THE DEADLY CONVENIENCE OF RU-486 AND PLAN B:

By Mailee R. Smith

Staff Counsel, Americans United for Life

On September 10, 2003, 18-year-old Holly Patterson entered a Planned Parenthood Clinic in Hayward, California, seeking a “safe” abortion.¹ While at the clinic, Holly ingested RU-486. As instructed by employees at Planned Parenthood, Holly later ingested a second drug at home. Three days later, Holly went to an emergency room with severe pain and bleeding. ER personnel instructed her that her symptoms were normal for a chemical abortion, treated her with pain killers, and sent her home. Holly also called Planned Parenthood, which echoed that her symptoms were normal.

On September 17, Holly—weak, vomiting, and suffering from severe abdominal pain—was rushed to the ER. She died from septic shock at 1:52 p.m. Holly had developed a severe bacterial infection because “fragments of the fetus” remained in her uterus after her chemical abortion. This was the third reported death in the United States since the Food and Drug Administration (FDA) approved the RU-486 regimen. In total, five women in the U.S. have died within one week of using RU-486, and the FDA has now acknowledged a total of eight deaths associated with RU-486.²

ISSUES

RU-486:

The Population Council filed a new drug application with the FDA in 1996 for approval of RU-486 and granted Danco Laboratories the exclusive license to distribute RU-486 in the United States. A Chinese drug manufacturer—which has previously been cited by the FDA for tainted drugs—manufactures the pills.³ On September 28, 2000, the FDA approved RU-486 under Subpart H, its accelerated approval regulations specifically enacted to quickly approve drugs for HIV patients.⁴

Taken alone, RU-486 fails in one-third of cases.⁵ Thus, a prostaglandin must also be ingested.⁶ A woman first takes three RU-486 tablets at a doctor’s office or abortion clinic.⁷ This initial ingestion blocks progesterone from getting to the baby, and the baby starves to death.⁸ 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.⁹ The woman returns for a third visit three weeks later for an exam to confirm that the baby has been completely expelled and to monitor bleeding.¹⁰ If the procedure fails, a woman must undergo a surgical abortion.¹¹

Emergency Contraception:

In 1999, the FDA approved the distribution of emergency contraception (EC), also known as Plan B, by prescription.¹² EC is allegedly prescribed after a woman has had sex without contraception. Within 72 hours after intercourse, the woman takes the first dose; 12 hours later, she takes a second dose.¹³ When taken according to this regimen, EC is only 75 to 85 percent effective in preventing pregnancy or implantation.¹⁴

Controversy surrounded the status of EC as a prescription-only drug. In 2001, a group of organizations petitioned the FDA to make EC available over the counter.¹⁵ On May 6, 2004, the FDA declined to make EC available without a prescription, but left the issue open for further consideration.¹⁶ In September 2005, the FDA requested public comment on whether EC should be available over the counter with age restrictions.¹⁷ On June 9, 2006, the FDA again denied the petition. Yet on August 24, 2006, the FDA approved over-the-counter sales of Plan B to women 18 years of age and over. While minors under the age of 18 must have a prescription to obtain the drug, nothing prevents adults—including adults exploiting young women—from purchasing the drug for minors.

KEY TERMS

RU-486 is a chemical abortifacient which is also known as mifepristone, or by its brand name, Mifeprex. It is taken to end pregnancy, not to prevent it.

An abortifacient is a drug that causes an abortion.

Emergency contraception (EC) is used to prevent pregnancy after unprotected sexual intercourse. It is also referred to as the morning-after pill or postcoital contraception. The two particular products approved by the FDA are known as Plan B and Preven. While other forms of EC include massive doses of regular birth control pills or insertion of an intrauterine device, any references to EC in this overview deal specifically with the morning-after pill.

TALKING POINTS

RU-486:

The approved RU-486 regimen is dangerous and does not adequately protect women. It does not require an ultrasound, which is necessary to determine the number of days gestation of the pregnancy and whether the pregnancy is ectopic.¹⁸ Moreover, anyone with a medical license, including untrained psychiatrists, podiatrists, and other non-related specialists, can prescribe RU-486.¹⁹ RU-486 is particularly dangerous because its side effects are confusingly similar to the symptoms of an ectopic pregnancy.²⁰

Doctors and clinics are not using RU-486 as approved by the FDA, which is “for the medical termination of intrauterine pregnancies through 49 days’ pregnancy.”²¹ The approved regimen also requires at least three office visits.²² Yet RU-486 is openly administered to women with pregnancies beyond 7 weeks and, as in Holly’s situation, the second office visit is often eliminated.²³ Failing to follow the approved regimen of an already dangerous drug puts women’s health and lives even more at risk.

"The FDA has acknowledged the deaths of 8 women associated with the drug, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. These and other cases have added up to a total of 950 adverse event reports as of March 31, 2006.”²⁴

Emergency Contraception:

Because Plan B is only 75-89 percent effective, that means it is 11 to 25 percent ineffective.²⁵

Plan B is believed to act principally by blocking ovulation, but it also prevents the implantation of an already fertilized egg.²⁶Thus, Plan B may act as an abortifacient.

Over-the-counter access to Plan B is inherently unsafe. First, over-the-counter access makes Plan B available to a larger population of women than any trial has tested upon.²⁷ Second, if the hormones in regular birth control pills render such drugs unsafe for non-prescription status, the higher amounts found in Plan B cannot be safe, either.²⁸ Third, a study has revealed that one-third of women who read the instructions for Plan B do not understand that it is not to be used as a regular form of birth control.²⁹ Over one-third did not understand that a second dose must be taken 12 hours after the first.³⁰

Plan B is used to exploit women. A study done in Thailand, where EC has been available without prescription for almost 20 years, had the following comments: “Although many feminists believe that the morning-after pill gives them more control over their own bodies, it would seem, judging from the few studies conducted so far, that it is actually being used by men to exploit women.”³¹ Indeed, studies revealed that men were the most frequent buyers.³² Many women did not even know what they were taking; they were simply told by their partners that the pill was a health supplement.³³ In addition, easy access to an easily-administered drug encourages the continued exploitation of women by sexual predators.

MYTHS & FACTS

RU-486

Myth: Proper clinical trials demonstrate that RU-486 is “safe and effective.”

Fact: One of the FDA’s rules is that “uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval claims of effectiveness.”³⁴ Yet neither the French trials nor the U.S. trial solely relied upon in authorizing RU-486 were blinded or controlled, and they did not yield “safe and effective” results.³⁵ Furthermore, RU-486 has not been tested on females under the age of 18, yet it is given to females in that age group.³⁶

Myth: A chemical abortion is safer than surgical abortion and carries fewer and less severe side effects.

Fact: The common side effects of RU-486 are painful contractions, nausea, vomiting, diarrhea, pelvic pain and spasms, dizziness, and headaches.³⁷ Most women experience excessive bleeding, which can last for weeks.³⁸ RU-486 patients report “significantly longer bleeding” and “significantly higher levels” of pain, nausea, vomiting, and diarrhea than women who have surgical abortions.³⁹ In one study, RU-486 failed in 18.3 percent of patients, while surgical abortions failed in only 4.7 percent of patients.⁴⁰ In addition, the potential long-term effects of chemical abortion, such as effects on fertility and future pregnancies, are not known.⁴¹

Myth: RU-486 was properly approved through the FDA’s channels, so it must be safe.

Fact: RU-486 was actually 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 treatments.”⁴² Yet, as demonstrated above, RU-486 was not adequately tested for its safety and effectiveness and it does not provide meaningful therapeutic benefit over the surgical abortions already available. In addition, pregnancy is not a serious or life-threatening illness. RU-486 should not have been approved under this accelerated procedure.

Emergency Contraception

Myth: Over-the-counter access to EC like Plan B will reduce the number of unplanned pregnancies and abortions.

Fact: Studies reveal that emergency contraception does not reduce pregnancy and abortion rates. In one study, abortion rates increased by nearly 6,000 in a one-year period, jumping 3.2 percent.⁴³ Once EC became available without prescription in the United Kingdom, use among teenage girls doubled from 1 in 12 to 1 in 5.⁴⁴ In fact, one study reported that 4 out of 12 women were influenced to have unprotected sex because of the easy access to EC.⁴⁵ With the increased rate of sexual activity and the substantial failure rate of EC, the over-the-counter availability of Plan B cannot be expected to reduce the number of pregnancies or abortions. Furthermore, in those areas with easy access to EC, the number of sexually transmitted diseases has skyrocketed.

Myth: Restricting over-the-counter access to those females over 18 years of age will prevent minors from using Plan B.

Fact: These age restrictions allow one person to buy Plan B and another to actually take the drug, and thus such restrictions are ineffective in preventing use by teenagers. In addition, Plan B is easy to slip to a teenager—or any woman, for that matter—without her knowledge or consent.

Myth: Plan B is safe for females under the age of 18.

Fact: The maker of Plan B has not researched what happens when adolescents take Plan B.⁴⁶Moreover, the maximum safe dose for levornorgestrel, the active ingredient in Plan B, and the effects of overdose have not been determined by scientific study on any age group.⁴⁷

State of the States:

Where Are We Now?

CURRENT LAW

RU-486 is available by prescription. The FDA’s approval has not been stayed, despite citizen petitions requesting such action.

Any person with a medical license can prescribe RU-486.

Women 18 years of age and older can obtain EC without a prescription. However, even before the FDA’s decision, Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont, and Washington already maintained laws allowing pharmacists to dispense EC directly without prescriptions.

At least 13 states require that sexual assault victims be given information about and/or access to EC: Arkansas, California, Colorado, Connecticut, Illinois, Massachusetts, Minnesota, New Jersey, New Mexico, New York, Oregon, South Carolina, and Washington.

What Happened in 2007

Arkansas, Colorado, Connecticut, Minnesota, and Oregon passed laws requiring that hospitals provide sexual assault victims with information about and/or access to EC. Similar measures were considered in Arizona, Florida, Hawaii, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, West Virginia, and Wisconsin. Similarly, New York considered enacting an EC awareness and education program.

Oregon enacted legislation requiring its department of justice to fund medical assessments of sexual assault victims, including the provision of EC. The law also provides a prescription for EC if a victim is under 18 years of age.

Minnesota enacted legislation allowing nurse practitioners to dispense contraceptives to women 12 years of age and over. It is unclear whether this law includes EC.

The governor of Oklahoma allowed legislation to become law without signature which amends the definition of “abortion” in the state to include chemical abortion.

Illinois, New Jersey, and New York considered legislation allowing pharmacists and/or nurses to dispense EC directly to women without a prescription.

Illinois also considered a measure allowing practical nurses, registered nurses, and advanced practice nurses to dispense EC.

New Hampshire, Tennessee and Texas considered measures requiring pharmacists dispensing EC to inform patients of basic drug information and/or to post a sign stating that EC may act as an abortifacient.

Oklahoma considered measures requiring that RU-486 be dispensed and used in accordance with federal law and FDA guidelines.

Litigation continues in Ohio where, in 2004, the state legislature passed a law requiring abortion clinics to follow the FDA-approved regimen when administering RU-486. The law is currently enjoined and pending in the Sixth Circuit. Similar legislation was considered in 2007 in Oklahoma.

What To Do In 2008

State legislatures should demand investigations by their health departments as to why abortion clinics are not following the FDA-approved RU-486 regimen.

State legislatures should pass legislation like that promulgated in Ohio, which demands that those prescribing RU-486 abide by the regimen approved by the FDA.⁴⁸

State legislatures should, in the interest of protecting the health and lives of women, pass legislation requiring further safeguards on RU-486, such as:

o Requiring that prescribing physicians be qualified to handle complications resulting from incomplete abortions or ectopic pregnancies.

o Mandating that prescribing physicians be trained to perform surgical abortions.

o Mandating that ultrasounds be used to date pregnancies and detect ectopic pregnancies.

o Requiring that, due to the many medical complications of RU-486, prescribing physicians have admitting privileges at a nearby hospital.

o Requiring that RU-486 be used only in the first 49 days of pregnancy and that clinics adhere to the three-visit regimen.

Endnotes

¹ For information related to the death of Holly Patterson, see, e.g, Pamela Wong, Father Speaks Out on Daughter’s Death Due to RU-486, available at: http://www.cwfa.org/articles/6388/CWA/life/index.htm (last visited Aug. 17, 2007).

² Dave Andrusko, Investigations Proving RU-486’s Lethal Dangers, available at: http://www.nrlc.org/news/2006/NRL06/LethalDangers.html (last visited Aug. 17, 2007).

³ Wendy Wright, RU-486: Killer Pills, available at: http://www.cwfa.org/articles/1561/CWA/life/index.htm (last visited Aug. 17, 2007) [hereinafter Wright I].

⁴ See U.S. Dept. of Health & Human Serv., FDA Approves Mifepristone for the Termination of Early Pregnancy, HHS News, Press Release P00-19 (Sept. 28, 2000); see also 21 C.F.R. §§ 314.500-314.560.

⁵ Wendy Wright, RU-486: Deadly Approval, Family Voice 7, 10 (Jan./Feb. 2003) [hereinafter Wright II].

⁶ See Americans United for Life, Citizen Petition to the U.S. Food and Drug Administration, at 6 (1995).

⁷ Wright I, supra.

⁸ Id.

⁹ Id. However, misoprostol is not necessary if the woman has already expelled the baby.

¹⁰ Id.

¹¹ Id.

¹² Bethanie Swendsen, Does Plan-B Approval Really Put Science on the Line?, available at: http://www.cwfa.org/articles/7967/CWA/life/index.htm (last visited Aug. 17, 2007).

¹³ Id.

¹⁴Id.

¹⁵ Id.

¹⁶ See Letter to Barr Research, Inc. from Dep’t Health & Human Services (May 6, 2004), available at http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf (last visited Aug. 17, 2007).

¹⁷ Wendy Wright, FDA Seeks Your Input on Morning-After Pill, available at: http://www.cwfa.org/articles/8951/CWA/life/index.htm (last visited Aug. 17, 2007) [hereinafter Wright III].

¹⁸ RU-486 is only approved for the first 49 days of pregnancy and is completely ineffective in ending ectopic pregnancies. See, e.g., Beth Kruse et al., Management of Side Effects and Complications in Medical Abortion, Am. J. Obstet. Gyn. 183:S65-S75, S72 (2000). In the U.S. clinical trial, RU-486 was only 83 percent effective in patients with pregnancies between 50 and 56 days and 77 percent effective in patients with pregnancies between 57 and 63 days. FDA, Medical Officer’s Review of Amendments 024 and 033: Final Reports for the U.S. Clinical Trials Inducing Abortion up to 63 Days Gestational Age and Complete Responses Regarding Distribution System and Phase 4 Commitments, at 11 (Table 1). Even for pregnancies less than or equal to 49 days, RU-486 has an 8 percent failure rate. Id.

¹⁹ See Michael Schwartz, The Patient Health and Safety Protection Act: H.R. 486, available at: http://www.cwfa.org/articledisplay.asp?id=3982&department=CWA&categoryid=life (last visited Aug. 17, 2007).

²⁰ See, e.g., Medical Management of Abortion, ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists 6 (Apr. 2001).

²¹ Letter from FDA/CDER to Sandra P. Arnold, Population Council (Sept. 28, 2000).

²² See Dosage and Administration on the Mifeprex Label, available at: http://www.fda.gov/cder/foi/label/2000/20687lbl.pdf (last visited Aug. 17, 2007).

²³ See AAPLOG et al., Citizen Petition and Request for Administrative Stay, at nn.313 & 317 & accompanying text. Instead, the patients administer misoprostol vaginally – not orally, as approved – at home. Id. The second visit is important not only because the physician can check on the progress and complications of the abortion but also because it eliminates the need to ingest misoprostol if the abortion is already complete.

²⁴ Andrusko, supra (quoting a briefing paper of a committee hosted by the Centers for Disease Control, the FDA, and the National Institutes of Health). In fact, adverse effects were so serious that on April 17, 2002, Danco, in conjunction with the FDA, issued a letter to health care providers alerting them to a number of “serious adverse events” following use of RU-486. Danco Laboratories, Open Letter to Health Care Providers (Apr. 19, 2002), available at: http://www.fda.gov/medwatch/SAFETY/2002/mifeprex_deardoc.pdf (last visited Aug. 17, 2007). The letter reported ruptured ectopic pregnancies, systemic bacterial infections, a heart attack, and deaths stemming from these complications. Id. These complications were followed by the death of Holly Patterson in 2003.

²⁵ See Wendy Wright et al., The Morning-After Pill at 3 (2006), available at: http://www.cwfa.org/articles/6085/CWA/life/index.htm (last visited Aug. 17, 2007).

²⁶ Duramed Pharmaceuticals, How Plan B Works (2007), available at http://www.go2planb.com/ForConsumers/AboutPlanB/HowItWorks.aspx (last visited Aug. 17, 2007).

²⁷ Wright et al., supra. For example, Plan B would be available to women who unknowingly have medical conditions that put their health and lives at risk. Wendy Wright, Talking Points on the Morning-After Pill (MAP), available at: http://www.cwfa.org/articles/5621/CWA/life/index.htm (last visited Aug. 17, 2007) [hereinafter Wright IV].

²⁸ One EC pill contains “amounts of estrogen and/or progesterone 10 to 15 times higher than a single day’s dose of the birth control pill” – and yet it is to be taken twice in 12 hours. Testimony of Jill L. Stanek Concerning the Morning-After Pill, Joint Meeting of the FDA Nonprescription Drugs Advisory Committee and the FDA Advisory Committee for Reproductive Health Drugs (Dec. 16, 2003), available at: http://www.cwfa.org/articles/4998/CWA/life/index.htm (last visited Aug. 17, 2007).

²⁹ Wright et al., supra.

³⁰ Id. The FDA Advisory Committee chairman declared this study a “failure.” Wright IV, supra.

³¹ See Karnjariya Sukrung, Morning-After Blues, Bangkok Post, June 10, 2002.

³² Id.

³³ Id.

³⁴ 21 C.F.R. § 314.126(e) (emphasis added).

³⁵ Almost 86 percent of patients in the first French trial and 93 percent in the second French trial experienced at least one adverse effect as a result of the procedure. See AAPLOG et al., supra, at 26-27. Ninety-nine percent of patients in the U.S. trial experienced adverse effects – 23 percent of which were severe. See id. at nn.313 & 317 & accompanying text. Furthermore, every study done on Plan B has simply tested its reliability in decreasing the birth rate – studies have not tested the effects Plan B has on the women who take it. Written Testimony of Carole S. Denner Concerning the Morning-After Pill, Joint Meeting of the FDA Nonprescription Drugs Advisory Committee and the FDA Advisory Committee for Reproductive Health Drugs (Dec. 16, 2003), available at: http://www.cwfa.org/articles/4997/CWA/life/index.htm (last visited Aug. 17, 2007).

³⁶ Without explanation, the FDA waived the Pediatric Rule, which requires that applicants seeking approval for new drugs contain safety and effectiveness information on relevant pediatric age groups. See 63 Fed. Reg. at 66634; 21 C.F.R. § 314.55(a). In addition, adequate research has not been done on the effects on children who survive chemical abortions.

³⁷ Wright I, supra.

³⁸ Id.

³⁹ Jeffrey T. Jensen et al., Outcomes of Suction Curettage and Mifepristone Abortion in the United States: A Prospective Comparison Study, Contraception 59:153, 156 (1999).

⁴⁰ Id.

⁴¹ Wright I, supra. While an article published in August 2007 in the New England Journal of Medicine implies that RU-486 does not affect subsequent pregnancies, that study in reality only determined that RU-486 is not more likely than surgical abortion to cause complications in subsequent pregnancies. The study did not compare women who used RU-486 to women who had no abortion at all, thus skewing the results to favor use of RU-486. See J. Virk et al., Medical Abortion and the Risk of Subsequent Adverse Pregnancy Outcomes, 357 N.E. J. Med. 648-53 (2007); S. Ertelt, Pro-Life Advocates Say Abortion Pill Study Misleading, Drug Hurts Women (2007), available at http://www.lifenews.com/nat3283.html (last visited Aug. 17, 2007); Abortion Pill not “Safe” Despite Media Spin—Study Only Suggests Pill as Safe As Surgical Abortion (2007), available at http://www.lifesite.net/ldn/2007/aug/07081601.html (last visited Aug. 17, 2007).

⁴² 21 C.F.R. § 314.500.

⁴³ UK Reports Nearly 6000 More Abortions in 2003 over 2002 (July 21, 2004), available at: http://www.lifesite.net/ldn/2004/jul/04072110.html (last visited Aug. 17, 2007).

⁴⁴ S. Doughty, Morning-After Pill Lures Teens, Herald Sun (Mar. 28, 2003). A study done at the University of San Francisco also demonstrated that Plan B does not reduce the number of pregnancies. Swendsen, supra.

⁴⁵ P. Bissell et al., The Sale of Emergency Hormonal Contraception in Community Pharmacies in the UK: The Views of Users, Int’l J. Pharm. Practice R47 (Supp. 2002).

⁴⁶ Wright III, supra.

⁴⁷ Wright et al., supra.

⁴⁸ “Doctors quite simply do not have the right to practice medicine free from any oversight by the state…. When the state believes that a medication is particularly dangerous or subject to abuse, the state has every right to regulate its use by doctors.” Wendy Wright, Ohio Defends RU-486 Law, available at: http://www.cwfa.org/articles/6307/CWA/life/index.htm (last visited Aug. 17, 2007) (quoting one of Ohio’s legal arguments).