Dear Colleague:
 
This May, the FDA is expected to either approve or disapprove
over-the-counter (OTC) availability of so-called "emergency
contraception"(EC), the morning-after pill (MAP).
 
Last week, PRI's Weekly Briefing focused on the risks of MAP to
adolescents. Morning-after pills are dangerous not only to teens, but to
all women.
 
Given these dangers, we urge the FDA to disapprove OTC distribution of the
morning-after pill.
 
Steven Mosher
President
 
PRI Weekly Briefing
12 March 2004
Vol. 6 / No. 10
 
The Dangers of the Morning-After Pill
 
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 have 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 pregnancy (5) 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. From the makers of
Plan-B, MAP "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&r1=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
US, 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 MAP, 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.
 
 
ENDNOTES
 
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 use 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/viewarticle/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.
5. "A Communication to All Doctors from the Chief Medical Officer," Chief
Medical Officer Update No. 35, U.K. Department of Health, January 2003.
Available at www.doh.gov.uk/cmo/cmo_35.htm#20.
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."
8. "Repeated Use of Emergency Contraception: The Facts," International
Consortium for Emergency Contraception, Policy Statement, July 2003.
Available at www.cecinfo.org.
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, Quinnipiac University.
Available at www.quinnipiac.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.
 


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