Planned Parenthood Sues to Violate FDA Protocols, Injure Women With Dangerous Abortion Drug
by Steven Ertelt | Phoenix, AZ | LifeNews.com | 3/5/14 6:42 PM
The abortion drug is responsible for the deaths of dozens of women worldwide, including several in the United States alone, and it has injured at least 1,100 women in the United States alone as of 2006 figures from the Food and Drug Administration. Yet, the abortion business has filed suit to void an Arizona law to require FDA protocols be followed when dispensing the dangerous abortion drug RU 486 (mifepristone).
The dangerous RU 486 abortion drug has nearly claimed the lives of two million unborn children in the United States since its approval at the end of the Clinton administration.
In addition to the number of unborn children whose lives have been lost to the abortion drug, women have suffered as well, as a Planned Parenthood study admits at least one woman is seriously injured from the abortion pill daily.
The federal lawsuit filed in U.S. District Court in Tucson by Planned Parenthood Arizona and Tucson Women’s Center alleges that the new rules required under a 2012 law will effectively block the ability of many women to use medication abortions. Lawyers for the Center for Reproductive Rights and the Planned Parenthood Federation of America are representing them.
The rules released in January by the Arizona Department of Health Services are set to take effect April 1. They require that the most common abortion-inducing drug be administered only at the FDA-approved dosage no later than seven weeks into a pregnancy rather than nine weeks, and that both doses be taken at the clinic.
But the president of the Center for Arizona Policy, a pro-life group, tells LifeNews Planned Parenthood is putting women at risk. From Cathi Herrod:
Arizona’s largest abortion provider has once again put profits before the health and safety of women by challenging common sense medical standards in court.
Planned Parenthood is suing the state because our elected officials believe that the dangerous and deadly abortion pill should be dispensed pursuant to Federal Food and Drug Administration rules.
The abortion pill has been responsible for at least 21 deaths, yet Planned Parenthood is taking the state to court in order to dispense this dangerous medication outside FDA protocol (FDA protocol says the abortion pill should only be dispensed through 7 weeks of a pregnancy. Planned Parenthood is suing to dispense the pill through 9 weeks).
Arizona has a strong record of passing constitutionally sound laws to protect women and preborn children. Since 2009, 27 different common sense pro-life provisions have been signed into law. Twenty-five of those are in effect today, and only two have been overturned by courts.
What’s more, Federal Circuit Courts have already ruled that this provision is constitutional. The Sixth Circuit Court of Appeals ruled this same law in Ohio was constitutional, and the Fifth Circuit Court of Appeals denied a preliminary injunction from Planned Parenthood in Texas, saying that the law is likely to be upheld.
It is a shame that when Planned Parenthood can’t win public opinion, they try to use the courts to impose their will and bail out their abortion business.
The FDA, with no fanfare, released its April 2011 report showing 14 women in the United States alone have died from using the mifepristone abortion drug and 2,207 women have been injured by it.
Of the women experiencing medical and physical problems resulting from the abortion drug, 612 women required hospitalizations, 339 experienced blood loss significant enough to require a transfusion, 256 experienced infections and 48 women experienced what the FDA labeled as “severe infections.” Given that the RU 486 abortion drug caused sepsis, a potentially lethal infection that resulted in the deaths of women from around the world, the “serious infections” were very likely life-threatening situations.
“Severe infections generally involve death or hospitalization for at least 2-3 days, intravenous antibiotics for at least 24 hours, total antibiotic usage for at least 3 days, and any other physical or clinical findings, laboratory data or surgery that suggest a severe infection,” the FDA report stated.
Women developing infections from usage of the RU 486 abortion drug experienced endometritis (involving the lining of the womb), pelvic inflammatory disease (involving the nearby reproductive organs such as the fallopian tubes or ovaries), and pelvic infections with sepsis (a serious systemic infection that has spread beyond the reproductive organs).
The FDA figures also reveal that abortion businesses like Planned Parenthood are still misusing the abortion drug.
Despite the FDA indicating, “Administration of mifepristone and misoprostol is contraindicated in patients with confirmed or suspected ectopic pregnancy (a pregnancy outside the uterus,” the abortion drug was given to women in 58 cases where they had an ectopic pregnancy at that time.
An FDA panel eventually investigated the deaths and found that the vaginal, rather than oral, use of the abortion drug was likely contributing to the deaths. Planned Parenthood had been going against the FDA guidelines on using the abortion drug and changed its protocols to allow for oral use after women died at their facilities.
In 2012, Chris Gacek, who received a Bachelors of Science in economics from the Wharton School, University of Pennsylvania, a Masters and Ph.D. in political science from Stanford University, and a J.D. from the University of Virginia School of Law, authored a comprehensive report on mifepristone.
On the unsafe effects of RU 486 for women:
Dr. Ralph Miech, emeritus professor at Brown University’s medical school, has published two peer-reviewed articles describing potentially undesirable effects related to RU-486 and its anti-glucocorticoid properties. First, he believes that RU-486′s blockade of cortisol receptors on bacteria-destroying white blood cells may impede the antibacterial defense mechanism of the innate immune system. Such interference, he hypothesizes, played a significant role in the deaths of at least five North Americans in which there was a post abortion, bacterial invasion of the uterus and subsequent septic shock. Second, prompted by an article describing mifepristone-related adverse events with significant and unexpected levels of hemorrhage, Miech’s second article argues that RU-486 appears to interfere with the body’s ability to control uterine hemorrhage. Such interference, if true, would be a dangerous feature of an abortion procedure that is designed to produce a simulated miscarriage. As will be noted below, the number of hemorrhage/transfusion and serious infection cases revealed by FDA support Miech’s concern about RU-486 and hemorrhage.
Looking at specific cases of the abortion drug hurting women:
FDA’s April 2011 RU-486 Adverse Events Summary states that “[t]he estimated number of women who have used mifepristone in the US through the end of April 2011 is approximately 1.52 million women.” As noted above, FDA calculated that by that date there had been 2,207 adverse event reports submitted to FDA. Prior to a 2006 oversight hearing on RU-486 safety, FDA told Rep. Mark Souder (R-Ind.) that it had received 1,070 AERs. Thus, in the second five years of mifepristone marketing in the United States, the FDA received an additional 1,137 AERs-a total which seems consistent with the first five years.
The April 2011 RU-486 Adverse Events Summary states that there were 612 reports of hospitalization received as of April 30, 2011.
FDA’s April 2011 RU-486 Adverse Events Summary indicates that 339 women “experienced blood loss requiring a transfusion” after taking the RU-486 abortion regimen.
By April 2011 FDA had fifty-eight reports of ectopic pregnancy cases – with two resulting in death – in conjunction with mifepristone-misoprostol use.
In the April 2011 RU-486 Adverse Events Summary FDA associated fourteen American deaths to the use of the mifepristone-misoprostol abortion regimen.
And, according to a study on medical abortion’s safety and effectiveness published in Obstetrics & Gynecology and that Gacek noted, the abortion drug is more dangerous for women than surgical abortions:
“Overall, medical abortion had roughly four times the rate of adverse events than surgical abortion did: 20.0% of women in the medical-abortion group and 5.6% of women in the surgical-abortion group had at least one type of adverse event. Hemorrhage, as an adverse event, was experienced by 15.6% of medical abortion patients compared with 2.1% for surgical patients. Incomplete abortions were experienced by 6.7% of medical abortion patients while only 1.6% of surgical patients had incomplete abortions. The rate for surgical (re)evacuation of the uterus was 5.9% (medical) versus 1.8% (surgical) for all causes (hemorrhage, infection, incomplete abortion).
Jeanne Monahan, formerly of the Family Research Council, previously said the danger associated with the RU 486 abortion drug are abortion drug is not limited to the United States.
“It is not only women in the U.S. who are suffering as a result of chemical abortion, it is a worldwide trend. A recent Australian health department audit of nearly 10,000 abortions performed in 2009 and 2010 compared the safety of RU-486 with surgical abortion, with the outcome being in the words of one major media outlet “The Abortion Pill ‘Less Safe than Surgery,’” Monahan explained. “The Australian report showed that 1 in 18 patients who used RU-486 had to be re-admitted to hospitals (a total of 5.7% of women vs. only .4% of surgical abortions.) The same study revealed that as many as 33% of women who had second trimester RU-486 abortions required some form of surgical intervention.”
“Despite the seriousness and intensity of adverse effects related to RU-486, use of this form of abortion is on the rise, and frequently the regimen is dispensed with less medical oversight than surgical abortion,” Monahan said. “Even more troubling, nationally and internationally, “telemed” dissemination of RU-486 is increasing. Telemed abortions involved doctors proscribing RU-486 through Skype or over the Internet rather than during a patient visit.”
“The bottom line is that abortion drugs are not about improving women’s health but are more accurately about advancing a radical pro-abortion agenda regardless of the impact on women’s health, even when it proves deadly,” she concluded.
Danco Laboratories has been granted an exclusive license from the Population Council, a pro-abortion group, to manufacture, market and distribute Mifeprex in the United States.