 6, the day after Labor Day, The Hill reported.
ABORTION FACTS — The number of abortions in the United States is at its lowest level since 1976, according to a new study by an abortion rights research organization.
The Alan Guttmacher Institute reported about 1.29 million women had abortions in 2002, as compared to 1.61 million in 1990, according to The Washington Post. Other statistics from the analysis, The Post reported, include:
— White women who are non-Hispanic obtained about 40 percent of the abortions in the United States in 2002, while black women had 32 percent and Hispanic women 20 percent.
— Six of 10 women undergoing abortions in 2002 already had children.
— About 56 percent of women who had abortions are in their 20s, while women between 15 and 19 had 19 percent of the abortions.
— The number of abortion providers in the country fell by 11 percent to 1,800 from 1996 to 2000.