“Premenstrual Mental Illness”: The Truth About Sarafem
by Paula J. Caplan, Ph.D.
Published in The Network News, National Women’s Health Network, Washington,
D.C.May/June, pp. 1,5,7.
New television commercials and magazine advertisements tell us that women go crazy
once a month: We don't just get bloated and have chocolate cravings, breast tenderness
and irritability, but we become mentally ill and need to be treated with the drug Sarafem.
The Internet is buzzing with messages from women insulted by ads that depict women as
shrews. Neither the drugs nor the ads would exist without close interactions among the
American Psychiatric Association, which creates the Diagnostic and Statistical Manual
of Mental Disorders (DSM), Eli Lilly and other pharmaceutical companies, the media,
and women who sometimes feel physically bad and/or terribly upset – and long for
respect for those feelings.
Since the early 1980s, when influential DSM authors invented the alleged mental disorder
now called “Premenstrual Dysphoric Disorder” (PMDD), a cultural climate friendly to
the view of women as emotionally out of control rapidly reified “PMDD.” From the
outset, some women were so relieved to have their physical discomfort and unpleasant
feelings recognized that they rushed to defend the label rather than asking for compassion
and help that stopped short of diagnosing them as mentally ill.
Research and clinical reports related to the premenstruum are extensive, but there is no
proof that premenstrual mental illness exists. In a brilliant 1992 study, Sheryle Gallant
and her colleagues took the symptoms listed for PMDD – then called Late Luteal Phase
Dysphoric Disorder (LLPDD) in the 1987 edition of DSM – and asked three groups of
people to document every day for two months the symptoms they experienced. The
groups were women who reported severe premenstrual problems, women who reported
no such problems, and men. The answers did not differ among the three groups.
Circumventing the System
The first inclusion of PMDD in DSM was controversial and achieved in a disingenuous
way. The American Psychiatric Association, noting a massive protest at the 1986
conference of the Association for Women in Psychology that led to petitions and letters
from individuals and organizations representing more than six million people, initially
suggested leaving PMDD out. But Robert Spitzer, head psychiatrist of the 1987 edition
(DSM-III-R), proposed what he called a compromise: The category would go in a
specially created appendix "for categories requiring further study."
Since the manual’s main text is supposedly based on scientific research, it seemed a
victory for women that the label was given only provisional status. But once DSM-III-R
was published, three things became clear. One, in the appendix, PMDD was given a fivedigit code, a title, a list of symptoms and a cutoff point (patients must have a specified
number of symptoms to qualify for the label), exactly like the categories in the main text.
Two, the appendix did not warn clinicians to avoid applying the label to patients. And
three, the category was listed in the main text (under Mood Disorders), despite the APA’s
claims that it was not.
Seven years later, the 1994 edition (DSM-IV) followed similarly extraordinary procedures
to include PMDD. In the early 1990s, the LLPDD subcommittee had assembled a
massive literature review in which they concluded that (1) very little research supported
the existence of such a thing as a premenstrual mental illness (in contrast to PMS); and
(2) the relevant research was preliminary and methodologically flawed.
Nonetheless, the subcommittee reported to Allen Francis, who led the work on DSM-IV,
that they could not reach consensus about whether or not LLPDD should go in the
manual. Francis then chose two other people to make the final recommendation, but
concealed their identities from the media and the public for months. Then DSM officials
announced that the category (now called PMDD) would "continue" to be listed "only" in
the provisional appendix.
When DSM-IV appeared, sure enough, PMDD was not only in the appendix but also in
the main text, now under "Depressive Disorders." Was it coincidence that A. John Rush,
a specialist in depression, was one of the two people chosen to make the final
recommendation? And one has to wonder why PMDD ended up in this category, since
women need not be depressed in order to meet its criteria (one need only have a single
mood symptom – “marked” depression, anxiety, anger or lability, plus four physical
symptoms). A strange collection of symptoms for an alleged mental illness.
In addition, some members of the LLPDD subcommittee, including myself, were never
notified of meeting dates nor given crucial information and data the subcommittee
possessed. Nor was our feedback solicited until after the deadlines had passed. (After the
publication of DSM-III-R, I had contacted Allen Francis and offered to send him the
reviews that my students and I planned to write. He invited me to join the subcommittee,
assuring me that "this time" decisions about the manual would be based on scientific
evidence.)
Denial and “Science”
From the beginning, the only recommended psychiatric therapy for PMDD has been
antidepressants, usually fluoexetine (Prozac). Although dietary and exercise changes or
participation in self-help groups are sometimes recommended, the big push has been for
drugs. Despite documentation that this diagnostic label has harmed women, from childcustody challenges to increased depression, LLPDD subcommittee chair Judith Gold has
publicly denied reports of harm.
In June 1999, with the patent on Prozac about to expire, its manufacturer, Eli Lilly & Co.,
organized a roundtable discussion attended by many of the PMDD subcommittee
members. Getting Prozac approved for a different “mental illness” would give new life to
the patent – explaining why Lilly needed to insist that PMDD is a real condition.
Shortly afterward, an article called "Is Premenstrual Dysphoric Disorder a Distinct
Clinical Entity?" in the Journal of Women's Health and Gender-Based Medicine was
presented as the state-of-the-science result of that roundtable. Presumably recalling their
own description of pre-DSM-IV research as sparse and poor, the authors claimed that later
evidence proved PMDD to be real and Prozac to be an effective treatment. But only a
tiny number of the articles cited were truly post-DSM-IV research, and those provided no
evidence that a premenstrual mental illness exists. A huge chunk of the article constituted
a promotion of Prozac, by reporting that Prozac improves symptoms of women with
PMDD. Certainly, if you give Prozac to any group of depressed or upset people, some
will feel better. But that reveals nothing about the causes of their upset and, in this case,
doesn’t prove the upset is related to menstrual cycle changes.
The FDA’s Psychopharmacological Drugs Advisory Committee (PDAC) met on
November 3, 1999. There, representatives of Eli Lilly & Co. brought PMDD
subcommittee member Jean Endicott, first author of the roundtable paper, to speak.
According to the minutes, "There was consensus among [PDAC] committee members
that PMDD is a recognized clinical entity that is well-defined and has accepted diagnostic
criteria." The PDAC voted "yes" unanimously on the question, "Has the sponsor provided
evidence from more than one adequate and well controlled clinical investigation that
supports the conclusion that Fluoxetine is effective for the treatment of Premenstrual
Dysphoric Disorder?" It's hard to imagine what the outcome of that vote might have been
without the assistance of Dr. Endicott and the roundtable article.
A Profitable Motive
Why was the FDA’s decision bad for women? First, Sarafem is Prozac. Many women
prescribed Sarafem won’t know that and might not choose to take a mind-altering drug if
they did know. Second, Prozac has side effects. By associating its use with PMS, Lilly
hopes to broaden its use to millions of women, many of whom will not benefit from the
drug. Side effects such as digestive and sleep problems and sexual dysfunction might be
acceptable to women with depression, but they are completely unnecessary in women
whose only complaints are physical discomforts associated with premenstrual syndrome.
Other, safer options exist for women with troublesome PMS, including calcium
supplementation, exercise and dietary changes. The decision to accept Lilly’s description
of Sarafem as effective for “PMDD” exacerbates the misleading and dangerous
assumption that this condition even exists.
The first Sarafem commercial, which showed a woman frantic because she couldn't
extract a shopping cart from a row of carts, included a voiceover warning women that
they might think they have PMS when they really have PMDD. This ad was quickly
taken off the air. One might have assumed it was removed because women found it
offensive. Not true. According to an article in Drug Marketing, it was removed because
the FDA took Lilly to task for supposedly trivializing the seriousness of this nonexistent
disorder.
The problem with PMDD is not the women who complain of premenstrual emotional
problems but the diagnosis of PMDD itself. Excellent research shows that these women
are significantly more likely than other women to be in upsetting life situations, such as
being battered or being mistreated at work. To label them mentally disordered – to send
the message that their problems are individual, psychological ones – hides the real,
external sources of their trouble.
The creation of Sarafem has extended Lilly’s patent on Prozac by seven years, adding
untold millions to its bottom line. This is an example of a company taking cynical
advantage of the legal and regulatory system to increase its profits at the expense of
women’s health.
Paula J. Caplan, Ph.D. (Paula_Caplan@Brown.edu), is an Affiliated Scholar at Brown
University’s Pembroke Center for Research and Teaching on Women.
References
Caplan PJ, They Say You're Crazy: How the World's Most Powerful Psychiatrists Decide
Who's Normal, 1995. Addison Wesley, Reading, MA.
Endicott J, et al. “Is Premenstrual Dysphoric Disorder a Distinct Clinical Entity?”
Journal of Women's Health and Gender-Based Medicine 1999; 8(5):663-79.
Gallant S, Popiel D, Hoffman D, Chakraborty P and Hamilton J. “Using daily ratings to
confirm Premenstrual Syndrome/Late Luteal Phase Dysphoric Disorder. Part II. What
makes a ‘real’ difference?” Psychosomatic Medicine 1992; 54, 167-81.
SIDEBAR
(if there’s room)
Paula J. Caplan will lead a workshop on strategies for responding to the PMDD/Sarafem
matter on June 8, at the Society for Menstrual Cycle Research Conference in Avon,
Connecticut. She welcomes suggestions at Paula_Caplan@Brown.edu. For information
about the conference, contact Joan Chrisler at jcchr@conncoll.edu.