How does this FDA decision affect your center, your clients and your community?
Considerable changes were made to the Risk Evaluation and Mitigation Strategy (REMS) safety program. These changes affect how it can be prescribed and dispensed. This decision by the FDA will affect thousands of women in the coming year.
There are over 20,000 prescription drugs approved by the FDA, there are just 74 medications deemed so dangerous to warrant a REMS restriction and one of these was mifepristone.
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
This was one last safety barrier in place for chemical abortion of a process that’s been shown to be four times more dangerous than surgical abortion.
The REMS for mifepristone was intended to minimize the significant risk of hemorrhage, retained fetal tissue, and infection – symptoms that can quickly become life-threatening for women. This was not restrictive – it was protective of the thousands of women who take this drug every year in the US.
We really do not have a true picture of the dangers of mifepristone because the FDA made the decision in 2016 to stop collecting data on nonfatal adverse events related of mifepristone - instead they have only been collecting data on maternal fatalities related to the drug. Unless women actually died, they did not make note of the complications or injuries to women caused by mifepristone for more than five years. With only voluntary reporting, no one in America is systematically collecting data on the women hurt or killed by mifepristone complications.
However, recent analysis of the Adverse Events submitted to the FDA with the REMS in place shows over 3000 women suffering with complications, of which 24 of those women died, and another 500 would have died if they had not reached emergency medical care in time. And we know that up to 7% of women will need surgical intervention after a chemical abortion.
Mifepristone causes pain and bleeding that can become perilous, but the FDA also warns women to expect nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness in the first day or two. Chemical abortion is quite a miserable experience for nearly all women who take these drugs, dangerous for the thousands suffering complications and can even be deadly for the most unfortunate.
The FDA said it made changes "to minimize the burden on the healthcare delivery system" and "to ensure that the benefits of the drug outweigh the risks." Sadly, the FDA has chosen to ignore the thousands of women in need of emergency care who were injured by chemical abortion and has caved to the pressures of ACOG, World Health Organization, the American Medical Association and Big Abortion.
Although the FDA continues to allow in-person dispensing at a clinic or other medical setting, the FDA removed the requirement that it must be dispensed in person. This means that abortion pills can now be sent in the mail across state lines without seeing a doctor. Regrettably, telemedicine has emerged as a viable option to expand the availability of abortion. By lifting the REMS, the FDA has allowed providers in states without telehealth restrictions to dispense mifepristone without a clinic visit. There is much risk in not providing assessment for ectopic pregnancy, accurate determination of gestational age, testing and treatment for Rh- incompatibility, fully informed consent, and assessment for coercion prior to prescribing mifepristone.
Mifepristone must be prescribed by or under the supervision of a certified healthcare provider who meets certain qualifications. The prescriber must sign a Prescriber Agreement Form with the manufacturer and patients must still sign a "Patient Agreement Form.” When signing this form, women agree they were counseled regarding the dangers of bleeding, infection and ectopic pregnancy; the failure rate of chemical abortion (estimated by the manufacturer to be 3-7%); and what to do in the event of emergency symptoms. They also must agree to take the second drug, misoprostol, 24-48 hours later, which inappropriately seems to remove their rights to withdrawal their informed consent if they wish to continue their pregnancies. They are also provided with a letter to take to the emergency department if symptoms require urgent medical care.
Previously, mifepristone was not available by prescription at commercial pharmacies. Women couldn’t just pick it up at Walgreens or CVS; it was most frequently prescribed and dispensed at an abortion facility. The FDA is now allowing prescriptions at certified pharmacies, helping to facilitate e-prescriptions for mifepristone. This certification is between the pharmacy and the manufacturer of the abortion drug and is not regulated by the FDA.
Informed consent is the idea that patients have the right to know as much information as possible about the risks and benefits of a medical procedure and use that knowledge to decide whether they want to receive the procedure. There are many ways your center can assist women to be fully informed about their pregnancy decisions:
If your client has started a chemical abortion and has regret, she can learn more about reversing the effects of chemical abortion and possibly continuing her pregnancy by contacting the Abortion Pill Rescue® Network hotline 877.558.0333 or at the APR website to begin a live chat. We have a team of nurses waiting to answer questions, explain reversal, and connect her with an APRN Provider in her area.
Women deserve to know the truth; they don’t give up that right when they seek an abortion. Help is available for women who have taken the first abortion pill and experience regret. APRN offers the chance to reverse the effects of the chemical abortion pill and potentially continue their pregnancies. Statistics show that more than 2,500 babies have been saved through the APRN.
Heartbeat International is the first network of pro-life pregnancy resource centers in the U.S. and the largest and most expansive in the world. Since 1971, Heartbeat has supported, strengthened and started pregnancy help organizations, including pregnancy medical clinics, pregnancy resource centers, maternity homes, and adoption agencies all over the world. Currently, Heartbeat serves over 3,000 affiliate locations on all six inhabited continents to provide alternatives to abortion.
We are a nonprofit, interdenominational Christian association of faith-based pregnancy resource centers, medical clinics, maternity homes, and nonprofit adoption agencies endorsed by Christian leaders nationwide.
...is to make abortion unwanted today and unthinkable for future generations.
...is to Reach and Rescue as many lives as possible, around the world, through an effective network of life-affirming pregnancy help, to Renew communities for LIFE.
To achieve our mission, we do the following:
We REACH those who are abortion-vulnerable through Option Line's® 24-hour call center and cutting-edge website, www.OptionLine.org.
"Reach down your hand from on high; deliver me..." - Psalm 144:7
We RESCUE those who are reached through our life-support network of pregnancy centers providing true reproductive health care, ministry, education, and social services where lives are saved and changed.
"Rescue me, O Lord, from evil men; protect me from men of violence. " - Psalm 140:1
We RENEW broken cities around the world, by developing pregnancy centers where abortion clinics are the only alternative for abortion-vulnerable women.
"He sent me to bind up the brokenhearted...to proclaim the year of the Lord's favor... They will renew the ruined cities that have been devastated for generations." - Isaiah 61:1-4
by Susan Dammann RN LAS, Medical Specialist
Did you know most abortions are unwanted, including as much as 64 percent of U.S. abortions involving coercion? Abortion-related coercion can lead to violence, including even homicide—the leading cause of death among pregnant women.
Do you know teens are especially at risk for unwanted, coerced and forced abortions, as well as the many forms coercion can take?
Escalating pressure to abort can come from employers, husbands, parents, doctors, partners, profit-driven abortion businesses, landlords, friends and family or even trusted financial, personal, academic or religious guides, gatekeepers or authorities.
These subjects and many more are included in the peer-reviewed Special Report from the Elliot Institute, Forced Abortion in America.
This valuable resource is free to download, and is an excellent tool for educating yourself and your staff about what society commonly calls a woman’s choice, but in reality is often the un-choice. The report contains the following information:
• Nearly 80% of abortions take place in non-hospital facilities, ill-equipped for emergency care.• 31% had health complications afterwards.• 65% suffer multiple symptoms of post-traumatic stress disorder.• 65% higher risk of clinical depression. • 10% have immediate complications, some are life-threatening.• 3.5x higher risk of death from all causes. • Suicide rates are 6 times higher if women abort vs. giving birth.
This is just a sampling of the information contained in this report, complete with many documented case reports. As clients come into our centers looking for our help, it is critically important to educate our staff about what is happening to so many women who find themselves in an unexpected pregnancy.
Equipped with this information, your staff can be vigilant to listen for and explore any indications the client may give, suggesting she may be in a situation involving potential or real violence and coercion.
A woman dealing with both an unexpected pregnancy and coercion-related issues may be frightened to verbalize the threats she is experiencing so we must pray for God’s discernment as we meet with our clients, while developing screening skills to identify potential abuse victims, as well as policies and procedures for intervention when a case of abuse is identified.
Statistics above compiled April 2014.
Book by Janet MoranaReview by Jay Hobbs, Communications Assistant
From forward—written by the brilliant Fr. Frank Pavone—to conclusion, Janet Morana’s Recall Abortion makes a compelling case that now is the time to take the “failed product” of abortion off the proverbial shelves of American life.
Janet, who serves as Executive Director of Priests for Life and is the Co-Founder of the Silent No More Awareness Campaign, leads off chapter two with an especially gripping statement:
Abortion is the greatest hoax ever perpetrated against women, and those who profit from abortion are the snake oil salesman of our time. This statement may strike some as sensationalism, but I assure you it is not. The evidence in this book will show that it is no exaggeration. (pg. 15)
Indeed, the evidence Recall Abortion presents supports Janet’s claim, and then some. After summarizing several cases of women who have endured (in some cases permanent and chronic) physical complications stemming from abortion, Janet wraps up chapter two with a compelling comparison of recalled American products, ranging from 1978 Ford Pintos to 2000 Firestone tires.
What is expertly implied throughout is made explicit to end this foundational chapter:
Think back to the heartbreaking stories of the women who have testified on Silent No More. Think back to the testimonies of former abortion doctors. Abortion kills babies. And it harms women, physically, psychologically, and emotionally. Isn’t it time to rethink our abortion policy? Isn’t it time to recall abortion?
Another excellent feature of this book—which makes it a good “loaner” or gift to your friends, family, and church leadership—is its weaving in and out of the firsthand accounts of women (and men!) who have been deeply damaged by past abortion.
If one and four women will submit to an abortion by age 45, as Planned Parenthood research arm Guttmacher Institute estimates, then those on the fringes of the prolife movement—your pastor, minister, priest, or friendly theology student—somehow need to be brought into contact with these real women and men. Recall Abortion l is a great place for these friends to start.
Recall Abortion does an excellent job of replacing numbers with faces, pie charts with stories. But its reach doesn’t end there. It also tackles the so-called “hard cases,” including abortion in the cases of rape and incest, fetal deformalities, and the life of a mother.
Pick up a copy or five—or 10—and spread the word that now is the time to recall abortion.
Director of Education and Research for the National Right to Life Educational Trust Fund Randall K. O’Bannon Ph.D and Director of Research and Public Policy for the American Association of Pro-Life Obstetricians and Gynecologists Dr. Donna Harrison have written a duo of fantastic articles that you can read and download in their entirety at http://www.abortionresearch.us/images/Vol24No1.pdf for use in your centers as well as education for your staff.
Let me whet your appetite with a few excerpts from the 12 page well-referenced articles…
By Randall K. O’Bannon Ph.D, Director of Education and Research for the National Right to Life Educational Trust Fund
“The discovery of the pregnancy hormones progesterone (1929) and estrogen (1934) opened up whole new possibilities. Gregory Pincus, one of the co-inventors of the oral contraceptive pill, theorized that “anti-progestins should be implantation inhibitors,”
“Etienne-Emile Baulieu visited Pincus in Puerto Rico, where trials were being conducted of the new birth control pill, and came away determined to devote his life to steroid research, believing Chemical contraception central to women’s health and to control of the world’s population (Lader, RU-486, 29-30, Baulieu, 69).
“He returned to France and began working as a consultant to French pharmaceutical giant Roussel Uclaf…”
“Normally in pregnancy, progesterone, produced by the corpus luteum, functions to build and maintain the endometrium, which welcomes and then sustains the developing child in his or her earliest days. As pregnancy progresses, the placenta takes over progesterone production, but those critical first weeks are crucial to the establishment of the child’s nurturing and protective environment.”
“Anti-progestins bind to the same receptor sites as progesterone, but then do not carry out the same tasks. With the progesterone signal effectively blocked, the endometrial lining decays and sloughs off, depriving the developing child of essential nutrients, essentially starving her or him to death as the protective environment around her or him collapses.”
“Ultimately, under what The New York Times termed “sustained political pressure from the Clinton administration, a deal was struck granting U.S. licensing rights to the Population Council of New York in May of 1994. Roussel agreed to turn over all rights and responsibilities connected to the drug to the Population Council for free, hoping to avoid becoming a boycott target.”
“A common medical issue in many of these deaths is how difficult it is, for both patients and doctors, to distinguish between the ordinary side effects of chemical abortion, which are often severe, and the signs of a serious problem like hemorrhage, ruptured ectopic pregnancy, or infection.”
“Women are told to expect heavy bleeding, akin to a heavy period, and understand that the abortion will be painful. When these occur, they assume that they are related to the abortion process. If the pain and bleeding become so substantial that they call the clinic or go to the emergency room, even the medical professional may consider the events to be abortion-related. Brenda Vise called the clinic repeatedly and was told that her considerable pelvic pain was normal. The doctor at the ER did a physical exam of Holly Patterson and sent her home with more pain medication. Both were dead before the week was out.”
“Many abortion clinics are ignoring the FDA protocol, changing doses of the drugs extending the cutoff date from 49 days to 63, eliminating the second visit and letting women take the misoprostol at home (San Francisco Chronicle, 12/5/11), or even going so far as to prescribe the drugs via webcams, eliminating all direct physical contact between doctor and patient entirely (KCCI, 5/1910; Sioux City Journal, 10/8/10). Failures and complications are not only common, but more problematic, as women are farther removed from the careful medical monitoring that is essential to this process.”
“The Guttmacher Institute estimated that in 2008, more than a quarter of all abortions done at 9 weeks gestation or earlier were chemical abortions and both the overall percentage of chemical abortions and the number of clinics offering these abortions have been steadily increasing. If things continue trending as they are, it means that we can expect more women will die, along with tens of thousands more of their unborn children.”
Dr. Harrison’s article reports that multiple studies demonstrate that first trimester medical abortions utilizing mifepristone and misoprostol result in:
By Donna Harrison, M.D,, Director of Research and Public Policy, American Association of Pro-Life Obstetricians and Gynecologists
“The use of non-surgical (medical) abortion in the developing world has had great appeal for abortion advocates. Surgical procedures in third world countries with poor medical infrastructure, lack of dependable transportation to emergency centers, and even inadequate water supplies pose health risks for patients electing to have a surgical abortion. On the other hand, simply taking a pill to undo the pregnancy appears to be a good solution for third world women. “
“The reality is that surgical abortions are still necessary in a number of cases because the pill fails; medical abortions are being attempted in settings with inadequate backup to care for complications; and hemorrhaging, a common side-effect of RU-486 abortions, is harder to control in third world environments. Unfortunately, there is a tendency to disregard such problems by enthusiastic abortion advocates, eager to expand abortion use in these countries.”
“In a moment of unguarded honesty, an ironic article, entitled Medical abortion: Is it a blessing or curse for the developing nations?, was published in the medical literature in 2011 ... [T]his article gives a rare glimpse into the reality of willy-nilly access to drugs which can end a pregnancy … The abstract opens with this statement:
"Medical abortion is definitely a safer and a better option, but in developing countries, its widespread misuse has led to partial or septic abortion thereby increasing maternal mortality and morbidity.”
“When the medical methods of abortion were launched in developing countries like India it was thought that frequency of illegal unsafe abortions by local dais and unregistered practitioners will decrease to a large extent and it will help in managing such unwanted pregnancies through safe and legalized abortions in peripheral health centres (PHCs), community health centres (CHCs), and civil hospitals. No doubt, though unsafe surgical abortions have decreased largely due to strict legislations but these have been replaced by increasing number of unsafe medical abortions.”
“Because medical abortion is being used increasingly in several countries, it is likely to result in an elevated incidence of overall morbidity related to termination of pregnancy.”
Download both articles in their entirety: http://www.abortionresearch.us/images/Vol24No1.pdf.
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