RU-486: Ten Years After
09/28/2010
Today, September 28, 2010, marks the ten-year anniversary of the U.S. Food and Drug Administration’s (FDA) approval of Mifepristone (popularly known as RU-486). RU-486 is the only drug the FDA has approved for the sole intention of inducing abortions.
While proponents often claim that abortion should be “safe, legal and rare,” one could make a strong case that chemical abortions, while indeed legal, have over the last ten years posed major safety concerns including infection, life-threatening bleeding and even maternal death.
Chemical abortions have become anything but rare. Despite this dubious safety record, it appears to be a major goal of the abortion industry to increase the number of chemically induced abortions.
By way of explanation, RU-486 is in a class of drugs called selected progesterone receptor modulators (SPRM). RU-486 is “effective” because it blocks the necessary action of progesterone, the key hormone that a baby needs to implant in the uterus and survive during the first ten weeks of development. In this way RU-486 cuts off nutrition to a developing unborn child.
Looking back at the spring and summer of 2000, the FDA approval process of RU-486 was flawed, rushed, politicized and deviated from the FDA norm in a variety of ways, including the use of inferior clinical trials to support its safety. For example, when the FDA’s advisory panel voted to approve RU-486 in 1996, American trial data was neither finished nor sufficient, so the FDA relied on French data primarily, which is atypical.
Worse yet, this same data had been found by the FDA to be marked by “carelessness,” “fraud” and “evidence tampering.” Those were the FDA’s own words! This is one example of many.
Over the course of the next six years story after story hit the news about the serious side effects of RU-486—the most grievous ones being death. One of the most well-known tragedies involved the death of Holly Patterson, an 18-year-old from California. In 2003, Holly received RU-486 at a Planned Parenthood clinic and died a week later from septic shock.
In her father’s words, “The medical community treats this as a simple pill you take, as if you’re getting rid of a headache. The procedure, the follow-ups, it’s all too lackadaisical. The girl gets a pill. Then she’s sent home to do the rest on her own. There are just too many things that can go wrong.”
Holly is only one of many negatively impacted by this “safe” and legal drug. In fact, as recent as 2006, only six years following its approval, the FDA admitted that they had received over 1,000 adverse-event reports related to RU-486. Of these, 116 cases involved blood transfusions, 232 required hospitalizations, and most grimly, 8 were fatal incidents. As shocking as these numbers are, they are a gross underestimation because approximately only 10% of problems with drugs are submitted in reports to the FDA.
Yet despite concerns about safety, use of RU-486 is increasing. A recent New York Times article touted the growing popularity of the drug. One group recently reported that the number of Planned Parenthood Clinics providing chemical abortions with RU-486 has increased over the last few years: in 2007, 108 facilities administered RU-486 whereas in 2009, the number had increased to 131.
One reason for the increase in RU-486 abortions is that Planned Parenthood has begun a process called “telemed abortions.” In these abortions, the doctor is no longer physically present with the patient when prescribing RU-486 and its accompanying drug. The doctor does it by closed circuit TV.
The procedure is attractive to abortionists given their declining ranks. With telemeds, fewer doctors can prescribe a greater number of abortions. Unfortunately, fewer doctors also mean reduced patient oversight, attention and care. For example, the doctor might be in another state when the woman having the abortion needs critical attention—like a transfusion caused by a failed abortion or damaged ongoing pregnancy—and has to go to an emergency room. Despite the gross inferiority of this procedure, in May 2010, Planned Parenthood announced a five-year plan to nationalize “telemed” abortions.
As RU-486 celebrates its ten-year anniversary, one thing is ironic. The abortion movement promised decades ago that women having abortions would have the best medical attention—no more unsupervised, lonely abortions with women bleeding away in back alleys. Well, now with chemical, and especially with telemed abortions, women have less medical attention and still bleed away, having a lonely, unsupervised abortion over a toilet. Progress for women’s health? No. Instead, pursuing an agenda of increasing chemical abortions at all costs, the abortion industry is reverting women’s health back to the Dark Ages.
While proponents often claim that abortion should be “safe, legal and rare,” one could make a strong case that chemical abortions, while indeed legal, have over the last ten years posed major safety concerns including infection, life-threatening bleeding and even maternal death.
Chemical abortions have become anything but rare. Despite this dubious safety record, it appears to be a major goal of the abortion industry to increase the number of chemically induced abortions.
By way of explanation, RU-486 is in a class of drugs called selected progesterone receptor modulators (SPRM). RU-486 is “effective” because it blocks the necessary action of progesterone, the key hormone that a baby needs to implant in the uterus and survive during the first ten weeks of development. In this way RU-486 cuts off nutrition to a developing unborn child.
Looking back at the spring and summer of 2000, the FDA approval process of RU-486 was flawed, rushed, politicized and deviated from the FDA norm in a variety of ways, including the use of inferior clinical trials to support its safety. For example, when the FDA’s advisory panel voted to approve RU-486 in 1996, American trial data was neither finished nor sufficient, so the FDA relied on French data primarily, which is atypical.
Worse yet, this same data had been found by the FDA to be marked by “carelessness,” “fraud” and “evidence tampering.” Those were the FDA’s own words! This is one example of many.
Over the course of the next six years story after story hit the news about the serious side effects of RU-486—the most grievous ones being death. One of the most well-known tragedies involved the death of Holly Patterson, an 18-year-old from California. In 2003, Holly received RU-486 at a Planned Parenthood clinic and died a week later from septic shock.
In her father’s words, “The medical community treats this as a simple pill you take, as if you’re getting rid of a headache. The procedure, the follow-ups, it’s all too lackadaisical. The girl gets a pill. Then she’s sent home to do the rest on her own. There are just too many things that can go wrong.”
Holly is only one of many negatively impacted by this “safe” and legal drug. In fact, as recent as 2006, only six years following its approval, the FDA admitted that they had received over 1,000 adverse-event reports related to RU-486. Of these, 116 cases involved blood transfusions, 232 required hospitalizations, and most grimly, 8 were fatal incidents. As shocking as these numbers are, they are a gross underestimation because approximately only 10% of problems with drugs are submitted in reports to the FDA.
Yet despite concerns about safety, use of RU-486 is increasing. A recent New York Times article touted the growing popularity of the drug. One group recently reported that the number of Planned Parenthood Clinics providing chemical abortions with RU-486 has increased over the last few years: in 2007, 108 facilities administered RU-486 whereas in 2009, the number had increased to 131.
One reason for the increase in RU-486 abortions is that Planned Parenthood has begun a process called “telemed abortions.” In these abortions, the doctor is no longer physically present with the patient when prescribing RU-486 and its accompanying drug. The doctor does it by closed circuit TV.
The procedure is attractive to abortionists given their declining ranks. With telemeds, fewer doctors can prescribe a greater number of abortions. Unfortunately, fewer doctors also mean reduced patient oversight, attention and care. For example, the doctor might be in another state when the woman having the abortion needs critical attention—like a transfusion caused by a failed abortion or damaged ongoing pregnancy—and has to go to an emergency room. Despite the gross inferiority of this procedure, in May 2010, Planned Parenthood announced a five-year plan to nationalize “telemed” abortions.
As RU-486 celebrates its ten-year anniversary, one thing is ironic. The abortion movement promised decades ago that women having abortions would have the best medical attention—no more unsupervised, lonely abortions with women bleeding away in back alleys. Well, now with chemical, and especially with telemed abortions, women have less medical attention and still bleed away, having a lonely, unsupervised abortion over a toilet. Progress for women’s health? No. Instead, pursuing an agenda of increasing chemical abortions at all costs, the abortion industry is reverting women’s health back to the Dark Ages.
Jeanne Monahan is the director of the Center for Human Dignity at the Family Research Council. Prior to FRC, Jeanne worked for the U.S. Department of Health and Human Services in the Office of the Secretary. She has an undergraduate degree in psychology from James Madison University and a Masters degree in the theology of marriage and family from the Pope John Paul II Institute for Studies on Marriage and Family.
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