SSBG

A worldview is a set of claims that purport to be based on ultimate reality.

Little Pills: Targeting Youth with New Abortion Drugs

Posted by ssbg on January 8, 2006

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From Family Research Council;  http://www.frc.org 
by: Mrs. Teresa Wagner
In March 2001, the Virginia General Assembly defeated a bill calling for over-the-counter distribution of the “morning after pill,” a drug regimen taken after sexual relations to stop or prevent pregnancy. The morning after pill can contain as much as eight times the daily hormone dose of the traditional birth control pill.[1] Both are currently available by prescription, but abortion advocates are working to remove this requirement for the morning after pill, and are enlisting the medical profession in the cause. Just one month earlier, for example, America’s most vocal pro-abortion litigation organization, the Center for Reproductive Law and Policy (CRLP), filed a Petition with the Food and Drug Administration requesting this change. The Petition represented such major medical groups as the American Medical Association (AMA) and the American Public Health Association.[2]  

At about the same time, the morning after pill made news both domestically and abroad because of its distribution to minors in school-based clinics–often without parental knowledge or consent. In the United States, public officials had learned from the Congressional Research Service that girls as young as thirteen were able to obtain the pills through federally funded “family planning” programs at 180 elementary and secondary schools.[3] Senator Jesse Helms of North Carolina introduced an Amendment to the Labor/Health and Human Services/Education appropriations bill (H.R. 4577) in June of 2000 to stop this. In Europe, articles had surfaced about the very same practice in England and France, with tragic effect in the case of fourteen-year-old Caroline Bacon of Britain, whose mother only learned Caroline had taken the pills after her death by stroke. In both countries, as here, the stated justification for such secret distribution to minors is the need to curb teenage pregnancies.[4]

Rarely does one hear that the long-term effects of such high dose pills are unknown. Nor does one hear that teenagers may be a vulnerable group, since adolescents, by definition, are still developing, and the drugs affect precisely those reproductive organs and tissues in the process of maturing. While promoters admit that “routine or repeated use is contraindicated,” they continue to target the young–the very group that is most likely to engage in such use, since they are at the start of their fertile years. Indeed, one program in Edinburgh, Scotland, distributed five packets of the morning after pill–a total of twenty pills–to young women for free. This effectively encourages “routine and repeated use.”[5]

The heavy push for the morning after pill in the United States comes on the heels of the FDA’s September 2000 approval of RU 486, another drug regimen taken after sexual relations, in early pregnancy. While the makers and marketers of RU 486 have been clear about its function as an agent of abortion, the publicity surrounding the morning after pill (sometimes mistakenly called “emergency contraception”) has not been so candid. Additionally, the public is inclined to confuse the two, since both drug regimens hit the market in roughly the same time frame.

Fertility 

To understand the function of the morning after pill and RU-486, one must first understand some basics about female fertility, which include:

 Ovulation: The release of the ovum from the ovary, occurring at about the midpoint of a woman’s menstrual cycle.

 Fertilization: The joining of one sperm with one ovum, creating a zygote, the first stage of the new human being (the single-celled new organism). This stage immediately gives way to further cell division–the morula at approximately sixteen to thirty-two cells, and the blastocyst at approximately thirty to one-hundred-and-fifty cells. The term “embryo” encompasses all these stages, however, and is applicable until the end of the second month of gestational life, after which point the term “fetus” is used.[6] (The term “pre-embryo,” introduced by those wanting to dehumanize the human embryo and intended to argue that human life does not begin until the embryo implants [see below], is not a medically recognized term or developmental stage.[7]) Fertilization must occur within 24 hours of ovulation (after which point, the ovum disintegrates) and is able to occur within minutes of sexual relations if conditions are correct (see Cervical fluid production).

·  Implantation: The point at which the human embryo embeds within the wall of the womb. This occurs five to seven days after fertilization.

·  Cervical fluid production: Women also produce certain fluids that help transport sperm to the ovum and are an essential feature of female fertility. This production usually spans many days, preceding and building up to ovulation, and waning thereafter.

Anti-Fertility Drugs 

Fertility (and/or anti-fertility) drugs typically affect one or more of these four events in the female cycle.

True contraceptive drugs and devices aim either to prevent ovulation, or to alter the fluids that help join sperm and ovum. Such effects are authentic contraception because they prevent fertilization and therefore prevent the beginning of a new human life. A standard-dose birth control pill, with combined synthetic estrogen and progesterone components (known as “combined oral contraceptives” or “COCs”) for example, has both of these functions.[8]

However, those drugs and devices that aim to prevent implantation by altering a woman’s uterine lining are properly called “anti-implantation” and are not contraception. They function, instead, as early abortions, or abortifacients, since they prevent the newly conceived life from embedding within the womb where it is normally nourished until birth. In effect, anti-implantation drugs starve the new life to death.

Any drug or device that aims to alter the uterine lining is therefore anti-implantation in function, and qualifies as a possible abortifacient. The intra-uterine device (IUD) is the most obvious example of this type of anti-implantation device.

 

Fostering Confusion 

Contraception and abortion industries deliberately confound the events of female fertility for self-serving reasons. For example, they attempt to redefine the beginning of pregnancy: They claim that pregnancy starts upon implantation of the embryonic human being, rather than when the new life is created at fertilization. By insisting that “pregnancy begins at implantation,” they then market drugs that destroy life before or upon implantation as “contraception,” even though such anti-implantation drugs are actually abortifacients. They also gain ground in their efforts to classify the pre-implantation embryo as an entity lacking in rights, and therefore available as material for scientific research, or as a subject for genetic screening.

The abortion and contraception lobbies believe they can get away with this rather bad faith “sleight-of-definitions” because doctors have traditionally been able to confirm pregnancy only upon implantation.[9] At this point, the early developing placental tissue produces HCG (human chorionic gonadotropin), a hormone which doctors can detect in the mother’s urine and blood to verify pregnancy. The mother is obviously pregnant before that point, however, since the embryo’s journey to the uterus requires five to seven days.

The ability to confirm life’s existence is of course different from the point at which the life begins. But confounding the two allows the contraception industry to market abortifacient drugs as “contraceptives” to an unsuspecting public.

PHARMACOLOGICAL FUNCTIONS AND ADMINISTRATION OF RU 486 AND THE MORNING AFTER PILL

 

RU 486: Function 

RU 486 indisputably acts as an abortion agent, since this drug regimen seeks to alter the mother’s uterine lining and then induces contractions to expel the developing life.

RU 486 is the popular term for the combination of two drugs:[10] The first is mifepristone (trade name–Mifeprex), a synthetic steroid which blocks progesterone receptors. Progesterone is the female hormone needed to sustain pregnancy, because it works to thicken the uterine lining to prepare for and sustain the new life which embeds there. When progesterone is “blocked,” the uterine lining cannot sustain the newly conceived human being. (Women who miscarry early in pregnancy often lack progesterone. Some are given progesterone tablets to help the uterine lining develop so that it can receive and carry the newly conceived child.)

The second drug in the RU 486 regimen is misoprostol (trade name–Cytotec), a prostaglandin that stimulates uterine contractions to expel the human embryo (and placenta).[11] Cytotec is an anti-ulcer drug that is not intended (nor is it approved) for any use other than ulcer treatment.[12]

The FDA approved RU 486 for use up to forty-nine days of pregnancy, dating from the day of the mother’s last menstrual period. The embryonic human being is roughly thirty-five days old at this time. A woman usually does not suspect pregnancy until she is late for her menstrual period, when the embryo is approximately three weeks old. Even at that early stage, the child has a heartbeat (detectable at twenty-four days).

 

RU 486: Administration 

Administration of RU 486 takes three clinic visits and spans at least two weeks, often more. The FDA approved the drugs in pill form, to be taken orally–three 200 milligram pills of mifepristone (600 milligrams total)–two 200 microgram pills (400 micrograms total) of misoprostol forty-eight hours later.[13] The woman must agree to return in approximately two weeks to ensure that the child has passed completely. (There is no mechanism to ensure this, however.) In 5 to 8 percent of cases, RU 486 does not work, at which point surgical abortion is needed.[14]

Within a month of FDA approval, however, abortion proponents moved to use the chemicals even later in pregnancy (up to fifty-six days, or eight weeks) and to reduce the number of visits required.[15] Given the rapidity of the proponents’ action, deviating from the FDA-approved protocol was obviously the plan from the start.

 

The Morning After Pill: Function 

The “morning after pill” consists of synthetic hormones (both estrogen and progesterone types, known as “ethinyl estradiol” and “norgestrol”), along the lines of the traditional birth control pill, although in much higher doses–as much as eight times the dose of the typical oral contraceptive pill. The morning after pill is also called “post-coital contraception,” or “emergency contraception.”

As indicated above, the word “contraception” is problematic where a drug’s primary or dominant function is to prevent implantation. (Anti-implantation drugs and devices cause abortions and are therefore abortifacients.) While there are four possible action modes of the morning after pill (inhibition of ovulation; effect on tubal transit time; alteration of the normal cycle pattern; and prevention of implantation due to damage to the endometrium),[16] its principal function is an anti-implantation, or abortion, effect. As the medical textbook, The Developing Human:Clinically Oriented Embryology, explains:

The administration of relatively large doses of estrogens (“morning after pills”) for several days, beginning shortly after . . . sexual intercourse, usually does not prevent fertilization but often prevents implantation of the blastocyst. . . . Normally, the endometrium progresses to the secretory phase of the menstrual cycle as the zygote forms, undergoes cleavage, and enters the uterus. The large amount of estrogen disturbs the normal balance between estrogen and progesterone that is necessary for preparation of the endometrium for implantation of the blastocyst. Postconception administration of hormones to prevent implantation . . . is contraindicated for routine contraceptive use.[17]

In Contraceptive Technology, Robert Hatcher states that:

Emergency contraceptive pills . . . danazol or progestin only . . . temporarily disrupt ovarian hormone production and cause an absent or dysfunctional luteal phase hormone pattern. An inadequate or absent luteal phase results in out of phase endometrial development, so the uterine lining is unsuitable for plantation.[18]

Thus, calling the morning after pill “contraception” is misleading: While it can have a contraceptive effect, most of the literature on it confirms that it is more likely to act as an abortifacient if fertilization has taken place.

However, the actual function of the morning after pill in any given case depends on where the woman is in her fertility cycle when she takes it: If the woman has not yet ovulated, the drugs may act to suppress ovulation. But if the woman has already ovulated, the drugs obviously cannot have that effect. Obstetrician John Wilks explains:

To maintain a truly contraceptive action, the morning after pill cannot be given close to the usual day of ovulation. If the pill failed to prevent ovulation, fertilization might occur, with a consequent loss of the fetus. . . . For women at or a few days past ovulation, the morning after pill could not be used as a contraceptive for the same reason: the possibility of fertilization coupled with an impaired endometrium could result in loss of the embryo.[19]

The literature suggests that the contraceptive function is not primary even under such pre-ovulatory conditions, since the drugs act “principally” upon the uterine lining (“endometrial development”) which occurs in the “luteal phase,” or post ovulation.

 

The Morning After Pill: Administration 

While there are variations of the morning after pill, two regimens are most widely recognized and both are now available in the United States.

The first consists of a combination of synthetic hormones, or hormone derivatives, taken within seventy-two hours of intercourse, twelve hours apart. Sold in the United States as Preven (marketed as “an emergency contraception kit,” distributed by Gynetics Corporation), it is popularly known as the “Yuzpe” regimen.[20] The regimen totals two hundred micrograms of ethinyl estradiol (synthetic estrogen) and either 2.0 milligrams of norgestrel, or 1.0 milligram of levonorgestrel (synthetic progesterone). Nausea, vomiting, dizziness and breast tenderness are common side effects. The FDA approved Preven in 1998.

The second regimen, less often used and available in the United States since 1999, consists of synthetic progesterone pills (levonorgestrel) only. In the methods studied, pills containing .75 milligrams of levonorgestrel are given to a woman no later than eight hours after intercourse; this same dose is then repeated twenty-four hours later.[21] This method is marketed as “Plan B” in the United States and was approved by the FDA in 1999.

REGULATION, LEGAL STATUS AND MEDICAL CONCERNS OF RU 486 AND THE MORNING AFTER PILL

Because RU 486 was known to be an abortion agent, its approval by the FDA was a major national news story. By contrast, the morning after pill was marketed as just another contraception option and caused much less fanfare. In truth, the two moves were steps into an era of chemical abortion or chemical killing.

 

RU 486: FDA Approval, Medical Issues and Discarded Guidelines 

From the beginning, the application for FDA approval of RU 486 was controversial.[22] For the first time, the nation’s premiere health agency gave consideration to (and then authorization of) a drug solely for killing, rather than healing.

But even the drug’s proponents recognized the novelty of chemical abortion and the need, therefore, for safety regulations to govern its use. For example, most people involved in the approval process initially agreed that only physicians skilled in surgical abortion should prescribe RU 486. This seemed common sense since the drugs failed 5 to 8 percent of the time, requiring surgical abortion as a back-up.

Also proposed was mandatory use of ultrasound technology to date pregnancy, since the RU 486 regimen cannot effectively destroy the embryonic human being after the forty-ninth day (hence the FDA’s limit). In fact, the complication and failure rates more than double with RU 486 if a pregnancy is just one week over forty-nine days. This may be in part because the embryo almost doubles in size between forty-nine and fifty-six days gestation.[23]

The use of ultrasound also can confirm an intrauterine pregnancy (where the embryo is within the uterus), and rule out an ectopic pregnancy (where the embryo is lodged in the fallopian tube). This distinction is important because RU 486 will not cause an abortion in the case of an ectopic pregnancy. In fact, ectopic pregnancy is a contraindication for its use: Left unattended, an ectopic pregnancy can be fatal, and its symptoms are similar to the effects of RU 486 (bleeding and pain). Thus, if a woman mistakenly takes mifepristone with an ectopic pregnancy, she cannot distinguish between RU 486’s side effects and the symptoms of an extrauterine pregnancy, which is putting her life at risk.

Finally, even abortion advocates recommended that the physician administering RU 486 have admitting privileges to hospitals with emergency services, and the FDA proposed that those services be within an hour’s drive of the doctor’s office.[24]

But when many of these proposed measures became public in June of 2000, abortion advocates changed course and pressured the FDA to drop them, claiming that they would curb access to the drug. In the end, the FDA only required that RU 486 “be provided by or under the supervision of a physician,” who is able to assess the duration of a pregnancy (no ultrasound need be used) and who can refer to a doctor skilled in surgical abortion.[25] No regulation on nearby emergency services exists.

To make matters worse, the FDA requested that information regarding complications (such as blood transfusions, hospitalizations or continued pregnancies) and “failures” be reported to the drug’s sponsor, Population Council, or “its designate.” [26] The latter is a new corporation called Danco Laboratories, founded specifically to promote RU 486 in the United States. Richard Hausknecht, a well-known abortion advocate, is Danco’s “Medical Director.”[27] No requirement exists to make this information public.

Non-public complication reports to Mr. Hausknecht hardly constitute safety regulations and accountability for patients. While the FDA has tried to characterize such conditions as “distribution controls” for RU 486, they look, instead, like protection shields for its marketers and providers.

 

Legislation and Miscellaneous Regulations 

Surprised by the lack of regulations issued by the FDA, some Members of Congress introduced the “RU 486 Patient Health and Safety Protection Act” early in the 107th Congress.[28] Sponsors included Representative David Vitter of Louisiana; Senators Chuck Hagel of Nebraska, Mike DeWine of Ohio, and Robert Smith of New Hampshire. The bill seeks to restore the safety regulations discarded by the FDA, such as requiring that the prescribing physician himself can do surgical abortions, or handle complications from RU 486. It also calls for a program to be completed before a physician can prescribe mifepristone, and requires that a hospital be within one hour’s travel time for the patient. The bill requires certification in ultrasound dating of pregnancy, but, unfortunately, falls short of requiring use of ultrasound before RU 486 administration. Similar bills and other regulations have been introduced in approximately sixteen states.[29]

Interestingly, the expected popularity of RU 486 is proving illusory to its proponents. According to the New York Times, doctors are not attracted to it because of the complicated and time-consuming administration.[30] It is just as expensive as a surgical abortion, with a possibility that surgery will still be needed; and the stigma of it has discouraged many medical facilities from considering it, including medical centers on university campuses. (This list includes: Rutgers and Princeton Universities, the University of Michigan, the University of Wisconsin at Madison, the University of California at Los Angeles, and the University of Georgia.[31])

 

Remaining Problems 

In addition to these clinical and regulatory concerns, legal issues and production problems surround RU-486’s approval. For example, FDA documents reveal that the drug regimen was cleared under “Subpart H” regulations. Subpart H was created in 1992 (and codified by Congress in 1997) to expedite clearance of experimental drugs for the treatment of AIDS and cancer and is titled:”Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses.”[32] How RU-486 was placed on this track is a serious and as yet unanswered legal question.

What’s more, the FDA has not approved Cytotec, the second drug of the RU 486 regimen, for abortion use. In fact, Cytotec’s manufacturer, the Searle unit of the Pharmacia Corporation, wrote health care providers to remind them that its administration is contraindicated in pregnant women, whether for abortion or labor induction. That letter cited “serious adverse events” associated with such off-label use, including uterine rupture and perforation, hysterectomy and shock.[33] The FDA’s formal recommendation not only of an “off label” use of a drug, but a use that its own manufacturer opposes, is unprecedented.[34]

Finally, and most disturbing given the focus of policy makers on adolescents, is the little-reported fact that RU-486 was never tested or studied for its effects on minors, including the effects on their future fertility.[35]

Morning After Pill

As indicated above, the FDA’s 1998 approval of the morning after pill has led to an aggressive campaign to promote it not just from the usual contraception and abortion advocates, but from within the medical profession.

 

Promotion: From Prescription to Over the Counter 

This promotion has taken the form of increased publicity (what’s called “education” by its advocates) and a very vocal call for the morning after pill to be distributed over the counter (OTC) rather than by prescription. Several websites have actually begun to offer the morning after pill by mail through the Internet and/or by phoning a physician listed on line (without a physical exam).

At its annual convention in December of 2000, the American Medical Association’s (AMA) Council on Medical Service proposed that AMA physicians be more assertive in promoting the morning after pill, and that the organization support efforts to drop the prescription requirement. The AMA House of Delegates responded by approving a resolution calling on the FDA to “consider” making the morning after pill available over the counter.[36] Less than six months later, the new head of the American College of Obstetricians and Gynecologists (ACOG), Dr. Thomas Purdon, did one better and proposed to the group’s 40,000 members that they offer advance prescriptions for future use.[37]

Medically Irresponsible 

These offensive steps to increase the morning after pill’s availability and circulation–even eliminating physical exams–are startling, given the high dosage of the pills, and the severity and frequency of side effects. As one pharmacological textbook explained:

These high doses of estrogens frequently produce serious side effects, including cramps. Nausea and vomiting occur routinely and often are severe enough to warrant anti-emetics. Because of the severity and frequency of side effects . . . post-coital [drug] is not appropriate for routine use and is normally reserved for emergency situations such as rape and incest.[38]

One is left to wonder why the medical profession is pushing a drug regimen that has thus far been “reserved for emergency situations.” It also appears strange that there is no parallel effort to change the status of the traditional birth control pill, which is much lower in dose and potency. Typically the change from prescription to over-the-counter occurs for lower-dose drugs.

The need for a structural check on morning after pill use–whether by prescription or otherwise–is fairly plain. Oversight allows for verification of health conditions, so that patients are screened for contraindications. It is also a way to guard against repeated use, which OTC status obviously cannot prevent–and may encourage. (The advance prescription proposal is no less worrisome on this point, since drugs, once in hand, can easily pass from one user to the next–an especially likely prospect among teenagers in frightening and seemingly desperate situations.)

Finally, serious–even life-threatening–side effects can occur with the morning after pill: blood clots, strokes, and heart attacks.[39] Given these risks, the advisability of medical oversight should be obvious. One can only conclude that those doctors advocating its indiscriminate distribution are acting irresponsibly.[40]

CULTURAL IMPACT

The development and promotion of anti-fertility drugs for adolescent females have had serious consequences. The degradation of the medical profession–becoming more obvious, but still little discussed–is just one. Despite reservations, many doctors went along with legal abortion in large part because groups like the AMA led them there.[41] But abortion advocates are rarely satisfied with just “going along.” They demand more and more support, including open approval, and now, as Thomas Purdon illustrates, an unfettered license. It is one thing for Dr. Purdon to support abortion and contraception distribution to minors; it is quite another for him to lend the prestige of his profession to such a cause.

Equally serious is the misrepresentation by Dr. Purdon and others about the actual function of certain drugs (in this case, the abortifacient action of the morning after pill). The failure on his part, and on the part of the profession generally, to raise questions regarding the potency, and therefore the safety, of this drug regimen (especially to a vulnerable population) is also seriously negligent. While positions on controversial issues may compromise professionalism (such as the AMA’s abortion stance), misrepresentation and omissions of this sort violate medical ethics. This is by definition a disservice to patients, and to the public at large.

Second and more broadly speaking is the degradation of human sexuality in modern society, with all the physical and spiritual problems that entails.[42] One seldom even hears the word “promiscuity” anymore, since it sounds unacceptably judgmental. Instead, the mechanical, even positive-sounding phrase “sexually active” is the preferred term, suggesting that those not engaging in indiscriminate sexual relations are passive and sickly.

Few, even within medicine, seem to realize that the stigma of promiscuity (which is simply the flip side of honoring chastity) was born of both moral and practical considerations. Practically speaking, sexual promiscuity has meant enormous societal problems, including (perhaps especially) problems of public health. While everyone contends with the effects of rising illegitimacy, doctors more than anyone else must contend with sexually transmitted diseases, abortion and related injuries, and the consequent infertility. Given this, one might expect the medical profession to speak out against promiscuity, if only to prevent the disease and destruction it causes. Instead, public health professionals have not only made peace with sexual license (against society’s practical interests), but now virtually advocate it. The campaign for the morning after pill is just one case in point.[43]

CONCLUSION

In some ways, the introduction of abortion in pill form is not that newsworthy. The destruction of our young, and the concomitant risks to their mothers, are an injustice whether by drugs or otherwise. That said, pills appear more medical and simple–and the more medical and simple a practice appears, the more acceptable it appears. The abortion lobby is fully aware of this and has lobbied intensely for medical approval and involvement in its cause. That is why the morning after pill and RU 486 are so important; and that is why the complicity of the medical profession in the abortion movement is so tragic.

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