Guess who has a mental disorder!
Drug Firms Treat PMS As a Mental Disorder
February 23, 2001
By Tara Parker-Pope
Staff Reporter
C) Wall Street Journal
IS SEVERE PMS, or premenstrual syndrome, a mental illness? Some
pharmaceutical companies and psychiatrists are treating it as one. In new
television ads, drug maker Eli Lilly is promoting the drug Sarafem to treat the
problem, now dubbed Premenstrual Dysphoric Disorder (PMDD). But the
pink and purple pills aren't a new drug -- they are simply repackaged Prozac,
the popular antidepressant.
Makers of similar antidepressants, known as serotonin reuptake inhibitors, or
SSRIs, also may follow suit. In January, Pfizer asked the FDA to approve
Zoloft to treat PMDD. Forest Laboratories' Celexa and GlaxoSmithKline's
Paxil also have been studied.
The medical community, however, remains divided about whether PMDD is a
real disorder or simply a way for drug companies to cast a wider net in search
of new customers. Critics are particularly concerned about labeling women as
mentally ill because of problems associated with menstrual cycles.
"When you start calling what PMS is a psychiatric disorder, what are you
saying about the women of this world?" says Nada Stotland, director of
psychiatric education at the Advocate Illinois Masonic Medical Center in
Chicago. "This lends itself to prejudices people already have about women
being moody and unreliable."
ALTHOUGH THE FDA has approved Sarafem to treat PMDD, the
psychiatric community is still debating the legitimacy of the disorder. The
American Psychiatric Association includes PMDD in the appendix of its current
Diagnostic and Statistical Manual of Mental Disorders, the part of the manual
reserved for issues needing further research before being officially accepted as
a mental illness.
Fueling skepticism about PMDD and Sarafem is the
fact that in August, Lilly, based in Indianapolis, loses
patent protection on Prozac, a drug with $2.6 billion
in sales last year, according to IMS Health. With
Sarafem, the firm now has a separate patent to use
the drug for PMDD through 2007, allowing it to
partially offset losses in sales as rivals produce
generic Prozac.
Repacking prescription drugs for other uses is
becoming more common. Glaxo, for example, has
repackaged its antidepressant Wellbutrin as the
stop-smoking aid Zyban.
Many physicians argue that PMDD is a legitimate mental illness triggered by
normal hormonal fluctuations in a woman's menstrual cycle. About 3% to 5% of
menstruating women are affected. "This is a subset of women who have really,
really severe mood changes and changes in their behavior," says Jean Endicott,
professor of clinical psychology at Columbia University's College of Physicians
and Surgeons. "It can be very debilitating."
Unlike other mental illnesses that affect a patient on a daily basis, PMDD is said
to affect women during the week to two weeks before their period. The
symptoms include depression, anxiety, tension, anger, irritability and the feeling
of being overwhelmed or out of control. Other symptoms also are typical of
traditional PMS, such as breast tenderness, headache, bloating and weight gain.
In order to be diagnosed with PMDD, a patient must have at least five
symptoms, including one involving mood change, and be markedly impaired as
a result. Patients should track symptoms for two months before a diagnosis is
made.
About 60% of women who take Sarafem for PMDD will be helped, according
to Dr. Endicott. Currently, the drug is taken every day, but researchers are
studying dosing that would reduce the pills to several days a month, limiting side
effects, which can include tiredness, upset stomach, nervousness, dizziness and
difficulty concentrating.
A 38-YEAR-OLD Chicago flight attendant named Betsy, who didn't want her
full name used, says the week before her period she felt like an "over-wound
spring, getting wound tighter and tighter," and would often scream and lose
control. "That's not my normal disposition," she says. "I knew something wasn't
right."
She noticed the correlation with her menstrual cycle and discussed her
problems with her gynecologist, who prescribed Sarafem. "It has completely
taken away the symptoms," she says.
Dr. Stotland and other critics, however, worry that eager patients may push to
be prescribed Sarafem as a quick fix, preventing doctors from diagnosing other
serious health problems. Dr. Stotland says research has shown that more than
half of the women who believe they have severe PMS actually suffer from other
problems, such as depression, panic disorder or even domestic violence.
Lilly's marketing of Sarafem also has sparked controversy. The first ads
showed a frustrated woman wrestling with a shopping cart. "Think it's PMS? It
could be PMDD," the ads said. But the FDA said the ads trivialized the
seriousness of PMDD, and the campaign was pulled. New ads show one
woman arguing with her husband and another frustrated because she can't
button her pants.
Lilly spokeswoman Laura Miller says the ads attempt to show the full gamut of
PMDD symptoms. "It's up to the doctor and the woman to determine whether
she has PMDD and whether treatment is appropriate," she says.
But Paula Caplan, a psychologist and affiliated scholar at Brown University's
Pembroke Center for Research and Teaching on Women, says instead of
labeling women as mentally ill, physicians should urge diet changes, exercise,
less caffeine and even calcium supplements. "But nobody makes much money
off calcium tablets," she adds. |
