2/24/01 • Drug Firms Treat PMS As a Mental Disorder

By TARA PARKER-POPE, THE WALL STREET JOURNAL
As appeared in The Wall Street Journal, Section B, Front Page

NOTE FROM DR. TRACY:

Here comes the crowd!! Now that Lilly has their approval by the FDA to use
Prozac for PMS (PMDD), all the other makers of SSRIs are racing to get their
drugs approved to get their share of the profits. If this was not such a
horrifying situation with so many dying such terrible deaths everyday, many
more becoming so disabled from these drugs, and so many families being torn
apart from the behavioral reactions, it would almost be funny.

What is most ironic is that the psychologist mentioned at the end of the
article is right. I see women with severe PMS who mix some purified water
with lemon juice and drink a gallon a day for the week before their period
and any sign of PMS leaves. There are so many simple alternative choices for
this that it is amazing that Lilly has convinced so many that they have the
answer in a drug! Even more amazing is that they convinced the FDA - but
then the FDA is always amazing me with what they allow the public to be
exposed to as "safe"!

Dr. Ann Blake Tracy, Executive Director, International Coalition for Drug
Awareness www.drugawareness.org

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.

E-mail comments to Tara Parker-Pope at healthjournal@wsj.com1