The making of a disease: female sexual dysfunction Ray Moynihan, journalist. - Commentary by Fred A. Baughman Jr., MD

BMJ 2003;326:45-47 ( 4 January )

Education and debate
The making of a disease: female sexual dysfunction

Ray Moynihan, journalist.

Australian Financial Review, GPO Box 506, Sydney 2201, NSW, Australia
Correspondence to: R Moynihan, 4/1312 21st Street NW, Washington, DC, 20036, USA
raymond.moynihan@verizon.net

Is a new disorder being identified to meet unmet needs or to build markets for new
medications?

The corporate sponsored creation of a disease is not a new phenomenon,1 but the making
of female sexual dysfunction is the freshest, clearest example we have. A cohort of
researchers with close ties to drug companies

[Fred A. Baughman Jr., MD:
"Close ties" means they, the
researchers, are given sufficient money to assure the result/conclusions desired by the
pharmaceutical corporation(s) sponsoring the researchers, their departments, their
institutions. Without exception, the commission of all in psychiatric research/academia
is to sustain the validity of the invented disease (all psychiatric "disorders"/ "diseases)
and to uphold the "necessity", safety and efficacy of the drug(s) manufactured for the
invented disease by the corporation(s) in question]

are working with colleagues in
the pharmaceutical industry

[Fred A. Baughman Jr., MD:
Paid, hardly less, by their Pharma employer than
the supposedly independent researcher. Despite protestations to the contrary, the
"researcher" is no more able to defy the pharmaceutical corporation(s) than are their
"colleagues in the pharmaceutical industry" ]

to develop and define a new category
of human illness at meetings heavily sponsored by companies racing to develop new
drugs. The most recent gathering, featured Pfizer as chief sponsor and Pfizer-friendly
researchers as chief speakers. The venue? The Pfizer Foundation Hall for Humanism in
Medicine at New York University Medical School.

[Fred A. Baughman Jr., MD:
The NYU School of Medicine
is my alma mater. They have chosen the slippery slope of industry sponsorship to such a
degree that nothing they say or do regarding Pfizer or Big Pharma, generally, can be
believed. The activities of those in the NYU Child Study Center and department of
psychiatry, generally, has long had me wondering about industry ties; it all comes into
focus now. See attachment re the Smithsonian, AACAP, NIH and Pfizer]

Since the launch of sildenafil (Viagra) in 1998, more than 17 million men have had
prescriptions written for it as a treatment for erectile dysfunction

[Fred A. Baughman Jr., MD:
elevated, with
the help of Bob Dole of Kansas to male disease status]

, with Pfizer reporting sales
in 2001 of $1.5bn.2 The emerging competitors, Bayer’s vardenafil and Lilly-ICOS’s
tadalafil, are likewise expected to have annual markets in excess of $1bn each.
To build similar markets for drugs among women, companies first require a clearly
defined medical diagnosis with measurable characteristics to facilitate credible clinical
trails.

[Fred A. Baughman Jr., MD:
When I discovered "curly hair, ankyloblepharon, nail dysplasia syndrome--
CHANDS (syndrome = disease, or, at least, it should) in 1971, one had but to delineate
an objective physical abnormality or abnormalities (saying a disease was present) that
had never been described before (saying a new, never-before-described, disease was
present. Today, as with "female sexual dysfunction" and with every single psychiatric
"disorder"/ "disease" in the DSM, the drug, strangely, comes first and then the
"researchers"/academics and "their colleagues from industry" huddle and conjure up
contrive the "disease", whereafter this same cohort of researchers/academics begins
publishing "research" on the disease in journals, the editors of which, are from the same
cohort of researchers/academics. It has become ever so much more complicated, the
business of discovery and research on new diseases, notably those destined for treatment
with drugs, known or as yet unknown, manufactured by one or several pharmas.
]

Over the past six years the pharmaceutical industry has funded, and its
representatives have in some cases attended, a series of meetings to come up with just
such a definition (table).

Defining the new disorder

In a ground breaking gathering in May 1997, clinicians, researchers, and drug company
representatives met for two days at a Cape Cod hotel “to discuss the future direction of
clinical trials”

[Fred A. Baughman Jr., MD:
what did I tell you! First they decide on a name for the "new"
disease, then they decide who will author and conduct the trials and which, of the editors
in the group, will publish the trials/research providing friendly editorial comment, which
will have as it's main goal to put forth, far and wide, the name of the new disease until it
gains acceptance as a disease, not scientifically at all, but by acclaim]

in this area,
against a backdrop of “widespread lack of agreement about the definition” of female
sexual dysfunction.3

[Fred A. Baughman Jr., MD:
Whats more the "clinicians, researchers, and drug company
representatives" who met for two days at a Cape Cod hotel to plan the invention of this
disease were all funded by Pfizer, at that time and every step of the way since until the
invention of the "disease" was complete, and it was accepted by acclamation by
"treating" physicians everywhere and they had taken to "treating" it with the Pfizer
product. ]

In response to an email inquiry about the Cape Cod meeting, co-chair Raymond Rosen
wrote: “The meeting is completely supported by pharmaceutical companies, and
approximately half of the audience will be pharmaceutical representatives.

[Fred A. Baughman Jr., MD:
what
did I tell you?]

The goal is to foster active and positive collaboration between the
two groups. Only investigators who have experience with, or special interest in working
collaboratively with the drug industry have been invited.

[Fred A. Baughman Jr., MD:
There can be no doubt
they are bought and paid for and they are by no means free to conduct science or
practice scientific-based medicine]

” The subsequent publication of the meeting’s
presentations and discussions acknowledged sponsorship from nine drug companies.3
Eighteen months later, in October 1998, the first international consensus development
conference on female sexual dysfunction took place in Boston under “closed session”
deliberations.4 Participants for this multidisciplinary meeting were hand picked by a
group from the American Foundation for Urologic Disease on the basis of their research
or clinical expertise and their positions as “thought leaders.”

[Fred A. Baughman Jr., MD:
I thought it was
"Only investigators who have experience with, or special interest in working
collaboratively with the drug industry have been invited."]

Working with existing
classification systems, including the American manual of psychiatric disorders
(Diagnostic and Statistical Manual of Mental Disorders, 4th edition), participants
produced a new definition and classification featuring disorders of desire, arousal,
orgasm, and pain, to be used in “medical and mental health settings.”4

[Fred A. Baughman Jr., MD:
leave it for
the American Psychiatric Association and the DSM Committee to provide the forum.
The DSM is a manual of fictions of which there are literally hundreds more each
edition.]

Publication of the proceedings of the consensus conference

[Fred A. Baughman Jr., MD:
simple proof—a
macroscopic, microscopic or chemical abnormality demonstrated to the satisfaction of
scientists on a scientific journal's editorial board or board of referees, has, in this new
industry-directed, pseudo-science of discovery been replaced by the consensus
conference, or by a show of hands. This is the DSM way; the biological psychiatry way
and it has worked so well in psychiatry why shouldn't other specialties, beset as all of
them are by generalist-specialist excess/glut, invent diseases also, so one and all have
enough to diagnose as well as prescribe as well as bill for. Every pseudo-disease that is
voted into the DSM gets near-automatic acceptance by government and insurance
payers.]

disclosed support from eight pharmaceutical companies and showed that
18 of the 19 authors of the new definition had financial interests or other relationships
with a total of 22 drug companies.4

[Fred A. Baughman Jr., MD:
what results, and is straight-faced, called a
disease, even to trusting human beings in distress, is pure, unadulterated scientific fraud.
Physicians (all of whom are responsible for knowing disease from no disease) who lie to
patients, telling them they have a disease when they know otherwise, are guilty of
abrogation of informed consent/medical malpractice, and, perhaps of slander, as
well.]

In October 1999 the Boston University School of Medicine

[Fred A. Baughman Jr., MD:
It is not
just researchers and academics that are bought, and not just research teams or
departments but entire medical schools. It is doubtful today that any medical school in
the US is free to do science, and surely this conclusion pertains to every area with a
potential pharmaceutical application/interest]

hosted a further conference, which
was supported by 16 companies.

[Fred A. Baughman Jr., MD:
Ah! Yes, all in the interest of pure
science]

In a response to a question from a speaker at the conference, a show of
hands at one session revealed that around half of the participants were connected to the
drug industry.5

[Fred A. Baughman Jr., MD:
A voluntary show of hands, always voluntary. You try to get the
details of the financial connections out of any of the individuals—good luck. And yet
the evidence is right in front of their eyes: sufficient money has made it's way from the
Pharma's to all researchers, academics, teams, departments and medical schools that that
none are free to do or to speak true science or practice, true, Hippocratic, scientific
medicine]

In 2000 and 2001, the newly formed Female Sexual Function Forum
hosted annual conferences in Boston supported each time by more than 20 companies,
with Pfizer as a key sponsor.

[Fred A. Baughman Jr., MD:
"20 companies, with Pfizer as a key sponsor" and
you are going to believe the "researcher" or "professor" who asserts that he/she is
"above" being spoiled by industry support, that science could not possibly proceed
without this (ever so convenient, comfortable) industry-academia collaboration. So
comfortable that some lowly professors of psychiatry manage, somehow to garner nearly
a million dollars a year, jetting about the world participating in "continuing education
conferences" presenting on the latest disease that he or she has discovered…I mean,
invented. Do not buy into their moral outrage at being questioned or doubted, they have
no such thing, stand your ground and their faux outrage will pass. They do not like
confrontation with others not of the same ilk and they do everything possible to avoid
it]

Interviewed just before Christmas 2002, Pfizer’s Urology Group’s leader, Dr
Michael Sweeney, said the company had played a passive role in sponsoring a series of
discussions about the disorder, simply providing unrestricted grants in response to
requests from physicians.

[Fred A. Baughman Jr., MD:
"Unrestricted grants" this is where, for pivotal disease
inventors (more valuable even than those who invent new, unnecessary treatments) the
gross incomes become suddenly so un-academic, un-professor like. All pharmas give
unrestricted grants sufficient to assure compliance, sufficient to assure that they continue
their unquestioned control over all that is medical academia]

On the international stage, female sexual dysfunction was discussed as part of the first
international consultation on erectile dysfunction in Paris in 1999, hosted chiefly by
urology associations and sponsored heavily by pharmaceutical companies. A second
meeting is planned for Paris in June 2003, with one aim being the adoption of an
“internationally accepted instrument for assessment of sexual function.”6

[Fred A. Baughman Jr., MD:
Even
before an abnormality has been demonstrated to validate female sexual dysfunction as a
disease, an "accepted instrument for assessment" must be voted in, no doubt to tell
patients of to further the illusion of legitimate medical practice, research and science,
where none exists, where the "patient" not a patient at all becomes a profit-
point]

All three Boston meetings (1999-2001) were chaired by Dr Irwin Goldstein, professor of
urology and gynaecology at Boston University School of Medicine, who is also a key figure
at the international gatherings. Originally trained as an engineer, Goldstein has widened his
focus in recent years from male to female sexual dysfunction. A regular speaker at meetings
funded by industry and a consultant and lecturer for virtually every pharmaceutical
company, he is a passionate advocate for building a new discipline of sexual medicine,
because, as he told the recent New York gathering, in this emerging field “there is such joy
in treating these people successfully.”

[Fred A. Baughman Jr., MD:
Is not Goldstein's presence as a professor at
the BU School of Medicine a blight on the reputation of that once-fine medical school. But
again, although not to excuse BU, the pollution—for that is exactly what it is—is of medical
academia, nation-wide. Is it any wonder we spend nearly double the amount for medical
services for each citizen, every year as in any other country in the world but leave so much
necessary care un-done and 43 million working Americans unable to afford basic health
care coverage. In the state of Washington, the invented/fraudulent "disease" ADHD is the
number one health expense in that state's Medicaid program. ]

All three Boston meetings (1999-2001) were chaired by Dr Irwin Goldstein, professor of
urology and gynaecology at Boston University School of Medicine, who is also a key figure
at the international gatherings. Originally trained as an engineer, Goldstein has widened his
focus in recent years from male to female sexual dysfunction. A regular speaker at meetings
funded by industry and a consultant and lecturer for virtually every pharmaceutical
company, he is a passionate advocate for building a new discipline of sexual medicine,
because, as he told the recent New York gathering, in this emerging field “there is such joy
in treating these people successfully.”

when the attention should be paid to other aspects of the woman’s life. It’s also likely to
make women think they have a malfunction when they do not,” he said during a telephone
interview. In response, Laumann defends his use of the term “dysfunction” but concedes
that many women among his 43% are “perfectly normal” and that a lot of their problems
“arise out of perfectly reasonable responses of the human organism to challenges and
stress.”
‘s clinical associate professor of psychiatry, Dr Leonore Tiefer, contends that the medical
model itself is severely limited for dealing with problems of sexuality because of its mind-
body split, biological reductionism, focus on diseases rather than people, and reliance on
norms.12 She claims pharmacological research runs the risk of oversimplifying the sexual
difficulties of both men and women because it “promotes genital function as the centrepiece
of sexuality and ignores everything else”13

What is healthy and what is sick?

While the measurement of sexual problems in men has focused almost exclusively on
erections, female sexual responses have proved much more difficult to quantify, creating
problems for researchers testing pharmacological therapies. In recent years, however, a host
of new methods have been identified, and some clinicians now recommend, along with a
physical and psychosocial examination, a comprehensive evaluation that can include the
measurement of hormonal profiles, vaginal pH, and genital vibratory perception thresholds,
as well as the use of ultrasonography to measure clitoral, labial, urethral, vaginal, and
uterine blood flow. In 1999, Dr Jennifer Berman, assistant professor of urology at the , ,
wrote “Normative data are being gathered for comparison to determine what normal
physiologic responses are for women in particular age groups.”8
Studies by Berman, Goldstein, and others have used those physiological measurements to
test the effects of sildenafil on women with “female sexual arousal disorder.”14 In October
2002, Berman presented results from another study of sildenafil, conducted with three
authors from Pfizer, at a conference where the company was chief sponsor.15 Last month
she told me: “There is clearly a role for medical therapies but not in isolation from
emotional and relationship issues, which are equally if not more important with women.”
On the basis of studies of the genitalia of female New Zealand White rabbits, Goldstein and
colleagues have developed animal models of “vaginal engorgement insufficiency and
clitoral erectile insufficiency.”16 Using data from studies comparing the testosterone levels
of “normal” women with the levels of his patients, he told the December meeting in that
women with “female sexual dysfunction” might have a “specific defect in steroid
synthesis.”

Goldstein regularly cites the 43% prevalence figure and dismisses suggestions from his
colleague Dr Leiblum that it may indicate the prevalence of difficulties rather than real
dysfunction: “I love psychologists but they don’t deal with evidence.” Asked during a break
in the gathering about criticisms that medicine may not be best equipped to deal with sexual
problems, Goldstein’s replied: “Who’s best equipped to deal with it? The horticulturists? It’s
a form of medicine. I think physicians are most appropriate.” He added that he worked
within a “mind-body relationships” framework and a multidisciplinary team that includes
psychologists and nurses.
The pharmaceutical industry’s role in helping build the science of this new disorder has
been “paramount,” according to Goldstein, and he rejects suggestions that closeness
between drug companies and academic researchers may be inappropriate. Asked whether
marketing campaigns worth hundreds of millions of dollars may ultimately tend to amplify
particular views of sexual difficulties and promote certain therapeutic options over others,
he said: “I’m an academic clinical doctor. That’s a question for some philosopher.”

Another view of women’s problems

In contrast to the definition driven by Goldstein and others, Tiefer and colleagues are
promoting a women-centred definition of sexual problems: “discontent or dissatisfaction
with any emotional, physical, or relational aspect of sexual experience,” with four categories
of causes: sociocultural, political, or economic; relationship related; psychological; and
medical.5 “Sex is like dancing,” Tiefer told me during an interview in her office, “If you
break an ankle while you’re dancing you go to a doctor. But your doctor doesn’t take a
dance history and wouldn’t advise you whether your dancing is normal. The medical model
is about defining what’s healthy and what’s sick but sex isn’t like that.”
The potential benefits of this current medicalisation campaign are a more humanised
doctor-patient relationship, effective and safe new drugs, and increased public and research
attention to the complexity of female sexual problems. The potential risk, in a process so
heavily sponsored by drug companies, is that the complex social, personal, and physical
causes of sexual difficulties and the range of solutions to them will be swept away in the
rush to diagnose, label, and prescribe. Perhaps the greatest concern comes from the flip side
of inflated estimates of disease prevalence the ever-narrowing definitions of “normal”
which help turn the complaints of the healthy into the conditions of the sick.
These revelations about female sexual dysfunction should spark a more widespread and
rigorous investigation into the role of drug companies in defining and promoting new
diseases and disorders.

Acknowledgments

Thanks for comments on early drafts to medicalisation-watcher and drug policy analyst
Alan Cassals and to sociology lecturer Jo Ellins, who is working on a doctoral thesis on
“lifestyle” drugs.

Footnotes

Competing interests: None declared.

References

1.
Moynihan R, Heath I, Henry D. Selling sickness: the pharmaceutical industry and disease mongering.
BMJ 2002; 324: 886-891Free Full Text.


2.
Pfizer. Annual report 2001. www.pfizer.com/pfizerinc/investing/annual/2001/p2001ar21.html (accessed).


3.
Special supplement. Int J Impotence Res 1998; 10(suppl 2): S1-142. (The conference: sexual function
assessment in clinical trials, 30-31 May, 1997. .)


4.
Basson R, Berman J, Burnett A, Derogatis L, Ferguson D, Fourcroy J, et al. Report of the international
consensus development conference on female sexual dysfunction: definitions and classifications.
Urology 2000; 163: 888-893.


5.
Kaschak E, Tiefer L, eds. A new view of women’s sexual problems. : Press, 2001:70.


6.
Second international consultation on erectile and sexual dysfunctions, , June 28-. www.congress-
urology.org/index.htm (accessed ).


7.
Laumann E, Paik A, Rosen R. Sexual dysfunction in the : prevalence and predictors published erratum
appears in JAMA 1999;281:1174. JAMA 1999; 281: 537-544ISI[Medline.


8.
Berman J, Berman L, Goldstein I. Female sexual dysfunction: incidence, pathophysiology, evaluation,
and treatment options. Urology 1999; 54: 385-391ISI[Medline.


9.
Cooke R. There’s gold in them there pills. Observer 2002 October 27.


10.
Bancroft J. The medicalization of female sexual dysfunction: the need for caution. Arch Sex Behavr
2002; 31: 451-455.


11.
Segraves R, ed. Historical and international context of nosology of female sexual disorders. J Sex
Marital Therapy 2001; 27(2): 81-245ISI.


12.
Tiefer L. The medicalization of sexuality: conceptual, normative, and professional issues. Annu Rev Sex
Res 1996; 7: 252-282.


13.
Tiefer L. Sexology and the pharmaceutical industry: the threat of co-optation. J Sex Res 2000; 37: 273-
283ISI.


14.
Berman J, Berman L, Lin H, Flaherty E, Lahey N, Goldstein I, et al. Effect of sildenafil on subjective
and physiologic parameters of the female sexual response in women with sexual arousal disorder. J Sex
Marital Therapy 2001; 27: 411-420ISI.


15.
Berman J, Berman L, Toler S, Gill J, Haughie S. Efficacy and tolerability of sildenafil citrate in women
with sexual arousal disorder: a double-blind, placebo-controlled study abstract. Annual meeting of the
International Society for the Study of Women’s Sexual Health, :49.


16.
Park K, Goldstein I, Andry C, Siroky M, Krane R, Azadzoi K. Vasculogenic female sexual dysfunction:
the hemodynamic basis for vaginal engorgement insufficiency and clitoral erectile insufficiency. Int J
Impotence Res 1997; -37ISI[Medline.