March 19, 2004
Volume 6 / Number 11
In rejecting Plan B’s application to approve the morning-after abortion pill (MAP) for over-the-counter (OTC) distribution, the FDA should also designate this chemical as an abortion drug. The medical establishment, which has abandoned the science of human fertility for radical feminist ideology, should be pressed to re-adopt the traditional and accurate definition of when pregnancy begins (at conception) and when abortion occurs (at any point thereafter).
Steven W. Mosher
Action item: Urge the FDA to not approve OTC/MAP: Write:
FDA, 5630 Fishers Lane
Rockville, MD 20857-0001
Re: Docket Number 01P-0075 “Switch Status of Emergency Contraceptive from Rx to OTC”
Comments can be sent to FDA over the Internet
Attention: FDA Commissioner
The Morning-After Pill and Abortion
In 1998, a pivotal study of the morning-after pill was conducted by the World Health Organization (WHO) Task Force on Postovulatory Methods of Fertility Regulation.(1) The postovulatory effect of MAP could not be denied by this Task Force, since the purpose of this task force was to study what was already understood to be its postovulatory effect, not to determine whether there was one. Since the postovulatory effect of MAP was already established, the abortion-inducing nature of MAP could also not be denied.
However, the denial of the abortion-inducing nature of the morning-after pill was deemed essential to promoting its widespread use. One important “study” asserted that “A clear distinction must be drawn between emergency contraception and abortion, especially in countries where abortion is legally restricted or carries a moral stigma. A confusion of emergency contraception with abortion can seriously impede efforts to prevent unintended pregnancy through use of emergency methods . . . . Emergency contraception should be cast as an important way to reduce the need for
Redefining “conception” as beginning at “implantation” rather than “fertilization” is an attempt to stifle opposition to the abortion-inducing nature of the morning-after pill from the pro-life community: fertilization may occur, but since conception was posited to occur at implantation, it could also be posited that no early abortion could occur.(3) As moral opposition intensified, however, even flawed definitions did not provide the complete cover the abortion community sought to press ahead. New studies emerged purporting that the question of whether the morning-after pill alters the endometrium can never be
Among human embryologists globally, “there is 100% consensus” that a new human being, or human person, begins his existence at fertilization.(5) An especially comprehensive scientific review of the issues surrounding the abortion-inducing effect of the morning-after pill was provided to the December 2003 FDA advisory committee by Dr. Dianne Nutwell Irving, a former research biochemist/biologist. Dr. Nutwell Irving explained that, “By the time of implantation, the living human embryo is approximately already 5-7 days old. This is not a…’belief’ or ‘opinion’, but rather it is an objective scientific fact that has been known scientifically for over a hundred years.” Dr. Irving stated, “If other scientists and physicians are not aware of these scientific facts, that is more a reflection of their lack of knowledge…rather than a reflection of any ‘confusion’ on these scientific facts.”(6)
Still, members of the December 16, 2003, FDA review committee questioned Plan B’s manufacturer about whether or not MAP has an abortion-inducing effect or, more to the purpose, whether it is understood by MAP users to have an abortion-inducing effect. During the hearing, some attempted to point out the hypocrisy of Plan B’s manufacturer in claiming that this product is not aborfacient. Dr. Joseph Stanford of the review committee referred to a Plan B Label Comprehension Study, which tabulated answers to the question, “What is Plan B used for?” Plan B’s manufacturer included as correct answers: “an abortion type of thing if you think you are pregnant” and “an abortion type thing for the day after.”(7)
Dr. Valerie Montgomery Rice focused on implantation: “There is some data out there that really does suggest at very high dosages that there may be the possibility that you’re interfering with the implantation,”(8) she said. Despite her acknowledgement of MAP’s abortion-inducing nature, Dr. Rice voted in favor of OTC status for Plan B — without insisting upon disclosure of its abortion-inducing nature to properly inform
Dr. Charles Lockwood explained that, “We know that progesterone given at around the time of attachment can affect HOXA-10 expression. It can affect integrin expression. It can affect Lith expression by endometrial glands, et cetera. So the issue becomes…does it affect attachment, and does it act, in other words, like an IUD rather than an anti-fertilization agent. And it sounds like you’re telling me that no one has done the studies.” Plan B’s manufacturer’s representative, Dr. Ben-Maimon, reiterated this lie: “The studies are not available.”(10)
Dr. Lockwood voted to approve Plan B for OTC status, with the following package labeling: “the mechanism of action may be the prevention of fertilization or implantation” but “Plan B cannot cause an abortion”(11).
Dr. Joseph Stanford admitted, “I don’t think it’s quite as clear-cut as has been presented here that there’s no data on one side and all data on the other side…I would like to point out what I think is the most to date compelling piece of data on the side that says this may work after fertilization at times, and that is the data that it’s effective up to four or five days after…There’s certainly some epidemiologic evidence from there that suggests that it is working after fertilization some of the time, and I think it is misleading to say we have no suggestion of that happening.”(12)
But this point was gratuitous, since the American medical establishment had defined pregnancy as beginning with implantation, and an abortion as occurring only after that point. Human life was sacrificed with wordplay, and wordplay generated more lies.
As efforts were intensifying to approve OTC/MAP,(13) a 2002 study by the Alan Guttmacher Institute (AGI) emerged wielding broad claims that MAP prevented 51,000 induced abortions in 2000 nationally.(14) This claim, of course, disregarded early abortions induced by MAP itself.
The claim that OTC/MAP would dramatically cut the number of induced abortions resonates powerfully with many health professionals. Therefore, it is important to carefully examine the faulty methodology, findings and conclusions of the 2002 AGI study.
The 2002 AGI Contraceptive Use study was in fact a self-administered questionnaire at 100 abortion facilities, completed by women while they waited for their abortions. 10,683 “usable” questionnaires were returned to AGI.(15) Study data were gathered under circumstances of extreme stress, emotion and possible confusion, often resulting in missing data. Since the morning-after pill was relatively new on the American reproductive health scene at the time, the vague question on MAP was often omitted by women who had never heard of it before. To compensate for missing data, survey authors “imputed missing items,” on the presumption that “women who did not provide responses to these items resembled women who did provide responses.”(16)
Having fabricated data, the study found that 1.3% of the 10,683 aborting women surveyed reported use of MAP.(17) The study concluded that nationwide, 1.3% would represent 17,000 women obtaining abortions that year. Relying on an unfounded “estimate” that for every MAP failure resulting in pregnancy, three unintended pregnancies are avoided,(18) the study concluded that MAP use had prevented 51,000 induced abortions.
The Actual Use Study conducted by Plan B’s manufacturer reported that 60% of the women requesting MAP had used no contraception whatsoever,(19) contradicting claims made by advocates that the morning-after pill is a fair remedy for “contraceptive accident.”
No studies to date show that MAPs reduce unintended pregnancy rates (20) or lower abortion rates. In fact, studies show that morning-after pills increase rates of unintended pregnancy and abortion. After MAP was introduced on a widespread basis in Sweden, adolescent abortion rates increased from 17/1,000 to 22.5/1,000.(21) The British Medical Journal found that teenagers whose pregnancies ended in induced abortion were more likely to have used the morning-after pill before conception. The study surmised that MAP use is an indicator of willingness to engage in “risk-taking” behavior.(22)
Still, the self-evident reality that life begins at fertilization, and that abortion can occur at any time after this point, should be revisited by America’s medical establishment.
But first, given this immediate crisis, let the application for OTC/MAP be denied.
1. Task Force on Postovulatory Methods of Fertility Regulation, “Randomised Controlled Trial of Levonorgestrel versus the Yuzpe Regimen of Combined Oral Contraceptives for Emergency Contraception,” The Lancet, Vol. 352:428-33, August 8, 1998. Study sponsored by UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization.
2. Anna Glasier, Evert Ketting, V.T. Palan, ” Case Studies in Emergency Contraception from Six Countries .” International Family Planning Perspectives. June 1996; 22(2) p.57-61.
3. ” Contraception, Not Abortion – An Analysis of Laws and Policy Around the World ,” Center for Reproductive Rights, April 2002, Item: B012.
4. ” Briefing Document: Nonprescription Drugs and Reproductive Health Drugs Advisory Committee Meeting ,” Women’s Capital Corporation, Plan B for Emergency Contraception Rx-to-OTC Switch, 14 November 2003, Appendix 1: Mechanism of Action.
(To supports its claims that Plan B is not abortifacient, Women’s Capital Corporation’s Briefing Document included a Medical Bulletin from International Planned Parenthood Federation entitled, “Emergency Contraception Pills: How Do They Work?” According to the report, since it is never known whether MAPs were taken before or after ovulation and since no study could ethically or logistically make such determinations, “there is no direct evidence for or against the hypothesis that MAPs prevent pregnancy by interference with post-fertilization events.” The report discusses studies of endometrium alterations where endometrium biopsies were obtained. The report states that “treated cycles in which the ovulatory process is believed to be abnormal or suppressed are excluded since endometrial development would reflect abnormal ovarian function rather than a direct effect of the EC pill.” However, where abnormal or suppressed ovulation occurs, consequent changes in endometrial development would be an indirect but still abortifacient effect of the morning-after pill.)
5. Dianne Irving, PhD., ” New Drug Application 21-045 Levonorgestrel [Plan B, and Preven, Emergency Contraceptives] and Their Possible Abortifacient Effects ,” Letter to FDA Advisory Committee, December 5, 2003.
6. Ibid., Irving.
7. Ibid., Briefing Document; FDA 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. 288, 289. Transcript .
8. Ibid., FDA Transcript .
12. Ibid., p. 269-271.
13. ” Center for Reproductive Rights Petitions FDA Petitions FDA to Change Emergency Contraception from Prescription to Over the Counter ,” Center for Reproductive Law and Policy [now Center for Reproductive Rights], February 14, 2001.
14. Rachel K. Jones, et al., ” Contraceptive Use Among U.S. Women Having Abortions in 2000-2001 ,” Perspectives on Sexuality and Reproductive Health, The Alan Guttmacher Institute, Vol. 34, No. 6, November/December
2002. (The study reported that 46% of the aborting women were described as not using contraception in the month they became pregnant.)
18. Ibid. (Interestingly, James Trussell, whose studies claim a 75% effectiveness rate for MAP, was a voting member of the December 16, 2003, FDA advisory committee which recommended OTC status for MAPs.)
19. Briefing Document.
20. Tina Raine, MD, MPH, et al., ” Does Improving Access to Emergency Contraception Through Pharmacies Make a Difference in Unintended Pregnancy Rates? ” American Public Health Association 2003 Annual Meeting, November 19, 2003, Abstract #70869. (It is unclear whether the results of this study have been published. This study was supported by a research grant from Women’s Capital Corporation, manufacturer of Plan B.) 21. K. Edgardh, ” Adolescent Sexual Health ,” Sexually Transmitted Infections, 19 July 2002; 78:352-356.
22. Dick Churchill, et al., ” Consultation Patterns and Provision of Contraception in General Practice Before Teenage Pregnancy: Case-Control Study ,” British Medical Journal, 2000 August 19; 321 (7259): 486-489.