RU 486 Approved, Dangers to Women Ignored

September 28, 2000, was a black day in America. For the first time in our nation’s history, the Food and Drug Administration [FDA] approved a drug with the sole purpose of killing innocent human life. RU 486 — the generic name is mifepristone and marketed in the US under the name of Mifeprex — is the chemical abortion pill. It received the final okay to be dispensed to abortionists and will silence the beating heart of preborn babies through the forty-ninth day of pregnancy. Counting from the day she missed her period. It is most effective for the next three weeks. The FDA has allowed its use for two more weeks during which time its effectiveness increasingly diminishes.

The FDA caved under political pressure and dropped nearly all of the patient protections it proposed earlier in the year. The FDA did specify that physicians may prescribe RU 486 if they can accurately determine the age of the preborn child. In addition, the abortionist must be able to confirm that it is not an ectopic (tubal) pregnancy, as RU 486 has no effect on a pregnancy in the tube, which can be life threatening. The abortionist must also be trained in surgical abortion techniques for the 5-8% of women who will not abort and experience complications. If he is not able to perform a surgical abortion, he must have made prior arrangements for another abortionist to do it for him. Danco, the promoter and provider of RU 486, will send the drug directly to the abortionists. Pharmacies will not have access to it.

It is possible that the enacted protections for patients are only a smoke screen. In a letter to the Population Council, holder of the American patent for RU 486, the FDA said, “Mifeprex must be provided by or under the supervision of a physicianÂ…” For example, let’s take an abortion clinic that employs an abortionist who weekly commutes from another state to perform abortions every Saturday. Is this clinic considered to be “under the supervision of a physician”? If so, is the staff free to administer RU 486 to abort women? If not, how will women be safeguarded against such abuses?

There is further evidence that the enacted patient protections may be hollow. It appears that the abortionists are on an honor system to state that they conform to the patient protections but are not required to provide documentation to that effect. According to the Prescriber’s Agreement approved by the FDA, the only training the abortionist is required to complete before he can perform chemical abortions on women is reading prescribing information for RU 486, which can be downloaded from their web site. Abortionists are asked to report any incomplete abortions and complications to Danco, which has been assigned by the FDA the responsibility of compiling this information.

During the US trials in Iowa, a woman nearly bled to death. When asked by the media if there were any complications during the trials, a Planned Parenthood spokesperson lied and said no. A Waterloo physician, who believes that abortion should remain legal, came forward to set the record straight. He saved the woman’s life with emergency surgery and four units of blood. Now the FDA is asking the abortion industry to police itself on chemical abortion. Wouldn’t that be like hiring a convicted child molester to run a daycare center?

Gone are the original patient safeguards the FDA earlier proposed that would require the abortionist to have hospital admitting privileges within an hour travel time in the event of life-threatening complications. Also discarded was the required registry of abortionists who prescribe RU 486, facilitating the tracking of the drug from the factory to the abortionist’s office and to the patient.

During the US clinical trials of this human pesticide, women under 18 and those with any of 20 pre-existing conditions were excluded from taking the drug. The FDA has dropped the age limit as well as most of the pre-existing conditions. We do not know how this will affect the health and lives of many women and underage girls who take RU 486.

It will be manufactured at the Hua Lian pharmaceutical factory near Shanghai in China. This raises additional concerns about the safety of women due to the fact that China’s drug quality controls are far less stringent than those in America. Will women receive a tainted drug that is the equivalent of a chemical coat hanger? All other drugs approved by the FDA must pass a rigid evaluation through inspection of the drug production facility, etc. Eight US Senators expressed serious concerns about this aspect to Donna Shalala, Secretary of Health and Human Services, and asked her to delay the approval of RU 486 until basic questions and concerns have been answered. She refused.

There is also considerable controversy regarding the second drug. By itself, RU 486 is not effective in causing abortion. Therefore a prostaglandin drug is also administered to complete the deadly process. The generic name for this drug is misoprostol and the Searle Drug Company markets it under the name of Cytotec. It was not developed to kill but to heal. It is indicated for the prevention of gastric ulcers in patients who need large doses of anti-arthritic medication. An unintended side effect is that it causes uterine contractions in pregnant women. Cytotec is an essential follow-up drug to increase the effectiveness of RU 486, which alone only kills the baby 60 to 80% of the time.

Recently, in a letter to physicians nationwide, Searle fiercely condemned the use of Cytotec for abortion purposes. The letter is so strongly and specifically worded that we have printed it in its entirety. Should an abortionist use this drug off-label (other than the for the purpose the FDA approved it), his liability will increase substantially with no effective legal defense. According to reliable reports, this letter was sent with the full knowledge of and apparent cooperation with the FDA which has even posted it on its web site. In the face of this cooperation by the FDA, why would they approve a drug that requires Cytotec to be successful? This is further evidence that the FDA is using RU 486 and the health and well being of women as a political football.

Patient protections in France where RU 486 is already being used are much more thorough than those to be observed in the US. It can only be used for three weeks after her missed period. All chemical abortions are performed in a hospital outpatient facility where women have immediate access to emergency services such as defibrillators and respirators should serious complications occur. The French government continues to exclude women with any of 20 preexisting conditions from receiving RU 486. Abortionists are required to have office space and staff to monitor women for four hours after they take the second drug, Cytotec. Should women abort at home, they are requested to collect the baby parts in a jar and return it with them to the abortion facility. The contents are then examined to be sure that the abortion is complete. If not, life-threatening complications are likely to occur.

The FDA does not require the safeguards used to protect French women. American abortionists are far more likely not to use expensive sonograms to confirm an intrauterine pregnancy before and a completed abortion after, but may rely only on physical examinations, which are far less accurate. The two-week follow-up visit in France is a mandatory part of the abortion process. If the woman does not keep her appointment, the abortion staff searches her out and asks her to return. The FDA asks her to return in two weeks, but there is no enforcement mechanism. History has demonstrated that American abortion clinics are far less concerned with patient follow up compared to their French counterparts.

RU 486 has been touted by the abortion industry as a more private way to abort unborn children. However, the medical facts disprove this pro-abortion rhetoric. The woman must make three visits to the abortionist. During the first visit, the age of her unborn baby is determined and she orally takes three 200-milligram pills of Mifeprex, which kills the unborn baby by blocking progesterone, a nutrient hormone critical for maintaining the life of the unborn child. Two days later the woman returns and takes two 200-microgram pills by mouth of Cytotec, which causes uterine contractions that expel the dead baby. The second drug’s effects are not immediate. Women will most likely be sent home alone to abort their babies. According to the FDA, 90% of women report adverse reactions to Cytotec when used in abortion. Profuse bleeding is an expected side effect. Pro-lifers and many in the medical community are concerned that countless women will not know how much bleeding to tolerate before it develops into a serious complication requiring emergency medical treatment. Two in a hundred bleed so profusely that they need their wombs scraped out and some may require emergency blood transfusions.

Bleeding generally continues from an average of 9 to 16 days. One in ten bleed for 30 days or more. Additional side effects include abdominal pain (1/3 need narcotics), nausea, headache, vomiting, diarrhea, dizziness, fatigue, back pain, fever, viral infections, vaginitis, chills, insomnia, weight loss, leg pain, anxiety, anemia, leukorrhea (vaginal discharge) and pelvic pain. Less common are other life-threatening complications such as blood clots, pulmonary embolism and disseminated intravascular coagulation (sudden inability of the blood to clot).

There have been no long-term studies to determine the possible carcinogenic effect of RU 486. It is also unknown if nursing mothers will pass this toxic drug to their babies. No studies have been done regarding specific drug or food interactions with this drug. However, grapefruit juice and St. John’s Wort (a daily supplement) are among those that may reduce RU 486’s effectiveness.

The RU 486 abortion regiment is long and complicated. It requires accuracy in administration and follow-up. A notable percentage of women in America do not speak English. What assurances are there that they will receive truly informed consent? Will they even know that their babies are being aborted with a potential risk to their own health?

How will the pro-life volunteers who staff women help centers be affected? These counselors may see women who have taken Mifeprex and changed their minds about the abortion. She should be advised to seek immediate medical help from a pro-life physician. When she chooses life for her unborn child at this stage of the abortion, she needs to be counseled to accept the possibility that her baby may be born with a severe handicap. As a result, she will face even more pressure to abort, as the abortionist and clinic will fear a lawsuit. In addition to the physical anguish imposed on women, there is the mental hardship to overcome. Edouard Sakiz, then-chairman and CEO of Roussel Uclaf, the original manufacturer of RU 486 said that for the woman who takes this drug, “It’s an appalling psychological ordeal.”

Post-Abortion trauma may be compounded with such a chemical abortion. In the past, women have taken some solace in the fact that the abortionist did the abortion to her. With a chemical abortion she takes the Mifeprex and the subsequent Cytotec. She does it to herself and will shoulder the added psychological burden that she was more directly responsible for the death of her baby.

Grass roots pro-lifers will be called upon to use peaceful, legal means to determine if your local physician is being seduced into the abortion industry. If so, initiate an effective dialogue with the physician to try to persuade him or her to avoid making abortion part of their professional services. We recommend that you share the Searle letter with the physician. If this fails, the community and the physician’s patients should be alerted. He or she must then be publicly denounced as an abortionist and sidewalk counselors should keep vigil outside of their office.

US Representative Tom A. Coburn from Oklahoma has been a leader in congress opposing this human pesticide. Rep. Coburn is a practicing physician who has delivered 3,500 babies, 400 while serving in congress. On October 4, 2000, he and Senator Tim Hutchinson from Arkansas introduced the RU 486 Patient Health and Safety Protection Act designed to codify and strengthen the FDA’s patient protections that had been proposed earlier in the year but dropped by the FDA. The bill would require a national registry of all abortionists prescribing the drug. Clearly, only physicians not nurse practitioners, trained in surgical abortions would prescribe the drug. The abortionist must be credentialed in ultrasound administration, and have admitting privileges at a hospital within one hour of his office. The bill would require that a reliable follow-up study be done of all women who have had chemical abortions. We encourage all pro-lifers to contact their Senators and Congressmen and ask them to cosponsor HR 5385, the RU 486 Patient Health and Safety Protection Act.

In addition, pro-lifers must be prepared to assist women who have fallen victim to Mifeprex and the abortion industry.

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