Seasonale

Despite Cox’s enthusiasm, the company’s own findings raise a slew of concerns about the efficacy of the product. A trial, begun in 1999 and lasting for one year, started with 397 English-speaking, heterosexual women between the ages of 18 and 40. Forty-seven test sites were established so that women from every region of the U.S. could participate. Although the protocol reads like a typical drug study, a report written for Barr by scientists F.D. Anderson and Howard Hait indicates that more than half of those enrolled in the trial—90 percent of whom had taken oral contraceptives before— dropped out before the 12-month study was completed. In fact, only 161 women finished the program. Reasons for withdrawal included excessive bleeding, weight gain, mood swings, and acne. 

These problems, says Cox, are similar to those experienced by women taking all oral contraceptives, and usually abate once the body adjusts to the hormone regimen. The FDA’s division of drug marketing saw it differently, however, and sent Barr a letter in late December 2004 chastising them for “false and misleading ads” that failed to mention “frequent and sometimes substantial bleeding.” As a result TV and print ads now warn potential Seasonale users that unplanned bleeding is likely during the first six months of use. 

Critics have not been fully appeased by this remonstration. On the medical end, some doctors worry that Seasonale will cause women to have more heart attacks and strokes because they will not rid themselves of excess iron each month. Other flags have also been raised. The late Dr. John R. Lee, an expert in progesterone and hormone replacement therapy, wrote in October 2003, “Shedding the endometrium each month is one of Mother Nature’s strategies for protecting a woman from too much growth in the uterus which can result in cancer or fibroids…. It’s a good bet that taking synthetic hormones will increase bone loss and increase the risk of endometrial cancer, infertility, blood sugar problems and chronic hormone imbalances later in life that we can only speculate on now.” 

The National Women’s Health Network (NWHN) is concentrating on the way Seasonale is being promoted. “It’s being presented in a way that stigmatizes menstruation,” says Amy Allina, NWHN’s program director. “Women are being told that having their period is a drag and that this pill will help them avoid it. This is untrue for many women. Barr has also brought doctors to press events who either misrepresent the research on women’s feelings about menstruation or invent stuff outright. At one event a doctor said that girls do not do as well on their SATs when they are menstruating. When reporters asked for research to back this up, they got nothing.” 

Allina is also angry about  statements that imply that because women 100 years ago had approximately 150 periods during their lifetimes—they were pregnant, nursing, or too stressed to menstruate for the bulk of their lives—today’s woman is abnormal because she has three times that number. “This is an effort to medicalize a phase of life,” Allina adds. Yet she and the NWHN stop short of denouncing the drug. “Barr is trying to put Seasonale in the best possible light so they are downplaying problems. Instead of saying that menstruation is normal but some women don’t like it and this will help those women avoid it, they go six steps further and make it seem as if menstruation is unhealthy or unnatural. The facts should not be hidden. If they say that when you take Seasonale there’s a tough transition period, but most women get through it, and that if having four periods a year is important enough to you that you’ll go through six months of breakthrough bleeding, then they’re presenting the facts.”  In the end, Allina says, it’s a matter of making an informed choice. 

Opponents of hormonal contraceptives argue that the playing field on which women exercise this choice is far from even. Indeed, Barr has a 250- person women’s health sales force in place to promote Seasonale and other contraceptive products. The generous distribution of samples that doctors can offer to patients, alongside a $50 million marketing campaign that boasts “Sex and the City” creator Candace Bushnell as spokesperson, gives this “lifestyle pill” the cachet of the hip and savvy. Time Magazine dubbed it “one of the coolest inventions of 2003.” 

Barr is presently working on several new 28-day and extended- use oral contraceptives. They are also pushing to make Plan B, the prescription emergency contraceptive pill, available as an over-the- counter option in U.S. pharmacies. Their efforts are paying off. While pharmaceutical competitors Merck and Pfizer have been thwarted by lawsuits over Celebrex and Vioxx, Barr posted a net profit of $59.4 million for the second quarter of fiscal 2005.