Leonore Tiefer Female Sexual
Dysfunction: A Case Study of Disease Mongering and Activist Resistance
Also
published in:
PLoS Med 3(4): e178 DOI: 10.1371/journal.pmed.0030178,
April 11, 2006 The
creation and promotion of “female sexual
dysfunction” (FSD) is a
textbook case of disease mongering by the pharmaceutical industry and
by other agents of medicalization, such as health and science
journalists, healthcare professionals, public relations and advertising
firms, contract research organizations, and others in the
“medicalization industry.” Whether one relies on
Lynn Payer's original
definition of disease mongering (“trying to convince
essentially well
people that they are sick, or slightly sick people that they are very
ill” [1]),
her checklist (Box 1), or
the analysis of our pill-popping society that was recently offered by
Greg Critser [2],
the sequence of events and cast of participants involved in FSD matches
the classic disease-mongering tactics [1,2].
“Taking
a normal function and
implying that there's something wrong with it and it should be
treated” (p. 88) “Imputing suffering that isn't
necessarily there” (p. 89) “Defining as large a proportion of
the population as possible as suffering from the
‘disease’” (p. 89)
“Defining
a [condition] as a deficiency disease or disease of hormonal
imbalance” (p. 93) “Getting the right spin
doctors” (p. 93) “Framing the issues in a particular
way” (p. 94) “Selective use of statistics to
exaggerate the benefits of treatment” (p. 95)
“Using
the wrong end point” (p. 96) “Promoting technology as risk-free
magic” (p. 96) “Taking a common symptom that could
mean anything and making it sound as if it is a sign of a serious
disease” (p. 98)
Each
physical condition or life event that has been subject to
disease-mongering tactics has its own unique history. Sexual life has
become vulnerable to disease mongering for two main reasons. First, a
long history of social and political control of sexual expression
created reservoirs of shame and ignorance that make it difficult for
many people to understand sexual satisfaction or cope with sexual
problems in rational ways. Second, popular culture has greatly inflated
public expectations about sexual function and the importance of sex to
personal and relationship satisfaction. Thus the public is led
to want and expect high rewards from sexual life without having tools
to achieve these rewards. People fed a myth that sex is
“natural”—that
is, a matter of automatic and unlearned biological
function—at the same
time as they expect high levels of performance and enduring pleasure,
are likely to look for simple solutions. This sets the stage for
disease mongering, a process that encourages the conversion of socially
created anxiety into medical diagnoses suitable for pharmacological
treatment. In
this essay, I begin by examining sexual attitudes
in the 20th century that were crucial in setting the scene for the
creation of FSD. I then highlight key steps in the history of FSD and
of the campaign to challenge its reductionist approach to women's
sexual problems. In
the early 20th century, sexual life and interest were stimulated by
intensive urbanization and immigration that disrupted old
community-based patterns of sexual regulation [3,4].
Sexual choices and expectations, however, were still largely governed
by traditional religion and a double standard. Public discourse around
sex was moralistic, and sex-education materials were limited and
stigmatized. By mid-century, surveys showed wide variation in sexual
habits, with behavior patterns related to social class, gender, cohort,
and other background factors [5].
Dramatic
liberalization occurred after World War II as purity campaigns failed
to hold back the sex-promoting impact of changes in longevity, leisure,
employment and childrearing, new technology, and mass media [4].
Effective oral contraceptives and medical treatments for venereal
diseases removed sexual inhibitions due to fear of pregnancy and
disease. A youth culture of charged eroticism developed. Changes in
obscenity laws permitted sexual explicitness in the mass media. The
women's and gay- and lesbian-rights movements of the 1960s and 1970s
raised the importance of sexual behavior and identity. Each new
technological development in communications—movies, car
radios,
television, videotapes, Internet—was used to promote
sex-related
products and to escalate the importance of sexual life and the
availability of stimulation. Beginning
in the 1970s, along with the increasing sexual explicitness in popular
culture, there were two competing academic theories of sexuality. In
the social sciences and humanities, a social-constructionist
perspective emphasized political, economic, and social determinants of
sexual life [6].
It tended to
see learning and education as keys to sexual satisfaction. In
psychology and medicine, by contrast, a reductionist view of sexuality
prevailed that stressed universal, evolution-based patterns of sexual
motive, attraction, and conduct. This view saw satisfaction as an
inherent result of normal function. In truth, however, there wasn't
much academic sex research of any sort, as the topic was controversial
and hence underfunded. There were very few academic or professional
training programs, and sexological organizations, conferences, and
journals were lively but small and somewhat defensive, rather than
parts of an established specialty area of sexuality studies.
In
the 1980s, the nature of sex research and expertise began to shift as a
new “sexual medicine” focused on function was
created by urologists,
insurance reimbursement programs, diagnostic technologies, science and
medicine journalists, and, then, the pharmaceutical industry [7].
Urologists
looked to new opportunities in genitourinary sexual medicine as their
surgical careers were limited by the new (1984) kidney stone
lithotripsy and by effective medications for benign prostate disease.
Insurance-based reimbursement for sex-problem treatments (including
psychotherapy) became linked to a diagnostic classification system that
recognized only discrete sexual “dysfunctions” such
as low desire,
inadequate arousal/erection, and premature or delayed
orgasm/ejaculation. Technologies for measuring genital blood flow and
nerve function were widely used to substantiate dysfunction diagnoses.
Taking advantage of post-1980s deregulatory policies, the
pharmaceutical industry began to redirect its pipeline to new
“lifestyle drugs” and its marketing to consumer
advertising. Science
and medicine journalists played key roles in whetting the public's
appetite for medical news about sex by breathlessly covering each new
discovery and treatment. In the 1980s and 1990s, urologists
created organizations, journals, and “sexual health
clinics” that
focused on men's erection problems. In 1992, a US National Institutes
of Health consensus conference on “impotence”
legitimized this work.
Its outcome was a 34-page document that mentioned factors involved in
etiology, maintenance, and treatment such as culture, partners, and
sexual techniques, but, for the most part, it reified
“erection” as the
essence of men's sexuality, and called for new treatments and vastly
expanded research into physiological details and treatments [8].
The creation of “erectile dysfunction” as a
serious, prevalent, and
treatable medical disorder was firmly in place by the time Viagra was
launched in 1998 with an unprecedented global public-relations
campaign, as Joel Lexchin describes in this issue of PLoS
Medicine [9].
Although
journalists began calling for a “female Viagra”
only days after the
March 1998 US Food and Drug Administration (FDA) approval of Viagra
(examples of journalists’ calling for a “pink
Viagra” are collected on http://www.fsd-alert.org/press.html),
it was far from clear what medical condition Viagra was supposed to
treat in women. Urologists had used the term “female sexual
dysfunction” as early as 1997, referring to aspects of
genital
pathophysiology that might be akin to erectile dysfunction. Figure 1
offers a timeline of events shaping the creation and promotion of FSD,
from 1997 to the present.
AUA,
American Urological Association; CME, Continuing Medical Education;
JAMA, Journal of the American Medical Association (Figure: Rusty Howson) (Click
on picture)
A
May 1997 Cape Cod conference, “Sexual Function Assessment in
Clinical
Trials,” which was sponsored by pharmaceutical companies, was
a
watershed moment in the FSD story [10].
These companies bypassed existing sexology organizations and their
annual conferences to convene an invitation-only
industry–sexologist
get-together. Papers and discussion were published in a special
supplement to the International Journal of Impotence Research
[10].
Significantly, the introduction stated: “In
the area of female sexual dysfunction, there is widespread lack of
agreement about the definition of sexual dysfunction, its
pathophysiology or clinical manifestations, and the optimal approach
for research or clinical assessment (p. S1).”
Definitional
issues have plagued the FSD literature ever since, despite repeated
industry-supported attempts to draw a bright line between healthy
sexual function and medical disorder. The quest for a valid and
reliable FSD assessment instrument has become a small growth industry
in and of itself. For
the first few years, the key players in
the medicalization of women's sexual problems were a small group of
urologists who capitalized on their relationships with industry and
recruited many sex researchers and therapists as allies. Irwin
Goldstein of Boston University, an active erectile dysfunction
researcher, opened the first Women's Sexual Health clinic in 1998 [11].
He convened the first conference on female sexual function (called
“New
Perspectives in the Management of Female Sexual Dysfunction”)
in
October 1999 in Boston. Goldstein is the editor of a journal that
launched in 2004—the Journal of Sexual Medicine
(http://jsm.issir.org)—which
has already published an industry-supported supplement on FSD [12].
Jennifer
Berman, Goldstein's urology trainee at Boston University, together with
her sister, sex educator Laura Berman, became the female face of FSD,
opening a clinic at University of California Los Angeles (UCLA) in
2001, and continuing to popularize FSD and off-label drug treatments on
their television program, Web site, and books; in appearances on the
television show “Oprah”; and in innumerable women's
magazines [13].
The UCLA clinic was closed in 2005, as both Jennifer (in Los Angeles,
California) and Laura (now in Chicago, Illinois) opened fee-for-service
women's sexual-health centers that offered medical assessments and
treatments plus spa and yoga services [13]. Laura
will also have her own reality TV sex-advice show later in 2006 (http://www.sho.com/site/announcements/051005sexual.do).
One clear future angle to the FSD story will be its intersection with
the new “holistic” and
“boutique” (specialized, retainer, or
cash-paying) medical trends as well as with drug-friendly celebrity
experts. Pfizer,
the world's largest pharmaceutical company, was
the main promoter of FSD from 1997 to 2004, when its quest to have
Viagra approved to treat “female sexual arousal
disorder” ended because
of consistently poor clinical-trial results. In its public statement,
Pfizer said that that several large-scale, placebo-controlled studies
including about 3,000 women with female sexual arousal disorder showed
inconclusive results on the efficacy of the drug [14].
Commenting on these trial results on Viagra, John Bancroft, director of
the Kinsey Institute, told the BMJ:
“The recent history of the study of female sexual dysfunction
is a
classic example of starting with some preconceived, and non-evidence
based diagnostic categorisation for women's sexual dysfunctions, based
on the male model, and then requiring further research to be based on
that structure. Increasingly it is becoming evident that women's sexual
problems are not usefully conceptualised in that way” [14].
Nevertheless, Viagra (and the idea that it must
work for women) has been so successfully branded that it continues to
be prescribed off-label for women [15].
Next
in line with a potential drug for FSD has been Procter & Gamble
(P&G), the multibillion-dollar soap, shampoo, and snack company
that makes only five prescription drugs [16].
P&G's 2004 annual report states that its drug risedronate
(Actonel,
approved in 1998 for Paget disease and in 2000 for osteoporosis),
“became a billion-dollar brand faster than any other brand in
P&G
history” [17].
Perhaps
encouraged by this success in selling medicine to women, P&G
had
begun investing heavily in a testosterone patch (brand name Intrinsa)
to treat “hypoactive sexual desire disorder.” The
unnoticed shift in
2004 in FSD identity and promotion from female sexual arousal disorder
to hypoactive sexual desire disorder is another hallmark moment in the
FSD story, illustrating how the effort to match up some drug with FSD
moved freely among symptoms and labels. P&G's trials with
Intrinsa
got many gynecologists and their organizations heavily involved in the
new sexual pharma–medicine for the first time. Unfortunately
for the
drug company, an FDA advisory panel voted unanimously not to approve
Intrinsa, saying that P&G had not provided sufficient long-term
safety data and questioning the clinical significance of the Intrinsa
trials [18].
However,
testosterone researcher Jan Shifren estimates that one-fifth of all the
prescriptions of testosterone products approved for men are actually
written (off-label) for women [19].
By
2006, FSD has become a medical and media reality, despite the obvious
ongoing difficulties in defining the condition and in getting a drug
approved. Disease mongering has led to the successful
“branding” of FSD. In
1999, I became concerned that the imminent inaugural Boston conference
on FSD would represent only the reductionist view of women's sexual
problems and would likely ignore the fundamental political and
interpersonal reality of women's sexual lives. I had been employed as a
research and clinical psychologist in urology departments from 1983 to
1996, and I worried that the mechanistic view of sexuality I had seen
applied to men's sexual function would just be transposed to women.
Viagra had just been approved, I knew about the Cape Cod conference,
and I feared that urologists (with financial backing from Pfizer) would
use a conference on FSD to promote Viagra for women.
Although I
had no experience in organizing, I felt I had to take steps to make
sure a space was created for diverse (i.e., not just medical) opinions
about women's sexual problems. I submitted a critical essay about the
new FSD to a Boston feminist newsletter [20], and,
with Carol Tavris, I wrote an oped for the Los Angeles Times
[21].
Through Internet communication, I invited feminist critics of
medicalization to meet with me in Boston and take some action at the
FSD conference. Figure
2
offers a timeline, beginning in 1999, of the activism that came to be
called the “Campaign for a New View of women's sexual
problems” [22].
(Figure: Rusty Howson) (Click
on picture)
The
pharmaceutical industry has taken an aggressive interest in sex.
The campaign and its challenge
to FSD disease mongering have had two crucial components [23].
The first, a theoretical critique of the medical model of sexual
problems, was developed in the New View Manifesto, books, articles, and
lectures. The manifesto, now available in several languages [22],
was authored by a group of feminist academics, activists, and
clinicians calling themselves “The Working Group on a New
View of
Women's Sexual Problems.” The second component of the
campaign is
pharma–watchdog activism, consisting of media interviews,
conferences,
FDA and professional presentations, and a Web site (http://fsd-alert.org).
The
New View Manifesto focuses on weaknesses of the prevailing sexual
dysfunction classification and medical model. It promotes a politically
sensitive social-constructionist perspective and recommends abandoning
the effort to define “normal” sexual function. It
offers an alternative
classification system of causes for sexual problems rooted in society,
relationships, psychology, and disease. The activism challenges claims
made for each emerging FSD drug in terms based on recurring biases in
clinical trials, dangers of off-label promotion, researchers’
conflicts
of interest, and neglect of nonmedical theory and research on sexuality.
Sexual
life and its pleasures, problems, and satisfactions are subject to
changing demands and expectations. Recently, the pharmaceutical
industry has taken an aggressive interest in sex, using public
relations, direct-to-consumer advertising, promotion of off-label
prescribing, and other tactics to create a sense of widespread sexual
inadequacy and interest in drug treatments. The public finds
medicalization attractive because the notion of simple but scientific
solutions fits in with a general cultural overinvestment in biological
explanations and interventions, and promises to bypass sexual
embarrassment, ignorance, and anxiety. This wish will inevitably end in
stories of personal disappointment, but media promotion, advertising
hyperbole, and an active pipeline will create continuing hope for the
next new drug along with a neglect of other models of sex and ways to
deal with sexual discontent. The New View Campaign to challenge
the disease mongering of FSD can be seen as part of a widespread new
arena of public-health advocacy that deals with corporate practices
that affect health, such as those in the tobacco, automobile, and food
industries [24].
Activism on
behalf of women's sexuality leads also to coalition with sexual-rights,
sex-education, and reproductive-rights organizations. It has taken the
work of many public-spirited people and organizations to shed the
necessary light on FSD disease mongering. But the difficulties the
industry and its experts continue to have in nailing down FSD testify
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