Dear Colleague

Dear Colleague:

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 Mosher
President

Action item: Urge the FDA to not approve OTC/MAP: Write:
FDA Commissioner
FDA, 5630 Fishers Lane
Rockville, MD 20857-0001
Re: Docket Number 01P-0075 "Switch Status of Emergency Contraceptive from
Rx to OTC"
(1-888-463-6332)

Comments can be sent to FDA over the Internet
Attention: FDA Commissioner
http://www.fda.gov/comments/webform.html

PRI Weekly Briefing
19 March 2004
Vol. 6 / No. 11

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
abortion."(2)

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
answered.(4)

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
consumers.(9)

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.

ENDNOTES

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. Available at
http://www.hsph.harvard.edu/Organizations/healthnet/SAsia/suchana/0507/glasier_etc.html.

3. "Contraception, Not Abortion - An Analysis of Laws and Policy Around
the World," Center for Reproductive Rights, April 2002, Item: B012.
Available at: www.reproductiverights.org/pub_bp_icpdec2_endnotes.html
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. See
www.fda.gov/ohrms/dockets/ac/03/briefing/4015B1_01_WCC-Briefing%20Document.pdf.
(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. Available
at: www.lifeissues.net/writers/irvi/irvi_19newdrug21-045.html.
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 available at:
www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.pdf.
8. Ibid., FDA Transcript;
www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.pdf.
9. Ibid.
10. Ibid.
11. Ibid.
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. Available at: http://www.crlp.org/pr_01_214ecpetition.html.
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. Available at: http://www.agi-usa.org/pubs/journals/3429402.html.
(The study reported that 46% of the aborting women were described as not
using contraception in the month they became pregnant.)
15. Ibid.
16. Ibid.
17. Ibid.
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. Available at:
http://apha.confex.com/apha/131am/techprogram/meeting_131am.htm. (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. Available at:
http://sti.bmjjournals.com/cgi/content/full/78/5/352.
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.
Available at:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=27465&rendertype=abstract.

© 2004 Population Research Institute. Permission to reprint or use in any
form granted. Credit requested.
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