In the mid-nineties, the World Health Organization (WHO) began to realize that increased access to routine methods of contraception led to increased rates of abortion. So a new method of post-coital “contraception” was zealously sought and promoted: the morning-after pill.1
Despite subsequent WHO studies which described routine post-coital contraception as “unsuitable primarily because of the high incidence of cycle disturbances,”2 efforts to approve and market MAP globally continued. Today, these efforts have washed up on our shores, in the form of Women’s Capital Corporation/Barr Laboratories’ application to the FDA to approve MAP for over-the-counter distribution. Women’s Capital Corporation is the manufacturer of the Plan B morning-after pill.
As the evidence shows, these efforts are motivated by ideology and profit, not by concern for the health and well being of women.
Even the notorious abortion promoter, David A Grimes, MD, who was a presenter for Plan B’s manufacturer before the FDA advisory committee in December 2003, acknowledged in a 2002 interview that MAP use has a serious negative effect on a woman’s menstrual cycle: “Repeated use of EC wreaks havoc on a woman’s cycle,” Grimes said, “so the resulting menstrual chaos acts as a powerful deterrent to using this method too often.”3 In fact, the menstrual chaos Grimes warns about does not deter women from repeated and routine use of MAP, as studies have shown. But MAP-induced menstrual irregularities do make it hard for women to determine whether or not they are pregnant or experiencing delayed menses.
At home and abroad, the abortion, family planning, and population control groups which seek to promote MAP ignore the scientifically-proven risks of levonorgestrel (the sole active ingredient of Plan B MAP). These well-documented adverse side effects include significant weight gain (on average 15 pounds), depression, ovarian cyst enlargement, gallbladder disease, high blood pressure, respiratory disorders,4 increased risk of ectopic pregnancy5 and death. In some women, these serious adverse effects of levonorgestrel-type MAP could lead to further health risks for bulimia, anorexia, or clinical depression.
While these risks are multiplied with increased use, the advocates of MAP promote its increased, frequent, and repeated use. The makers of Plan-B, MAP suggest it “can be provided as frequently as needed,”6 as if it were candy or Tums. The wholesale promotion by the profiteers is undercut by solid evidence, and warnings advising women and physicians to limit usage, or to not use it at all.7 Norplant, the drug very similar to Plan B, was linked to severe medical problems which were never adequately studied or acknowledged by the FDA or the drug manufacturer (please see PRI’s Norplant information page, posted at http://www.pop.org/main.cfm?id:197&rl=2.25&r2=9.00&r3=0&r4=0&level=2&eid=368
While public awareness of the dangers of MAP was steadily growing in the U.S., the international abortion community stepped up to the plate. In 2003, the International Consortium for Emergency Contraception stated that “Medical and behavioral research conducted to date does not provide any basis for limiting the number of times that women use ECPs [emergency contraceptive pills], in a year or in a month… Women should use ECPs as often as needed.”8 No evidence was provided to back up this outlandish. politically motivated, assertion.
The international abortion community made MAP a routine part of its emergency health battery for displaced peoples. In Albania, a prominent clinic director lamented that young people especially “use it every time they have sexual intercourse.”9
The “fear of pregnancy’” factor in other countries has been used by international abortion peddlers to promote the chemical with no safeguards or restrictions, leading some women into taking increased dosages. One study from Hungary reported women taking 4–5 pills (3.0 to 3.75 mg total, which is 4–5 times the approved dose) as a first dose, followed by one .75 mg pill 12 hours later.”10
Clearly, over-the-counter distribution of MAP would occasion misuse and overdose. Still, presenters for Women’s Capital Corporation/Barr Laboratories blankly assured the FDA advisory committee that MAP are completely safe with “no potential for overdose…”11
The total number of women damaged by MAP throughout the developing world is untallied. Today this threat is aimed at American women.
No doubt, the greatest risk of MAP is loss of human life. Packaging for MAP omits clear warnings of the risks and abortion-inducing function of the chemical. Women must be informed of the total risks of MAR to themselves and their children.
Over-the-counter approval of MAP would unleash great harm on American women. The FDA should act to protect women and children by denying OTC approval for Plan B or any other MAP product.
1 “Fuller Information and More Choice — The Responsible Way Ahead,” Progress in Reproductive Health Research, 1995, No. 35, part 2. World Health Organization. Available at: www.who.int/reproductive-health/hrp/progress/35/news35_2.en.html.
2 Mitchell D. Creinin, MD, “Emergency Contraception: More Than a Morning After Pill,” Medscape General Medicine, 1999. Available at: www.medscape.com/viewarticle/408799. Without oversight of any medical professional, OTC/MAP will enable possible routine us by women and adolescents.
3 Laurie Barclay, MD, “Over-the-Counter Emergency contraception: A Newsmaker Interview with David A. Grimes, MD,” Medscape Medical News, 2002. Available at: www.medscape.com/viewarticvle/442258 Dr. Grimes is Vice President of Biomedical Affairs, Family Health International, Research Triangle Park, North Carolina.
4 “Contraceptive Implants Come of Age,” Progress in Reproductive Health Research No. 61, World Health Organization. Available at: www.who.int/reproductive-health/hrp/progress/61/news61.html.
6 “Health Professionals,” Plan B Clinical Information. Available at: http://www.go2planb.com/section/health_professionals.
7 G. Ugocsai, et al., “Scanning Electron Microscopic (SEM) Changes of the Endometrium in Women Taking High Doses of Levonorgestrel as Emergency Postcoital Contraception.” Contraception 66: 433–437 (2002). The study also urges counseling for EC users “as the main side effect of breakthrough bleeding frequently occurs.”
9 Etlava Sahatci, “Lessons Learned From Family Planning and Contraception Programs in CEE/NIS Region,” 2002 Schweitzer Seminar Series, Albert Schweitzer Institute/Open Society Institute, Quinnipac University. Available at: www.quinnipac.edu/x3363.xml.
10 G. Ugocsai, et al. The short-term and long-term safety risks of such overdoses are unknown. Whether most women, especially adolescents, who overdose would seek medical care afterward is also unknown.
11 Transcript, Nonprescription Drugs Advisory Committee in Joint Session with the Advisory Committee for Reproductive Health Drugs Meeting, Food and Drug Administration, December 16, 2003, P. 35. Transcript available at: www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.pdf.