Seasonale




I

f
you watch television, chances are you’ve seen ads for Seasonale,
a new oral contraceptive that allows women to have four menstrual
periods a year. The tag line is enticing: “Fewer periods. More
possibilities.” 


Since
Seasonale was approved by the FDA in September 2003, U.S. doctors
have penned more than 260,000 prescriptions for it. A small percentage
were placed on the drug for medical reasons; that is, Seasonale
allows women with anemia or endometriosis to bleed less frequently,
thereby reducing the sometimes-incapacitating pain associated with
menstruation. This group aside, the bulk of Seasonale users take
the pill to avoid the mess, discomfort, and inconvenience of their
monthly visitor. 


But
how does it work and is it safe? The pill—which is chemically
identical to the traditional oral contraceptive mix of ethinyl estradiol
and levonorgestrel—is taken for 84 days. A placebo is then
taken for seven days to cut the number of annual periods from 13
to 4. As for pregnancy prevention, Seasonale stops ovulation and
simultaneously causes cervical mucus to thicken. This makes it difficult
for sperm to travel toward the uterus, thus reducing the chance
that a fertilized egg will attach to the uterine wall. When used
correctly—when it is taken without fail at roughly the same
time each day—it is 99 percent effective. 


Barr
Pharmaceuticals, the largest supplier in the $3.4 billion oral contraceptive
market and the maker of Seasonale, is singing the pill’s praises.
“We believe in it,” says Carol A. Cox, Vice President
of Investor Relations and Corporate Communications for the Woodcliff
Lake, New Jersey company. “Oral contraceptives, more than any
other drugs, have been watched for 40 years. The long-term effects
of hormone therapy have been well-studied and have been proven safe.
Seasonale opens up possibilities for women. It’s another contraceptive
for them to consider.” 


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.



 





Eleanor Bader
is a freelance writer and author of



Targets of Hatred.