She got pregnant at 17 while taking birth control pills. Single mother Lindsey Wallette, psychology freshman, now cares for her 10-month-old daughter Ryleigh between attending classes, studying and working seven-hour shifts to make ends meet. Thirty percent of women who become pregnant unexpectedly get pregnant despite the use of contraception, said Dr. Philip Hindelang, University Women’s Clinic physician. Birth control pills approved by the FDA between 1960 and 1970 saw less than one pregnancy per 100 women. But over the past decade, the agency approved pills with rates above two per 100 women. A panel of experts is challenging the FDA to more realistic methods of evaluating the effectiveness of “new generation” birth control, at a time when a growing number of American women struggle with obesity and smoking.
A DAY IN THE LIFE OF A SINGLE, TEEN MOM 4:30 a.m. – She awakens. Wallette gets all of her daughter’s things together – bottles, diapers and personal belongings. After getting dressed, she and the baby then travel from Central, La., to day care on College Drive. 9 a.m. – She arrives at school or work. On Tuesdays and Thursdays, she sits through classes well into the afternoon. On Mondays, Wednesdays and Fridays, she trudges through a seven-hour shift at C.C.’s Coffeehouse on Burbank Drive. 4:30 p.m. – She picks Ryleigh up from day care. They fight through the afternoon traffic to get home, where Wallette feeds, bathes and plays with her daughter until she is ready for bed. 9 p.m. – “That’s when I start studying,” Wallette said. The teen mother pores through notes and textbooks until she falls asleep, but she is often jolted awake by her daughter’s cries. “It gets really stressful if I have an exam the next day and she’s screaming, crying at 3 o’clock in the morning,” Wallette said. Wallette said Ryleigh’s father, a former boyfriend of two years, takes no financial responsibility for the baby. “If it weren’t for Pell Grants, I wouldn’t survive,” Wallette said. “Between day care, diapers and all those expenses – it really adds up.” Wallette said the baby’s father, upon hearing the news of her pregnancy, “wanted me to get rid of her.” She refused. Wallette was taking Ortho Tri-Cyclen birth control pills when she conceived. She is a nonsmoker, not overweight and said if she missed a pill, she would take two the next day as directed and use condoms during intercourse as backup. About 20 years ago, Wallette’s mother, Donna, got pregnant with two of her siblings while taking the pill and said she was not surprised to discover the same thing happened to her daughter. “My sister is 21 now and my brother is about 18,” Wallette said. “She got on [the pill] a month before her honeymoon. She actually waited ’til she got married to, you know … She took it to the tee. I would believe she would take it to the tee because she takes her medications the same time every day.”
EVALUATING EFFECTIVENESS As the hormone content of birth control pills has slumped increasingly over the decades, failure rates have climbed. Hindelang said new generation pills contain significantly less estrogen and progestin than their predecessors of 50 years. “The very first pill had 180 micrograms of estrogen,” Hindelang said. “The highest-dose pill today has 35 micrograms of estrogen.” Newer pills reduce the risk of blood clots and other cardiovascular problems. Hindelang said despite popular belief that today’s pills are less effective, “effectiveness has always been [99 percent] with ideal use.” Hindelang said the failure rate for women ages 18 to 22 is less than 96 percent due to user failure. “That’s the problem with young people – getting them to take the pill like they’re supposed to,” Hindelang said. “They skip a pill here, skip a pill there, [or] go out of town and forget their pill pack at home.” MEDICAL EXPERTS: “REAL WOMEN” NEED CONTRACEPTIVES, TOO In late January, a panel of medical experts told the FDA that drugmakers should employ more realistic methods in evaluating the effectiveness of contraceptives. Overweight women and smokers are at high risk for blood clots, which is a common side effect of birth control. These women are often excluded from clinical studies. “These women, like all women, need contraceptives,” said panelist Dr. Julia Johnson of the University of Vermont to Reuters. According to HealthDay, several years ago the FDA discussed the possibility of removing higher-dose birth control pills from the market. At the meeting, one panel member overheard another panel member, who was a physician, say, “Don’t do that. All of my overweight patients are going to get pregnant.” Because overweight women have a higher metabolism, the pill may be “used up” more quickly, said Victoria Holt, member of the Public Health Sciences Division at Fred Hutchinson Cancer Research Center in Seattle to HealthDay. Several news services recently reported the FDA called on the advisers to help the agency take a closer look at how it evaluates hormonal contraceptives. MSNBC said FDA officials reported seeing higher pregnancy rates in recent trials. Panelists said estimating the risk per 100 women is a “crude” way to establish pregnancy risk, thus drugmakers should move toward a more comprehensive method, MSNBC said.
THE FDA FIGHTS BACK The FDA released a statement on the effectiveness of new generation birth control pills in response to recent news articles. “Recent wire service stories about [birth control] have created misperceptions about the effectiveness of newer generation hormonal contraceptives. The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago,” the statement read. “In fact, the newer generation products are highly effective in preventing pregnancy.” Also in the statement, the FDA said recent articles mistakenly reported that the FDA called the meeting to discuss the need for higher standards for new birth control products.
“The purpose of this two-day meeting is to discuss clinical trial designs that reflect the diversity of users of hormonal contraceptives, expectations for efficacy and safety and user acceptability of the newer generation products,” the statement read. NO REGRETS “I’m a single mother, unwed so I’m not able to live the ideal college life,” Wallette said. “But I wouldn’t trade Ryleigh for anything in the world.” Wallette said Ryleigh has a sweet personality. “At the day care, she’s very loving,” she said. “She’ll hug other babies if they’re crying. She’ll stroke ’em and hug ’em and kiss ’em.” Wallette said Ryleigh looks just like her mother. “If you get a picture of her when she was a baby and a picture of me when I was a baby we look identical,” she said. “Brown hair, brown eyes. She has very curly hair.” Wallette said even though raising a child without a full-time father, going to school and working presents hardships, she has “no regrets.”
—–Contact Leah Square at lsquare@lsureveille.com