Tag Archives: DSM

04/22/15

A Drug in Search of a Disorder

© Sergey Nivens | 123RF.com

© Sergey Nivens | 123RF.com

When the DSM-5 was published in May of 2013, binge eating came out of the closet of Appendix B, the section for potential “disorders” needing further study. “Binge Eating Disorder” became a psychiatric diagnosis (Code: 307.51) in its own right. Before that time, binge eating had received a backhanded diagnosis under the rubric of “eating disorder not otherwise specified.”  Without official standing as a coded eating disorder, binge eating suffered from diagnostic insecurity and poor self-esteem. It didn’t have an official diagnostic category like anorexia and bulimia or an FDA-approved medication to treat it. But now, less than two years since it became an official psychiatric disorder, that is no longer the case.

The American Psychiatric Association (APA) defined binge eating disorder as: “recurring episodes of eating significantly more food in a short period of time than most people would eat under similar circumstances.” Some episodes would include marked feelings of a loss of control. A binge eater might eat too quickly, even when not hungry. They may feel guilty, embarrassed or disgusted. They may binge eat alone to hide the behavior. “This behavior is associated with marked distress and occurs, on average, at least once per week over three months.” There is a more complete description of the diagnostic symptoms here in “Promoting Amphetamines for Over-Eating.”

On January 30, 2015, the FDA announced that the ADHD drug Vyvanse (lisdexamfetamine dimesylate) was approved to treat binge-eating disorder in adults. It is the first such drug approved to treat this condition. “Vyvanse was reviewed under the FDA’s priority review program.” Expedited reviews can be done to treat a serious condition, especially if it’s seen to provide “a significant improvement” over available therapies. But, “Vyvanse is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied.”

Common side effects from Vyvanse include: dry mouth, insomnia, increased heart rate, jittery feelings, constipation, and anxiety. More serious, but less common side effects include: “psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults.”  Vyvanse might also cause “psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.” Oh, and it’s a Schedule II controlled substance with a high potential for abuse. In fact, OxyContin, fentanyl and cocaine are also Schedule II controlled substances. The DEA said these drugs are considered dangerous, “with use potentially leading to severe psychological and physical dependence.”

The FDA Adverse Events Summary for Vyvanse reported the following adverse events out of 14,311 consumers to its FDA Medwatch reports between 2004 and 2012: off-label use; insomnia; DECREASED APPETITE; aggression; headache; anxiety; nausea; DECREASED WEIGHT; irritability; fatigue; SUICIDAL  IDEATION; depression; agitation; overdose; feeling abnormal; abnormal behavior.

The New York Times reported that the marketing strategy for Vyanse sheds light on how pharmaceutical companies seek to “influence the treatment and diagnosis of a medical condition” in order to make billions of dollars in sales. Shire, the pharmaceutical company dispensing Vyvanse, seems to have followed a familiar drug industry method of promoting awareness of a disorder before more directly marketing its treatment.

Soon after Shire won FDA approval of its drug to treat Binge Eating Disorder, Monica Seles began to make the rounds of television talk shows such as “Good Morning America” and “The Dr. Oz Show” to relate her personal struggle with binge eating. She was also interviewed by People Magazine. Seles said that one of the reasons she decided to do this campaign was “to raise awareness that binge eating is a real medical condition.” Seles is a paid spokesperson for Shire. She declined to say what she’s getting paid by Shire.

Shire CEO Flemming Ornskov said that about five years ago researchers noticed the similarities between ADHD and binge eating, so they decided to study Vyvanse for the condition. As early as 2011, Shire’s CEO said that the company hoped to generate “multiple billions of dollars” from expanding Vyvnase use into new areas of illness, like schizophrenia, depression and binge-eating. International Business Times reported that Vyvanse made $1.228 billion for Shire in sales for 2013. The company hoped to grow its overall revenue from the $4.91 billion it made in 2013 to $10 billion by 2020 and Vyvanse is a significant part of that projection. Shire’s current patents for Vyvanse don’t expire until 2023. The approval of Vyvanase for BED means that Shire will gain an additional three years of exclusivity with the drug.

In September of 2014 Shire paid $56.5 million to settle claims it violated the False Claims Act related to marketing and promotion practices with some of its various drugs. According to the Justice Department memo detailing the settlement, Shire promoted Adderall XR for “certain uses despite a lack of clinical data to support such claims.” Shire also allegedly promoted Adderall XR to “prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease.” Vyvanse was also mentioned in the lawsuit. Shire sales reps and other agents “made false and misleading claims” about the efficacy and abuseability of Vyvanse. Oh, and it was said to prevent “car accidents, divorce, arrests and unemployment.”

The allegations resolved by the settlement arose from a lawsuit filed by Dr. Gerardo Torres, a former Shire executive, and a separate lawsuit filed by Anita Hsieh, Kara Harris and Ian Clark, former Shire sales representatives.  The lawsuits were filed under the False Claims Act’s whistleblower provisions, which permit private parties to sue for false claims on behalf of the government and to share in any recovery.  Torres will receive $5.9 million.

In her article for The New York Times, Katie Thomas quoted Dr. Timothy Walsh of Columbia University, as saying: “Once a pharmaceutical company gets permission to advertise for it, it can often become quite widely prescribed, and even tend to be overprescribed, and that’s a worry.”

There were 3 clinical trails in process for additional potential drug treatments for BED:  Cymbalta (Eli Lily), Lamictal (GlaxoSmithKline), and Nuvigil. Cosgrove et al. reported that the DSM-5 work group that approved binge eating as a diagnosis included three individuals with financial ties to Eli Lily, three people with relationships to GlaxoSmithKline and one person with a relationship to Shire.

Several articles have noted a variety of concerns with the FDA approval of Vyanse to “treat” Binge Eating Disorder. International Business Times quoted Sandy Walsh of the FDA office of media affairs as saying they had no direct evidence of how Vyvanse worked in BED: “The exact mechanism of action of the drug in reducing the symptoms of BED is … unknown.”  Melissa Gerson, the clinical director of an outpatient treatment center specializing in eating disorders, said she would not recommend a drug alone to treat BED. “I can’t imagine how you would see any long-term improvements in the symptoms.”

A Shire website, BingeEatingDisorder.com noted how someone could talk to their doctor about BED. They provided a Doctor Discussion Guide, saying on its link, “Not sure how to start the conversation with your health care provider?” A tip at the bottom of the homepage suggested that the individual could “Print, e-mail, or take a screen shot of this page, and bring it to discuss with your health care provider.”  The New York Times reported that some experts were concerned that the content appeared to coach patients on how receive a diagnosis or shop for a new doctor if they weren’t successful.

Some drug safety experts questioned why the FDA fast tracked approval of Vyanase—even foregoing a review by an advisory committee. For decades, amphetamines like Vyanase, have been known to be a widely abused class of drugs when prescribed for obesity. The marketing end run done by Shire to avoid this pitfall was to promote Vyanase for binge eating and acknowledge that about 80% of the people with BED are overweight or obese WHILE COMPLETELY IGNORING the history of amphetamine abuse with weight loss. Don’t forget that weight loss and appetite suppression are already known to be common side effects when taking Vyanase and other amphetamines. And the FDA didn’t see this move or call them on it?

A spokesperson for the FDA said that Vyanase was granted priority approval because there was no other drug treatment available for BED. “And it did not ask an advisory committee to review the issue because Vyanase is already sold as an ADHD drug and its safety profile is well known.” REALLY?  Dr. Daniel Carlatt said:

I’m concerned that the FDA’s approval of Vyvanse for binge eating disorder is going to worsen our problems with stimulant abuse. . . . Vyvanse is a derivative of Dexedrine. We’ve seen epidemics of Dexedrine abuse in the past when it was used to help people diet. I predict that the FDA has just opened the gates to another similar epidemic – after all, binge eating disorder is a subjective diagnosis that could be potentially expanded to cover many millions of people.

Revised and updated with information on Shire paying $56.5 milion to resolve civil claims it violated the False Claims Act.

12/24/14

Where There’s Smoke …

As much as 4 ½ years before the publication of the DSM-5, there was growing public criticism of the American Psychiatric Association (APA) and the process they used to develop it. The amazing thing about this criticism is that it was from within the ranks of psychiatry itself … by psychiatrists who had been in charge of previous revisions of the DSM.

In a 2008 article, Benedict Carey of the New York Times pointed out the importance of the DSM as a “medical guidebook and a cultural institution.” It is used to help doctors make diagnoses and to provide diagnostic codes to insurance companies. The National Institute of Mental Health made the use of DSM criteria a requirement for funding research. But for the first time, the APA required its DSM contributors to sign a nondisclosure agreement.

Research psychiatrist Robert Spitzer said that when he first heard about the agreement, he went “bonkers.” Spitzer said: “Transparency is necessary if the document is to have credibility, and, in time, you’re going to have people complaining all over the place that they didn’t have the opportunity to challenge anything.”

Robert Spitzer, the chair of the “landmark” third edition of the DSM, has been hailed as the rescuer or savior of psychiatry. Allen Frances, the chair of the 4th edition of the DSM said in his book, Saving Normal, that Spitzer was a rare man. “Without Robert Spitzer, psychiatry might have become increasingly irrelevant.” Even critics of modern psychiatric diagnosis, such the authors of the book Mad Science, acknowledge Spitzer’s importance to psychiatry: “Robert Spitzer was a most unlikely rescuer of American psychiatry.”

On June 26, 2009, Frances published an article in the Psychiatric Times where he identified what he saw a grave problems with the DSM-5. He also was critical of the lack of transparency. Pointing to his own efforts with the DSM-IV, he said their goal had been to ensure that everyone would understand what they were doing and how they were going about it. “There was explicit accountability for decision making on all changes.” He cautioned against the stated ambition to effect a “paradigm shift” in psychiatric diagnosis with the DSM-5.

So long as psychiatric diagnosis is stuck at its current descriptive level, there is little to be gained and much to be lost in frequently and arbitrarily changing the system. Descriptive diagnosis should remain fairly stable until, disorder by disorder, we gradually attain a more fundamental and explanatory understanding of causality.

Frances specified his concerns with the DSM-5 process, which included the following: 1) there was no scientific basis to justify a paradigm shift in psychiatric diagnosis at this time; 2) there was a failure to provide clear methodological guidelines on the level of empirical support for the changes; 3) there was a failure to be open to wide scrutiny and useful criticism; 4) there was a failure to set and meet clear timelines; there was a likelihood that time pressure would lead to an unconsidered rush on last-minute decisions.

The members of the APA working on the DSM-5, including the DSM-5 Chair, David Kupfer, responded to Frances on July 1, 2009. They suggested that both Spitzer and Frances were repeating “factual errors and assumptions” about the development of the DSM-5. After their refutation of the concerns expressed by Frances, they stated:

Both Dr. Frances and Dr. Spitzer have more than a personal “pride of authorship” interest in preserving the DSM-IV and its related case book and study products. Both continue to receive royalties on DSM-IV associated products. The fact that Dr. Frances was informed at the APA Annual Meeting last month that subsequent editions of his DSM-IV associated products would cease when the new edition is finalized, should be considered when evaluating his critique and its timing.

Robert Spitzer responded to the criticisms raised about Allen Frances and himself on July 2, 2009. Spitzer noted how the DSM-5 debate had taken an ugly turn, by suggesting that he and Frances were critiquing the DSM for financial reasons. He limited his comments to what he saw as the core issue of transparency. After raising a series of questions with regard to the opaqueness and “empty rhetoric” on the DSM-5 as the most open and inclusive DSM ever, Spitzer saw two possible reasons for the lack of transparency. First, the answers to his questions were known, but for some reason, the DSM leadership was withholding it; perhaps to shield themselves from criticisms. A second possibility was that the DSM-5 leadership didn’t know the answers to his questions. “Given their plan to publish DSM-V in May 2012, if the second possibility is the case, it is inconceivable that this publication deadline could realistically be met. “

Both Spitzer and Frances continued their challenges to the process of review and approval of the DSM-5 by the APA and gained more support and even some victories. You can also read a more detailed description of the dispute here. The publication of the DSM-5 was delayed until May of 2013, but the controversy merely grew. Allen Frances became one of the most vocal critics of the DSM-5, with multiple blogs and articles looking at the problems and concerns. He’s even written two books, Saving Normal and Essentials of Psychiatric Diagnosis as a result of this controversy. You can scroll through some of his articles on the Huffington Post for starters.

Oh and with regard to the veiled accusation of Spitzer and Frances criticizing the DSM-5 for financial reasons, David Kupfer, Chair of the DSM-5 Task Force, has been outed for failing to report financial interests in Adaptive Testing Technologies, a company that designs tests and implements large scale adaptive testing systems for mental health assessment. After an investigation, the APA said (Letter-to-Assembly-20140114.pdf; now removed from the APA website): “Dr. Kupfer should have disclosed to APA his interest in PAI in 2012.” However, it did not find that his interest in PAI had any influence on DSM-5’s inclusion of dimensional measures for further study in Section 3. One blogger, 1 Boring Old Man said:

It seems like Dr. Kupfer et al. are pursuing a strategy of only acknowledging this particular Conflict of Interest when forced, as in the situation with JAMA Psychiatry, and avoiding talking about it otherwise – mirrored so far by the APA President and Board of Trustees.

 

11/19/14

Evidence-Based Treatment … Lacks Evidence

21828750_sEvidence-based medicine (EDM) began in the early 1990s and was seen as a revolutionary movement that would improve patient care. It grew to become the buzz-word for all medical and behavioral health care—make sure treatment is evidence-based! And yet, there is little evidence that EDM has achieved its aim. Health care costs have soared and there is a distinct lack of “high-quality evidence suggesting that EBM has resulted in substantial population-level health gains.”

Given that EBM firmly favours an empirical approach over expert opinion and mechanistic rationale, it is ironic that its widespread acceptance has been based on expert opinion and mechanistic reasoning, rather than EBM ‘evidence’ that it actually works.

The article from which the above critique was taken suggested that the lack of evidence for the overall benefit of EBM was a consequence of it not being implemented effectively. A cornerstone of EBM methodology—the randomized trial—has been corrupted by vested interests.  The authors, Every-Palmer and Howick, defined EBM as “the conscientious and judicious use of current best evidence in conjunction with clinical expertise and patient values to guide health care decisions.” They singled out the field of psychiatry for specific concern, where “the problems with corruption of randomized trials are dramatic.”

Most of the medical psychiatric evidence base has been funded by the pharmaceutical industry, often without the relationships being disclosed. “Between two-thirds and three-quarters of all randomized trials in major journals have been shown to be industry funded.” One of the consequences of this has been publication bias: positive results are published; negative results are not. The best current estimate is that half of all completed clinical trials have never been published in academic journals. Some trials are never registered.

There is also evidence that industry-funded studies exaggerate the treatment effects in favor of the product preferred by their sponsor. One study reviewed industry-funded studies of atypical antipsychotics and found that 90% of the trials showed superiority of the sponsor’s drug. The studies had been designed “in a way that would virtually guarantee the favoured drug would ‘win.’”

Among their recommendations, Every-Palmer and Howick suggested that all clinical trials should be registered and reported. There needs to be more investment in independent research. Evidence-ranking schemes also need to be modified to account for industry bias. These suggestions would be helpful corrections for the corruption of the randomized trial methodology, but what if there are additional problems? For example, merely correcting problems with the misuse of randomized trials would not address concerns related to clinical expertise or patient values.

If current medical science is reaching its limits with some complex illnesses, as Every-Palmer and Howick said was one possibility for the lack of progress with EBM, then further gains will be hard to come by. This would seem to be true with mental illness and addiction, which are diagnosed with the Diagnostic and Statistical Manual (DSM), 5th edition. DSM diagnoses are consensus-based decisions about clusters of symptoms and do not have any objective laboratory measure. Thomas Insel, the Director of the National Institute of Mental Health (NIMH), said that diagnosis with the DSM was equivalent to “creating diagnostic systems based on the nature of chest pain or the quality of fever.”

A further compounding error could be when the role of clinical judgment is neutralized as a result of an overreliance upon the trump of scientific—real or imagined—evidence. Kiene and Kiene noted how the reputation of clinical judgment in medicine has undergone a “substantial transformation” over the last century with the rise of modern research methodology.  “A primary mission [in medical progress] therefore became ‘to guard against any use of judgement’, and it was executed through clinical trials.”

Giovanni Fava pointed to the increasing crisis in psychiatric research and practice because “Psychopathology and clinical judgment are often discarded as non-scientific and obsolete methods.” He noted how the concept of evidence-based medicine has achieved widespread endorsement in all areas of clinical medicine, including psychiatry. But randomized trials were not intended to answer questions about the treatment of individual patients. “The results may show comparative efficacy of treatment for an average randomized patient, but not for pertinent subgroups formed by characteristics such as severity of symptoms, comorbidity and other clinical nuances.”

An aura of authority is given to collections of “best available evidence”, which can in turn lead to major abuses that produce “inappropriate guidelines” for clinical practice. The risk is especially serious as a result of the substantial financial conflicts of interest in medical societies and with the authors of the medical guidelines for clinical practice within those societies.

Special interest groups are thus using evidence-based medicine to enforce treatment through guidelines, advocating what can be subsumed under the German language term of “ Leitkultur ”, which connotes the cultural superiority of a culture, with policies of compulsory cultural assimilation. In psychiatry, such process has achieved strong prescribing connotations, with a resulting neglect of psychosocial treatments.

Given the existing crisis within psychiatry, especially with the questionable validity and reliability of diagnosis within the DSM, evidence-based treatment guidelines that were developed and disseminated within such a culture require radical revision or should be used with extreme caution. The evidence for their efficacy is lacking.

10/15/14

Psychiatry’s Mythical Phoenix

Prominent research psychiatrists are beginning to sound like their “antipsychiatric” critics. They are saying the current DSM diagnostic system isn’t valid; that something new, something scientifically sound and useful for treating patients is needed. One of these research psychiatrists is Thomas Insel, the Director of the Director of the National Institute of Mental Health (NIMH). He dropped a bombshell last year when he announced that the NIMH would be “re-orienting its research away from DSM categories.” The New York Times quoted Insel as saying: “As long as the research community takes the D.S.M. to be a bible, we’ll never make progress. . . . People think that everything has to match D.S.M. criteria, but you know what? Biology never read that book.”

So the NIMH has developed a new research strategy to classify mental disorders based upon “dimensions of observable behavior and neurobiological measures.” This strategic plan is known as: Research Domain Criteria (RDoC), a framework for collecting data needed for a new nosology. The goal is for RDoC to “transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system.” It was not meant to be a useful clinical tool.

RDoC is in search of the holy grail of psychiatry: reliable biomarkers (measurable indicators of a biological state or condition) for mental disorders. This search for biomarkers has been going on for decades. David Kupfer, the chair of the DSM-5 Task Force said: “We’ve been telling patients for several decades that we are waiting for biomarkers. We’re still waiting.” Susan Kamens suggested that the imminent discovery of biomarkers has been “the driving expectation of psychiatry since its birth in the 18th century.” But there are some problems with the RDoC quest.

What RDoC proposes is to replace the DSM diagnoses used currently to frame mental health research with broad categories based upon cognitive, behavioral and neural mechanisms. This means that the NIMH will be supporting research projects that look across or sub-divide existing DSM categories. But this very same DSM is what is used to assess the potential of future NIMH-funded research under RDoC.

In an article found in Nature, “Psychiatry Framework Seeks to Reform Diagnostic Doctrine,” Nassir Ghaemi said: “It is very hard for people who have been following the DSM their entire professional lives to suddenly give it up.” Ghaemi has felt shackled by the DSM. He wanted to do some research that cut across DSM categories. But his colleagues warned him against straying too far from the DSM structure when he applied for funding from the NIMH, because peer reviewers tended to insist on research structured by the DSM. So he held off from applying.

Steven Hyman, a former NIMH director, blames the DSM for hampering research into the biological or genetic basis of psychiatric illness. He said it was “a fool’s errand” to use symptom-based DSM diagnosis with little basis in nature to try and find a biomarker. Hyman urged the NIMH to think about how biomarkers identified by RDoC would be incorporated into mental health practice with the DSM. “It would be very problematic for the research and clinical enterprises to wake up in a decade to a yawning gulf.”

But Susan Kamens sees a deeper problem with blaming the DSM for hampering the search for biomarkers—it takes for granted that the biomarkers exist. In other words, it presumes what it seeks to find. According to Kamens:

“The main difference is belief versus doubt in the hypothesis that what we call mental disorder is primarily a disorder of biology. We treat that hypothesis as unfalsifiable, as if the proof [that mental disorder is biological] arrived before the evidence. We don’t test whether the hypothesis holds; we test whether and how to make the data fit it. When critics raise doubts, they’re often accused of ignoring the very same evidence that psychiatric researchers have recently declared to be utterly insufficient.”

Kamens noted that the RDoC “blueprint” is no less theoretical that the DSM-5. While the RDoC constructs are more measurable than the categories listed in the DSM, they are “essentially no more than basic human emotions and behaviors.”  She asked how RDoC would make clinically meaningful determinations into its “domains” and “constructs”? How would the research reveal anything beyond the coordinates of normal psychological processes? “In other words, how is RDoC anything beyond basic (nonclinical) neuroscience?”

RDoC is developing a new research model that will undoubtedly yield unprecedented data, but it focuses on the biogenetic correlates and normative mapping of basic psychological processes like visual perception, language, fear responses, and circadian rhythms. The idea is to create interventions for psychological and physiological processes that deviate from the norm. For this reason, RDoC is less likely to save psychiatry than it is to resurrect eugenics.

The quest for biomarkers in psychiatry can be likened to the legend of the phoenix, a mythological bird that repeatedly rises out of the ashes of its predecessor. The DSM seems to be near end of its life-cycle. Now psychiatry is building an RDoC “nest” that it will eventually ignite, reducing both the DSM and RDoC to ashes. And from these ashes, it is hoped, a new diagnostic system—a new phoenix—will arise.

Also see my blog post, “Psychiatry Has No Clothes.”

09/3/14

Psychiatry Has No Clothes

On April 29th of 2013, there was an astounding blog post by Thomas Insel, the Director of the National Institute of Mental Health (NIMH). He said that although the DSM-5 was due to be released in a few weeks, the NIMH would be “re-orienting its research away from DSM categories.” He noted that while the DSM has been referred to as a “Bible” for the field of mental health, “It is, at best, a dictionary, creating a set of labels and defining each.” Did you get that? The Director of the NIMH said the DSM was a “dictionary” that created “labels.” It was not, then functioning adequately, in his opinion, as its title suggests: as a Diagnostic and Statistical Manual of Mental Disorders! (emphasis added)

Insel said its strength had been “reliability”, meaning that it provided a way for clinicians to use the same terms in the same way. Its weakness was that it lacked validity. DSM diagnoses are based upon a consensus about clusters of symptoms and not any objective laboratory measure. “In the rest of medicine, that would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever.”

Insel was not using “reliability” in a statistical sense. In “The Myth of the Reliability of DSM,” Stuart Kirk and Herb Kutchins demonstrated conclusively that the DSM-III and DSM-IIIR were not statistically reliable. In fact, using the same statistic that Robert Spitzer used to justify the major changes to the DSM in the 1970s, they demonstrated that:

The reliability problem is much the same as it was 30 years ago [before the DSM-III]. Only now the current developers of the DSM-IV have de-emphasised the reliability problem and claim to be scientifically solving other problems.

Unfortunately, the tables in Figures 1 and 2 have been removed from the online version of their article. But the tables are still available in the original article found in the Journal of Mind and Behavior, 15 (1&2), 1994, p. 71-86. These tables plainly showed how the DSM statistical reliability was not what it was claimed to be. The Selling of the DSM (1992) by Stuart Kirk and Herb Kutchins has the tables. And there is a graphic comparison of the data within Mad Science (2013) by Stuart Kirk, Tomi Gomory, and David Cohen.

Insel went on in his blog to say that the NIMH will be supporting research projects that “look across current categories” or sub-divide them in order to begin to develop a better system. “We are committed to new and better treatments, but we feel this will only happen by developing a more precise diagnostic system.” In order to work towards that goal, the NIMH launched the Research Domain Criteria (RDoC). RDoC is only a research framework for now; a decade-long project that is just beginning. You can learn more about RDoC here (on the NIMH website).

Robert Whitaker, author of Anatomy of an Epidemic, said in a March 2014 interview that Insel stating that the DSM lacked validity was an acknowledgement the “disease model” has failed as a basis for making psychiatric diagnoses.

When Insel states that the disorders haven’t been validated, he is stating that the entire edifice that modern psychiatry is built upon is flawed, and unsupported by science. That is like the King of Psychiatry saying that the discipline has no clothes. If the public loses faith in the DSM and comes to see it as unscientific, then psychiatry has a real credibility problem on its hands.

Two weeks later on May 13, 2013, a joint press release was made by Thomas Insel and Jeffrey Liebermann, the President-elect of the American Psychiatric Association (APA). They said that the NIMH and the APA had a shared interest to ensure that patients and healthcare providers had “the best available tools and information” to identify and treat mental health issues.

Today, the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM), along with the International Classification of Diseases (ICD) represents the best information currently available for clinical diagnosis of mental disorders. . . . The National Institute of Mental Health (NIMH) has not changed its position on DSM-5. As NIMH’s Research Domain Criteria (RDoC) project website states: “The diagnostic categories represented in the DSM-IV and the International Classification of Diseases-10 (ICD-10, containing virtually identical disorder codes) remain the contemporary consensus standard for how mental disorders are diagnosed and treated.”

The DSM and RDoC were said to be complementary, not competing frameworks. As research findings emerge from RDoC, they may be incorporated into future DSM revisions. “But this is a long-term undertaking. It will take years to fulfill the promise that this research effort represents for transforming the diagnosis and treatment of mental disorders.”

Saul Levine, the CEO and Medical Director of the APA said on May 5, 2014 that the DSM and the RDoC will “begin to come together” as the research from NIMH is included into the way they diagnose mental illness. They know that mental illness and substance use disorders are a bio-psycho-social illness. “We work very well together with NIMH. And I think that the whole field is looking to the science coming out of NIMH to include it as a way to help get better treatment for patients in this country.”

So the APA and NIMH affirm they are working towards the same goals as complementary research frameworks. Someday the research findings of RDoC may even be included into the DSM. But until then, the NIMH will have to continue to “ooh and aah” at the APA’s DSM and ignore the nay-sayers crying: “Look at the DSM; look at the DSM!” Also see my blog post, “Psychiatry’s Mythical Phoenix.”

 

07/23/14

Creation of a Psychiatric Disorder

I became interested in the history of Premenstral Dysphoric Disorder (PMDD) when I met two husbands in marital counseling who believed their wife’s mood changes during menstruation caused most of their fights. They even kept track of their wife’s menstrual cycle and charted it in conjunction with their marital conflict.

Robert Spitzer, the “creator of the modern DSM” was the first to propose that severe PMS symptoms should be classified as a psychiatric disorder. According to Alix Spiegel of NPR, Spitzer has personally conceived of more mental disorders “than any other living person on the face of the earth.” But despite his efforts, in June of 1986 the APA Board of Trustees voted against making PMDD (then known as Late Luteal Phase Dysphoric Disorder, LLPDD) an official DSM diagnosis. This outcome was largely through the efforts of people like Paula Caplan.

Caplan and others opposed adding LLPDD to the DSM–III-R and later the DSM-IV. They (rightly) felt it would pathologize women. Caplan gives a detailed description of her efforts to keep LLPDD and out of the DSM in her book, They Say You’re Crazy.

But LLPDD was added to a specially created appendix of the DSM-III-R for “provisional categories needing further study.” Following the advice of Robert Spitzer, it was also given an official number just like the approved diagnoses in the main part of the manual. Psychiatrists were encouraged to use the diagnosis as if it was official. LLPDD even appeared in the main text of the DSM-III-R, where only fully tested and scientifically supported diagnoses were supposed to be included.

When the DSM-IV was published in 1994, LLPDD was renamed as PMDD and kept in the appendix. But PMDD was still a pseudo-diagnosis in the sense that it was still in the appendix and not in the main section of the manual.

About one year before Eli Lilly’s patent rights were about to run out on Prozac (fluoxetine) in August of 2001, the FDA approved Serafem to treat the pseudo-diagnosis of PMDD. Although both Zoloft and Celexa had been used to “treat” PMDD, Serafem was the first prescription drug that the FDA said could be marketed specifically for treating PMDD. What were these changes that warranted the approval of a newly patented form of fluxetine for Eli Lily? In “Sarafem: The Pimping of Prozac for PMS” Alicia Rebensdorf said:

The company changed the color of the pill from green to girly pink and turned the depression-stigmatized label Prozac to the oh-so-feminine name Sarafem. Yet Sarafem/Prozac both require daily 20 mg. doses of fluoxetine hydrochloride. You don’t take Sarafem any less often. You don’t take it any smaller doses.

Here are the first two Serafem commercials.

With the publication of the DSM-5, PMDD finally came out of the closet appendix. In their recent article reviewing the DSM history of PMDD, Peter Zachar and Kenneth Kendler commented: “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.” But functionally, it was approved for “routine clinical use” when Spitzer and the APA gave it a DSM number and created an appendix for it in 1987 as LLPDD. The reason that officially moving PMDD to the main section was not controversial was because the above actions placed it there in 1987, BEFORE THE RESEARCH INTO PMDD as a psychiatric disorder was done.

According to Caplan in a May 12 1986 press conference, Robert Spitzer admitted that there no proposed treatment for PMDD/LLPDD at that point. However, “that is the very reason we need to put the category in the DSM, because that will make it possible to conduct research to find out what will help.” So PMDD had to be coined as a disorder so research could be done to help women with a disorder … that wasn’t yet an official disorder. As Zachar and Kendler said:

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.

This history of how PMDD became a DSM diagnosis illustrates the unscientific manner in which many psychiatric disorders are created. Paula Caplan cautioned that the danger of the DSM is that it is used with so little monitoring of when the line is crossed from normalcy to disorder in its decisions.

In his essay, “Mental Illness is Still a Myth,” Thomas Szasz said that psychiatrists have succeeded in persuading us that the conditions they call “mental disorders” are diseases—phenomena independent of human motivation or will. “Until recently, only psychiatrists—who know little about medicine and less about science—embraced such blind physical reductionism.”