Should a drug that is similar to RU-486, the abortion drug, be approved as a morning-after pill? The Food and Drug Administration (FDA) will decide whether to approve ulipristal acetate (under the brand name Ella) as a prescription drug to be used up to five days after intercourse.
Ulipristal, or Ella, is similar to mifepristone (RU-486), a drug that causes an abortion. If the FDA approves Ella, it will combine the serious medical and ethical issues of RU-486 with the troubling problems of the morning-after pill.
At an FDA Advisory Committee hearing, the drug sponsor avoided answering whether the drug causes an abortion — even when repeatedly asked.
Dr. Jeffrey Bray, a pharmacologist at the Food and Drug Administration, said that Ella may both delay ovulation and prohibit embryos from implantation in the uterus. Dr. Scott Emerson, a member of the FDA Advisory Committee and professor of biostatistics at the University of Washington, pressed the drug sponsor on why Ella is more effective the later it is taken. He asserted that any drug must do more than delay ovulation if it can prevent pregnancy up to five days after sex.
Despite this, the panel voted unanimously not to inform people that the drug can do something other than prevent pregnancy by delaying ovulation and that it may cause an abortion. Dr. Melissa Gilliam stated there should be “no extra burdens due to the mechanism of action.”
While the drug sponsor, HRA Pharma, is not currently requesting non-prescription access, approval of the drug is the first step to gaining such status. Advocates of “reproductive health” have forthrightly stated that their goal is to make abortion easily and directly accessible without medical oversight or safety protocols.
Dr. Valerie Montgomery Rice, an FDA panel member and dean of Meharry Medical College, insisted the drug should be over-the-counter, asking, “Why would we not move to O.T.C. status?”
I. Ella is chemically similar to RU-486
Ella operates in the same manner as the abortion drug RU-486 by blocking progesterone receptors. RU-486 was approved without adequate trials and, even with restricted distribution, has resulted in thousands of complications including deaths. Over one thousand adverse events from RU-486 have been reported to the FDA. The most frequent were hemorrhage and infection. Most disturbing are seven deaths. In addition, as of 2006, the FDA reported nine life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. This is the minimum number since many people, including doctors, are not willing or unaware of how to report adverse events.
A series of deaths linked to RU-486 of previously healthy women from a rare form of bacterial infection forced the FDA to convene a medical symposium to investigate. The FDA did not foresee this fatal complication, perhaps because the appropriate trials and information were not required or submitted to the FDA prior to its approval of RU-486.
Even though the FDA placed restrictions on administering RU-486, abortion providers flagrantly violated the protocol. Planned Parenthood openly posts its deviations from the FDA’s protocol on its websites. (Holly Patterson, a healthy 18-year-old, died from a Planned Parenthood administered RU-486 abortion. She had visited the organization’s website, where it claimed that RU-486 was “extremely safe.”) FDA officials could not or would not enforce their restrictions.
The lesson is quite clear: abortion providers, or those who seek to cause an abortion on a woman, are willing to ignore FDA guidelines and endanger women’s lives and health. Instituting regulations on a drug that can end a pregnancy will not restrain those who are intent on aborting a woman’s baby. While advocates for RU-486 may claim it is safe, the families of the women who died from the drug will beg to differ.
II. Ella’s possible risks to women
The clinical trials looked at by the European Medicines Agency (EMA) reported on a single dose per menstrual cycle in a limited group of women. In the real world, it will be used more frequently and by all types of females. Of particular concern are adolescents and those less capable of understanding the complicated language on a drug label (i.e. non-English speakers). Women or girls who are fearful of a pregnancy will be inclined to take a double dose or repeated doses within a month, going to different doctors or pharmacies if necessary.
EMA noticed an effect on all tissues, particularly the liver, “if the drug is used again a month later. Most likely this has no implications, because ulipristal acetate is given as a single dose, but in repeated dose this could result in toxicity due to accumulation.”
The clinical trials report a pattern of infections and bleeding disturbances that are similar to the complications reported for RU-486. Pain and bleeding are also the warning signals of an ectopic pregnancy. One known RU-486 fatality was a patient who died from a ruptured ectopic pregnancy. Brenda Vise called the abortion provider numerous times to report pain and bleeding. She was told these are the usual effects of RU-486 and not to go to a hospital. By the time she went to a hospital, it was too late. Women taking Ella may mistake the signs of an ectopic pregnancy and not receive critical medical care.
The subjects in the clinical trials were females 16 years and older. However, if Ella is approved, it will be taken by girls younger than 16. Adolescents are especially vulnerable to relying on it as a regular form of birth control, because they generally don’t plan ahead or don’t want to admit they’re regularly having sex.
Also missing in the trials are women with anemia or respiratory disease and women who are already using hormonal contraceptives who may take Ella for missed pills. The selected subjects do not reflect the widespread types of women who will use the drug who think that an FDA approval assures it is safe for all women.
III. Ella’s possible risk on pregnancies
The lack of adequate trials leaves open the question as to whether Ella is teratogenic and what kinds of birth defects it may cause in surviving or subsequent pregnancies. In the Phase III trials, 49 of the women who took Ella became pregnant, 31 had induced abortions, 11 had spontaneous abortions, two had live births (one baby suffered optic nerve hypoplasia and developmental delay), and five were lost to follow-up. There was no indication if the babies who were aborted or miscarried suffered defects.
The EMA admitted, “Extremely limited data are available on the health of the foetus/new-born in case a pregnancy is exposed to ulipristal acetate.” It also noted, “The safety for a human embryo is unknown.”
Although voting unanimously on the drug’s safety, several panel members expressed concern that there is not enough information on the drug’s effect on a pregnancy.
But then the FDA panel “strongly recommended” that the FDA not require a pregnancy test before taking the drug, instead making women rely on a doctor’s opinion on whether they’re pregnant.
Why would the panel insist on not ensuring that a woman is not pregnant before taking Ella? It’s possible a woman could be pregnant from a previous sexual encounter. Why do they want women and researchers to be in the dark, not fully certain whether she is pregnant when she takes Ella? Perhaps to avert liability from the drug company if a woman later miscarries, her surviving baby suffers health issues or to deceive women on whether Ella caused them to abort a baby.
If Ella is approved, there is no adequate reporting mechanism to ascertain the numbers and kinds of complications women or their surviving and subsequent babies are likely to experience. This can leave the false impression that the drug is safe and effective when, in reality, complications are not reported or made available for women to make an informed decision.
One FDA committee member, Dr. Melissa Gilliam, argued against long-term studies on pregnancy outcomes. She claimed it would be “biased” because people who experience a negative effect are more likely to report. This reveals a deep distrust of women and allowing women to have full information. While researchers may want statistical minutia, mothers care more about what kind of effect a drug may have on their baby.
The FDA panel exposes the radical view of many in the “reproductive health” community who view pregnancy as the worst possible condition, and any negative effect caused by a drug on women and babies is merely collateral damage.
Interestingly, the panel chairman Dr. Sandra Carson strongly recommended that the drug label restrict use by lactating mothers. This clearly indicates that she believes the drug could have an effect on a nursing baby. It’s only common sense, then, that babies in utero, receiving nutrition and oxygen from their mothers, may also be affected by the drug.
IV. Ella’s abortifacient effect and lack of informed consent
Ella blocks progesterone receptors, causing a hostile environment for an embryo by interfering with the uterine lining so that an embryo cannot implant or, if implanted, not receive nutrition.
The EMA states, “Ella is contra-indicated during an existing or suspected pregnancy.” However, most women would not know if they are pregnant at an early phase of the pregnancy.
If Ella is easy to obtain, it will be used past 120 hours. A large selling point of Ella is the claim that it is effective for a longer time postcoitally than Plan B. Women and predators will be enticed to use it beyond 120 hours, putting the woman at greater risk of aborting an implanted embryo (by any definition, a pregnancy).
Women who are led to believe that Ella is a “morning-after pill” may find out too late it may have aborted their baby, causing them emotional and psychological harm. Not providing women full information will be viewed as a deliberate effort to manipulate women for profit or ideological purposes.
V. Abuse of easy to obtain reproductive drugs
If Ella is easy to obtain, woman will be victims to it being slipped to them without their consent. A pattern of abuse has already emerged with abortion-inducing drugs.
Reports (compiled by Life Issues Institute, LifeNews, LifeSiteNews and Concerned Women for America) include:
In 2007, a 21-year-old Virginia man was sentenced to five years in prison for trying to poison his girlfriend with the intent of trying to cause an abortion. Daniel Riase crushed two misoprostol pills and put them into 19-year-old Sharii Best’s drink, after which she began to bleed. She went to the hospital, where her 11-week pregnancy ended in miscarriage. She later discovered an e-mail receipt for his purchase of the drug. In 2007, a 34-year-old Wisconsin man named Manish Patel was arrested and charged with attempted first-degree homicide of an unborn child for trying to cause the abortion of his unborn twins. He obtained mifepristone (RU-486) from his native India and put it in his girlfriend’s drink. Darshana Patel never drank the spiked drink, but turned it over to the authorities after suspecting foul play. Testing confirmed the presence of the drug. She believes a previous miscarriage was also caused by Manish slipping the drug in her drink. In 2009 in Alaska, Airman First Class Scott Boie faced a court martial for causing his wife to have an abortion. He did a computer search and got a friend to obtain misoprostol for him. He crushed up the pills and put them in his wife Caylinn’s food. She miscarried a week later, thinking it occurred naturally. She learned about his actions from a friend. In 2010, 38-year-old New York pharmacist Orbin Eeli Tercero was arrested for causing his Pennsylvania girlfriend to have an abortion. He allegedly inserted misoprostol tablets vaginally during two sexual encounters. He also dissolved misoprostol tablets in her drinks. As she started miscarrying, she discovered the partially dissolved pill in her discharge. He is charged with the murder of an unborn child in the first degree. In 2010, 31-year-old Jered Ahlstrom from Utah pleaded guilty to unlawful termination of his girlfriend’s pregnancy. He put misoprostol in her food twice to cause an abortion. She delivered a 16-week stillborn baby. He later admitted over e-mail that he had caused her abortion. In 2007, a 25-year-old Maryland man, William Stanley Sutton, spiked his girlfriend’s drink in an attempt to cause an abortion. He used a cattle hormone sometimes used to cause abortions in cows. Lauren Ashley Tucker went to the hospital complaining of a possible poisoning after consuming the foul drink that burned her throat. Both she and her 15-week-old unborn baby survived. He was charged with reckless endangerment, assault, and contaminating her drink. The girlfriend of a Canadian man, Gary Bourgeois, refused to have an abortion. During sexual relations, he inserted misoprostol. Later she experienced violent cramps, then felt a partly dissolved pill drop from her vagina. Her baby died. In September 2003, he pleaded guilty to aggravated assault and administering a noxious substance. Dr. Stephen Pack pled guilty to injecting Joy Schepis with an abortion-inducing drug in April 2000. The New York doctor jabbed his former lover with a syringe filled with methotrexate to cause an abortion because she refused to have one.
These cases are known because charges were filed. No one knows how many other women suffered “miscarriages” or abortions forced upon them by someone else.
The EMA assumed a warning on a label that “use of ulipristal acetate is not recommended in females with severe hepatic impairment, is considered sufficient.” The EMA also restricts use by those with severe asthma. Label warnings of contra-indications will not necessarily deter a predator whose goal is to prevent or end a woman’s pregnancy.
Easy to access abortion drugs, while touted as giving women more control over their bodies, are just as easily used by men to exploit women.
VI. Abuse of minors
Minors who are sexually activity are oftentimes victims of sexual abuse. Interaction with medical professionals is an important line of defense. Making Ella easy to obtain will remove a critical opportunity for abused minors to get the real help that they need.
The Alan Guttmacher Institute reported: “The younger women are when they first have intercourse the more likely they are to have had unwanted or nonvoluntary first sex, seven in 10 of those who had sex before age 13, for example.”
“The possibility of sexual abuse should be considered routinely in every adolescent female patient who has initiated sexual activity,” stated Dr. Joycelyn Elders in the Journal of the American Medical Association. The rush to choose “pregnancy outcome options” may preempt efforts to rule out sexual abuse. “Sexual abuse is a common antecedent of adolescent pregnancy, with up to 66% of pregnant teens reporting histories of abuse. Pregnancy may also be a sign of ongoing sexual abuse. Boyer and Fine found that of 535 young women who were pregnant, 44% had been raped, of whom 11% became pregnant as a result of the rape. One half of these young women with rape histories were raped more than once.”
VII. Approval of morning-after pill based on false promises
Many lessons can be learned from the approval of the morning-after pill Plan B — and should not be repeated.
Advocates for the morning-after pill claimed that it would dramatically reduce pregnancies and abortions. Planned Parenthood states that the morning-after pill “could prevent 1.7 million unintended pregnancies and 800,000 abortions each year in the U.S.”1 That would mean reducing abortions by fifty percent. Claims like this won support inside and outside the FDA, yet the reality is quite different.
Advocates have since admitted that easy access to the morning-after pill does not reduce pregnancies or abortions.
Dr. James Trussell, an aggressive proponent of “emergency contraceptive pills” (ECP), concluded in several studies subsequent to the FDA’s approval that easy access to the morning-after pill has not reduced pregnancies or abortions. His most recent analysis in May 2010 stated, “No published study has yet demonstrated that increasing access to ECPs can reduce pregnancy or abortion rates in a population although one demonstration project and three clinical trials were specifically designed to address this issue.” .”2 This is true even when women are given advance supplies of the drug.
Concerned Women for America had warned that easy access to the morning-after pill would not reduce pregnancies or abortions, but lead to women relying on it (the least effective form of contraception) as a regular form of birth control and multiple use.
Dr. Trussell reluctantly admits that “reanalysis of one of the randomized trials suggests that easier access to ECPs may have increased the frequency of coital acts with the potential to lead to pregnancy. Women in the increased access group were significantly more likely to report that they had ever used emergency contraception because they did not want to use either condoms or another contraceptive method. Increased access to EC had a greater impact on repeat use among women who were at lower baseline risk of pregnancy.” 3
Moreover, previous studies (certainly some that the FDA relied on) miscalculated estimates of the effectiveness of morning-after pills. As Dr. Trussell put it, “The risk of pregnancy for women requesting ECPs appears to be lower than assumed in the estimates of ECP efficacy, which are consequently likely to be overestimates.” 4
VIII. Ideology Trumping Women’s Health
Abortion advocates cloak abortion-causing drugs as a woman’s “right.” This is a facade used to promote their own ideological crusade.
With Ella, women will be enticed to buy a poorly tested abortion drug under the guise that it’s a morning-after pill.
The FDA should not unleash Ella on unsuspecting women, a drug promoted by activists with a history of overstating the efficacy of reproductive drugs while understating the overall risks to women.
Planned Parenthood Affiliates of New Jersey, Fact Sheet: Emergency Contraception (accessed June 15, 2010)http://www.plannedparenthoodnj.org/library/topic/emergency_contraception/factsheet Trussell, Raymond “Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy” (published online) (May 2010) http://ec.princeton.edu/questions/ec-review.pdf , p. 10 Trussell, Raymond “Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy” (published online) (May 2010) http://ec.princeton.edu/questions/ec-review.pdf p. 9 Trussell, Raymond “Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy” (published online) (May 2010) http://ec.princeton.edu/questions/ec-review.pdf p. 3