A Real Lifesaver

Fifty years after its FDA approval, the Pill has a new calling.

By the time the oral contraceptive known as the Pill was approved by the FDA in 1960, 500,000 American women had already used it—for infertility. Within two years, 1.2 million had prescriptions for Enovid, its trademarked name.

Today, few will dispute the fact that the Pill revolutionized contraception. But it’s also raised serious questions about the use of synthetic hormones. Public concern, in fact, has prompted the Association of Reproductive Health Professionals and Planned Parenthood to launch the public health program, “You Decide: Making Informed Health Choices about Hormonal Contraception.”

According to the ARHP, compliance issues and the dangers associated with synthetic hormones have prompted the introduction of a new chapter in the history of birth control: the promotion of its non-contraceptive benefits. Perhaps most encouraging is its proven protection against ovarian cancer.

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A recent compilation of data from several long-term studies of British women shows that those using the Pill for a decade or more reduced their ovarian cancer risk by a third. Beneficial effects were consistent in all subjects, regardless of age or factors like alcohol and tobacco use, and lasted up to 30 years after they went off birth control.

A 2008 study suggests that, after the Pill’s nationwide acceptance in the 1960s, about 200,000 ovarian cancers and 100,000 deaths from the disease have been prevented. Scientists aren’t sure why this is so, but it may have to do with the way the body is tricked into thinking it’s pregnant. In other words, spending years on the Pill may not be all that different from the continuous pregnancies women endured in earlier centuries.

“You’re interrupting your cycles and the way hormones cause the lining of the uterus to thicken,” said Dr. David Holtz, a Paoli-based gynecologic oncologist with Main Line Health.

Research on the Pill’s role in guarding against ovarian cancer is focused on progesterone, the hormone produced by the ovaries. “One theory is that there’s something about progesterone that prevents abnormal blood cells from dividing and growing,” says Holtz. “It may also alter the blood flow to the ovaries.”

Scientists at the University of Rochester in New York first identified progesterone in 1928, nearly 30 years after the initial discovery of hormones. At the time, it was then being studied for its role in preparing the womb for—and sustaining—pregnancy.

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Today, the combined oral contraceptive pill is the most commonly prescribed. Like Enovid, it combines synthetic estrogen and progesterone (progestin). Most COCPs now have lower doses of synthetic hormones—especially estrogen, which has been linked to cancer. But its formulation is still designed to mimic the way real estrogens and progesterone work in the female body.

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When Enovid was first approved by the FDA for “gynecological disorders,” the label warned that the drug would prevent ovulation. Suddenly, countless women developed severe menstrual disorders to get prescriptions.

Only then did Enovid’s maker, the small G.D. Searle pharmaceutical company in Illinois, push for its FDA approval as a contraceptive. As early as 1951, Searle had declined to support the research of birth-control pioneer Gregory Goodwin Pincus, a Harvard University biologist who, at 31, made national headlines for creating the first “test tube” rabbit. By then, however, he’d already achieved opposite results, preventing pregnancy in rabbits.

Twenty years earlier, scientists determined the structure of steroid hormones—including progesterone—by extracting them from plants. But the process proved too expensive. In 1944, Pincus left Harvard and established a lab in Shrewsbury, Mass. That same year, lack of funding prompted Penn State chemistry professor Russell Marker to relocate to Mexico City, where he’d found a type of yam that was a potent source of progesterone. As it turns out, Mexican women had been using the yam to prevent ovulation.

Marker’s small lab, Syntex, was the first to break the European monopoly on steroid hormones. But he and others remained focused on production.

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It was Pincus who made the leap from in-vitro fertilization to “birth control by hormone therapy.” He teamed with John Rock, an ob/gyn treating infertile patients at his office just a few miles down the road from Pincus’ lab. Rock would provide the bridge from abstract theory to practical use, since FDA approval was impossible without human subjects.

Among the pioneers in early plant steroids, only one, Carl Djerassi, is still living. Now 87 and a novelist and playwright, he doesn’t see FDA’s 1960 approval of the Pill as much of a landmark at all.

In his 2001 book, This Man’s Pill: Reflections on the 50th Birthday of the Pill, he places the Pill’s conception firmly in the 1950s—“the heyday of new drugs, but also a rather short window of opportunity.” It’s one that would slam shut in the tense climate triggered by the thalidomide tragedy, when it was discovered that this so-called “wonder drug” caused serious birth defects.

Back in 1953, open dialogue between scientists made it possible for Djerassi—then a young organic chemist at Syntax—to think nothing of sending norethindrone to Pincus, who was working with another progestin called norethynodrel. Combining the two laid the groundwork for the combined oral contraceptive pill.

These days, Djerassi is considered the father of the Pill, in part because he was the first to synthesize a progestin that was effective when taken orally. Until then, scientists couldn’t get around the fact that progesterone was derived from plants and destroyed in the digestive system.

“We talk about the Pill as if there is only one,” Djerassi says today. “But there is actually thousands of formulations, all based on five or six active ingredients used in the 1950s and still used today.”

So now we know of at least one expert who won’t be celebrating the Pill’s 50th anniversary this year.

To learn more, visit arhp.org.

For “The Evolution of the Pill” and “Pros & Cons of the Pill,” see page 3 …

The Evolution of the Pill

» 1934: First test-tube rabbit created.
» 1941: Synthetic progesterone derived from a yam.
» 1951: Injections of certain progestins found to suppress ovulation in rabbits; first oral progestin synthesized.
» 1952: Another oral synthetic progesterone developed.
» 1954: Human trials begin.
» 1957: FDA approves Enovid for infertility and menstrual disorders.
» 1960: FDA approves Enovid as a contraceptive; it remains on the market until 1988.
» 1962: FDA approves Ortho-Novum, the second contraceptive pill.
» 1965: Supreme Court makes oral contraceptives legally available to married women in all states.
» 1972: Supreme Court makes oral contraceptives legally available to all women.

The Pill: Pros & Cons

Today’s Pill contains much lower doses of hormones than the original. But no birth control pill is 100-percent risk free or without side effects. Consider the following facts when discussing a prescription with your doctor—especially if you smoke and have a history of hypertension and diabetes.

Health Concerns: Increased risk of deep-vein thrombosis, pulmonary embolism, heart attack, stroke, cervical cancer and elevated blood pressure.

Side Effects: Nausea, bloating, breast tenderness, mood changes, headaches, breakthrough bleeding, decreased libido, variations in
contact lens tolerance and changes in vaginal secretions.

Health Benefits: Decreased risk of ovarian and endometrial cancers, ectopic pregnancy, ovarian cysts, uterine fibroids, benign breast disease and iron-deficiency anemia. Less severe menstrual cramps, relief from PMS, improvement in acne, and a possible lower risk
for postmenopausal hip fracture.

Source: MayoClinic.com

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