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Emergency Contraception [EC] is a very potent medication.
EC is also called the Morning After Pill [MAP]. (A specific brand of EC sold in the USA is Plan B.)
EC is being provided in local health department clinics in most states. It is billed as a way to avoid pregnancy.
State Health Departments are NOT required to dispense this medication. Based on HHS Secretary Tommy Thompson’s clarification that states are not required to dispense EC at county health clinics, we urge states to stop the distribution of EC, and we urge the FDA to NOT approve the sale of EC over-the-counter [OTC] for the reasons that follow:
The Alabama Department of Public Health calls EC distribution “Good Public Health Policy” to prevent unplanned pregnancy and decrease abortion rates.
Even if this were proven, the use of EC without medical oversight is very contrary to sound medical principles.
1. The ACOG recommends regular STD testing for sexually active women, and especially for those outside a monogamous relationship. That there would be an increase in sexual activity and exposure to STDs with the use of EC is a given, with no physician oversight.
The Swedish Institute for Disease Control1 and the Washington State Health Department2 have noted a significant increase in Chlamydia infection in women, especially teens, in the 5 years following OTC availability of EC. (Free distribution of EC at all county health departments may not be equivalent to OTC purchase; but the ease of availability is certainly similar.) Untreated Chlamydia is a major cause for infertility.
Who can imagine how many of these women, especially teens, would be infertile after several years of untreated (and asymptomatic) Chlamydia? A pharmacist cannot fill this role; this lack of medical testing would be very harmful Public Health Policy.
2. ADPH is recommending that EC be dispensed by county health departments in cases of rape or incest. Surely, good Public Health policy would require that victims of rape or incest go immediately to a hospital Emergency Department for examination of injuries, for collection of forensic evidence, such as vaginal swabs for sperm samples, STD testing, and other needful care. We are trying to determine if our ADPH is recommending taking EC at home in this situation.
3. Surveillance of EC in the United Kingdom showed an ectopic pregnancy rate of 6% in EC users who become pregnant.3 This is triple the expected rate. This is a pending Public Health (and personal) disaster, with no medically responsible oversight of such a patient. This would be poor Public Health policy indeed, and potentially lethal for the patient.
4. Whether the ADPH distribution of EC would greatly decrease induced abortion is pure assumption, and at variance with the Swedish experience showing a 32% increase in abortion in the 5 years after EC became available.4 Abortions reached an all-time high in England in 2003.
The official statistics showed that 181,600 British women procured abortions in 2003, an increase of 3.2 percent. The abortion rate was highest, at 31.4/1000, for women in the 20-24 age group; the under-16 abortion rate was 3.9 (3.7 in 2002). EC was made available pharmacist-direct 1January01 for women and girls over 16. Girls under 16 were given EC free without parental knowledge in certain pilot projects throughout U.K.5 Basing Public Health decisions on wishful thinking or assumption is certainly not in the best interest of patients.
5. There is no question that this product, even with age restriction, would become the leading “date rape” drug in our state. How do we know that older males are not driving their teenage sexual partners to different county health clinics for EC, possibly 2-3 times per week? Have we researched the long-term effects of these high-dosage hormones on immature female bodies?
We must not forget the long-term consequences of DES. Diethylstilbestrol was a high-dose estrogen given to women in the 1950s which caused cancer in their daughters and in some sons. We have all heard the controversy over HRT. Who will take medical, and legal, responsibility when these young women (or their children) develop serious EC-associated health problems? How can we give high-dose hormones OTC when OCs require a medical exam and a prescription?
6. APFLI has serious concerns regarding this apparent unsupervised medical treatment and lack of total care and concern for the women receiving EC: Is a medical history obtained and a physical exam performed on the woman/teen prior to receiving the EC? Is a pregnancy test performed each time she presents herself for the EC? Is STD testing performed? How often is a pap smear taken? Is she checked periodically when she presents herself for EC at later times?
Is she questioned about her sexual partner? Do the local health departments question every young woman for the possibility of incest or statutory rape? How will ADPH and local health departments provide the standard of good medical care for these women to protect them from predation, and from the possible contraction of other diseases? Will the ADPH assume medical and legal accountability?
Who will check for these factors if the FDA allows EC – OTC?
7. Teens will soon learn that EC is likely more effective when taken hours before the sexual contact. This will become the junior high and high school “Friday morning” pill. Are teens clearly informed of the failure rate of 15%-25%, and the importance of timing, as stated on the ADPH website? It is apparent that without appropriate medical oversight, EC could do great harm, especially to teenagers.
8. Are teens and young women who present themselves for MAP being informed of the health benefits of sexual abstinence, and of the physical and psychological health risks of sexual activity outside marriage? Shouldn’t they at least have the risks printed on the EC container? Do they understand that EC does nothing to stop ST
9. It is apparent from the testimony of EC proponents, and from the literature,
that no one knows the mechanism of action for EC the majority of the time. Post-fertilization effect part of the time is a high probability. For women sensitive about sanctity of life issues, this probability should be clearly explained to women presenting themselves for EC.
Are the women seeking EC informed that EC can possibly have an abortifacient effect (cause a very early abortion)? The statement on the ADPH website that EC will have no effect on a current pregnancy is very misleading. ADPH is speaking of an embryo already established in the lining of the uterus (endometrium).
Throughout medical history, “conception” has been equated to “fertilization”, both meaning the union of the sperm and the egg.
However, in the last 20-30 years, “conception” has been arbitrarily redefined to mean implantation of the tiny embryo (“blastocyst”) in the uterus. This allows for a period of about 6-10 days from fertilization of the egg by the sperm, until the blastocyst – about 100 cells in size – arrives in the uterus. Of course, since EC proponents have changed the definition of conception to mean implantation, there would be no current pregnancy, “only” the loss of a blastocyst [which APFLI refers to as an early abortion].
10. The ADPH webpage, “Facts About Emergency Contraception (ECP)” [http://www.adph.org/FAMILYPLANNING/fhs505.pdf] provides women the ability to self-medicate: “Any of the birth control pills listed below can be used as ECPs…” No mention is made that women should check with their primary care physicians first.
We are asking ADPH if it will assume responsibility for these “web-surfing” patients. We wonder if the physicians of these women realize and appreciate that their patient-physician relationship is being usurped.
For women who follow this website information and self-medicate with extra OCs, the hormone levels used are associated with risks of deep venous thrombosis, pulmonary embolism, stroke, myocardial infarction, gallbladder disease, hepatic adenomas, and possibly breast cancer.
It is inappropriate for ADPH to circulate this, suggesting or inferring that women should self-medicate in this fashion, just as it would be inappropriate for the FDA to release this potent medication OTC so that women and girls would perceive it to be safe to self-medicate.
APFLI thanks Dr. Galson, Acting Commissioner for FDA, for his medically correct and very courageous stand in 5/04 for refusing to release EC- OTC, for adequate safety data regarding EC. APFLI strongly urges the FDA to make a final and permanent decision on EC which, based on the above medical information, will be in the best interest of women’s health.
As HHS Director Thompson and Dr. Alma Golden made quite clear, stopping EC distribution will have no effect on federal funding from Title X for ADPH (“…the current guidelines do not require projects to make available to clients all FDA-approved methods of contraception.”).
APFLI thanks Dr. Galson, and every citizen who reads this, for seriously considering the information, and then standing for sound, evidence-based, responsible medical principles which will truly protect women’s long-term health.
1. K. Edgardh, "Adolescent Sexual Health," Sexually Transmitted Infections, 19July 2002; 78:352-356; [http://sti.bmjjournals.com/cgi/content/full/78/5/352]. The adolescent infection rate for Chlamydia is up by 45% since EC became OTC available in Sweden in the late 1990's.
2. Washington State Health Dept found a 13% increase in Chlamydia among teens after the introduction of the (more restrictive) pharmacist direct pilot project in l998.
3. CMO Update 35A [communication to all doctors from the Chief Medical Officer) January 2003; Department of Health, Published 04/02/2003. Overseas Post-marketing Surveillance of EC use in the UK showed a reported ectopic pregnancy rate of 6%, three times the usual rate (reported to the Committee on Safety of Medicines from the WHO Task Force trial). The UK Dept of Health even issued a warning to its doctors to be aware of this. http://www.dh.gov.uk/PublicationsAndStatistics/LettersAndCirculars/CMOUpdate/CMOUpdateArticle/fs/en?CONTENT_ID=4003844&chk=2uZJEX
4. Gabriella Falk, et al., “Young Women Requesting Emergency Contraception Are, Despite Contraceptive Counseling, A High Risk Group for New Unintended Pregnancies,” Contraception, Vol. 64 Issue 1, July 2001, pp. 23-27. This study of Swedish youth found that "teenage abortion rates have gone up from 17/1,000 in 1995 to 22.5/1,000 in 2001"; during that time frame, EC became widely available without prescription in Sweden.
5. In 2002, there were 175,900 abortions; increased to 17.5 abortions/1,000 women in 2003. Bulletin 2004/14, 27 August 2004, ISBN 1 84182 883 1; http://www.publications.doh.gov.uk/public/sb0414.htm.
copyright 2006 Alabama Physicians For Life, Inc.