Mar. 22, 2006 – The political firestorm over a drug regimen that terminates pregnancies has been reignited in the wake of two deaths linked to the so-called "abortion pill."
The Food and Drug Administration (FDA) announced Friday that the women had died, but did not disclose the exact time, place or cause of death. The reproductive healthcare provider Planned Parenthood has acknowledged that it provided the two women with "medical abortions," which involve a brief drug regimen as an alternative to surgery.
There have now been six known deaths in the United States associated with the use of the abortion drug, RU-486, since its approval for the market in 2000. The confirmed cause of death in the prior four fatalities, all of which occurred in California between 2003 and 2005, was an extreme infection resulting from the bacteria Clostridium sordellii. The FDA has stated that although it is investigating the deaths associated with medical abortion, it is unable to confirm whether the procedure itself directly caused the lethal infections.
While the government and medical experts have generally urged greater precaution when administering the drug and monitoring for complications, groups opposed to legal abortions have seized on the latest deaths to renew their call to have the medical-abortion pill taken off the market altogether.
Though it is often confused with the emergency contraceptive Plan B, RU-486, also known as mifepristone, is actually designed to terminate a pregnancy. The nature of the connection between medical abortion and Clostridium sordellii is unclear, but the four confirmed cases of infection fatalities involved a method of administering the regimen that the FDA does not officially recommend.
According to Planned Parenthood?s estimates, since mifepristone?s FDA approval in September 2000, women have undergone about 560,000 medical abortions in the US.
Under the regimen prescribed formerly by Planned Parenthood and currently by many other healthcare providers, mifepristone taken orally is followed two days later by vaginal insertion of a second drug known as misoprostol. Misoprostol causes uterine contractions, completing the procedure. Misoprostol can also be absorbed buccally, by insertion between the cheek and gum.
The FDA recommends oral administration of both drugs and has stated that the safety of vaginal administration of misoprostol has not been fully tested.
Providers like Planned Parenthood have used the "off-label" vaginal method because medical research indicates that it produces the same outcome with fewer side effects. But following the FDA?s announcement, Planned Parenthood said that it would immediately end its practice of vaginally administering misoprostol.
Vanessa Cullins, Planned Parenthood?s vice president of medical affairs, told The NewStandard that "looking at the constellation of information that we had in front of us, we felt the best possible thing that we could do at this point in time is to only focus on the oral and buccal routes for misoprostol administration."
The medical community may face the toughest challenge in this controversy, as it peers into the science behind medical abortion while ducking the surrounding political maelstrom.
According to Planned Parenthood?s estimates, since mifepristone?s FDA approval in September 2000, women have undergone about 560,000 medical abortions in the US. Planned Parenthood itself has administered over 200,000 procedures since January 2001. The pharmaceutical corporation Danco Laboratories exclusively controls the US marketing of mifepristone under the brand name Mifeprex.
Cullins said her organization?s revision of its protocol was part of an ongoing process of adjusting practices to reflect emerging data on health risks. Nonetheless, the move contrasts sharply with the group?s previous efforts to broaden channels for administering mifepristone to women, such as a successful attempt in 2004 to undo an Ohio law restricting off-label use of the drug.
Even without a concrete causal link between these latest deaths and medical abortion, any implication of danger surrounding medical abortion further polarizes the deep national divide over reproductive rights.
In a statement issued Friday, Senator Jim DeMint (R-South Carolina) called mifepristone "a deadly drug that is killing pregnant women." He warned that "Congress needs to wake up and force [the FDA] to pull this drug before more women die." DeMint is one of several lawmakers who have pushed legislation to ban medical abortions, sponsoring the RU-486 Suspension and Review Act last year to ban and initiate a government investigation of the drug.
An article published last December in the New England Journal of Medicine acknowledged the possibility of fatal infection as a concern for healthcare providers and patients. But the researchers noted that the estimated infection fatality rate is low from a medical standpoint: less than one per 100,000 -- though this figure did not account for the most recent two deaths.
For health professionals involved with medical abortions, rethinking the procedure means refocusing an ideologically fraught debate back onto the woman?s well-being.
Nonetheless, drawing a comparison with surgical abortions administered within the first eight weeks, the researchers found an even lower reported fatality rate for conventional abortions of one per 1 million. They also noted, "in the United States, the risk of death from any cause associated with attempting to carry a pregnancy to term is eight to ten times" the estimated medical-abortion death rate.
Compared with surgical abortions, drug-induced abortions are tied to higher incidence of side effects, like excessive bleeding, as well as somewhat lower success rates, sometimes requiring surgical intervention to complete the termination process. But according to a review of existing research published in 2000 by the New England Journal of Medicine, when administered under close supervision, medical abortions offer a viable, less-invasive alternative to surgical procedures.
Cullins said that medical abortion is a vital option for women who prefer "the privacy, the comfort of being able to actually abort in one?s home or with one?s friends and family, going through a miscarriage-like process."
But anti-abortion-rights groups portray medical abortion not as an option but as a threat.
Concerned Women for America (CWA), a conservative group working to bring "Biblical principles" into all levels of public policy, argues that the latest deaths bolster its claim that the FDA should never have approved the drug. In 2002, CWA and other groups filed a 92-page petition to the FDA arguing that mifepristone had been illegally shuttled through the approval process without rigorous testing or sufficient attention to health risks.
Centering the group?s opposition on moral as well as safety grounds, CWA President Wendy Wright told TNS: "This drug has only one purpose, and that?s to kill a human being. But what?s been discovered is it?s killing not only one, but two ? the baby and the mother." Citing what she called a physical "repercussion" of the "violence" of abortion against the pregnant woman, she argued, "An immoral act does have cascading effects."
Wright argued that Planned Parenthood?s decision to drop its vaginal misoprostol regimen was a political strategy to "divert blame onto the second drug and away from the first drug [RU-486]," which is the "abortion pill" that anti-abortion campaigns have vilified since the 1990s.
However, Cullins read a similar political calculus in CWA?s rhetoric, viewing the reactions of the anti-abortion-rights movement as "an attempt to push their ideology on all men and women in America."
"Unfortunately," she said, "we get pulled into politics, even though our major focus is the health and safety of those individuals that are seeking reproductive and sexual health services."
The medical community may face the toughest challenge in this controversy, as it peers into the science behind medical abortion while ducking the surrounding political maelstrom. The FDA, the Centers for Disease Control and Prevention, and the National Institute of Allergy and Infectious Diseases will convene in May to discuss the fatal infections that have followed medical abortion and other illnesses related to the bacteria Clostridium sordellii.
James McGregor, a visiting professor of obstetrics and gynecology at the University of Southern California?s Keck School of Medicine, says RU-486 deserves closer scrutiny, but he urges a measured approach to improving the safety of medical abortion.
McGregor, who has researched pregnancy-related Clostridium sordellii infections, told TNS that if medical abortion is in fact responsible for the deaths, the danger could lie not just in the vaginal administration of the second drug, but in a synergy between the two medications.
He said that because mifepristone, the first pill, could disrupt the body?s normal immune function, it might in effect be "blocking the body?s response to an infection." He suggested that if mifepristone does pose a significant risk, one potentially safer alternative could actually involve using the second drug, misoprostol, on its own. Clinical studies show misoprostol can induce abortion when taken without mifepristone. A potential side benefit is that misoprostol typically sells for less than $1 per tablet, whereas an RU-486 regimen could cost $270.
For health professionals involved with medical abortions, rethinking the procedure means refocusing an ideologically fraught debate back onto the woman?s well-being.
"Overall," McGregor said, "unwanted pregnancy is much more dangerous, in the great scheme of things."
