ORIGINAL ARTICLE

A Diagnostic and Statistical Manual of Mental Disorders History of Premenstrual Dysphoric Disorder Peter Zachar, PhD* and Kenneth S. Kendler, MDÞ Abstract: The proposals to include a menstruation-related mood disorder in the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition (DSM-III-R), and DSM-IV led to intense public and behind-the-scenes controversy. Although the controversies surrounding the DSM-5 revision were greater in number than the controversies of the earlier revisions, the DSM-5 proposal to include a menstruation-related mood disorder was not among them. Premenstrual dysphoric disorder was made an official disorder in the DSM-5 with no significant protest. To understand the factors that led to this change, we interviewed those psychiatrists and psychologists who were most involved in the DSM-IV revision. On the basis of these interviews, we offer a list of empirical and nonempirical considerations that led to the DSM-IV compromise and explore how key alterations in these considerations led to a different outcome for the DSM-5. Key Words: Premenstrual dysphoric disorder, DSM-IV, DSM-5, history, premenstrual symptoms (J Nerv Ment Dis 2014;202: 346Y352)

PREMENSTRUAL SYNDROME, PREMENSTRUAL DYSPHORIC DISORDER, AND THE DSM What is now called premenstrual dysphoric disorder (PMDD) was first clearly described by Frank (1931) under the name premenstrual tension. It was renamed premenstrual syndrome (PMS) by Greene and Dalton in 1953. Its psychiatric symptoms are irritability, affective lability, depression, and anxiety. These symptoms occur during the last week of the luteal phase of the menstrual cycle and begin to remit with the onset of menses. Interest in the condition increased in the 1980s after Dalton helped acquit a woman of murder by testifying that she experienced severe PMS. According to Figert (1996), the original impetus for including a severe form of distress and impairment related to menstruation in the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition (DSM-III-R), came from Robert Spitzer, the architect of the DSM-III revolution. Spitzer reported to her that he had been invited to several conferences on PMS, a condition about which he had limited information. What interested Spitzer was that PMS had caught the attention of mental health professionals. As the chair of the Work Group to revise DSM-III, Spitzer saw it as his responsibility to make sure that they considered all the conditions that were of concern to mental health professionals, leading him to convene a PMS advisory committee. The story of what *Department of Psychology, Auburn University Montgomery, AL; and †Virginia Institute of Psychiatric and Behavioral Genetics, Department of Psychiatry and Department of Human and Molecular Genetics, Virginia Commonwealth University School of Medicine, Richmond, VA. Send reprint requests to Kenneth S. Kendler, MD, Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University Medical School, Box 980126, 800 E. Leigh St, Room 1-123, Richmond, VA 23298-0126. E-mail: [email protected]. A longer version of this article will be published as a book chapter in Philosophical Issues in Psychiatry III: The Nature and Sources of Historical Change. Oxford, UK: Oxford University Press. Copyright * 2014 by Lippincott Williams & Wilkins ISSN: 0022-3018/14/20204Y0346 DOI: 10.1097/NMD.0000000000000128

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happened next has been told many times (Caplan, 1995; Figert, 1996; Spitzer et al., 1989). Classifying a menstruation-related mental disorder was not acceptable to some of the psychiatrists on the advisory committee because of their fear that it would stigmatize a normal part of a woman’s monthly cycle, but the advisory committee nevertheless recommended that the newly named PMDD be included in the manual. Those who disagreed organized an opposition that quickly grew in intensity, aided in part by participation of psychologists who were also concerned about other newly proposed disorders such as masochistic personality disorder and paraphilic rapism. There were closed-door debates, public debates, additional oversight committees, and protests. When the DSM-III-R was published in 1987, PMDD was not included as an official disorder; rather, it was renamed late luteal phase dysphoric disorder (LLPDD) and placed in a new section called ‘‘Appendix A’’Vas a proposed disorder in need of further study. In fact, this DSM appendix was created largely to contain this syndrome.

OVERVIEW OF DSM-IV AND DSM-5 Work on the DSM-IV began soon after the DSM-III-R was published. The LLPDD Work Group was formed to make recommendations for the diagnosis in DSM-IV. They had different opinions on whether to move the disorder to the main section of the manual, to keep it in the appendix, or to eliminate it (Endicott, 2000; Frank and Severino, 1995). When two senior psychiatrists were asked by the DSM-IV leadership to review the documentation prepared by the Work Group, they recommended retaining it in the appendix. In 1988, psychologist Paula Caplan was asked to be an advisor to the LLPDD Work Group but later discontinued her involvement when she concluded that her scientific input was not wanted (Caplan, 1995). After she heard about the decision to retain the disorder in the appendix, she organized a petition campaign and began speaking against classifying menstruation-related distress as a mental illness. The goal of the protest was to have the disorder eliminated entirely from the manual. It was not successful. LLPDD was renamed PMDD and kept in the appendix. When the DSM-5 was published in 2013, PMDD was moved to the main section of the manual as a diagnosis approved for routine clinical use. Interestingly, in the age of the Internet, the public and professional controversies about the DSM-5 revision greatly outnumbered those of previous revisions, but the status of PMDD was not among them. Our goal in this article was to try to understand the factors that led to the dramatic change in the reactions to the status of PMDD in the DSM-IV and the DSM-5.

DECISION VECTORS In her book Social Empiricism, Solomon (2001) proposed a normative model for understanding how consensus and dissent should be distributed to support scientific progress. To do so, she introduced the idea of a decision vector. According to Solomon, a decision vector is any factor that influences the outcome of a scientific decision such as accepting or rejecting a theory.

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A DSM History of PMDD

TABLE 1. List of People Interviewed Name

Role

Jean Endicott, PhD Michael First, MD Ellen Frank, PhD Allen Frances, MD Judith Gold, MD Barbara Parry, MD Harold Pincus, MD Sally Severino, MD Nada Stotland, MD Kimberly Yonkers, MD

Member of the DSM-III-R advisory committee and DSM-IV LLPDD WG Editor of text and criteria for the DSM-IV Member of DSM-IV Task Force and Mood Disorders WG consultant to LLPDD WG Chairperson of the DSM-IV Task Force Chair of the LLPDD WG and DSM-IV Task Force member Member of the DSM-III-R advisory committee and DSM-IV LLPDD WG Vice-chairperson of the DSM-IV Task Force Member of the DSM-III-R advisory committee and DSM-IV LLPDD WG Former chair of the APA Committee on Women and member of LLPDD WG Member of DSM-5 Mood Disorders and PMDD WGs

WG indicates Work Group.

Solomon also distinguished between empirical and nonempirical decision vectors. An empirical decision vector is any factor that leads scientists to prefer theories with empirical success. This includes predictive success, explanatory success, and descriptive success. Nonempirical decision vectors are any other factors leading a community to prefer one theory (or diagnostic construct) over another. These include economic, social-political, and ethical considerations, as well as psychological factors such as conservativeness and peer pressure. For example, if placing PMDD in the manual makes it more likely that research studying the condition will be funded, those who conduct such research will prefer it to be included. If a PMDD diagnosis encourages women to blame their bodies rather than their social situations for their distress, those who are concerned about the empowerment of women may prefer the construct not to be included. Previous generations of philosophers might have referred to empirical decision vectors as rational considerations and nonempirical decision vectors as biasing factors, but Solomon argued that they can both contribute to successful science and are inevitably part of any scientific change.

THE DSM-IV TASK FORCE AND THE LLPDD WORK GROUP In addition to reviewing the published literature on the PMDD controversy, we asked many of the participants in the DSM-IV revision to both reflect on that process and offer their perspectives about what had changed by the time of the DSM-5 proposal. Those who were interviewed are identified in Table 1. These interviews were conducted by telephone by Kenneth Kendler and occurred between October 19, 2011, and February 8, 2012. After the first draft of this article was written, a copy was sent to all those who were interviewed, giving them a chance to suggest corrections, which were then incorporated into the final draft. On the LLPDD Work Group, Barbara Parry, Jean Endicott, and Ellen Frank all supported moving the disorder to the main section of the manual. Michael First agreed with them. Judith Gold and

Sally Severino believed that it should remain in the appendix, as did Allen Frances and Harold Pincus. Nada Stotland favored eliminating the disorder from the manual altogether. Our listing of the vectors is based largely on the interviews. We make no pretension to having identified a complete list of vectors; rather, our goal was to develop a list that is comprehensive enough to represent the primary issues of dispute during the controversy. We have sorted these decision vectors into three categories, reflecting the options that were available to the Work Group. This sorting is presented in Table 2. When studying controversies that have been closed, it is easier to distinguish between empirical and nonempirical decision vectors. When a controversy is ongoing, however, one of the issues being debated is what implications ‘‘the evidence’’ has for diagnostic constructs or what it is evidence for (Kendler, 1990; Zachar and Kendler, 2010). For this reason, we begin by simply identifying decision vectors, without sorting them into the empirical and nonempirical boxes.

VECTORS FOR MOVING PMDD TO THE MAIN BODY OF THE DSM-IV Agreement on Symptoms and Time Course Many of the DSM-IV work groups conducted literature reviews of the research that had occurred on their assigned disorders after the publication of the DSM-III. The results of these literature reviews were published in the DSM-IV Sourcebooks (Widiger et al., 1996). With respect to their literature review, the members of the LLPDD Work Group recalled that there was general agreement about the factual material (Frank and Severino, 1995; Gold et al., 1996). For example, they agreed that there are women who meet criteria for the disorder with respect to symptoms and time course and who do not have another co-occurring disorder. The symptoms are also associated with clinically significant distress and impairment. The Work Group added one symptom to the criteria used in DSM-III-RVinvolving feeling overwhelmedVand reorganized the criteria so that depression and anxiety were listed first.

TABLE 2. DSM-IV Decision Vectors Move to Main DSM-IV Section

Agreement on symptoms Benefits of treatment The biomedical model

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Retain in the Appendix

Delete From the DSM-IV

Philosophical ideas about disorder Higher standard of evidence The politics of DSM Peer pressure consensus Reaction to public opposition

The problem of false-positives Questionable diagnostic validity Feminism and negative social consequences Criticisms of pharmaceutical industry

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The evidence also indicated that if hormonal levels are altered, the symptoms still occur during the time of the month that normally would be the late luteal phase. Not being the manifestation of a late luteal phase hormonal profile, the Work Group recommended changing the name from LLPDD to PMDD.

Benefits of Treatment The research reviewed by the Work Group indicated that anxiolytics and antidepressants were more effective than a placebo for treating many premenstrual symptoms. Suppression of ovulation by chemical means was a promising approach. Although not an acceptable treatment approach, when ovulation is surgically eliminated, the symptoms are also eliminated. The consensus view of those who wanted to move the diagnosis to the main section of the manual was that there are clearly women who are impaired by PMDD, and placement of the disorder in the main section would facilitate proper diagnosis and treatment. It would also encourage further research. Parry, in particular, reported being surprised that anyone would oppose putting this in the manual given the magnitude of the scientific evidence and its potential benefits to women. She believed that the criteria were quite narrow, identified the small group of women who were actually ill, and would reduce stigmatization as a whole. According to Frank and Severino (1995), the more certain benefits of being able to educate women about the nature of their symptoms outweighed the vague concerns about potential harms. In psychiatry, both clinical and personal experience can be decision vectors. For example, Barbara Parry said that, as a resident, she encountered a case of severe PMDD in a high-functioning health services provider. The symptoms included a florid psychosis that remitted after the onset of menses. This case was what got her interested in studying menstruation and recurrent psychiatric disorders. Several members of the Work Group mentioned the campaign of intimidation used by some opponents of the diagnosis. With respect to these opponents, Endicott stated that she was not intimidated because both she and her mother had PMS-related symptoms. According to her, these kinds of problems were a valid part of her experience and congruent with her reading of the empirical data.

The Biomedical Model of Psychiatric Disorders A concept such as PMDD was a good fit for an era in which the biological perspective in psychiatry was gaining dominance (Andreasen, 1984; Guze, 1992). Tied as it was to cyclical changes in a woman’s monthly cycle, PMDD was readily seen as a biologically based mood disorder. The Work Group specifically noted that the condition was an important exemplar of a biologically based psychiatric condition (Gold et al., 1996). It may even, they said, help call attention to the endrocrinological aspects of other psychiatric disorders. Keeping it in the manual, it was believed, would be an important boost to current and emerging biomedical research programs.

VECTORS FOR DELETING PMDD FROM THE DSM-IV The Problem of False-Positives The Work Group’s report in the DSM-IV Sourcebook noted that there was a tendency among some women to seek treatment of normal premenstrual distress and even to label it PMS but not actually meet the more stringent criteria for a diagnosis of PMDD (Gold et al., 1996). Furthermore, they noted that symptoms identified with PMDD might better be accounted for by the exacerbation of a preexisting disorder, such as depression and dysthymia, an anxiety disorder, a somatoform disorder, a substance use disorder, bulimia, or a personality disorder. Finally, women may prefer the more socially desirable PMDD diagnosis even if they meet criteria for another 348

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psychiatric disorder. In epidemiological terms, there was a high risk for false-positive PMDD diagnoses. Nada Stotland reported that her primary concern was that PMDD would be a diagnosis that many women would seek even if they did not actually have PMDD. Although the criteria were written tightly to eliminate these kinds of false-positives, she believed that because the diagnosis could be made provisionally (before daily ratings to confirm the symptom pattern were completed), it would be. Another concern of hers was that the evidence for the maladaptive effects of male hormones on violence and aggression was much stronger than the assumptions about female hormones and depression, but there was no corresponding disorder for men being considered. With respect to this vector, clinical experience and the relevance of salient data also played a role. Stotland said that she once saw a high-functioning woman who was seeking a prescription to treat her ‘‘PMDD.’’ This woman believed that PMDD was responsible for her strong negativity toward her husband and her son and was worried about harming her son psychologically. Stotland agreed to write the prescription, but 6 weeks later, the woman returned and declared that she was feeling better every day not just during her premenstrual phase. She had decided that she was really depressed and did not have PMDD.

Questionable Diagnostic Validity Severino noted that most of the research reviewed by the LLPDD Work Group studied PMS, not PMDD (Frank and Severino, 1995). According to her, much of what was believed to be known about PMDD was an extrapolation from PMS. Those who were more skeptical of the disorder contended that the symptoms are mostly physical and occur during menstruation; the psychiatric symptoms are not limited to the late luteal phase and might represent normal problems in living that are exacerbated by physical discomfort (Caplan, 1995, 2008; Severino and Gold, 1994). Although there were suggestive findings of differences between women with and without PMDD in levels of neurotransmitters and hormones, these differences were not tightly correlated with the onset and remission of symptoms as one might expect. As Parlee (1994) also noted, the diagnosis of PMDD is made only on the basis of self-report, not biological markers. Another concern acknowledged by the LLPDD Work Group was that both PMS and PMDD were deeply embedded in cultural assumptions about sex roles. Of particular concern was the assumption that women are less prone to anger than men and also more emotionally responsive than men. When adhering to these norms, a woman’s anger would have a lower threshold for being considered inappropriate and therefore pathological.

Feminist Values and Negative Social Consequences In The Female Malady, Showalter (1985) described the long and contentious relationship that exists between feminism and psychiatric diagnosis. For example, in the late 19th century, women who advocated for professional and sexual freedom were diagnosed as hysterics and degenerates. We would be remiss to not mention that, for many generations, the various symptom clusters classified under hysteria were explained by one or other versions of the uterine theory (Micale, 1990; Scull, 2009). Although the literal belief that hysteria was the result of a wandering womb was abandoned by the 17th century, it was replaced by a theory that stated that the symptoms of hysteria were caused by vapors that arose from the female reproductive system. Given this history, a new diagnostic category that traced psychiatric distress to menstruation readily looked like a repackaged and updated version of the uterine theory. * 2014 Lippincott Williams & Wilkins

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Many of those who favored deletion were concerned about PMDD being a disorder that, by its very nature, would be limited to women and could be used against women. For example, those who opposed equal opportunity in the workplace argued that the menstrual cycle makes women more emotionally unstable and dysfunctional every month. If PMDD became an official diagnosis, the opponents could also say that this was not only their opinion, nor was it bigotry; rather, it was science as demonstrated by the fact that it is in the DSM. Another worry was that PMDD would serve to mask the actual reason for a woman’s anger and distress. With PMDD in the manual, natural and justified reactions to abuse and mistreatment could be labeled a mental disorder. Rather than seeing the problem as being due to a negative external situation, the problem would be seen as located inside the woman’s body. On the Work Group, a variety of attitudes regarding feminism played a role in what members thought should happen in the DSM-IV. The person most obviously associated with women’s groups was Nada StotlandVwho was the chair of the American Psychiatric Association (APA) Committee on Women. Although Stotland favored deleting the disorder, several of the members of the Work Group stated that, during their deliberations, Stotland had a very nuanced view of the proposed disorder. She saw it as her duty to represent her constituency and to work within the system. In contrast, Sally Severino was newer to feminism. Many members of the Work Group recalled that, during this time, Severino’s exposure to feminism was a profound consciousness-raising experience for her. Severino herself reported that her training in psychoanalysis did not include a feminist perspective, and she did not have a serious encounter with feminism until she was promoting a book she had written on PMS (Frank and Severino, 1995; Severino and Moline, 1989). The perception of several Work Group members was that, at this time, Severino shifted more toward Stotland’s views, although she did not support eliminating the diagnosis from the manual. Ellen Frank considered herself a feminist of long standing. Frank reported that she was exposed to feminism in college and it was a part of her personal and professional identity (Frank and Severino, 1995). She did not believe that being a feminist required her to oppose moving PMDD to the main section of the manual. In her view, narrow-minded people who believe that women are less capable would not change their minds if PMDD was eliminated from the manual.

The Role of the Pharmaceutical Industry A final issue of contention that existed both inside and outside the committee structure was the belief that the diagnosis of PMDD was being pushed by the pharmaceutical companies because categorizing PMDD as a mood disorder would open a large and new market for antidepressant medication.

VECTORS FOR RETAINING PMDD IN THE DSM-IV APPENDIX Philosophical Ideas About the Nature of Disorders Some members of the Work Group believe that Severino’s exposure to feminism led her to change her opinion about what should occur in the DSM-IV, but Severino claimed that she did not switch her opinion on PMDD during the process and that she cannot be grouped either with the advocates for the diagnosis or with the opponents. Her concerns, she noted, were more philosophicalVrelating to the nature of a psychiatric disorder. In her opinion, if PMDD is not an exacerbation of a preexisting disorder, then it is also a kind of thing that is distinct from a mood disorder. Many of its symptoms such as sensations of bloating have nothing to do with mental * 2014 Lippincott Williams & Wilkins

A DSM History of PMDD

disorder. She reports that her opposition to what happened in the DSM-IV was a disagreement about listing PMDD in the mood disorders section as an example of a mood disorder not otherwise specified (NOS) and giving it an official mood disorder NOS code number in the appendix. This, she claimed, essentially moved PMDD into the main body of the manual.

Higher Standard of Evidence One of the arguments of the advocates for moving the diagnosis into the mood disorders section was that the evidence for the validity of PMDD was better than for many of the disorders already in the DSM. For example, one of the problems with past research on PMDD was the use of retrospective reports of symptoms, which tend to be inflated. Making a DSM-III-R diagnosis required prospective daily ratings of symptomsVa much more rigorous assessment than is required for other DSM disorders. The counterargument of the opponents was that the comparative superiority of evidence for PMDD does not mean that PMDD should be moved to the main section of the manual; rather, it means that the evidence for a large number of psychiatric disorders is inadequate. Both Judith Gold and Sally Severino favored keeping PMDD in the appendix because they believed that the risk that the diagnosis would be used against women meant that PMDD should have higher standards of evidence for inclusion. Their concern was that there was not yet enough research using these higher standards to separate PMDD from PMS or from an exacerbation of another psychiatric disorder. This meant that Gold and Severino joined Stotland in opposing moving the disorder to the main section of the manual, with their three opinions countering those of Parry, Endicott, and Frank, who argued that psychiatrists can neither predict nor control what corporations, lawyers, and other people will do and that scientific decisions should not be made with them in mind.

The Politics of DSM-IV Several members of the LLPDD Work Group suggested that they were set up to fail from the very beginning, but this was disputed by Allen Frances and Harold Pincus. Supporting the latter opinion, Figert (1996) reports conversations with Jean Hamilton (who was a leading figure in the DSM-III-R protests) and Robert Spitzer that occurred before the emergence of the DSM-IV controversy in which both of them hypothesized that the LLPDD Work Group had been set up to get PMDD into the main body of the manual. After the literature review and the many months of deliberation were complete, Frances spoke with the Work Group to try to reach consensus. When it became clear that there was not going to be agreement on what to do, Frances created a subcommittee composed of John Rush and Nancy AndreasenVtwo prominent research psychiatrists. Rush and Andreasen reviewed the Work Group’s report and recommended to the Task Force that PMDD did not meet the higher standard for being moved to the mood disorders section. After most of the Task Force agreed that the disorder should remain in the appendix, Frances left it to the Work Group to prepare the PMDD section. Frances believed that the scientific support for the disorder was being overestimated by the advocates, but several members of the Work Group believe that Frances was risk aversive and did not want to repeat the DSM-III-R controversies or the DSM-II era controversy about the deletion of homosexuality. The most adamant opponent is Parry, who believes that the LLPDD Work Group and the Task Force were too afraid of controversy and simply made the wrong decision. Endicott, in contrast, believes that the concerns about how the diagnosis would be misused were exaggerated and not shared by all women but understands why Allen Frances did not support it to protect the overall DSM process. www.jonmd.com

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The third member of the Work Group who opposed this decision, Ellen Frank, was very distressed at that time by the unwillingness of the Work Group to let science lead the way. She was also upset by the intimidation tactics of the opposition and, in retrospect, agrees with Frances’ political decision to not support its inclusion at that moment in history.

Peer Pressure Consensus The guiding assumption of the entire DSM-IV process was called ‘‘the consensus model.’’ Rather than committees deciding an issue by voting, the architects believed that if the data were clearly laid out, reasonable people would agree on its implications for the DSM. Frances’ notion of consensus was not limited to scientific consensus. It also included clinical consensus and organizational consensus. Requiring consensus was a strategy for being cautious about proposed changes. One thing that is clear in the interviews was that the LLPDD Work Group was cohesive. For example, Endicott reported that, after the final decision to keep PMDD in the appendix had been made, she was having lunch with Nada Stotland. One of her colleagues came upon them and was incredulous that they were interacting. Endicott told her that she and Stotland were friends who agreed to disagree.

Reaction to Public Opposition Given that the LLPDD Work Group (reluctantly in some cases) agreed on a consensus final opinion, the people interviewed generally held that much of the opposition came from outside the DSM process and largely from psychology. Caplan (1995), who later wrote a book titled They Say You’re Crazy: How the World’s Most Powerful Psychiatrists Decide Who’s Normal, figures prominently here. Referring to these events as PMSgate, Caplan (1995) noted that she did not believe that the scientific evidence supported the validity of a mental illness related to menstruation. Furthermore, the foreseeable harms to women that would be contingent upon such a diagnosis were alarming to her. Given her reading of the scientific evidence and the values issues, she saw no reason to compromise. As a result, during the time that the LLPDD Work Group was active, other critics had a more important influence on the Work Group’s deliberations. In her role as public face of the opposition, Caplan charged those directly involved with the DSM-IV revision with serious distortions of the truth and outright lies. She also suggested that many women were immersed in a belief system that taught them that women are inferior and that their inferiority is closely linked to biology. They failed to understand, she suggested, that, according to the evidence, mood problems before menstruation are not caused by being premenstrual. Late in the process, Caplan and her colleagues sent a letter to all the members of the APA Legislative Assembly and the APA Board of Trustees warning that psychiatrists would be legally liable for the harm done by giving a psychiatric diagnosis that is not justified by research. The letter also claimed that the consequence of retaining the diagnosis in the appendix will lead to increases in malpractice insurance and to public embarrassment to the profession of psychiatry as a whole. Many observers believed that the combination of personal attacks and dramatic warnings, especially about lawsuits, lost the opposition credibility in the larger psychiatric community.

THE DSM-5: OPPOSITION DOES NOT EMERGE When we examine the DSM-5 revision in light of the history just reviewed, two things stand out. One, this revision involved more professional and public controversy about the recommended changes than occurred in either the DSM-III-R or DSM-IV revisions. These controversies included proposals to eliminate the bereavement exclusion for major depressive disorder, eliminate half of the personality 350

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disorders, eliminate the diagnostic category of Asperger’s syndrome, add a psychosis risk syndrome, and introduce a new mood dysregulation disorder for children. There was, however, very little said in the public media about the decision of the Mood Disorders Work Group to move PMDD from the appendix to the main section of the manual.

Food and Drug Administration and Sarafem Those interviewed suggested that a key factor in the change was a ruling by the US Food and Drug Administration (FDA) in the year 1999. According to Endicott et al. (1999), in 1998, a panel of 16 experts were brought together to review and discuss newly available evidence on PMDD and concluded that it was a distinct clinical disorder that differed from other mood and anxiety disorders. Much of the new research focused on the efficacy of serotonergic antidepressants for approximately 50% to 60% of the women diagnosed with PMDD. Once the experts came to believe that PMDD was worthy of being considered as an indication for specific treatments, and Eli Lilly presented the results of its clinical trial using the PMDD diagnostic criteria, the FDA approved Prozac (fluoxetine) for the treatment of PMDD. Eli Lilly later repackaged it as Sarafem. Allen Frances, who was a major force in the opposition to many proposed DSM-5 changes, specifically noted that he chose to not ring the alarm bell about it being moved to the main section of the manual because the FDA action made the status of PMDD in the DSM largely irrelevant with respect to how the pharmaceutical companies target their drugs. At this point, Frances believed, moving it to the main section of the manual would not do much harm.

Dire Consequences Do Not Emerge One point that was very specifically mentioned by several people interviewed was that the predicted negative social consequences did not materialize after Sarafem was introduced. They took this as evidence that the concerns about negative consequences were exaggerated and that some of them were simply unfounded.

DSM-5 Politics Many of the debates that occurred during the DSM-5 revision were related to the intention of the architects to revolutionize psychiatric classification by implementing dimensional models in which psychiatric disorders lie on a continuum with normality (Kupfer et al., 2002). Rather than concern about the social and political consequences of false-positive diagnoses, the goal was to let science lead the way to a better taxonomy. This represented an important internal shift in politics, eliminating one of the high-magnitude vectors that kept PMDD in the DSM-IV appendix.

Next-Generation Feminism Jean Endicott believes that Sarafem normalized the treatment of PMDD. She noted that, if one reads popular women’s magazines, when discussing PMS, they give recommendations for lifestyle changes. If that does not work, the magazines tell women to go see their physician. They also inform women that this is a real entity and that they do not need to feel ashamed by it. Endicott, Ellen Frank, and Kim Yonkers (who were on the DSM-5 PMDD advisory committee) also suggested that there has been a generational change among feminists. According to them, professional women who were born in the 1970s and 1980s are more secure than those baby boomers born in 1945 to 1960. Less intimidated and less fearful of losing their status, they represent the kind of feminism that Frank felt that she possessed during the DSM-IV revision process. * 2014 Lippincott Williams & Wilkins

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Additional Research on Validity and Treatment Benefits The Mood Disorders Work Group for DSM-5 asked a panel of eight experts in women’s mental health a) to evaluate the DSM-IV criteria for PMDD, b) to assess whether there is sufficient empirical evidence to support its being moved out of the appendix, and c) to suggest changes to the diagnosis that are supported by the research conducted since the DSM-IV. The panel recommended that PMDD should be moved to the main section of the manual and suggested changes in criteria (Epperson et al., 2012). The reasons for this recommendation include the following: The consistent prevalence rates of PMDD across countries The rapid efficacy of selective serotonin reuptake inhibitors when taken only during symptomatic periods Clear distinction between PMDD and other mood and anxiety disorder, for example, those diagnosed with PMDD are less likely to have a co-occurring personality disorder The negative response to hormonal add-back only for those with a PMS history Let us briefly examine the issue of hormonal add-back. As was the case for the research available during the DSM-IV revision, no clear pattern of hormonal differences is associated with PMDD. This was taken as evidence against the validity of PMDD. There later emerged additional evidence that the key factor is not differences in levels of hormones but different CNS responses to fluctuating levels of hormones (Epperson, 2013). For example, if normal levels of hormones such as progesterone are blocked, when those hormones are ‘‘added back in,’’ women with a history of PMDD experience the typical psychiatric symptoms, but those without a history do not.

SCIENCE IN THE MAKING OR READY-MADE SCIENCE? Ready-made science is a term used by Latour (1987) to describe what occurs after a scientific controversy on some topic is closed and nature is seen as having spoken. In psychiatric classification, the closing of a controversy would mean that a putative disorder is considered ‘‘real.’’ Before this development, fact claims that are in the process of being established are open to scrutiny and critically examined. Putnam (1990) has argued that the concept of a fact includes the notion of an obligation. To call something a fact is to declare that others have an obligation to accept it, no matter what their preferences may be. To say that the facts now support the validity of PMDD is also to say that our obligations have been better specified. A plurality of obligations are relevant in establishing facts. In psychiatry, these include obligations to science and obligations to patients. Many professional women in particular accept that they have an obligation to support feminist values and therefore an obligation to take a particular stance with respect to something such as PMS and PMDD. But what are those obligations? And what is that stance? As we saw earlier, women who might be called next-generation feminists are more confident in their hard-earned social status and do not feel obligated to constantly defend it, but, as Stotland noted, to claim that sexism is no longer an issue because women have done so well is analogous to claiming that racism is no longer an issue because Barack Obama is the US president. In general, feminists believe that it is important to not blame women for their distressVwhich psychiatric constructs such as hysteria and borderline personality subtly do. This raises a specific set of obligations and directs attention to a particular set of facts. Feminist scholars who specialize in the philosophy of psychiatry, however, also believe that it is important to acknowledge women’s psychiatric distress and impairment as genuine and not * 2014 Lippincott Williams & Wilkins

A DSM History of PMDD

only as manifestations of cultural roles, powerlessness, and sexism (Potter, 2006, 2009; Radden, 2009). For example, to say that the emotional lability and irritability of PMDD are best understood as reactions to physical symptoms such as headaches could be construed as blaming a woman for lacking coping skills. Not merely dismissing a woman’s psychiatric distress as ‘‘all in her head’’ is also a kind of obligation that makes other facts relevant. In that light, consider the following quote from a young woman who experiences severe physical and emotional symptoms 7 days of every month. ‘‘One of the things I find frustrating about modern feminist critique I is that I’m expected to be tough no matter what my body deals me, otherwise I’m giving in to patriarchy. What if sometimes, I’m in pain and I can’t do it on my own. What has to happen to make that acceptable?’’ (Vargas-Cooper, 2012). Nor is it so simple as just accepting that there has been a generational shift among feminists. In what one of our colleagues has called third-generation feminism, some young women believe that being a feminist means that they can choose to stay at home and raise the children, wear lipstick and high heelsVand perhaps take a pill for premenstrual distress. It is not clear that they have accepted any feminist obligations, but as a group, they likely raise still another set of obligations among more traditional feminists (and reveal new facts). To some, the lack of opposition might suggest that the facts have spoken and science has won out, although many advocates for the diagnosis believed that the controversy should have been closed during the DSM-IV process. It may be that empirical considerations can now be seen as having led the way to the PMDD controversy being closed, but that outcome was made easier because the science came to be more supported by a host of nonempirical considerations than it was opposed by them. For instance, by the time that the DSM-5 development process began, PMDD was no longer a new diagnosis, and conservatism favored keeping it a disorder subject to routine clinical use. The approval of Sarafem played a role, but so did giving PMDD an official code number in the DSM-IV and listing it in the main text as an example of mood disorder NOS. Quite likely, a shift in the level of passion and commitment played another role. During the DSM-III-R debate, the opposition to PMDD was energized by opposition to masochistic personality disorder and paraphilic rapism. In the DSM-IV, it was energized by the heir of masochist personality disorder, specifically, self-defeating personality disorder. Neither of these two constructs was considered for the DSM-5. The key factor in what happened with the DSM-5 was clearly not that the new evidence silenced the opposition. In an article in Ms. Magazine, Caplan (2008) argued that one of the consequences of the Mood Disorder Work Group’s appointing a panel of experts was that those experts’ ties to the pharmaceutical industry were not subject to the same scrutiny as were those of the Work Group proper. Furthermore, given that research has still not found consistent hormonal differences between women with and without PMDD, Caplan continued to assert that the diagnosis of PMDD with its false assumption of a hormonal etiology leads women to ignore the real causes of their distress. It is, she is quoted by Vargas-Cooper (2012), to say, ‘‘an invented mental illness.’’ One could even claim that the new facts/evidence can be used to call the validity of PMDD into question. For example, women tend to rate the physical symptoms as more severe than the psychiatric symptoms. Furthermore, the more important psychiatric symptoms are affective lability and irritability/anger, not dysphoria (Epperson et al., 2012). Why, then, is the disorder considered a premenstrual dysphoria? www.jonmd.com

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One always has to worry about the extent to which a controversy is closed because the advocates for one side have successfully recruited enough allies to foreclose the debate. For example, the people at Elli Lilly brought Nada Stotland in with the hope of convincing her to end her opposition to Sarafem, but they were not successful. When ally building is successful, the debate ends because the remaining dissenters come to see little gain in continuing to expound effort on their critical activities, especially if they have been boxed up as fringe figures. Or perhaps the issue is that the opposition was never very large. More often than we realize, influential public opposition and protests tend to be fueled by a relatively small group of committed people who are less prone to compromise. The opposition to keeping the disorder in the DSM-IV was largely driven by Paula Caplan, and most of the opponents from the DSM-III-R battle did not participate. For instance, Jean Hamilton reported feeling emotionally battered by the DSM-III-R controversy and played no role in the DSM-IV protests (Figert, 1996). Initially, Caplan resumed her protest and criticized the plan to move PMDD into the main section of the DSM-5 but got little notice. Even this most outspoken opponent of the construct was weary. Just before the official publication of the DSM-5, Caplan (2013) reported that her recent silence was partly related to an existential nausea about her long battle with the powerful people who develop the DSM. With respect to other potential opponents, according to Stotland, the problems with the construct are much the sameVthey are just tired of fighting. In conclusion, the status of PMDD in the DSM-5 did not become controversial for a plurality of reasons, only some of which we have addressed here. The story we have told is a partial representation of events and is largely dependent on the memories and perspectives of those interviewed, all of whom were insiders to the DSM process. One of the advantages of interviewing insiders is that it offers insight into the ongoing tension between discovery and interpretation in formulating mental disorder constructs. We are cognizant that the formulation of disorder constructs always occurs in multifaceted historical and cultural frameworks that are subject to alternative interpretations. It is our hope that, when additional interpretations that enhance and deepen this history are offered, the various perspectives of those who made the history will still be considered informative. ACKNOWLEDGMENTS The authors thank Nancy Potter and Andrea Solomon for helpful suggestions on an earlier version of this article.

DISCLOSURE The authors declare no conflict of interest.

REFERENCES Andreasen NC (1984) The broken brain: The biological revolution in psychiatry. New York: Harper & Row. Caplan PJ (1995) They say you’re crazy: How the world’s most powerful psychiatrists decide who’s normal. Reading, MA: Addison-Wesley. Caplan PJ (2008) Pathologizing your period. Ms. Magazine. Retrieved from http://www.msmagazine.com/Summer2008/pathologizingyourperiod.asp. Accessed January 18, 2012.

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Caplan PJ (2013) My recent silence and a voice that matters. Psychology Today [online]. Retrieved from http://www.psychologytoday.com/blog/science-isntgolden/201305/my-recent-silence-and-voice-matters. Accessed June 20, 2012. Endicott J (2000) History, evolution, and diagnosis of premenstrual dysphoric disorder. J Clin Psychiatry. 61:5Y8. Endicott J, Amsterdam J, Eriksson E, Frank E, Freeman E, Hirschfeld R, Ling F, Parry B, Pearlstein T, Rosenbaum J, Rubinow D, Schmidt P, Severino S, Steiner M, Stewart DE, Thys-Jacobs S (1999) Is premenstrual dysphoric disorder a distinct clinical entity? J Womens Health Gend Based Med. 8:663. Epperson CN (2013) Premenstrual dysphoric disorder and the brain. Am J Psychiatry. 170:248Y252. Epperson CN, Steiner M, Hartlage SA, Eriksson E, Schmidt PJ, Jones I, Yonkers KA (2012) Premenstrual dysphoric disorder: Evidence for a new category for DSM-5. Am J Psychiatry. 169:465Y475. Figert AE (1996) Women and the ownership of PMS. New York: Aldine de Gruyter. Frank E, Severino SK (1995) Premenstrual dysphoric disorder: Facts and meanings. J Pract Psychiatry Behav Health. 1:20Y28. Frank RT (1931) The hormonal basis of premenstrual tension. Arch Neurol Psychiatry. 26:1053Y1057. Gold JH, Endicott J, Parry BL, Severino SK, Stotland N, Frank E (1996) Late luteal phase dysphoric disorder. In Widiger TA, Frances A, Pincus HA, Ross R, First M, Wakefield Davis W (Eds), DSM-IV sourcebook (Vol 2, pp 317Y394). Washington, DC: American Psychiatric Association. Greene R, Dalton K (1953) The premenstrual syndrome. BMJ. 1:1007Y1014. Guze SB (1992) Why psychiatry is a branch of medicine. New York: Oxford University Press. Kendler KS (1990) Toward a scientific psychiatric nosology. Arch Gen Psychiatry. 47:969Y973. Kupfer DJ, First MB, Regier DA (2002) A research agenda for DSM-V. Washington, DC: American Psychiatric Association. Latour B (1987) Science in action. Cambridge, MA: Harvard University Press. Micale MS (1990) Hysteria and its historiography: The future perspective. Hist Psychiatry. 1:33Y124. Parlee MB (1994) Commentary on the literature review. In Gold JH, Severino SK (Eds), Premenstrual dysphorias: Myths and realities. Washington, DC: American Psychiatric Press. Potter NN (2006) What is manipulative behavior, anyway? J Pers Disord. 20:139Y156. Potter NN (2009) Mapping the edges and the in-between. Oxford, England: Oxford University Press. Putnam H (1990) Realism with a human face. Cambridge, MA: Harvard University Press. Radden J (2009) Moody minds distempered: Essays on melancholia and depression. Oxford, England: Oxford University Press. Scull A (2009) Hysteria: The disturbing history. Oxford, England: Oxford University Press. Severino SK, Gold JH (1994) Summation. In Gold JH, Severino SK (Eds), Premenstrual dysphorias: Myths and realities. Washington, DC: American Psychiatric Press. Severino SK, Moline ML (1989) Premenstrual syndrome: A clinician’s guide. New York: Guilford Press. Showalter E (1985) The female malady. New York: Pantheon Books. Solomon M (2001) Social empiricism. Cambridge, MA: The MIT Press. Spitzer RL, Severino SK, Williams JB, Parry BL (1989) Late luteal phase dysphoric disorder and DSM-III-R. Am J Psychiatry. 146:892Y897. Vargas-Cooper N (2012) The billion dollar battle over premenstrual disorder. Salon [online]. Retrieved from http://www.salon.com/2012/02/26/the_billion_dollar_ battle_over_premenstrual_disorder/singleton/. Accessed June 20, 2012. Widiger TA, Frances A, Pincus HA, Ross R, First MB, Wakefield Davis W (Eds) (1996) DSM-IV sourcebook (Vol 2). Washington, DC: American Psychiatric Association. Zachar P, Kendler KS (2010) Philosophical issues in the classification of psychopathology. In Millon T, Krueger RF, Simonsen E (Eds), Contemporary directions in psychopathology (pp 126Y148). New York: The Guilford Press.

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Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

A diagnostic and statistical manual of mental disorders history of premenstrual dysphoric disorder.

The proposals to include a menstruation-related mood disorder in the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition (DSM...
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