Pill Pushing©

The Pill - You say you want a revolution - (12/1/2016)

By Dr. Ron Gasbarro

The drugs in question: Oral contraceptives

Before The Pill – A paste of dates and honey
In the ancient medical manuscript, the Ebers Papyrus (1550 BC), women were advised to grind dates, acacia tree bark, and honey together into a paste, apply this mixture to seed wool, and insert the seed wool vaginally. While acacia ferments into lactic acid, a well-known spermicide, it was the cotton itself that promoted its effectiveness as birth control, as the cotton fiber functioned as a physical barrier between the ejaculate and cervix. Interestingly, women during the times of American slavery would chew on the bark of cotton root to prevent pregnancy. Cotton root bark contains substances that interfere with the corpus luteum, which is the hole left in the ovary when ovulation occurs. The corpus luteum secretes progesterone to prepare the uterus for implantation of a fertilized egg. By impeding the corpus luteum’s actions, cotton root bark halts progesterone production, without which a pregnancy cannot ensue.

Tainted love 
In the year 200 AD, the Greek gynecologist Soranus advised women to abstain from sex during menstruation, which he mistakenly believed to be their most fertile time of month. He also recommended that women hold their breath during intercourse, followed by sneezing afterwards to prevent sperm from entering the womb. In 10th-century Persia, women were told to jump backwards 7 or 9 times after intercourse to dislodge any sperm, as those were believed to be magical numbers. And in the Middle Ages, women were advised to tie the testicles of a weasel to their thighs or around their necks during intercourse. That must have been a turn-on!

In medieval western Europe, any efforts to halt or prevent pregnancy were deemed immoral by the Catholic Church. Women of the time still used a number of birth control measures such as coitus interruptus, or inserting lily root and rue into the vagina. Knowledge of herbal abortifacients and contraceptives to regulate fertility decreased in the Early Modern period. This was attributed to attempts of European states to "repopulate" Europe after dramatic losses following the plague epidemics, such as the Black Death that started in 1348 and ultimately killed 25 million people.

The Pill: Development crawled and then soared 
According to Time magazine in 2015, the 20th century would eventually see the most advanced and revolutionary development of birth control in history. However, at the start of the century the phrase “birth control” was not part of the general vernacular. Margaret Sanger — a determined nurse and activist who would revolutionize reproductive rights in America — first coined the phrase in 1914 with the launch of a monthly newsletter called The Woman Rebel. The newsletter offered information about birth control and was a flagrant challenge to the country’s obscenity laws. Soon, Sanger was indicted for breaching the obscenity laws and fled to England to avoid trial. By 1916, Sanger was back and opening the first family-planning clinic in the US. It was shut down within 2 weeks. Five years later, Sanger founded the American Birth Control League, which would later become the Planned Parenthood Federation of America. 

By 1950, shocked at how many women died following self-induced abortions, Sanger had an idea for contraception. In 1951, she approached biologist Gregory Pincus — who experimented with in-vitro fertilization of rabbits and created the first test tube bunny — and asked him to conduct research on the use of hormones for contraception. Unknown to Sanger and Pincus, a scientist in Mexico City had already had success creating a progesterone pill, synthesized from wild yams, which could block ovulation. That chemist was Carl Djerassi, then just a twenty-something but already the associate director of research at the pharmaceutical company Syntex.

Endgame: It was all about the cash
On a chemical level, the Pill had been invented, but Djerassi was not funded to test, produce or distribute it. By 1952, the race was on. Pincus tested progesterone in rats and found it works. He met gynecologist John Rock, who has already begun testing chemical contraception in women. Frank Colton, chief chemist at the pharmaceutical company Searle, also independently developed synthetic progesterone. If Sanger was the activist behind the Pill and Pincus the scientist, Katherine McCormick — biologist, women’s rights activist and heiress to the International Harvester fortune — was the money. In 1953, she wrote Pincus a check for $40,000 ($350,000 in 2016 dollars) to conduct research. In 1954, Rock and Pincus conducted the first human trials on 50 women in Massachusetts. The Pill worked. By 1956, large scale clinical trials were conducted in Puerto Rico, where no anti-birth control laws existed. The Pill was declared 100% effective, but some serious side effects were ignored because the dose was ultimately found to be too high. In 1957, the FDA approved the contraceptive, but only for severe menstrual disorders, not as a contraceptive. Not coincidentally, an unusually large number of women reported severe menstrual disorders. In 1960, the pill was approved for contraceptive use.

Deception and exploitation 
According to a 2001 PBS report, Pincus's team would be accused of deceit, colonialism and the exploitation of poor women of color. The women of Puerto Rico had only been told that they were taking a drug that prevented pregnancy, not that it was a clinical trial, that the Pill was experimental or that there was a chance of potentially dangerous side effects. Pincus and Rock, however, believed they were following the appropriate ethical standards of the time. In the 1950s, research involving human subjects was much less regulated than it is today. Consent standards were minimal and only the most basic toxicity tests were required for human trials. 

To this day, questions linger over whether Pincus and Rock, in their rush to bring an effective pill to market, overlooked serious side effects from the original high dosage Pill during trials. The dosage of the Pill has since been dramatically lowered and the incidence of serious side effects has been greatly reduced. Still, the Puerto Rico Pill trials remain a controversial episode in the history of the Pill's development.

How hormonal contraception works
A woman becomes pregnant when an egg released from her ovary is fertilized by sperm. The fertilized egg attaches to the inside of the uterus, where it receives nourishment. Hormones in the woman's body control the release of the egg from the ovary – called ovulation – and prepare the body to accept the fertilized egg. 

Hormonal contraceptives (the pill, the patch, and the vaginal ring) all contain a small amount of man-made estrogen and progestin hormones. These hormones work to inhibit the body's natural cyclical hormones to prevent pregnancy. Pregnancy is prevented by a combination of factors. The hormonal contraceptive usually stops the body from ovulating. Hormonal contraceptives also change the cervical mucus to make it difficult for the sperm to go through the cervix and find an egg. Hormonal contraceptives can also prevent pregnancy by changing the lining of the womb so it is unlikely the fertilized egg will be implanted.

There are two types of birth control pills: combined and progesterone only. Combined pills contain synthetic forms of estrogen and progesterone. Today, oral contraceptives are commonly used to treat menstrual problems and decrease acne.

Impacts on society
The Pill became very popular and had a major impact on society and culture. It contributed to a sharp increase in college attendance and graduation rates for women. New forms of intrauterine devices were introduced in the 1960s, increasing popularity of long acting reversible contraceptives. 

Birth control innovations have had a remarkable impact on modern societies in the past five decades. They enhanced women’s opportunities to control childbearing and their careers, allowed them to choose contraception and plan fertility independently of their partner or spouse, and increased female capital accumulation, labor market options and earnings. The dramatic increase in women’s education, college and professional degrees since the 1960s can also be partly explained by birth control innovations.

There’s got to be a morning after 
In 1997, the FDA approved a prescription emergency contraception pill (known as the morning-after pill), which became available over the counter in 2006. In 2010, ulipristal acetate (Ella®), a more effective emergency contraceptive was approved for use up to five days after unprotected sexual intercourse. Fifty to sixty percent of abortion patients became pregnant in circumstances in which emergency contraceptives could have been used. These emergency contraceptives, including Plan B® and Ella®, proved to be another battleground in the war over reproductive rights. Opponents of emergency contraception consider it a form of abortion, because it may interfere with the ability of a fertilized embryo to implant in the uterus; while proponents contend that it is not abortion, because the absence of implantation means that pregnancy never commenced.
 
In 1982, European drug manufacturers developed mifepristone (RU-486), which was initially utilized as a contraceptive, but is now generally prescribed with a prostaglandin to induce abortion in pregnancies up to the fourth month of gestation. To avoid consumer boycotts organized by anti-abortion organizations, the manufacturer donated the US manufacturing rights to Danco Laboratories, a company formed by pro-choice advocates, with the sole purpose of distributing mifepristone in the US, and thus was immune to the effects of boycotts.
 
The birth control revolution is clearly not over yet: recent developments have focused on assisted reproductive technologies, which include in vitro fertilization (IVF) and sperm/egg banks. These also enhance freedom of fertility choices, just as the Pill prevents pregnancy. In principle, a technology that helps women and couples to conceive and have children should have a similar positive impact on female empowerment as the Pill because it also allows women to control the timing of childbearing, to have children later in life, and to improve opportunities, such as careers, outside of a marriage.

Impacts on culture
According to Germaine Greer, noted feminist and author of the book The Female Eunuch, the Sexual Revolution was a social movement that challenged traditional codes of behavior related to sexuality and interpersonal relationships throughout the Western world from the 1960s to the 1980s.  Sexual liberation included increased acceptance of sex outside of traditional heterosexual, monogamous relationships (primarily marriage). The normalization of contraception and the Pill, public nudity, pornography, premarital sex, homosexuality and alternative forms of sexuality, and the legalization of abortion all followed the advent of the Pill.

The Sexual Revolution brought about profound shifts in the attitudes to women’s sexuality, homosexuality, pre-marital sexuality and the freedom of sexual expression. Psychologists and scientists such as Wilhelm Reich and Alfred Kinsey influenced the revolution, as well as literature and films, and the social movements of the period, including the counterculture movement, the women’s movement, and the gay rights movement. The counterculture contributed to the awareness of radical cultural change that was the social matrix of the Sexual Revolution.

Let’s go to the dirty movies!
In 1969, Blue Movie, directed by Andy Warhol, was the first adult erotic film depicting explicit sex to receive wide theatrical release in the United States. The film was a seminal film in the Golden Age of Porn and helped inaugurate the "porno chic" phenomenon in modern American culture. During this time, porn was being publicly discussed by celebrities, and taken seriously by critics. According to Warhol, Blue Movie was a major influence in the making of Last Tango in Paris, an internationally controversial erotic drama film, starring Marlon Brando, and released a few years after Blue Movie was made. In 1970, Mona, the second adult erotic film, after Blue Movie, depicting explicit sex that received a wide theatrical release in the United States, was shown. Following mentions by Johnny Carson on his popular Tonight show, and Bob Hope on TV as well, the adult film Deep Throat achieved major box office success, despite being rudimentary by mainstream standards. In 1973, the far-more-accomplished, but still low budget adult film, The Devil in Miss Jones, was the seventh most successful film of the year, and was well received by major media, including a favorable review by film critic Roger Ebert. Later, in 1976, The Opening of Misty Beethoven, based on the play Pygmalion by George Bernard Shaw (and its derivative, My Fair Lady), and directed by Radley Metzger, was released theatrically and is considered, by award-winning author Toni Bentley, the "crown jewel" of the Golden Age of Porn. 

By the mid-1970s and through the 1980s, newly won sexual freedoms were being exploited by big businesses looking to capitalize on an increasingly permissive society, with the advent of public and hardcore pornography. Historian David Allyn argues that the sexual revolution was a time of "coming-out" about premarital sex, masturbation, and erotic fantasies.

Where the Pill is today
According to a 2015 Time magazine article penned by Megan Gibson, about the changes in sexual paradigms, The Pill is not without critics. The fact that its rise coincided with second-wave feminism and the Sexual Revolution meant that many people pointed to the contraceptive as the trigger that changed society. Some African-American leaders were especially critical of the Pill, claiming that it was being peddled in their community for the purpose of a “black genocide.” But nothing stopped the Pill from catching on. Today, more than 100 million women around the world use the Pill to prevent pregnancy. And that is not counting the women using other safe and effective forms of birth control, from DepoProvera® and the NuvaRing® to the contraception patch and the intrauterine device (IUD), which is considered by many health care experts to be one of the best forms of birth control available.

Yet, access to safe and effective birth control still is not a universal privilege. A report from the Guttmacher Institute in 2012 found that around 222 million women in developing countries want to use birth control but are not currently able to access modern contraceptives. Even in the US, there has been a political push to restrict access. The rise of “conscience clauses” has also meant that hospital employees, pharmacists and employers with religious views on birth control can refuse to fill prescriptions or cover employees’ coverage for contraception.

History — both ancient and more recent — has shown that women (and men) will risk their lives or reputations for effective birth control. Restricted access to contraceptives does not necessarily mean that women will not be able to prevent pregnancies, but, like the women of antiquity, they may be forced to resort to methods that could be harmful. That has not changed, but thanks to the dogged determination of activists, such as Sanger, and the pioneering research by scientists and physicians, such as Djerassi, that level of risk seems like the most preventable thing of all.

Ron Gasbarro, PharmD is a registered pharmacist, medical writer, and principal at Rx-Press.com. Visit him at www.rx-press.com. 


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