Contraception - Chemical Methods / Hormonal Contraception / Emergency / Morning After Pill

Major Medical Concerns Regarding EC/MAP, Plan B: APFLI Statement (9/04, updated 2006)

Emergency Contraception Supporters want EC (MAP – Morning After Pill) to be freely available in all county health departments (to girls as young as 14, without parental knowledge) nationwide. They are also pressuring the FDA to release EC over-the-counter (OTC).

When the FDA denied this request in 5/04, Barr Labs and other EC supporters returned to the FDA seeking that EC be released OTC to all women over age 16, and by prescription (without parental knowledge) to girls under age 16.  In 2005, the FDA has again postponed this OTC approval.

The EC supporters insist that EC will:
• Decrease pregnancy rates
• Decrease abortion rates

However, they do not provide medical facts to back up these claims, nor do they want to discuss the following points…

OUTLINE OF MAIN MEDICAL CONCERNS REGARDING EMERGENCY CONTRACEPTION (EC/MAP):

• increased exposure to STDs/STIs — Chlamydia: 45% inc OTC in Sweden, 13% inc in Washington State’s more restrictive pharmacist direct pilot program for teens

• increased ectopic pregnancy rates — 3 times the expected rate

• new data showing increased pregnancy and abortion rates

• lack of medical oversight

• increased sexual predation — statutory rape, incest

• increased sexual activity

• danger of high-dose estrogens on young female bodies has not been well evaluated

• danger of long-term damage from high-dose EC has not been well evaluated

These concerns will now be discussed in more detail:

Increased STD/STI Rates Associated with EC Use. The ACOG (American College of Obstetrics and Gynecology) 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.  The Swedish Institute for Disease Control (1) and the Washington State Health Department (2) have noted a significant increase in Chlamydia infection in women, especially teens, in the 5 years following OTC availability of EC. (Whether EC is distributed at local county health departments, or sold OTC, the ease of availability is similar.)

Untreated Chlamydia is a major cause of infertility (1/3 of reported cases). Who can imagine how many of these women, especially teens, would be infertile after several years of untreated (and asymptomatic) Chlamydia? (About 80% of women and 50% of men are asymptomatic – they have no noticeable symptoms of the infection.)

A pharmacist cannot fill this role; allowing distribution of EC without accompanying medical exams and STD testing would be very harmful Public Health Policy.

Citings:
      1. K. Edgardh, "Adolescent Sexual Health," Sexually Transmitted Infections, 19 July 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.

It should be noted that most states regularly test only for syphilis, gonorrhea, and HIV. Herpes Simplex II (HSV-2) infects 1 of every 5 Americans over the age of 11, and Human Papillomavirus (HPV) infects about 5 million Americans each year and is present in 99% of cervical cancer cases (cervical cancer kills 4000-5000 American women each year, more U.S. women than die from AIDS); yet, most health departments do not regularly test for these or the other major STDs/STIs.

It should also be noted that EC, albeit any chemical birth control method, does not provide any protection against any STD/STI.

Increased Ectopic (Tubal) Pregnancy Rates Associated with EC Use.  World Health Organization Surveillance of EC was reported in the United Kingdom in 2003. The data from the WHO Task Force trial showed an ectopic pregnancy rate of 6% in EC users who become pregnant.(3) This is triple the expected ectopic rate. In an ectopic pregnancy, the developing embryo gets caught in the Fallopian tube and cannot reach the uterus. If not found, the tube can rupture and the developing human embryo and the mother could both die. 

This is a potential Public Health disaster, with no medically responsible oversight of such a patient.  This would be poor Public Health policy indeed, and possibly lethal for the patient. 

Citing:
      3. CMO Update 35A [communication to all doctors from the Chief Medical Officer) January 2003; Department of Health, Published 04/02/2003. WHO Overseas Post-marketing Surveillance of EC use 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

Important Point: Terminology.  The words “fertilization” and “conception” (union
of sperm and egg to form the fertilized egg, in the Fallopian tube) had always been synonymous, and “pregnancy” began at that moment of union. In the 1960s/1970s, it was deemed necessary to change the medical terminology surrounding the beginnings of human life.

There was a meeting of officials of the ACOG, the U.S. FDA, some drug companies, and Dr. Alan Guttmacher. They “officially, but very quietly”, ruled that “henceforth the word ‘conception’ would no longer mean union of sperm and egg”. The new meaning was to be implantation in the uterus, which occurs 6-10 days after fertilization.

“The word ‘pregnancy’ was also a problem so they changed its definition from beginning at fertilization to beginning at implantation.”

Very few people were informed about this terminology change then, and even today, many doctors are not aware of it. However, this seemingly unimportant definitional change “enabled the drug companies to call the ‘pill’ and the IUD contraceptives”, and today, they insist that EC – emergency contraception – prevents conception and prevents pregnancy, simply because a small “elite” group quietly changed the terminology rules 40 years ago. They say this “while 99% of everyone else believes ‘conception’ and ‘pregnancy’ still carry their traditional meanings of union of sperm and egg.” [emphasis added] (4)

Citings:
      4. Life Issues Connector, 5/04; E. Hughes, Ed., OB & GYN Terminology, Philadelphia: F.A. Davis, 1972; Van Nostrand’s Scientific English, 5th ed, 1976, p. 943, Considine, ed.

New Data Showing Increased Pregnancy and Abortion Rates.  The ADPH (Alabama Dept of Public Health) website notes a 15%-25% “failure rate” with EC use; that is, a fertilized egg may result 15%-25% of the time, and the woman will be pregnant. Note [above] the tripled ectopic pregnancy rate with EC use. Obviously, women still get pregnant, even using EC.

Saying that 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.(5)

It is also at variance with the British experience. EC was made available without prescription on 1 January 2001. Surgical 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). As noted above, 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 the U.K.(6) [In 2004, the abortion rate again increased, by 2.1%, over the 2003 numbers.]

Basing Public Health decisions on wishful thinking or assumption is certainly not in the best interest of patients. 

Citings:
     5. 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"; EC became widely available without prescription in Sweden in the mid-1990s.   
     6. In England in 2002, there were 175,900 abortions; all 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

As noted earlier, EC likely causes a “post-fertilization effect” at least part of the time; that is, EC may prevent implantation of a human embryo in the uterus, thus causing an early abortion. 

Women who are sensitive about and respect the innate value of human life should be informed that there is a possibility that the use of EC may cause an early abortion.

Again, when EC supporters insist that EC will have no effect on a current pregnancy, they are speaking of a human embryo or fetus already established in the lining of the uterus (endometrium). They are not referring to the embryo just conceived and trying to implant in the endometrium.

If we must err, err on the side of life…

Lack of Medical Oversight. The ADPH website for EC use lists a number of common oral contraceptives and explains how women may use additional pills as EC. In other words, the Health Department is explaining how women can self-medicate. This is an usurpation of the physician-patient relationship. No one is aware that these web-surfing women are using high doses of hormones, if problems should develop.

Whether EC is provided to women/teens OTC, or at county health departments, it appears that they would be using these hormones with generally NO medical oversight (i.e., unsupervised medical treatment). This is a lack of total health care for women. 

What is the Medical Protocol for EC use? If EC is provided OTC,
     How is a medical history taken?
     How is a physical exam performed?
     How is STD testing conducted? Pap smear?
     How is a Pregnancy test performed?
     How does she receive periodic exams when she presents herself for subsequent EC?
     Who questions her about her sexual partner? (to determine if statutory rape or incest are involved)
     What is the protocol if predation is found? Is there protocol to check?
     What is the protocol for checking for/protecting teens from STDs?
     Does anyone ever think to mention sexual abstinence to these girls?

A pharmacist cannot accomplish these tasks.
If the woman/girl receives the EC at the health depar

tment, what is the protocol for the exams and testing mentioned above?
Is there protocol for EC use?

Who, or what organization, is responsible/accountable if the woman experiences health problems, either immediate or long-term?

Increased Sexual Predation – Lack of Inquiry to Determine Statutory Rape or Incest.  Sexual predators recognize the “value” of EC. If provided OTC, they will purchase EC and give it to their young sex partners to decrease the risk of pregnancy. If provided through health departments, they will likely drive the girls to the health department.

Victims of rape or incest should always immediately go 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. 

It is unconscionable that EC supporters would recommend that a traumatized rape/incest victim would simply purchase EC over-the-counter and take it at home without appropriate medical care. It is hoped that they are not recommending this, although they have not made it clear…

Danger Of High-Dose EC On Young Female Bodies Has Not Been Well Evaluated. Emergency Contraception [EC] is a very potent medication.  All estrogen substances were placed by the federal government on a list of carcinogens a few years ago. There have been no serious studies to prove that EC is not chemically polluting young female bodies.

In many states, girls as young as 14 can receive EC at county health centers w/o parental knowledge. Thinking themselves invincible, teens will learn to take EC prior to sex as the “Friday morning pill”. EC provides a false sense of security to teens; they believe it is fool-proof.

There is also the major underlying concern that EC is being pushed on our young people as the only solution to avoiding pregnancy.  It appears that sexual abstinence is not even mentioned, much less promoted by EC/”safe sex” supporters.

Do they inform teens 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? It also took us decades to do this for cigarettes. Do teens understand that EC does nothing to stop STDs?

Danger Of Long-Term Damage From High-Dose EC Has Not Been Well Evaluated. In the 1950s, a high-dose artificial hormone termed DES (diethylstilbestrol) was given to women suffering hormone imbalance. Many years later, it was found that the daughters (and some sons) of these women had cancer. The cancers were traced to the mothers’ use of DES.

When oral contraceptives were introduced in 50s and 60s, the high hormone levels were associated with risks of deep venous thrombosis, pulmonary embolism, stroke, myocardial infarction, gallbladder disease, hepatic adenomas, and possibly breast cancer. Estrogen levels were lowered to decrease these health problems.

There is presently much controversy surrounding HRT (Hormone Replacement Therapy).

So here is the amazing situation we now face: Women are required to have an initial physical exam and have periodic exams while using low-dose oral contraceptives. Yet, EC/MAP, which often contains high-dose estrogens, is being handed out by health departments, and FDA is being pressured to release them over-the-counter!

Can we seriously doubt whether the same health problems incurred by high-dose estrogens over the years will recur with EC use?

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It should also be noted that State Health Departments are NOT required to dispense this medication. Former HHS Secretary Tommy Thompson, and Dr. Alma Golden clarified quite clearly that stopping EC distribution will have no effect on federal funding from Title X for state health departments (“…the current guidelines do not require projects to make available to clients all FDA-approved methods of contraception.”).

[To read a copy of the reply letter of Former HHS Secretary Tommy Thompson, click here.]

Based on HHS Thompson’s clarification that states are not required to dispense EC at county health clinics, and based on the serious medical concerns mentioned above, 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).

Instead, we urge state health departments and the FDA to stand for sound, evidence-based, responsible medical principles which will truly protect women’s long-term health
 
 c copyright 2006, Alabama Physicians For Life, Inc.