14 February 2013

The Morning After Pill And More

When I was in college, back in the early 1990s, my partner and I had occasion to use the "morning after pill" after a condom we were using busted.  At the time, it was an off label use of birth control pills that the campus health service at Oberlin actively promoted in the student handbook, with encouragement from the campus sex cooperative which provided contraceptives, sex toys, lubricant, and practical advice for sexually active people (hetrosexual, homosexual and bisexual) at cost.

The morning after pill (also known as "emergency contraception") is simply a high does of birth control pills taken within five days after unprotected sex or a contraceptive failure (preferrably sooner).  The morning after pill reduces the likelihood of getting pregnant by about 83%-89% if taken within 72 hours, and is more effective if taken within the first twelve hours after having sex.  (Incidentally, douching or similar methods to try to remove semen from the vagina immediately after sex without a contraceptive are almost totally ineffective.)

Insertion of a copper intrauterine device (IUD) by a medical provider in roughly the same time period also operates as a form of emergency contraception but is far less commonly used for the purpose.  Both methods were invented in 1975 and these became widespread off label uses of these forms of contraceptions in the 1980s. 

Since then, a great deal has changed.  The British approved the use of oral contraceptives for "morning after" use in 1984.  On label approval of this use of oral contraceptives in the United States came fourteen years later.  "The FDA approved emergency contraceptive pills in 1998 for use up to five days after intercourse." In 2006, the FDA authorized pharmacists to provide emergency contraception without a prescription to women eighteen or older.  Modifications to the FDA initial regulations later in 2006 allowed it to be purchased by men or women, and a court ruling in 2009 extended the availability of the pill to seventeen year old men and women. 

Young women sixteen or younger, however, still need a prescription to get emergency contraception, even though a young woman as young as twelve or thirteen years old (and in some cases even earlier) can get pregnant.

How often is the morning after pill used?

When it was available only with a prescription, in 2002, only 4% of sexually active women had used it.  When it was an off label use of oral contraceptives in 1995, a few years after I had an up close and personal encounter with emergency contraception, only 1% of women had used it.

Since it has been made available without a prescription for most women (although not always actually available at pharmacies, a story that I shared a staff journalism award with my colleagues covering at Colorado Confidential), 11% of sexually active women ages 15-44 have used it, a 275% increase. 

In truth, this understates the impact of making the morning after pill available without prescription, because morning after pill use is much greater among women who have been young ad unmarried since it became available without a prescription in 2006.

This data is based upon a recently released National Center for Health Statistics report "based on responses collected through in-person interviews with 12,279 women from 2006-2010" (of whom 10,605 were not virgins):
23% of sexually experienced women ages 20–24 had ever used emergency contraception, compared with 16% ages 25–29 and 14% ages 15–19. Just 5% of women 30–44 said they had ever used it, which the report notes may be due to it not being approved during their early reproductive years. . . . emergency contraception was most common among women 20-24, the never married, Hispanic and white women, and the college-educated.
The morning after pill is being used, as intended, for "emergencies" and not as a routine means of contraception: 59% of women who have used it have used it only once, and 24% have used it just twice. Only 17% of women who have used it (just 1.9% of all sexually active women) have used it three or more times.  According to the report about "one in two women reported using emergency contraception because of fear of method failure (45%), and about one in two reported use because they had unprotected sex (49%)."

Hispanic and white women are equally likely to have used emergency contraception (11%) but only 8% of sexually active non-Hispanic black women have used it. 

By education, 6% of sexually active women who are high school dropouts, 7% who have only high school educations, 11% who have some college and 12% who have four year college degrees or more education, have used emergency contraception.  Less educated women who used emergency contraception were far less likely to contraception failure (26% for high school dropouts and 30% for high school graduates v. 51% for women with some college and 58% for women with four year college degrees), as opposed to following sex without contraception.

The rate at which emergency contraception is used following sex without contraception is similar across women at all levels of education, but the rate at which emergency contraception is used due to suspected contraception failure is more than three times higher for women with college degrees than for high school dropouts.  White women and women ages 30 and older are also much more likely to use emergency contraception following contraception failure rather than after having sex without using contraceptives.

Clearly, making the morning after pill available without a prescription has had a huge impact in the everyday lives of women.  This isn't too surprising given that according to the report: "Roughly one-half of all pregnancies in the United States are unintended." 

Much more easily available emergency contraception that results in greater use of emergency contraception would be expected to greatly reduce the percentage of pregnancies that are unintended and unwanted.  So it isn't unreasonable to suppose that much greater use of emergency contraception since it has become available without a prescription is an important cause of the fact that the United States has had the lowest birth rates for young women in the history of the United States since 2006. 

Other findings regarding contraception use

The study also found that:
* 99% of sexually-experienced women have used at least one contraceptive method
* Nearly 30% have used five or more methods.
* 82% of sexually-experienced women have ever used the pill -- a percentage that's remained stable since 1995.
* Condom use (by a male partner) has jumped from 52% in 1982 to 93% in 2006-10.

* 93.4% of sexually-experienced women have used condoms.
* 23% have used Depo-Provera, a three-month injectable contraceptive.
* 10% have used the contraceptive patch.
* 7.7% have used any kind of IUD.
* 6.3% have used the contraceptive ring.
The morning after pill prescription requirement for minors considered

An FDA scientific advisory panel had recommended that it be made available for all sexually active women without prescription. The reasons were straitforward. Birth control pills are safer than many over the counter drugs (e.g. asprin). And, given the narrow time frame in which morning after pills are effective (and in general, the longer one waits at the margin, the less likely they are to be effective), the delays associated with the logistics of getting a prescription before getting it filled can materially reduce the effectiveness of the morning after pill in preventing pregnancy.

But, in this rare instance, the FDA ignored the recommendations of its scientific advisory panel for political reasons (a panel including a truly creepy conservative Christian gynecologist who set up an elaborate formal system of prizes for sexual favors from his wife before she divorced him).

Nine states have liberalized rules that allow women who are not required by law have non-prescription access to emergency contraception to obtains access to them without obtaining a prescription in advance from a doctor (as of June 1, 2012) - basically the pharmacists is allowed to write the prescription.  These laws follow strong regional patterns.  This is the case in all of the Pacific states except Oregon, and all of the New England states except Connecticut and Rhode Island.  But, no Mid-Atlantic, Midwestern, Great Plains or Southern states have such arrangements, and the only Mountain state to permit this is New Mexico.

The arguments for requiring young women under the age of seventeen to obtain a prescription to gain access to emergency contraception are dubious. 

One empirically invalid argument is that the easy availability of the morning after pill makes it more likely that young women will engage in unprotected sex because the consequences can be controlled.  Similar arguments were advanced in connection with the HPV vaccine which provides immunity from many varieties of a virus that caused cervical cancer and is the only major sexually transmitted disease that condoms are ineffective to prevent.  A wealth of quality research has shown that this presumed caused and effect isn't accurate.  Abstainance only sex education increased rather than decreases teen pregnancy and STD levels.  And, HPV vaccination has been rigorously shown to have no impact on sexual activity.  The women most likely to use emergency contraception are also the women most likely to use contraception at all.

Part of the opposition flows from the misguided view that parental control of the medical decisions of their children should extent to the reproductive health choices of their adolescent daughters.  Many parents emotionally think that they can impose abstainance on their children if they retain this kind of control, even though empirically, this theory isn't supported.

There is an unstated, but significant motivation for this limitation in the natalist and anti-homonal contraception view that is Roman Catholic doctrine and some conservative Christians.

Lastly, there is a fear, which is in practice vanishingly rare, that easier access to contraception facilitates the statutory rape of young women (or coerced in fact rape of young women).  Many women under the age of seventeen are legally incapable of consent to sex with many of their actual sexual partners in most states (a majority according to one study in California of teen births).  But, there is no evidence that this would actually happen more frequently with wider access to emergency contraception. 

Moreover, as hard as it is for many people to accept emotionally, if something like statutory rape or coerced in fact sex happens whether policy makers like it or not, harm reduction in those cases by preventing teen pregnancies is generally a good thing, rather than being something that facilitates acts that otherwise wouldn't have happened.

The same reasoning, of course, also applies to laws (upheld against constitutional challenge when a judicial bypass is available as it is in Colorado) that require parental consent for a minor's abortion.  Most states require notice to or the permission of a parent for minors who wish to obtain abortions, subject to judicial bypass laws in most cases, but not all such laws have survived court challenges.

Some physicians have recommended giving teens pre-pregnancy prescriptions for the morning after pill (either filled so it is on hand, or just a script) to overcome the prescription requirement when it is needed.

Religious controversies over emergency contraception mandates for pharmacies

Some states, such as Illinois, have mandates that individual licensed pharmacists and/or other providers (or firms that provide medical services) provide and/or have available the morning after pill and/or other contraceptives.

These mandates have been controversial on the grounds that they impair the religious freedom of pharmacists who object to the use of emergency contraception, although the universality of pharmacist dispensing of ordinary oral contraceptives, which are precisely the same drugs, makes conscience based objections to dispensing emergency contraceptives seem suspect.

These mandates are controversial, but I am not aware of any court cases that have invalidated these mandates on constitutional grounds.

Religious controversies over emergency contraception mandates for ERs

Twelve states and the District of Columbia mandate that emergency rooms notify rape victims of the emergency contraception option and provide rape victions with emergency contraception upon request (including Connecticut which allows this matter to be outsources to a third party), as of June 1, 2012.  Colorado and three other states (including Pennsylvania which requires not only notification but a referral to a non-objecting third party provider) require that they notify rape victims but do not mandate that the ER itself provide emergency contraception.  The other thirty-four U.S. states (including Ohio which has such laws on the books but has a policy of not enforcing the law) don't have a legal mandate to do either, but their emergency rooms in non-Catholic hospitals often do so as a matter of best medical practices in treating rape victims.

For the most part, these mandates follow the expected Red State-Blue State lines (with mandates being more common in Blue States).  But, both Texas and Utah, which are solidly Red States do have emergency contraception mandates, while a number of blue states lack them.

"Pregnancy rates among rape victims of child-bearing age are around 5%; in the U.S., and about half of rape victims who become pregnant have abortions.", according to Wikipedia citing Holmes MM et al., "Rape-related pregnancy: estimates and descriptive characteristics from a national sample of women". Am J Obstet Gynecol 175 (2): 320–4 (1996).  The impact of emergency contraception of rates of pregnancy from rapes has not been established.  But, given its effectiveness, it could meaningfully reduce the rape-related pregnancy and abortion rates and could very well have already done so.

These laws have been highly controversial, but as far as I know, with the possible exception of Ohio, no court has definitively invalidated them on state or federal constitutional grounds.

The Obamacare contraception mandate

More recently, the Affordable Care Act (aka "Obamacare"), requires health insurance plans and employer self-insured health care plans include coverage of contraception if they are to meet the Act's mandate.  The regulations implementing the contraceptive mandate of the Affordable Care Act are still in the process of being finalized, and their original version was scrapped.

For what it is worth, I think that Democrats were foolish to try to secure universal access to health care via the insurance mandate of the Affordable Care Act which predictably has led to fierce freedom of religion informed controversy, when universal health care is otherwise an issue where the Roman Catholic Church and Democrats could find common cause. 

A better alternative to the Obamacare contraception mandate

Given that the cost of contraception coverage is so modest compared to the total health care costs in the nation, a better approach would have been to reclassify oral contraceptives and emergency contraceptives as ordinary over the counter drugs like condoms, asprin and ibuprofin, and to provide universal access to other forms of contraception such as IUDs and contraceptive implants via a very inexpensive single payer system (similar to Medicare) separate from the private insurance system used to pay for other kinds of health care and housed in a small independent federal government agency.  The authority to regulate contraceptives and to fund ongoing reproductive health research could likewise be transferred from the Food and Drug Administration to this agency.

Requiring prescriptions for oral contraceptives is somewhat questionable when high doses of the same drugs are available to anyone aged seventeen or older without a prescription.

Such a program would probably cost less than $1 billion (a fraction of a percent of what is spent on either the Medicare or the Medicaid programs).  Worries about how to secure sustained funding for an agency with such a contraversial mandate could be addressed with some combination of a one time endowment of tens of billions of dollars in a federal trust fund while supporters were in control politically, some sort of excise tax (perhaps on pharmacutical and medical device companies, or medical malpractice insurers) on a class of taxpayers unlikely to complain bitterly earmarked for the federal trust fund supporting the agency, and private contributions to this federal trust fund.

This would allow employers, state and local governments, health insurance companies, health maintenance organizations, and even the federal Department of Health and Human Services, to wash their hands of involvement in provision of something that is politically controversial even though

A predominantly employer based system of universal healthcare is not a very good mechanism to provide contraception coverage in a world where some employers have sincere religious objections to the covered means of contraception.  A state administered system along the lines of Medicaid is also not a good path to universal coverage when some states are politically controlled by factions opposed to contraception, despite overwhelming popular support for contraception in every state and even among women affiliated with religious denominations that are doctrinally opposed to contraception.

The basis of religious objections to contraception

Religious institutions, primarily Roman Catholic ones, have resisted these mandates based upon their opposition to birth control generally (other than the "rhythm method" of timing sexual intercourse in relation to those times of the month when a woman is most fertile), a view applied with particular force to hormonal birth control on the grounds that it is in their view morally equivalent to abortion. 

Roman Catholic objections to birth control, in generaly, including condoms, flow basically from a natalist "full quiver", Psalm 127:5, view that God's will is that we "be fruitful and multiply", Genesis 1:28.  This had to be read together, however, with Saint Paul's statements about abstaining from sex entirely in many circumstances as the end times approach.  The Roman Catholic church addressed the issue by crafting a doctrine that the timing of sex should be a matter of choice, but that when sex happens for whatever reason, even rape, nature should be allowed to run its course even if this means pregnancy and a birth.

The gist of the Roman Catholic concern about hormonal birth control (and some other contraceptive methods), shared by many but not all abortion opponents, is that homonal contraceptives rather than preventing the fertilization of a woman's egg as a condom does, may sometimes operate by preventing the implantation of a fertilized egg in a woman's womb. 

The Roman Catholic stance on abortion today is consistent with the stance of the early Christian church in the Roman Empire which opposed the then common practice of husband (or in the case of unmarried women, male guardian) mandated infanticide, sometimes because an infant was sickly, sometimes because the husband suspected that he had been cuckolded, and sometimes on the grounds that economic resources were not available to support another child.  But, of course, in the early Christian era, safe intentional abortions at the stage of pregnancy when natural miscarriages are also common did not exist. 

There is also little or no widely known tradition regarding the attitude of the early Christian church towards contraceptive methods in the ancient world.

The morning after pill is not the same as the abortion pill

The morning after pill should not be confused with Mifepristone (aka RU-486), a different pill taken after a fertilized egg has implanted that chemically induces an abortion in the early months of a pregnancy that was approved by the FDA in 2000. 

This totally different drug has allowed primary care physicians to provide abortion services without the high profile, protest attracting, and highly regulated clinics where surgical abortions are performed.  It's use "accounted for 17% of all abortions and slightly over 25% of abortions before 9 weeks gestation in the United States in 2008 (94% of nonhospital medical abortions used mifepristone and misoprostol, 6% used methotrexate and misoprostol)."  Before it was approved, only a few percent of all abortions were induced by drugs rather than surgical.

Emergency contraception has probably reduced the abortion rate

Wider availability of emergency contraception may be a partial cause of the fact that the United States has had in the time period since emergency contraception is available to most women without a prescription, the lowest or nearly the lowest abortion rates since Roe v. Wade made early pregnancy abortions legal nationwide in the United States in 1973.

Thirty-nine states, although not Colorado, prohibit late term abortions to some extent, with some exception for the life (and except in the case of Michigan the health or the physical health) of the mother. Four different definition of what constitutes a late term abortion are used by those states: viability, 20 weeks, 24 weeks, and the third trimester (usually defined as 28 weeks). An average pregnancy carried to term lasts thirty-eight weeks from conception (usually calculated as forty weeks from the first day of the last menstral cycle) to birth, with about 80% of births taking place within plus or minus two weeks of conception). Fetal viability outside the womb was historically considered to be about twenty-eight weeks, but advanced in medical technology has made fetal viability possible as early as twenty-two or twenty-three weeks in some cases. A number of states also ban a particular abortion procedure sometimes used late in the second trimester, with mixed results when challenged in court. Many states also have waiting periods of up to twenty-four hours before an abortion can be obtained.

A practical limitation on the legal regulation of abortion is that many pregnancies end in miscarriages (which are usually defined as spontaneous terminations of pregnancy in the first twenty weeks of a pregnancy).
[A]nywhere from 10-25% of all clinically recognized pregnancies will end in miscarriage. Chemical pregnancies may account for 50-75% of all miscarriages. This occurs when a pregnancy is lost shortly after implantation, resulting in bleeding that occurs around the time of her expected period. The woman may not realize that she conceived when she experiences a chemical pregnancy.  Most miscarriages occur during the first 13 weeks of pregnancy.
In part, for these practical reasons associated with the difficulty of showing causation, English common law didn't recognize abortion as a crime prior to a "quickening" (basically after the first trimester when a woman can start to feel a fetus kick inside her at the 19th to 21st week of pregnancy), but abortion after that point was illegal for centuries until the 20th century, at a time when it usually involved taking questionable herbal poisons or risky intentional physical trauma to the pregnant woman.

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