Timeline: The Pill

Genesis-1950 | 1951-1990

1951 The Catholic Church remains resolutely opposed to artificial birth control, but Pope Pius XII announces that the Church will sanction the use of the rhythm
method as a natural form of birth control. Previously, the only option approved by Rome was abstinence.

The Planned Parenthood Federation of America runs 200 birth control clinics. Margaret Sanger has been successful in fighting legal restrictions on
contraceptives, and birth control has gained wide acceptance in America. Still, Sanger remains deeply unsatisfied, because women have no better
methods for birth control than they did when she first envisioned "the pill" over 40 years earlier.

January/February: Margaret Sanger, now 72 years old, makes one last ditch effort to find someone to invent her "magic pill." At a dinner party in New
York City she is introduced to Gregory Pincus and implores him to take up her quest. To her surprise, he tells her that it might be possible with
hormones, but that he will need significant funding to proceed.

April 25: Sanger manages to secure a tiny grant for Gregory Pincus from Planned Parenthood, and Pincus begins initial work on the use of hormones as a
contraceptive at The Worcester Foundation. Pincus sets out to prove his hypothesis that injections of the hormone progesterone will inhibit ovulation and
thus prevent pregnancy in his lab animals.

October: Pincus goes to the drug company G.D. Searle and requests additional funding from them for the pill project. Searle's director of research tells
Pincus that his previous work for them was "a lamentable failure" and refuses to invest in the project.

October 15: Unbeknownst to Pincus or Sanger, a chemist named Carl Djerassi working out of
an obscure lab in Mexico City creates an orally effective form of synthetic progesterone -- a
progesterone pill. The actual chemistry of the Pill has been invented, but neither Djerassi nor
the company he works for, Syntex, has any interest in testing it as a contraceptive.

1952 January: In less than a year, Pincus confirms that progesterone works as an anti-ovulent in rabbits and rats. He informs Planned Parenthood of his
findings and requests more funding. The organization, deciding his work is too risky, decides not to continue funding his research. The Pill project
stagnates for lack of funding.

Frank Colton, chief chemist at G.D. Searle, independently develops another oral form of synthetic progesterone.

At a scientific conference, Pincus has a chance encounter with the renowned Harvard obstetrician and
gynecologist Dr. John Rock. Pincus is astonished to learn that Rock has already been testing the chemical
contraceptive on women and demonstrating that it works. Rock has been giving the same drug to his infertility
patients with the eventual goal of stimulating pregnancy after his patients finish a 3 to 5 month regimen of
progesterone injections.

1953 June 8: Sanger realizes McCormick can fund Pincus' research and brings her to Shrewsbury to meet the scientist. The visit is a huge success. Katharine
McCormick writes Pincus a check for a huge sum -- $40,000 -- with assurances she will provide him with all the additional funding he will need. The Pill
project is restarted.

1954 Pincus knows progesterone will work, but in order to get FDA approval he will need to test the drug on humans, which only a clinical doctor can do.
Finally with adequate funding at hand, Pincus joins forces with Dr. John Rock to test the drug on Rock's female patients. In Massachusetts, a state with
extremely restrictive anti-birth control laws, Rock and Pincus begin the first human trials with 50 women, under the guise of a fertility study. Searle
provides the pills for the trial.

The Pill regimen still in use today is established. Pincus persuades Rock to administer the progesterone for only 21 days, followed by a 7-day break to
allow for menstruation. They know the Pill will be controversial and want oral progesterone to be seen as a "natural " process, not something that
interferes with the normal menstrual cycle.
1955 Katharine McCormick, eager for results, stays in Boston for the winter to keep tabs on Rock and Pincus' progress.

The results from the first human trials are conclusive. Not one of the 50 women in the experiment ovulates while on the drug. Pincus and Rock are
positive that they have found the perfect oral birth control pill.

October: Margaret Sanger invites Gregory Pincus to the 5th Annual International Planned Parenthood League conference in Tokyo, Japan, where Pincus
announces the results of his progesterone study. Despite the magnitude of his announcement, the press at the conference remains skeptical and does
not pick up the story.

December: At the prestigious Laurentian Conference on Endocrinology in Canada, before an audience of scientists involved in hormone research, Rock
presents a paper stating that the progesterone pill inhibits ovulation. Word spreads quickly through the scientific world and drug industry that Pincus and
Rock have found a birth control pill.

1956 After comparing the data from studies using both Syntex's and Searle's drugs, Rock picks Searle's formulation, called Enovid, to be the first birth control
submitted for FDA approval in America.

April: Since anti-birth control laws in Massachusetts and many other states make it impossible for Rock to conduct the larger human studies necessary for
FDA approval, Rock and Pincus launch the first large scale clinical trials for the Pill in San Juan, Puerto Rico.

November: The news of the Pill spreads to the general public. An article in Science magazine informs readers that women have taken a synthetic
hormone as an oral contraceptive and it works.

December: The medical director in charge of the Puerto Rico trials informs Pincus and Rock
that "Enovid gives 100% protection against pregnancy," but reports that the Pill causes too
many side effects to be "accepted generally." Pincus and Rock proceed with the trials,
convinced that while the Pill may cause discomfort, it is safe.

Pincus and Rock discover that Searle has been sending them pills contaminated with a
minuscule amount of synthetic estrogen in addition to the progesterone -- a major set back
for the trials. However, after testing new shipments of uncontaminated Enovid, they conclude
that the combination of estrogen and progesterone (the same combination still used today)
reduces some problems like breakthrough bleeding.

1957 Rock selects a high dosage for the Pill in order to be absolutely certain that Enovid will prevent pregnancy without fail.

Spring: In addition to the Puerto Rico trials, Pincus also sets up full-scale trials in Haiti and Mexico City.

Summer: The FDA approves the use of Enovid for the treatment of severe menstrual disorders and requires the drug label to carry the warning that
Enovid will prevent ovulation.

1959 President Dwight Eisenhower states in a press conference that birth control "is not a proper political or
government activity or function or responsibility" and adds emphatically that it is "not our business."

Less than two years after FDA approval of Enovid for therapeutic purposes, an unusually large number of
American women mysteriously develop severe menstrual disorders and ask their doctors for the drug. By late
1959, over half a million American women are taking Enovid, presumably for the "off-label" contraceptive
purposes.

Oct. 29: Excited by the vast potential market for the Pill, Searle files an application with the FDA to license the
10 milligram Enovid -- the same pill approved for menstrual disorders -- for use as a contraceptive. The
application is based on field trials with 897 women, making it one of the most extensively tested drugs to ever
come before the FDA for approval.

1960 With an eye on maximizing profits, Searle attempts to license lower doses of Enovid (2.5 and 5 milligram doses), but the FDA demands complete field
trials for the lower dose versions as well.

Winter: The FDA reviews Searle's application for the first drug in history to be given to a healthy person for
long-term use. Searle is doing $37 million in annual sales of the Pill for "menstrual disorders" and pushes the
FDA for approval.

April: John Rock tells the national press that the Pill, since it simply extends a woman's "safe period," should be
considered an extension of the Vatican-approved rhythm method.

May 11: Searle receives FDA approval to sell Enovid as a birth control pill. Searle is the first and only
pharmaceutical company to sell an oral contraceptive and it has a lucrative monopoly.
1960s As soon as Searle completes the requisite field tests demonstrating the effectiveness of the Pill at lower doses,
the FDA approves the drug for contraceptive use at 2.5 and 5 milligrams.

The pharmaceutical industry awakens to the huge market for effective contraception, and 13 major drug
companies, nine of them American, work to develop new birth control methods and their own versions of the
Pill.

1961 December: It is still a crime to use birth control in Connecticut. In bold defiance of Connecticut law, Dr. C. Lee Buxton, the chairman of the Yale Medical
School department of obstetrics and gynecology, and Estelle Griswold, the executive director of Connecticut Planned Parenthood, open four Planned
Parenthood Clinics. They are promptly arrested, but their case brings national attention to the anachronistic state laws.

The American public learns that Thalidomide, a sedative given to pregnant women in Europe to control morning sickness, causes horrible birth defects. In
the U.S., the drug has never received FDA approval, but the age of faith in "wonder drugs" appears to be over, and the American public begins to
question the safety of drugs. In the wake of the Thalidomide tragedy, the FDA will enact stricter regulations for human drug tests.

1962 With 1.2 million American women on the Pill, Searle's corner on the Pill market comes to an end. Syntex receives FDA approval to sell the drug Carl
Djerassi developed in the 1950s under the trade name Ortho Novum.

September 1: Word of serious side effects, such as blood clots and heart attacks caused by the Pill, begins to spread. Searle receives reports of 132 blood
clots, including 11 deaths, but the company declares that there is no conclusive evidence demonstrating that the blood clots are a direct result of the Pill.

1963 2.3 million American women are using the Pill.

In his crusade to make the Pill acceptable to the Catholic church, John Rock publishes The Time Has Come: A Catholic Doctor's Proposal to End the Battle
over Birth Control, and becomes the de facto public spokesman for the Pill.

1964 One quarter of all couples in America using birth control choose the Pill. Parke-Davis, another drug company eager for a share of the market, sells its
version of the Pill. Despite the competition, Searle earns $24 million in net profits from Pill sales, but neither Gregory Pincus nor the Worcester Institute
receive any royalties.

Less than a decade after President Eisenhower declared that the government should not get involved with birth control, President Lyndon B. Johnson
pushes through legislation for federal support of birth control for the poor.

June 23: Pope Paul VI creates the Papal Commission on Population, the Family and Natality, informally known as the "Birth Control Commission." This is
the year of Vatican II and monumental reforms in the Catholic Church. Many within the church support the use of the Pill. Both clerics and the laity are
extremely hopeful that the Pope will approve the use of the Pill for Catholics.

The Pill becomes the most popular form of reversible birth control in America.

Despite general public approval for birth control, ghosts of the Comstock Laws linger. Eight states still prohibit the sale of contraceptives, and laws in
Massachusetts and Connecticut still prevent the dissemination of information about birth control.

1965 June 7: Estelle Griswold and Lee Buxton take their Connecticut case all the way to the U.S. Supreme Court. By a vote of 7-2 in Griswold v. Connecticut,
the Court strikes down the Connecticut law prohibiting the use of birth control as a violation of a couple's right to privacy.

Just five years after the Pill's FDA approval, more than 6.5 million American woman are taking oral
contraceptives, making the Pill the most popular form of birth control in the U.S. Searle still dominates the
market, and does $89 million in sales of Enovid.
 Vatican II comes to an end and the Roman Catholic Church implements some reforms -- but
a decision on the Pill is not made.

1966 An FDA task force looks into the issue of side effects from the Pill, especially the danger of blood clots, cancer and diabetes. The task force finds no
smoking gun, but does allow the drug companies to bring lower doses of the pill to market with less red tape.

September 6: Margaret Sanger dies in Tucson, Arizona, just shy of her 87th birthday.

1967 Over 12.5 million women worldwide are on the Pill.

Massachusetts liberalizes its birth control laws, but still prohibits the sale of birth control to unmarried women.

August 22: In the prime of his career, Gregory Pincus dies in a Boston hospital at age of 64 from myeloid metaplasia, a rare disease of the white blood
cells, due to exposure to lab chemicals.

December 28: Katharine McCormick dies at the age of 92 in Boston, Massachusetts. No major newspaper gives her an obituary, and with her passing,
her contribution to the birth of the Pill is forgotten.

December: The Pittsburgh branch of the NAACP charges that Planned Parenthood clinics, which provide the Pill and other forms of birth control in low
income and minority neighborhoods, are devoted to keeping the black birth rate as low as possible. In a public statement the organization declares that
birth control is being used as an instrument of racial genocide. A strong accusation, it touches a cord in minority communities and the term "black
genocide" catches on.

1968 Sales of the Pill hit the $150 million mark. American women can now select from 7 different
brands.

David Niven and Deborah Kerr star in the Hollywood film Prudence and the Pill. Birth control,
once considered obscene and vulgar, is now a pop culture icon.

July 25: Pope Paul VI reveals his decision on the Pill in an encyclical titled Humanae Vitae (Of
Human Life). To the dismay of Catholics around the world -- and ignoring the
recommendations of the Papal commission on birth control -- the Pope states unequivocally
that the Church remains opposed to all forms of birth control except the rhythm method.

1969 September: Medical journalist Barbara Seaman publishes the controversial book The Doctor's Case Against the Pill and brings national attention to the
dangers of the Pill.

1970 Catholic Americans make their own decisions about birth control. In spite of Church doctrine, two-thirds of all Catholic women are using contraceptives,
and 28% of them are on the Pill.

January - March: Influenced by Seaman's book, U.S. Senator Gaylord Nelson convenes Senate hearings on the safety of the Pill. Radical feminists disrupt
the male-dominated hearings and demand women taking the Pill be informed of all the potential dangers and side effects.

June: In a victory for feminists and the women's health movement, the FDA orders that all oral contraceptive packages must contain a patient
information insert detailing possible side effects from the Pill.

1970s In the wake of the Pill hearings, sales drop by 20%, but the oral contraceptive remains America's birth control method of choice.

Scientists determine that smoking is major factor contributing to blood clotting in Pill users, but that the lower doses of pill not only greatly reduce the
risk of clots but also reduce other side effects such as weight gain, headaches and nausea.

1972 March 23: The U.S. Supreme Court, ruling in Eisenstadt v. Baird that a state cannot stand in the way of distribution of birth control to a single person,
strikes down Massachusetts law prohibiting the sale of contraceptives to unmarried women.
1973 Although sales of the Pill dropped for a brief period after the Senate Pill hearings, American women return to
the drug in record numbers. The number of users reaches 10 million.

1974 Just 15 years after President Eisenhower declared that birth control is not the government's business, the government supports birth control clinics in
2,379 of the nation's 3,099 counties. Of all the methods dispensed, the Pill is most popular.

Early The FDA reports that 10.7 million American women are on the Pill. Confidence in the safety of the pill has risen dramatically in the years since the Pill
1980s hearings.

1980s In spite of the Pope's ruling against the Pill and birth control, almost 80% of American Catholic women use contraceptives, and only 29% of American
priests believe it is intrinsically immoral.

New versions of low-dosage oral contraceptives are introduced. These products vary the amount of progesterone and estrogen in the drug during the 21-
day cycle. Only 3.4% of birth control pills on the market are the original high-dosage pills.

1982 The Pill's impact on women in the work force is significant. With highly effective birth control now at their disposal, 60% of women of reproductive age
are employed in America.

1984 December 4: John Rock dies at the age of 94 in Temple, New Hampshire.

An estimated 50 to 80 million women worldwide take the Pill.

1988 At the FDA's urging, drug companies remove the original high-dose oral contraceptives from the market.

Surveys show that birth control has disappeared from the list of medical research's 35 top priorities.

1990 According to the annual FDA Consumer report, the Pill is considered safe and effective by the government, medical establishment and public.

Genesis-1950 | 1951-1990

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