Angie Jackson received national attention for live-tweeting her chemical abortion.  Her aim was to “demystify” abortion and let women know it was “not that bad.”  What she achieved, however, was a muddling of the truth about the abortion drug RU-486 (also known as mifepristone, or by its brand name, Mifeprex).

Angie’s messages claim the side-effects of the abortion drug are exaggerated.  However, 99 percent of women in the U.S. clinical trial of the drug experienced at least one adverse effect from the drug – 23 percent of which were severe.

Women who take RU-486 report “significantly longer bleeding” and “significantly higher levels” of pain, nausea, vomiting, and diarrhea than women who have surgical abortions.  In addition, the long term effects of RU-486 on women, such as on fertility and future pregnancy, are not known.   And an improper regimen of RU-486, as pushed by Planned Parenthood, has proven fatal for women – including four women who died in one week alone after a California Planned Parenthood facility provided them with RU-486.

FDA approval of RU-486 should not be confused with its “safety.” The abortion drug was approved through the FDA’s “Accelerated Approval Regulations.”  These regulations were designed for drugs “that have been studied for their safety and effectiveness in treating serious or life threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatment.”

Yet, RU-486 was not adequately tested for its safety and effectiveness and it does not provide any meaningful therapeutic benefit over surgical abortions already available.  In one study, RU-486 failed in 18.3 percent of patients, while surgical abortions failed in only 4.7 percent of patients. (Taken alone, RU-486 fails in one-third of cases, so the regime includes a second drug – a prostaglandin – that must also be taken.) Moreover, pregnancy is not a serious or life-threatening illness.

RU-486 should not have been approved under this accelerated procedure.

While Angie may have lacked the agenda-motivation of abortion advocacy groups who claim RU-486 is “safe” and “easy,” her appeal to anecdotal experience and emotion instead of the facts is just as dangerous.

Instead of having RU-486 pushed as “legal and easy,” women deserve exposure of the risks the abortion drug poses to their health, and to know how it was wrongly fast-tracked for approval.  Women deserve a real “demystification” of abortion.

This article was published with permission from Culture of Life Foundation. To view the original publication, see their website.

By Jessica Sage
AUL Staff Counsel

Brenda Vise, a 38-year old pharmaceutical representative, died on September 12, 2001.  Holly Patterson, an 18-year old student, died on September 17, 2003.  Chanelle Bryant, 22-years old, died on January 14, 2004.  Vivian Tran, also 22 years old, died on December 29, 2003.  Orianne Shevin, a 34-year old attorney and mother of two, died on June 14, 2005.

What do these women have in common?  They all took RU-486, the so-called “abortion pill,” and died—most from a C. Sordelli infection and one from a ruptured ectopic pregnancy.  RU-486—a drug that its proponents claim is a “safe” and “easy” method of abortion—has killed at least 29 women worldwide including at least 8 American women.

This month marks the 21st anniversary of French approval of the controversial abortion drug.  Initially, the U.S. Food and Drug Administration (FDA) considered RU-486 dangerous and banned the importation of the drug.  However, later in 1993, following the wishes of then-President Bill Clinton, the FDA lifted the import ban and the Department of Health and Human Services (HHS) brokered a deal for the drug manufacturer, Roussel-Uclaf, to gratuitously donate the rights to distribute RU-486 in the U.S. to the Population Council, an organization whose mission is to research, develop and introduce birth control methods (including abortion) to control populations—“especially [for] disadvantage populations.”

Since the Population Council is a research and policy organization, not a drug company, it founded Danco Laboratories for the sole purpose of marketing and distributing RU-486 in the U.S.  Unable to find a U.S. company willing to manufacture the drug, Danco Laboratories turned to China—a nation known for coerced abortions—and a manufacturer formerly cited by the FDA for tainted drugs.

In September 2000—during the final days of the Clinton Administration—the FDA approved RU-486, or Mifeprex (generic name: mifepristone), under its accelerated approval regulations designed to expedite drug approvals for HIV patients.  Suddenly, the FDA deemed that the benefits of RU-486 outweighed the risks and required that it receive expedited approval.  In other words, the FDA succumbed to intense political pressure from the Population Council and abortion advocates to approve the drug.

On its website and in its literature, Danco Laboratories advertises RU-486 as a “safe” and “easy” abortion option.  However, the U.S. trials and subsequent market use are to the contrary.  It is neither safe nor easy. 

A RU-486 or chemical abortion is, in reality, a long, messy, and dangerous process.  RU-486 is a synthetic steroid that requires two drugs and three doctor visits to abort an unborn child at 7 weeks of gestation or less.  During the first visit, the woman takes three pills (Mifeprex) to chemically destroy the unborn child’s environment, deprive him/her of nourishment and subsequently starve the child to death.  During the second visit, if the woman is still pregnant she is given a prostaglandin (misoprostol), which causes cramping to expel the child in something similar to a very heavy and painful (and, at times, deadly) menstruation cycle.  The third office visit (14 days later) confirms the woman is well and the abortion complete.  If the RU-486 abortion is unsuccessful, the women must consider the possibility of birth defects and typically then undergoes a surgical abortion.

The Population Council—with vested interest in the success of RU-486—conducted and reported on the results of the U.S. clinical trials.  Despite the highly-controlled trials conducted from September 1994 to September 1995, the results reported in the New England Journal of Medicine remained alarming.  They revealed how RU-486 creates significant risks of life-threatening complications for the healthiest of women.

The study cited excessive bleeding as the most serious risk.  Excessive bleeding left 4 women needing blood transfusions, 25 women requiring hospitalization (including emergency-room visits), 56 women with “surgical interventions,” and 22 women needing intravenous fluids.  To the logical observer, these “adverse events” would equate to “medical emergencies,” but the Population Council dismissed these life-threatening complications as normal and expected with a chemical abortion.

The studies also indicated that women suffered from abdominal pain, nausea, vomiting and diarrhea.  Abdominal pain, referred to as “cramps,” was so significant that 68% of women received at least one pain medication and 29% received opiates.  One woman was hospitalized for the intense pain and actually needed two “surgical interventions.”

Further, the study results also confirmed that a chemical abortion “procedure” must begin within 49 days of conception, otherwise the baby’s size and development are too advanced and complications are admittedly too severe and dangerous.

Inexplicably, the report paid little attention to the other adverse events women reported including headache (32%); dizziness (12%); back pain (9%); fatigue (9%); fever (4%); vaginitis (4%); viral infections (4%); rigors (3%); dyspepsia (3% ); and asthenia, leg pain, anxiety, insomnia, anemia, syncope, leukorrhea, and sinusitis (2% each).  And if that is not enough, endometritis occurred in 19 women.  These are not just percentages and not simply insignificant statistics, but real women experiencing real complications (some requiring timely life-saving measures) after taking RU-486.

The Population Council acknowledged that the study showed that RU-486 had a low success rate and attempted to rationalize the discrepancy as merely “a lack of experience with [chemical] abortion in the United States as well as the design of [the] study.”  If this is true, then how much lower would the success rate and higher the complication rate be once approved by the FDA and introduced to the uncontrolled and unmonitored marketplace?  Unfortunately, U.S. women are finding out first-hand.

Since its September 2000 FDA approval, RU-486 has caused at least 8 deaths, 9 life-threatening incidents, 116 blood transfusions, and 232 hospitalizations for more than 1,100 women in the U.S. who experienced significant medical complications.  These numbers are only the incidents reported to and by the FDA and are likely an inadequate reflection of actual incidences.

The futile efforts by the FDA to make an unsafe drug acceptably safe by detailing certain limitations on who can prescribe the drug and the protocols to be followed are obviously insufficient.  On November 15, 2004, the FDA issued “important new safety changes” to the labeling of RU-486.  The FDA and drug manufacturer Danco Laboratories had received reports of serious bacterial infection, bleeding, ruptured ectopic pregnancies, and death.  The FDA’s response:  Change the black box labeling and nothing more.  The new label warns health care professionals and consumers about the “risk of serious bacterial infection, bleeding, sepsis, and death,” but does nothing to protect women from these risks actually occurring.

If past care is indicative of future care by abortion providers, none of these warnings will protect women.  Planned Parenthood and other abortion providers have notoriously failed to adhere to the labeling instructions or given appropriate medical attention to women who notify them of these dangerous complications after taking RU-486.  Since its approval, RU-486’s promoters have ignored the minimal FDA guidelines by recommending lower dosages, suggesting clinics drop follow-on visits to allow patients to self administer at home, promoting vaginal versus oral administration, and extending the usage deadline past the seven weeks prescribed by the FDA—all harming women who are entrusting their lives to these “reproductive care” providers. 

States can and must act to regulate and – in the case of minors – limit the use of RU-486.  Current FDA guidelines do nothing to restrict minors from obtaining RU-486 or restrict physicians from implementing the drug in “off-label” uses.  It does require the drug to be provided by or under the supervision of a physician who meets certain qualifications—but most abortion providers meet these requirements and have clearly shown their willingness to prescribe RU-486 in “off-label” and life-threatening ways.

In 2004, the Ohio General Assembly enacted a law requiring abortion providers to comply with the FDA-approval letter and the uses, dosages, and administration protocols contained in the drug label.  In July 2009 —after five years of legal battles with Planned Parenthood—the Ohio Supreme Court answered that the plain language of the law mandates that abortion providers follow the instructions contained in the medication guide and drug labeling when administering or prescribing RU-486.  Subsequently, the Sixth Circuit removed an injunction against the law’s enforcement and remanded the case to the district court.  In light of the dangers associated with RU-486 and its American track record, it is astounding that Planned Parenthood would even argue that it need not follow the approved and “safe” method of administrating RU-486.

States can and should further protect women from RU-486 by imposing administrative regulations on its administration by requiring that abortion providers follow the FDA-approved drug labeling.  Second, to prevent “satellite” prescriptions, states could consider physician-only limits on RU-486 explicitly requiring physicians to be physically present at the abortion facility when they prescribe and administer the drug and clearly prohibiting the delegation of actual administration duties to nurses, physician assistants, or others.  It would also be prudent to require the facilities to be able to provide or be proximate to emergency care and to mandate ultrasounds before prescribing RU-486 to accurately determine the gestational age of the unborn child and to rule out ectopic pregnancy.

Another necessary consideration is for states to review existing—and enact, if nonexistent—parental involvement laws requiring abortion providers to involve parents when a minor girl seeks a RU-486 or other chemical abortion.

Despite the real and evidenced dangers of RU-486, the FDA, the drug manufacturer, and prescribing abortion providers continue to believe the “adverse effects” are not statistically significant.  They continue to profess its safety and ease as more and more women are sacrificed at the altar of “reproductive choice.”  At what point will the harm to women be significant enough for the FDA to pull this deadly drug from the market?  The answer is unclear.  In the meantime, it is imperative to regulate and, when appropriate, restrict the use of RU-486 to protect women and to limit the “collateral damage” abortion advocates are clearly willing to accept.

It’s no secret that birth control and abortion have racist roots.  Margaret Sanger, the founder of Planned Parenthood, pushed vehemently for the use of birth control and abortion to eliminate populations of people she deemed unfit and detrimental to America. In her writings and interviews (including video-taped interviews), she did not even attempt to hide her racist motivations.  Her articles included titles such as “Birth Control: The True Eugenics.”

Sanger believed that sterilizing the “unfit” would be “the salvation of the American civilization.”  She was not alone.  Dr. S. Adophus Knopf, a member of Sanger’s American Birth Control League (ABCL), warned of the menace posed by the “black” and “yellow” peril.  Board member Dr. Harry Laughlin wanted to purge America’s “bad strains.”

It is amazing that Planned Parenthood has yet to publicly distance itself from its racist underpinnings.  Instead, it distributes “Maggie” awards every year to honor people who, like Margaret Sanger, push its blatantly anti-life agenda.  “Maggie” would be proud that Planned Parenthood is sticking so closely to her “ideals.”

Indeed, in recent months pro-life student Lila Rose has caught Planned Parenthood employees accepting donations aimed at exterminating minorities.  But it doesn’t take an undercover operation to discover Planned Parenthood’s true intent.  Just look at where Planned Parenthood focuses its attention and where it builds its clinics: 78% of their clinics are in minority communities.

But birth control and surgical abortion didn’t work the way Sanger and Planned Parenthood had hoped.  After all, we still have poverty and minority populations.

Enter RU-486, the abortion “wonder drug.”

Created in France in 1980, President George H.W. Bush banned its importation for personal use. 

But in 1992, President Bill Clinton was elected.  Later, in 1996, the Population Council filed an application with the FDA for approval of RU-486 in the United States.  The drug was fast-tracked and approved in 2000.

Changes are expected when a new administration takes office.  We’ve certainly seen that with the Obama Administration.  But a letter dated January 6, 1992, addressed to “President-To-Be Clinton,” demonstrates that RU-486 – just like birth control and surgical abortion – was envisioned as a means to wipe out populations in this country deemed “unfit” by abortion supporters.

Written by attorney Ron Weddington – a modern-day Sanger crony – he urged President Clinton to “start immediately to eliminate the barely educated, unhealthy and poor segment of our country.”  He states, “… what we need to do as a nation is prevent … as many poor babies as possible.”

His answer? “[G]overnment is … going to have to provide vasectomies, tubal ligations, and abortions … RU-486 and conventional abortions.”  He mentioned that he was contemplating the option of setting up a non-profit corporation to license and distribute the abortion drug.

After ending his letter stating, “We don’t need more poor babies,” he adds the following chilling post-script:

“I was co-counsel in Roe v. Wade, have sired zero children and one fetus, the abortion of which was recently recounted by my ex-wife in her book…. I have never had one moment of regret.”

Perhaps the timeline is mere coincidence: President Bush bans the drug, President Clinton is elected, President Clinton receives a letter pushing the eugenic potential of RU-486, RU-486 is hastily approved by the FDA.  But one thing is clear – abortion was, is, and always will be used for bigoted purposes. 

History has been made in this country – we now have our first African-American President.  Ironically, he ardently supports the very organization that has worked for decades to wipe out minorities. 

When will the American people say, “Enough is enough”?

Washington D.C. — The Sixth Circuit Court of Appeals has dissolved an injunction against the enforcement of an Ohio law strictly regulating the provision of the dangerous abortion drug, RU-486.

Dr. Charmaine Yoest, CEO and President of Americans United for Life, stated, “This is a victory for women’s health. Planned Parenthood and other abortion providers have readily admitted that they administer RU-486 in violation of the FDA-approved protocol for the drug. In response, Ohio rightly sought to protect women from such dangerous practices and the Sixth Circuit has ratified that decision.”

In July, the Ohio Supreme Court clarified that the 2004 law mandates that abortionists comply with the FDA-approved protocol when administering RU-486 and follow the instructions contained in the drug’s label. In light of that clarification, the Sixth Circuit vacated the injunction prohibiting the enforcement of the law and remanded the case to the federal district court.

Mailee Smith, AUL Staff Counsel, stated, “The drug manufacturer has publicly admitted that 29 women around the world have died after using RU-486. Eight of those women were American. That Planned Parenthood would even argue that it should be permitted to administer RU-486 in an untested and unapproved manner is appalling.”

AUL filed an amicus brief in the Sixth Circuit on behalf of Senator (Dr.) Tom A. Coburn, M.D. (OK), and Representatives Roscoe Bartlett (MD), John Boehner (OH), Steve Chabot (OH), Trent Franks (AZ), Jim Jordan (OH), Patrick McHenry (NC), Joseph Pitts (PA), Jean Schmidt (OH), Chris Smith (NJ), and Mark Souder (IN). It is available at
https://secure3.convio.net/xm_client/client_documents/briefs/AUL-PP_v_Strickland.pdf.
AUL also filed an amicus brief before the Ohio Supreme Court, which is available at
https://secure3.convio.net/xm_client/client_documents/briefs/Rogers_v_PlannedParenthood.pdf.

About Americans United for Life
Americans United for Life (AUL) is a nonprofit, public-interest law and policy organization whose vision is a nation in which everyone is welcomed in life and protected in law. The first national pro-life organization in America, AUL has been committed to defending human life through vigorous judicial, legislative, and educational efforts at both the federal and state levels since 1971. The Wall Street Journal has profiled AUL, and PBS’ Frontline program chronicled AUL’s successful efforts in Mississippi.

Media Contact
Heather Smith
202-270-9962
heather.smith@aul.org
##

Chicago, Illinois — Americans United for Life (AUL) today filed an amicus brief on behalf of ten U.S. Representatives supporting Ohio’s regulation of the deadly abortion drug, RU-486.

AUL President Dr. Charmaine Yoest stated, “RU-486 has a proven track record of ruining and even ending women’s lives. We must put a stop to abortionists’ dangerous, off-label use of this drug. Ohio’s statute is a step in the right direction, and as we argue in our brief, it should be upheld.”

Added Denise Burke, AUL Vice President & Legal Director, “Abortionists readily admit to dispensing RU-486 in a manner contrary to the FDA’s approved protocol. This puts women’s health and lives at additional risk, and demonstrates yet again that the abortion industry puts profits above women’s health.”

Abortionists filed suit challenging the law, arguing Ohio’s regulation of RU-486 is unconstitutional because the regulation’s requirements are unclear. The State of Ohio and AUL counter that the Ohio regulation is definitive in its requirement that abortionists can only use the RU-486 drug regimen in the way in which it was tested by the FDA, which is clearly laid out in the drug manufacturer’s instructions that accompany the drug.

“The argument that abortionists don’t know how to correctly dispense RU-486 is nonsensical,” stated AUL Staff Counsel Mailee Smith. “Physicians routinely follow the protocols approved by the FDA and described in manufacturer’s instructions when dispensing other drugs. Ohio’s regulation simply requires that abortionists do this with RU-486.”

AUL’s brief before the Ohio Supreme Court is available at AUL.org (PDF) and was filed on behalf of U.S. Representatives Roscoe Bartlett (MD), John A. Boehner (OH), Dan Burton (IN), Steve Chabot (OH), Trent Franks (AZ), Jim Jordan (OH), Robert E. Latta (OH), Joseph R. Pitts (PA), Jean Schmidt (OH), and Chris Smith (NJ).

In a related case challenging the same Ohio law, AUL filed a brief on behalf of a U.S. Senator and several U.S. Representatives before the Sixth Circuit. That brief is available at AUL.org (PDF).

In a blind and ideologically-driven quest to impose abortion-on-demand on a reluctant nation, the Supreme Court of Mexico blatantly ignored the country’s Constitution when it recently upheld a law permitting abortion-on-demand during the first 12 weeks of pregnancy. The Mexican Constitution clearly states that human life must be defended “from conception until its natural end”, but the Supreme Court succumbed to pressures from international pro-abortion groups including the Center for Reproductive Rights and Planned Parenthood who have been aggressively pushing for abortion-on-demand in Mexico and other Latin American countries.

As a result, since April 2007, abortion is now permitted without restriction during the first 12 weeks of pregnancy in the Federal District (Mexico City) and the pressure for other Mexican states to follow suit is increasing. Two other Mexican states, Morelos and Yucatan, currently restrict abortions to cases of life endangerment, rape, or birth defects in the unborn child.

To read the entire article, please visit our website at http://aul.org/InternationalPressur

On Monday, the Bush administration began circulating a proposed policy that would require all recipients of federal money under any program run by the Department of Health and Human Services to certify that they will not discriminate against healthcare providers who object to participating in abortions.

Although the announcement of this draft policy was met with predictable consternation from abortion advocacy groups, this policy simply provides an oversight mechanism to enforce more than a dozen existing (and many long-standing) federal protections for healthcare freedom of conscience.

For example, on June 19, 1973 (in the wake of the U.S. Supreme Court’s decision in Roe v. Wade), Congress passed, The Church Amendment, the first federal legislation protecting the right of healthcare providers to decline to participate in abortions.  Named after its sponsor, Senator Frank Church, it provides that an individual may not be forced to participate in abortions over moral or ethical objections.

More recently, the Hyde-Weldon Amendment, part of the Fiscal Year 2005 Labor, Health and Human Services and Education (Labor/HHS/ED) Appropriations bill, provides that no federal, state, or local government agency or program that receives federal health and human services funds may discriminate against a health care provider if the provider refuses to provide, pay for, provide coverage of, or refer for abortions.

Moreover, the laws of 47 states also provide similar protections for individual healthcare providers.  Only Alabama, New Hampshire, and Vermont do not supplement federal freedom of conscience protections.

In response to the proposed policy, abortion advocacy groups engaged in a classic attempt at misdirection, arguing that the policy would negatively impact women’s access to contraceptives.

However, a careful reading of both the draft policy and the multitude of existing federal laws protecting healthcare freedom of conscience clearly shows that this policy is directed at abortions, both surgical and chemical (e.g. those induced using RU-486).

The reasons for this attempted misdirection are obvious:  Abortion supporters realize that the majority of Americans do not support taxpayer funding of elective abortions.  Americans, by a large margin, also support the right of individuals to refuse to participate in procedures (like abortion) that violate an individual’s conscience, morals, or ethics.  So, rather engaging in a meaningful and honest discussion of the issues, abortion supporters are feverishly trying to shift the debate to one in which they feel more confident of acquiring some modicum of public support.

This step by the Bush Administration is necessary to ensure that existing federal law is enforced and to protect the freedom of conscience of all Americans.

For the last several years, the State of Ohio has been in litigation defending its law requiring that physicians prescribing RU-486 abide by the FDA’s protocol when dispensing the drug.  On June 23, the Sixth Circuit Court of Appeals ruled that the law should be evaluated by the Ohio Supreme Court.

Passed in 2004, the law was aimed at the abortion industry’s common failure to abide by the FDA’s protocol in prescribing the RU-486 drug regimen.  According to the regimen approved by the FDA, a woman first takes three RU-486 tablets at a doctor’s office or abortion clinic.  The woman is to return 36 to 48 hours later to take a second drug, misoprostol (a prostaglandin), which causes the woman to expel the baby.  The woman returns for a third visit three weeks later for an exam to monitor bleeding and confirm the abortion.

However, abortionists are commonly misusing RU-486, directing women to take the second dose vaginally and at home—rather than orally and in an office or clinic—and completely bypassing any follow-up appointments.  Misuse of RU-486 has devastating effects.  At least eight women have already died in the United States alone.

Ohio’s law states that abortionists must follow the federal protocol in prescribing and dispensing RU-486.  Planned Parenthood filed suit claiming that it does not understand what is meant by “federal protocol.”

AUL filed an amicus brief on behalf of physician members of the United States Congress, arguing that the law is not vague and educating the court on the dangerous effects of RU-486.  That brief can be viewed here. 

At least 14 women have now died—including 8 in the United States—after using the abortion drug RU-486.  A new study by University of Michigan scientists reveals that improper use of the drug regimen—as pushed by Planned Parenthood—is killing women.

When the FDA approved RU-486, it directed that the drug be taken according to a certain regimen.  Specifically, a woman first takes three RU-486 tablets at a doctor’s office or abortion clinic.  This initial ingestion blocks progesterone from getting to the baby, and the baby starves to death.  Under the regimen approved by the FDA, the woman is to return 36 to 48 hours later to take a second drug, misoprostol (a prostaglandin), which causes the woman to expel the baby.  The woman is supposed to return for a third visit three weeks later for an exam to confirm that the baby has been completely expelled, and to monitor bleeding.

However, abortion providers, including Planned Parenthood, routinely fail to follow this specific regimen.  Instead of instructing women to take the second dose (misoprostol) orally, they are instructing women to take it vaginally.  And instead of requiring women to take the second dose in a doctor’s office or clinic, they are releasing women to take the drug on their own, at home, without any medical support.  Thus, there is no follow-up care for the woman after the initial visit.

When four women died in one week after a California Planned Parenthood facility provided RU-486 to the women, the scientists began investigating the cause of those deaths.  They found that vaginal use of misoprostol allows bacteria to cause fatal infections.

That specific Planned Parenthood facility has begun instructing women to take the second dose orally, but it still has not revised its policy that allows women to take the second dose at home.

This new study adds to the evidence demonstrating that Planned Parenthood is killing the very women it claims to protect.