04/11/23

Guild Interests Behind DSM Diagnosis

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Now in its 5th edition, the DSM-5-TR, the text revision of the Diagnostic and Statistical Manual, was released in March of 2022. This happened to be the first update in almost ten years and it’s selling very well for the APA, the American Psychiatric Association. The paperback version, as well as the hardback and desk reference editions, are the top four best sellers in psychiatry for Amazon. Saul Levin, the CEO and medical director for the APA told Axios that the public has been dying to know more about mental illness. “I think what really caught the imagination was that we’re sitting at home now and looking to say, ‘Boy, I’m feeling depressed — let me now go and find out more about it.'”

It’s hard to tell from this quote if Dr. Levin’s comment was a reflection of APA sales data for impulse buys for the DSM-5-TR, but I doubt it. A quick look at the Amazon prices DSM-5-TR indicates the paperback edition sells for $110.76 and the hardcover for $174.90. The desk reference editions are more affordable at $49.14 and $59.99. A better explanation for its bestselling sales is the fact that psychiatry in the U.S. and increasingly around the world has been dominated by the DSM for the past 70 years. Wired Magazine said this so-called bible for psychiatry is used in prisons, hospitals, and outpatient clinics to diagnose patients, prescribe medications, dictate future treatment and to justify payment for these services.

Axios reported how mental health has gone mainstream, with younger workers demand it as an employee benefit. Ralph Lewis, a Toronto-based psychiatrist, said in Psychology Today that psychiatry is guilty of having oversold its ability to answer the problems of coping with life and regulating one’s emotions and behaviors. Life can be stressful and complicated, leaving people with a feeling they can’t cope. “Many assume that psychiatry has the answers to problems of coping with life and regulating one’s own emotions and behaviors.” The expectations are particularly intense on psychiatrists as medical specialists “who are designated as the ultimate gatekeepers for diagnosis of mental illnesses and, more broadly, mental disorders.”

Mental disorders are, by their very nature, difficult to define with specificity. Anxiety and depression are the most common reasons for seeking psychiatric help. There is much confusion among the general public, and even often uncertainty among psychiatrists, as to when to consider these experiences mental disorders: the diagnosis depends on severity, number of associated symptoms, degree of functional impairment, and persistence or recurrence. Unfortunately, psychiatric diagnostic classification systems and mental health awareness campaigns have overgeneralized the definition of mental illness.

Dr. Lewis said the tendency now is to pathologize everyday problems, labeling them as mental disorders. Here he referenced Saving Normal, by Allen Frances, a psychiatrist and the former chair for the DSM-IV. Frances said there should have been cautions in the DSM-IV warning about overdiagnosis and providing tips on how to avoid it. Professional and public conferences, and educational campaigns should have been organized to counteract drug company propaganda.

None of this occurred to anyone at the time. No one dreamed that drug company advertising would explode three years after the publication of the DSM-IV or that there would be the huge epidemics of ADHD, autism, and bipolar disorder—and therefore no one felt any urgency to prevent them. . . We missed the boat.

See “Medieval Alchemy” for more on Allen Frances and Saving Normal.

Dr. Lewis said the COVID-19 pandemic drove up the rates of anxiety, depression and several other mental disorders. Ironically, while the data are complicated, there does not appear to have been much of a rise in the actual rate of mental disorders. What seems to have happened is people’s perception they need psychiatric treatment increased. Although some of the increase represents people now seeking help for significant problems, there is also a phenomenon of these diagnoses being sought.

A diagnosis offers a person an explanation for their difficulties. It lets a person feel understood. It simplifies complexity, helping make sense of things and bringing a bit of order to the inexplicable and chaotic. It provides validation and legitimacy to one’s struggles, as well as sympathy, and it might offer justification for one’s shortcomings or behavioral difficulties. It also confers a sense of identity and group-belonging.

A diagnosis may deliver practical benefits such as sick leave, disability benefits, academic accommodations, and insurance coverage for therapy. Other factors include social media, the internet, and celebrity influence—think about the attention paid to Simone Biles when she withdrew from several events at the 2020 Summer Olympics. And don’t forget about pharmaceutical advertising—just ask your doctor. “In many ways, what we are witnessing is the success of, and unintended consequences of, years of mental health education and destigmatization campaigns.”

Not only does overdiagnosis lead to over-prescribing medications, it also trivializes severe mental illness. The CDC said more than 50% of Americans will be diagnosed with a mental disorder in their lifetime. One in five will experience a mental illness in a given year. “If everyone has a mental disorder, then no one does, and the concept of mental disorder becomes meaningless. It becomes harder for the people most in need of psychiatric services to access the already overloaded system.”

The CDC also stated there was no single cause for mental illness. Early adverse life experiences, the use of alcohol or drugs, feelings of loneliness or isolation as well as biological factors or ongoing chronic medical conditions like cancer or diabetes can contribute to the risk of mental illness. But psychiatry continues to press for the medical model of mental illness and it seems defending the legitimacy of DSM diagnosis goes along with it. This debate has continued without any real movement towards a resolution for the last fifty years.

Dr. Daniel Morehead lamented in “The DSM: Diagnostic Manual or Diabolical Manipulation?” that it would be hard to overstate the torrents of criticism because of the DSM. He said, “The DSM has been, and remains, the centerpiece of contemporary critiques of psychiatry.” Critics of the DSM were wrong. Psychiatry is not at odds with other medical specialties. “Psychiatry differs from them only in the sense that more of the diseases behind psychiatric syndromes lack full explication.”

This is not evidence of its inferiority, according to Morehead, rather it is evidence of the complexity of the human brain. The DSM is “simply the place where clinicians match diseases to treatments through the lens of medical syndromes—just like other doctors.” This seems to be the heart of the debate and the reason for the vigor with which psychiatrists like Dr. Morehead defend the medical basis of psychiatry and psychiatric diagnosis. In another article published around the same time, “Let’s End the Destructive Habit of Doubting Psychiatric Illness,” he said it is time to permanently retire the idea that mental illness may not be fully medical. It is a “pernicious and misleading idea” and he challenged all psychiatrists to no longer tolerate it—publicly or privately.

Dr. Morehead and others appear to recognize that psychiatry is facing an institutional crisis unlike anything it faced since David Rosenhan published “Being Sane in Insane Places” in the journal Science in 1973. Rosenhan has eight “pseudopatients” seek admission to twelve different psychiatric hospitals. Once admitted, they stopped simulating any symptoms of abnormality and waited to see how long it took before they were released. Their length of stay ranged from 7 to 52 days, with an average length of stay at 19 days. None of the pseudopatients were identified as such by hospital staff members; but other patients did.

For more on the Rosenhan study, see “A Censored Story of Psychiatry,” Part 1 and Part 2.

In their book, Psychiatry Under the Influence, Robert Whitaker and Lisa Cosgrove said the trustees of the APA called a meeting shortly after Rosenhan’s article was published. They lamented how the public did not view psychiatry as a medical specialty. The trustees recommended the formation of a task force that would define mental illness and become a preamble to publish the DSM-III. And they made Robert Spitzer the chair of the task force in 1974. Whitaker and Cosgrove said from that beginning, the APA trustees saw how creating a new diagnostic manual could also serve a guild interest.

Remaking psychiatric diagnoses could be part of a larger effort by psychiatry to put forth a new image, which, metaphorically speaking, would emphasize that psychiatrists were doctors, and that they treat real “diseases.”

By adopting the disease model and asserting that psychiatric disorders were illnesses, the APA addressed both its critics and its image problem. Whitaker and Cosgrove said this happened when the organization metaphorically put on a white coat and presented itself as a medical specialty. “This was an image that resonated with the public.” With hindsight, they said, it is easy today to see the ethical peril for the APA that arose when the DSM-III was published. While the APA had devised a new diagnostic manual that helped remake its image, “the peril was that the guild interests might now affect the story it told to the public about the nature of mental disorders, and the efficacy of somatic treatments for them.”

In an interview for Medscape in 2020, the now former chair of the department of Psychiatry at Columbia and former president of the APA, Jeffery Liberman discussed “The Future of Psychiatric Diagnosis” and biomarkers with Melissa Arbuckle, also of Columbia University. She is the vice chair for education and training in the Department of Psychiatry at Columbia. Robert Spitzer, the architect of the DSM-III, was a Professor of Psychiatry at Columbia until his retirement in 2003.

Lieberman acknowledged at the start of the interview there have been no biomarkers identified yet in research. “For the entire history of our discipline, as long as physicians have studied mental illness, we have not had a diagnostic test for it. It’s a clinical diagnosis.” Nevertheless, he has faith that someday there will be a diagnostic test for mental illness: “I do believe that certainly within my professional lifetime, and hopefully sooner rather than later, we will see a diagnostic test.”

The APA self-consciously tied its fate to the DSM in the aftermath of the institutional crisis after the Rosenhan study. It seems to have done so at least partially to affirm itself as a legitimate medical specialty, with the power and authority to prescribe medications. As T. M. Luhrmann noted in Of Two Minds, “psychopharmacology is the great silent dominatrix of contemporary psychiatry.” Prescribing medications is what psychiatrists do that other mental health professionals cannot do. “And as mental health jobs become defined more by their professional specificity, more and more psychiatrists spend more of their time prescribing medication.”

The disease model of mental illness has been a tremendous asset in the fight against stigma and the fight for parity in health care coverage. And it is clear that the disease model captures a good measure of the truth. Mental illness often has an organic quality. People can’t just pull themselves back together when they are hearing voices or contemplating suicide, and their illness is rarely caused by bad parenting alone. Yet to stop at that model, to say that mental illness is nothing but disease, is like saying that an opera is nothing but musical notes. It impoverished us. It impoverishes our sense of human possibility. (Of Two Minds, p. 266)

06/28/22

Time for a Fresh Look at Diagnosis

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Allen Frances, chair of the DSM-IV Task Force, has been a vocal critic of modern psychiatry and diagnosis. He was selected by fellow psychiatrist Awais Aftab to do the first interview for Conversations in Critical Psychiatry, a series for Psychiatric Times that aimed to engage prominent individuals who have made important and constructive critiques of psychiatry. Dr. Frances said while he considered psychiatry to be one of the noblest of professions, it had drifted away from best practice. Too many psychiatrists, he said, are reduced to pill pushing with too little time to really know their patients well. And psychiatrists have not done enough to educate primary care physicians, who prescribe 80% of psychiatric meds, on “the principles of cautious prescribing, proper indications, full consideration of risks, and the value of watchful waiting and the tincture of time.”

I despair the diagnostic inflation that results from a too loose diagnostic system, aggressive drug company marketing, careless assessment, and insurance company pressure to rush to judgement. Diagnoses should be written in pencil, and under-diagnosis is almost always safer and more accurate than over-diagnosis.

With regard to the philosophy of diagnosis, he saw three approaches that he likened metaphorically to three kinds of baseball umpires. The first kind called balls and strikes as they are. The second called them as he saw them. The third said there were no balls or strikes until he called them. Frances likened Robert Spitzer, the architect of the modern DSM, to Umpire 1, along with most biological psychiatrists (See “The Quest for Psychiatric Dragons” Part 1 and Part 2 and “Where There’s Smoke …” for more on Robert Spitzer).  “The credibility of this model has been destroyed as we have learned more about the unfathomable complexity of the human brain and the complete failure of genetics and neuroscience to provide useful answers about what causes psychiatric problems.” He thought most psychiatrists aspired to be like Umpire 2, doing their best to define mental disorders in useful ways without any pretention that it is the only way or that current constructs would withstand the test of time.

Dr. Frances expressed concern with the risks of over-diagnosis and advocated for a narrower system with higher diagnostic thresholds. He thought experts in each diagnostic area sought to expand their pet diagnoses and worried too much about missing patients (false negatives) rather than mislabeling patients (false positives). These experts were given a free rein in DSM-5, allowing mislabeling to dominate the field. This led to a checklist approach to diagnosis, which was not intended by the creators of the DSM.

The diagnostic exuberance of DSM 5 confuses mental disorder with the everyday sadness, anxiety, grief, disappointments, and stress responses that are an inescapable part of the human condition. DSM 5 ambitiously mislabels normal diversity and childhood immaturity as disorder, creating stigma and promoting the excess use of medications.

Frances thought if anything in DSM could be misused, it would be misused. “Data drawn from research studies on highly selected patients in the hothouse environment of a university research clinic generalize very poorly to the hustle and bustle of primary care.” On Twitter he pointed to a study he said “blows to bits any hope that statistical modeling” could eliminate the many inherent limitations of “Evidence Based Medicine.” This study, “Many Analysts, One Data Set” concluded that uncertainty in interpreting research results was not just a function of statistical power or the use of questionable research practices. It was also a function of the many reasonable decisions made by researchers as they conducted their research. This did not mean that analyzing data and drawing research conclusions from the data was subjective. Rather, it meant “that many subjective decisions are part of the research process and can affect the outcomes.”

Frances said “Evidence Based Medicine” often generalized poorly to everyday practice because: 1) patients in controlled studies aren’t like unselected patients; 2) research settings differ from real life; 3) biases influence data analyses. “EBM provides a necessary guide, but shouldn’t be worshipped.”

Returning to the interview for Conversations in Critical Psychiatry, he noted how there was an inherent financial, intellectual and emotional conflict of interest that leads every medical specialty to recommend over-diagnosis. He recommended that specialty groups like the APA, the American Psychiatric Association, should never be permitted sole power to determine the diagnostic guidelines for that specialty. Contributions from primary care, public health, health economics and consumers are important. With regard to psychiatric diagnosis, he thought the APA had a special conflict of interest because the DSMs were such a valuable publishing property. The income is crucial for meeting its budget. “This makes frequent revision too tempting and results in an unseemingly hyping of the product.”

Soon after the publication of the DSM-5 in 2013, Allen Frances published an article in World Psychiatry, “The past, present and future of psychiatric diagnosis.” He said psychiatric diagnosis is facing a serious crisis caused by diagnostic inflation. “The elastic boundaries of psychiatry have been steadily expanding, because there is no bright line separating the worried well from the mildly mentally disordered.” Drug companies have used their marketing muscle to sell psychiatric diagnoses by convincing potential patients and prescribers that life problems were really mental disorders caused by chemical imbalances and curable by pills.

We are now in the midst of several market-driven diagnostic fads: attention-deficit/hyperactivity disorder (ADHD) has tripled in rates in the past twenty years; bipolar disorder has doubled overall, with childhood diagnosis increasing forty-fold; and rates of autistic disorder have increased by more than twenty-fold. In the US, the yearly prevalence of a mental disorder is reported at 20–25%, with a 50% lifetime rate, and Europe is not far behind. A prospective study of young adults in New Zealand has reported much higher rates and another of teenagers in the US found an astounding cumulative 83% rate of mental disorders by age 21.

He said the DSM-5 was prepared without adequate consideration of clinical risk/benefit ratios and did not calculate the large economic cost of expanding the reach of psychiatry. It has been unresponsive to widespread professional, public and media opposition “based on the opinion that its changes lacked sufficient scientific support and often defied clinical common sense.”  A petition endorsed by fifty mental health associations, that called for an independent review, “using methods of evidence-based medicine, was ignored.” It was time for a fresh look at diagnosis.

On the podcast The Recommended Dose with Ray Moynihan, Frances said the tendency over the last forty years has been to turn the stuff of life into mental disorder. “The best customer for a drug, is someone who is basically well.” We get advertisements for drugs as frequently as we get advertisements for cars or brands of beer. When it comes to most psychiatric problems, people get better on their own in a few weeks. “My concern is that we’re way overmedicating the problems of everyday life and that parallel to that, we are terrifically neglecting people who are really sick.”

One of the areas he gave as an example of transforming ordinary life into mental illness is with mild forms of depression, that really aren’t depression, but are being diagnosed as major depressive disorder. “The drug companies have convinced the world that major depressive disorder is one entity, and that it is always a chemical imbalance, and that it always requires a chemical solution in the form of a pill.” Eleven percent of Americans are taking an antidepressant. Grief in particular is often over diagnosed and over treated with medication. Then there is anxiety; children who have temper tantrums; and so on. “In general, we have taken every day experiences, that are part of the human condition, and we’re over diagnosing them as mental disorders, and we’re way too often providing a pill, when there’s not really a pill solution for every problem in life.”

Children have been over medicalized with Attention Deficit Disorder, which should be properly diagnosed at around 2 or 3 percent of the U.S. population. In the U.S., by the time a child is 18, they have a 15 percent chance of getting the diagnosis. “This is absolutely ridiculous. We are turning immaturity into a disease.” There are also unwarranted increases in diagnosing childhood Bipolar Disorder. And there is a terrific overuse of antipsychotics in children with behavior problems. “I think we are doing a massive, worldwide experiment on immature brains, bombarding them with very powerful chemicals, with no knowledge whatever about what the long-term outcome will be; and without informed consent.”

He thinks the DSM-5 set off on in the wrong direction. Psychiatrists were worrying about underdiagnosis, when they should have been concerned with overdiagnosis. He said we have gone overboard in the developed world in giving too much treatment to people who can afford it, while neglecting people who can’t.

Then he was asked to comment on the role of good evidence that comes from systematic reviews, from summaries of evidence. Frances said evidence is absolutely crucial in making medical decisions, even though you can’t trust all of it. It takes time to gather enough reliable evidence to be confident. “But without evidence it’s a crapshoot that will be governed by commercial, for profit elements that so determine how people are treated.

I think the biggest role for change will come from the evidence-based guidelines and from a press that is educated to advertise to the people reading the article, not just the possible miracle medical benefit, which is always exaggerated, but also the possible realistic risks of side effects.

The biggest problem for the doctor is too little time. The more time you have to get to know the patient, the less likely you’ll be inaccurate in your diagnosis. “It’s the easiest thing in the world to give a diagnosis and to write a pill prescription. It’s the hardest thing in the world, often, to get rid of a diagnosis once it’s been established. . . A wrong diagnosis made in ten minutes can haunt for life.” Medication, given casually, can do great harm and you should be as careful in taking medication as you would be for a major life decision.

 

Originally posted on 5/19/2020

05/3/22

Medicalizing Normal, Human Grief

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Well, it’s official. If your bereavement over the death of someone close to you “lasts longer than social norms and causes distress or problems,” it could be a psychiatric disorder. The symptoms of what is called Prolonged Grief Disorder (PGD) include: avoiding reminders that the person is dead; emotional numbness; feeling life is meaningless; feeling intense loneliness, being detached from others; intense emotional pain related to the death. PGD can be diagnosed if someone is experiencing these symptoms within 12 months of the death of a loved one for adults or within 6 months for children or adolescents.

Prolonged Grief Disorder is the newest disorder added to the DSM. After studies suggested that many people were experiencing persistent difficulties with bereavement, PGD was approved by the APA’s Board of Trustees and Assembly in the fall of 2020 and included in the text revision of the DSM-5 (DSM-5-TR) published in March of 2022. The APA CEO and Medical Director said including prolonged grief disorder in the DSM-5-TR will mean that mental health clinicians and family members will “share an understanding of what normal grief looks like and what might indicate a long-term problem.” The President of the APA was quoted as saying:

The circumstances in which we are living, with more than 675,000 deaths due to COVID, may make prolonged grief disorder more prevalent. . . . Grief in these circumstances is normal, but not at certain levels and not most of the day, nearly every day for months. Help is available.

The reaction by mental health professionals has not been all supportive of the APA adding grief to the DSM listing of psychiatric disorders. Debate over this action has been going on for over a decade and it seems the APA has been incrementally moving in this direction. In 2013 when the bereavement exclusion was removed from the DSM-5 diagnosis of major depression, Allen Frances, who was the chair for the DSM-IV, thought it was a dreadful mistake that flew in the face of clinical common sense. He ranked it as the second worst mistake within the DSM-5. In a 2012 NYT article, “Grief Could Join List of Disorders,” he said: “What I worry about most is that the revisions will medicalize normality and that millions of people will get psychiatric labels unnecessarily.”

A recent NYT article about the addition of PGD to the DSM, “How Long Should It Take to Grieve? Psychiatry Has Come Up With an Answer,” said the new diagnosis was meant to apply to a narrow section of the population whose struggles with bereavement and grief kept them from resuming their previous activities. Joanne Cacciatore, who runs a retreat for bereaved people and has written extensively on grief, said she utterly disagreed that grief could be a mental illness. “To me, that is an incredibly dangerous move, and short sighted.”

Ellen Barry, the author of “How Long Should It Take to Grieve?”, predicted the new diagnosis will most likely open a stream of funding for treatments, “and set off a competition for approval of medicines by the Food and Drug Administration.” She noted how Holly Prigerson other researchers are investigating naltrexone in clinical trials as a form of grief therapy. Donna Schuurman, an internationally recognized authority on grief, predicted in “The Grief Pill is Coming!” that it will become “another massive disappointment in a long line of pharmaceutical marketing deceptions.” Their hypothesis is that PGD is a disorder of addiction; and that patients with PGD continue to “crave” their loved ones after they have died, as a result of the positive reinforcement of their memories of loved ones.

The Origins of Prolonged Grief Disorder

The origins of PGD date back to the 1990s and the work of a psychiatric epidemiologist named Holly Prigerson. She was part of a research team examining the effectiveness of depression treatment in older adults. She noticed many individuals responded well to antidepressant medications, but seemed to be unaffected when she looked at the grief measures used in the study. Her observations were dismissed by psychiatrists on the research team. She was told grief was normal, but she didn’t ignore her observations; she did more research.

Her further research showed that for most people, symptoms of grief peaked at six months postloss, six months after the death. In “An Empirical Examination of the Stage Theory of Grief,” she said a depressive mood in normally bereaved individuals tended to peak around six months postloss. Yearning, not depressed mood was the significant psychological response to natural death. She suggested her findings should lead to a revision of the DSM.

The results also offer a point of reference for distinguishing between normal and abnormal reactions to loss. Given that the negative grief indicators all peak within 6 months, those individuals who experience any of the indicators beyond 6 months postloss would appear to deviate from the normal response to loss. These findings also support the duration criterion of 6 months postloss for diagnosing complicated grief disorder, or what is now referred to as prolonged grief disorder. Unlike the term complicated, which is defined as “difficult to analyze, understand, explain,” prolonged grief disorder accurately describes a bereavement-specific mental disorder based on symptoms of grief that persist longer than is normally the case (ie, >6 months postloss based on the results of the present study). Furthermore, prolonged grief disorder permits the recognition of other psychiatric complications of bereavement, such as major depressive disorder and posttraumatic stress disorder. Additional analyses are needed to examine grief trajectories among those meeting criteria for prolonged grief disorder.

So it seems that Prigerson’s work and that of others who built upon it, led ultimately to the recent action by the American Psychiatric Association making PGD a formal diagnosis. Around 5% of the population experience grief feelings which are profoundly different, longer-lasting and more harmful than the typical bereavement after the death of a loved one. And according to some mental health professionals, this grief can be reliably distinguished from other MH conditions such as depression or post-traumatic stress disorder. Maarten Eisma told Gizmodo, “It diverges from normal grief in its duration and intensity as well as in its impact on everyday life.”

Prigerson said the American Psychiatric Association “begged and pleaded” to define the syndrome conservatively as a year after death to avoid a public backlash. The concern was that everyone feels they still feel some grief at six months. “It just seems like you’re pathologizing love.” She estimated the criteria for PGD should apply to around 4% of bereaved people.

Those who oppose the new diagnosis seem to voice concerns similar to that of Allen Frances, that it gives individuals a diagnostic label unnecessarily; it medicalizes normal human grief experience. Joanne Cacciatore told Gizmodo that the diagnostic criteria for PGD unfairly targeted a subset of grieving people to be diagnosed with a mental illness. Her own research with bereaved parents suggested a majority could experience symptoms that could lead to a diagnosis of PGD or other psychiatric diagnoses up to four years after their child’s death. If this many parents can feel this amount of grief, “perhaps it is the measures that are flawed, not the grievers.”

For example, the criteria states that at one year, you can be diagnosed with PGD if you are intensely yearning for the person who died. What parent would not yearn for a child who died? Intense emotional pain? After such traumatic losses, what person would not feel intense emotional pain one year later?

Cacciatore thinks the diagnostic system is “absolutely broken, and we need an ethical change.” Psychological care should not depend soley on a diagnosis. She thinks we need better grief support education. We need more facilitators and facilities to care for people who are grieving.

Sheila Vakharia noted that in a world where thousands of Americans per week are dying in an ongoing pandemic, how can anyone’s grief over the losses they’ve experienced be considered abnormal? “For a diagnosis such as this to be released at this moment, it just feels tone deaf, and it feels decontextualized, both within the broader policy environment and with the fact that we are in a mass disabling and a mass death event—we’re in a global pandemic.”

For more information on diagnosing grief, see “The Death of Grief” and “Pathologizing Grief.”

02/25/20

Rethinking and Transforming Psychiatry

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“We believe that a fundamental rethinking of psychiatric knowledge creation and training is in order.” This statement was made in a commentary published in the New England Medical Journal, “Medicine and the Mind—The Consequences of Psychiatry’s Identity Crisis.” The authors are two prominent Harvard researchers in psychiatry, Caleb Gardner and Arthur Kleinman, so their words cannot be dismissed as ‘anti-psychiatry.’ They went on to say biologic psychiatry has so far failed to produce a comprehensive theoretical model for any major psychiatric disorder. However, they think it would be “too great a loss,” to diminish its role drastically as suggested by Anne Harrington. Rather than contracting to an exclusive focus on biologic structure, “the field needs to expand if we are to meet the needs of real people.”

I have mixed feelings about their proposal. Their critique of biological psychiatry, the acknowledgment of over prescribing psychiatric medication, the abandonment of its social, interpersonal, and psychodynamic foundations are concerns I share. But they balked at Anne Harrington’s proposal in Mind Fixers to limit its scope to severe, mostly psychotic disorders. She said there is hardly any knowledgeable person who believes the so-called biological revolution of the 1980s made good on its therapeutic and scientific promises. “It is now increasingly clear to the general public that it overreached, overpromised, overdiagnosed, overmedicated, and compromised its principles.” If psychiatry needed to be rebuilt, as the authors said, won’t there have to be some dismantling first? Otherwise, there is a danger of building on an unstable, unreliable foundation.

Harrington pointed to how in 2013, just before the publication of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), Thomas Insel, who was then the director of NIMH, said the agency was re-orienting its research away from DSM categories; that is was critical to realize that “we cannot succeed if we use DSM categories as the ‘gold standard’” for diagnosis. He said it was like using the nature of chest pain or the quality of a fever to create a diagnostic system. Harrington said, “Put another way, there seemed to be little if any sound biology undergirding the psychiatric enterprise.”

In Psychology Today, Jonathan Shedler wrote, “A Psychiatric Diagnosis Is Not a Disease.” He said there was a circular logic to psychiatric diagnosis. “How do we know a patient has depression? Because they have the symptoms. Why are they having symptoms? Because they have depression.” He elaborated that psychiatric diagnoses were categorically different from medical diagnoses like atherosclerosis, myocarditis, or pneumonia, because they are descriptive rather than explanatory. “Medical diagnoses point to etiology—underlying biological causes.”

In an addendum, Shedler said he appreciated the lively discussion his article inspired. He was surprised by some of the comments, from individuals he assumed to be psychiatrists, who had impugned his credentials to discuss psychiatric diagnosis. But he took comfort in knowing that Allen Frances, MD, Chair of the DSM-IV Task Force, had the same view. Frances also said mental disorders were not diseases, but constructs. They were descriptive, rather than explanatory.

There was a study published in Psychiatry Research, “Heterogeneity in Psychiatric Diagnostic Classification,” that examined the heterogeneous nature of categories within the DSM-5, and its consequences for clinicians, clients and the diagnostic model itself. Heterogeneity was found in specific diagnostic criteria, including symptom comparators, duration of difficulties, indicators of severity, and the perspective used to assess difficulties. Each of the three researchers called for dismantling, not expanding DSM diagnosis.

The lead researcher of the study, Kate Allsopp, said for Medical Express: “Although diagnostic labels create the illusion of an explanation they are scientifically meaningless and can create stigma and prejudice.” Peter Kinderman, another author, said: “This study provides yet more evidence that the biomedical diagnostic approach in psychiatry is not fit for purpose.” He added the diagnostic system wrongly assumed that all distress resulted from disorder. John Read, who was the third author, said: “Perhaps it is time we stopped pretending that medical-sounding labels contribute anything to our understanding of the complex causes of human distress or of what kind of help we need when distressed.”

Psychiatric Times published an interview with Allen Frances for Conversations in Critical Psychiatry. Although he thought psychiatry was among the noblest of professions, “I fear that too many psychiatrists are now reduced to pill pushing, with far too little time to really know their patients well and to apply the rounded biopsychosocial model that is absolutely essential to good care.” He despaired that diagnostic inflation resulted in a too loose of a diagnostic system. “Diagnoses should be written in pencil, and under-diagnosis is almost always safer and more accurate than over-diagnosis.” With regard to epidemiological studies that tend to exaggerate rates of mental disorders, Frances said:

Never believe the extremely high rates of mental disorders routinely reported by epidemiological studies in psychiatry—usually labelling about 25% of the general population as mentally ill in the past year, about 50% lifetime. This entire literature has a systematic, but unacknowledged, methodological bias that inherently results in over-reporting. Because epidemiology requires such huge samples—in the tens of thousands—it is prohibitively expensive to conduct clinical interviews. Instead phone surveys are done by non-clinicians following a highly structured format that allows no clinical judgment whether the symptoms reported cause sufficient clinically significant distress and impairment to qualify as a mental disorder. Since there is no sharp boundary between normal distress and mental disorder, not assessing for clinical significance includes among those labelled mentally ill many who are merely distressed. The rates reported in studies are really only upper limits, not accurate approximations of true rates. They should be, but never are, reported as such.

His final word on DSM was: “DSM should be seen only as a tool helpful in guiding clinical judgment, not as a replacement for it.”

Returning to “Medicine and the Mind” by Gardner and Kleinman, psychiatrist Sandy Steingard said she shared their wish that research funding would be allocated to fields other than basic biologic research. But she was surprised they appeared to support buttressing psychiatry’s hold as leaders in research and program development. “I need some convincing that the problems we agree exist will be best addressed within my profession. In recent years, I have been most impressed by approaches to mental distress that emanate from outside of psychiatry.”

Finally, there was an article published in Public Understanding of Science that aimed to analyze the ‘critical reception’ of the DSM-5—how it has been received, discussed and criticized by different categories of people: “The Critical Reception of the DSM-5.” They noted two major themes surrounding the critical reception of the DSM-5, the pseudo-scientific nature of the manual and its normalizing power. Mental health professionals, especially psychiatrists, were more invested in the debate on the scientific nature of the DSM-5. There was a more eclectic variety of audiences in the debate over the normalizing power of the manual.

In the first debate (the scientific nature of the DSM), we found opposing argumentative positions regarding whether or not the manual is a scientific tool and questioning the type of science to which the manual adheres. In the second debate (the normalising power of the DSM), opinions were also polarised: while some argued that the manual was potentially socially harmful, some pointed out its lack of inherent agency and others mentioned its potential benefits. Although these debates have been noted in previous studies (Demazeux, 2015; Ecks, 2016), our research aims to deepen the understanding of such discussions.

They concluded the DSM was not simply a scientific manual. Rather, it is “a social laboratory where political, sociological, ethical and psychological issues are discussed and confronted.” In order to critically analyze the DSM, the authors said it was important to consider the claims that challenge the APA’s narrative of the DSM, namely its scientific and democratic nature. They said a range of arguments interacted and overlapped “in differing and opposing ways.” This was said to nuance the idea often presented academic publications that critiques of the DSM were mostly fixed, repeating the same themes and antagonistic positions.

The above issues were not being discussed in fringe, antipsychiatry forums. Rather, they appeared in well-received, medical and psychological arenas: The New England Medical Journal, Psychology Today, Psychiatry Research, Medical Express, Psychiatric Times, the National Institute of Mental Health. The people addressing them: Allen Frances, Thomas Insel, Caleb Gardner, Arthur Kleinman and others are or were key individuals within the mental health, psychiatric, diagnostic fields. The time is coming where just discussing the issues and concerns will not be enough; change will be necessary.

Psychiatry and diagnosis need to be reined in. They have extended their “reach” too far as it is, and scaling back is a necessary and essential step before any future recasting of the role of psychiatric treatment for mental “disorders.” Anne Harrington’s suggestion to limit its scope to severe, mostly psychotic disorders is a good first step. Dr. Joanna Moncrieff, a psychiatrist, seems to share this view. In “Rethinking Modals of Psychotropic Drug Action,” and “The Psychoactive Effects of Psychiatric Medication,”  she proposed a “drug centered model” of drug action, rather than the existing “disease centered model,” whose core assumption is that psychotropic drugs help correct “a biochemical abnormality that represents a biological substrate of a specific disease process.”

In The Myth of the Chemical Cure, Moncrieff acknowledged abandoning the disease-centered model would challenge “some of the most fundamental principles of modern psychiatry.” Yet she said it would also open the way “to a more honest practice” that requires its own specialist knowledge, and implements a more democratic treatment process:

Adopting a drug-centred model of drug action would require psychiatrists to become more informed about the effects of different psychoactive drugs, and become attuned to evaluating the subjective experiences of their patients in a more equal and reciprocal relationship. Where their function was to participate in mechanisms of social control this would be openly acknowledged and rigidly controlled rather than veiled, as currently, under the cloak of medicine.

In “The Psychoactive Effects of Psychiatric Medication,” she pointed out how re-orienting drug therapy towards a drug-centered model raised some questions about the validity and relevance of diagnostic systems like the DSM-5. The idea that psychiatric drugs exert “a disease- or disorder-specific action” has been one of the principal justifications for modern psychiatric classification. Using psychiatric drugs explicitly for their psychoactive effects would require a different understanding of the nature of psychiatric problems. It would break the link between diagnoses and treatment, “and enable a frank discussion about the purpose and ethics of the already frequent ‘off-label’ use of prescribed psychoactive medications, such as their use for behavioral control in children and the elderly.”

Gardner and Kleinman were not advocating going this far, but I think psychiatry needs a transformation. Long live the transformation!

12/10/19

Patients Deserve Better Than the DSM

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Even before the fifth  edition of the DSM was published in 2013 there were serious critiques of its reliability and validity. The then Director of the National Institute of Mental Health (NIMH), Thomas Insel, said it was at best, “a dictionary, creating a set of labels and defining each.” He went on to say its strength was its reliability, meaning it provided a way for clinicians to use the same terms in the same way. Its weakness was that it lacked validity. “Patients with mental disorders deserve better.” However, two weeks later, in a joint press release, Insel and the President-elect of the American Psychiatric Association, Jeffrey Lieberman, issued a statement. They said the NIMH had not changed its position on DSM-5. The DSM and the International Classification of Diseases-10 (ICD-10) remain “the contemporary consensus standard for how mental disorders are diagnosed and treated.”

The NIMH had developed a new research strategy to classify mental disorders based upon “dimensions of observable behavior and neurobiological measures,” known as Research Domain Criteria (RDoC). The project was to “transform diagnosis by incorporating genetics, imaging, cognitive science, and other levels of information to lay the foundation for a new classification system.” RDoC was described as the framework for collecting data to formulate a new nosology. Insel said they realized they could not succeed if they used DSM categories as the “gold standard,” so the NIMH would be “re-orienting its research away from DSM categories.” Yet Insel emphasized for now, RDoC was merely a research framework, not a clinical tool.

The situation has not changed much in the past six years. RDoC is still a research framework and the DSM-5 is still “the best information currently available for clinical diagnosis of mental disorders.” Dissatisfaction with the DSM-5 and perhaps some impatience with the promises of RDoC, led Jonathan Raskin, a psychology professor at SUNY New Paltz, to ask, “What Might an Alternative to the DSM Suitable for Psychotherapists Look Like?” Raskin has been previously critical of the DSM-5, co-authoring a previous article, “DSM-5: Do Psychologists Really Want an Alternative?

In “What Might an Alternative to the DSM Suitable for Psychotherapists Look Like?” Raskin said there seemed to be an uneasy relationship between psychotherapists and the medical model of the DSM diagnostic system they use. While more than 90% of psychologists and counselors say they use the DSM-5 they also expressed support for the development of an alternative. Writing for Mad in America, Jessica Janze quoted him as saying:

By seeing human suffering as a function of broken brains, the DSM often overlooks the complex and mutually determining interplay of psychological, sociocultural, contextual, and biological factors … While the DSM does not completely ignore psychosocial factors, it typically treats them as extraneous variables that influence, but are distinct from, the presumed primary cause of emotional suffering: a dysfunction inside the individual.

Raskin was skeptical of RDoC, saying the approach was misguided, because “it may not be possible to diagnose and explain all forms of human suffering in terms of underlying biological processes.” This wasn’t to say biology was irrelevant. “Psychological, social, and contextual factors influence biology just as much as biology influences them.” An alternative manual should contain five elements:

  1. Psychosocial factors are placed on equal footing with biological factors;
  2. It must categorize problems, not people;
  3. It must be scientifically grounded;
  4. It must be collaboratively developed;
  5. It must be usable across orientations, professions, and constituencies.

In “Heterogeneity in Psychiatric Diagnostic Classification,” Allsopp, Read and Corcoran analyzed five key chapters of the DSM-5 on ‘schizophrenia’, ‘bipolar disorder’, ‘depressive disorders’, ‘anxiety disorders’ and ‘trauma-related disorders.’ It was created to provide a common diagnostic language for mental health professionals and provide a definitive list of mental health problems, along with their symptoms. But the authors found that the psychiatric diagnoses all used different decision-making rules to codify the respective lists and their symptoms. There was a significant overlap of symptoms between diagnoses. And they told little about the individual patient and what treatment they needed. Neuroscience & News Research said: “The authors conclude that diagnostic labeling represents ‘a disingenuous categorical system.’”

Kate Allsopp said while the diagnostic labels created the illusion of an explanation, “they are scientifically meaningless and can create stigma and prejudice.” She hoped their findings would encourage mental health professional to think beyond diagnoses and consider other explanation of mental distress. Peter Kinderman said the study provided more evidence the biomedical diagnostic approach in psychiatry is not fit for its purpose. “Diagnoses frequently and uncritically reported as ‘real illnesses’ are in fact made on the basis of internally inconsistent, confused and contradictory patterns of largely arbitrary criteria.” It seems to assume all distress results from disorder, and relied heavily on “subjective judgments about what is normal.” Professor John Read concluded: “Perhaps it is time we stopped pretending that medical-sounding labels contribute anything to our understanding of the complex causes of human distress or of what kind of help we need when distressed.”

The Superior Health Council of Belgium published “DSM(5): The Use and Status of Diagnosis and Mental Health Problems” in June of 2019. The Report said there were several problems with the DSM and ICD and they recommended both be used with caution. DSM categories should not be at the center of care planning. At a clinical level, classifications do not provide a picture of symptoms, nor do they help manage needs and prognosis, “because they lack validity, reliability and predictive power.”

From an epistemological point of view, classifications are based on the assumption that mental disorders occur naturally, and that their designations reflect objective distinctions between different problems, which is not the case. The boundaries between people with a disease and those who are free from it are more dimensional than categorical.

The Report recommended a “multi-layered” diagnostic process, starting with a narrative description of the individual’s symptoms. These symptoms should then be re-contexualized, classifying them on the basis of a limited number of general syndromes. And finally, they should discuss these symptoms in terms of a continuum from crisis to recovery in order to assess the need for care, the level of crisis and the recovery perspective. Diagnoses should remain as working hypotheses and DSM and ICD use should be limited to broader categories of disorders. “Disorders should not be considered as a static characteristic, but rather as interactive.” Diagnostic labels should be used with caution.

It seems psychiatry is facing another crisis like that which occurred in the 1970s with Rosenhan’s classic “Being Sane in Insane Places.” Critiques of the validity and reliability of the most recent edition of the DSM have not faded and seem to be gaining more credibility. The Superior Health Council of Belgium said the diagnostic labels of the DSM-5 lack predictive power and should be used with caution. Yet it is “the contemporary consensus standard for how mental disorders are diagnosed and treated.” Paraphrasing the words of Thomas Insel: “Patients with mental disorders deserve better” than the DSM.

For more on concerns with psychiatric diagnosis, the DSM-5 and RDoC on this website, try: “The Quest for Psychiatric Dragons, Part 1,” “The Quest for Psychiatric Dragons, Part 2,” “Psychiatry Has No Clothes” and “Psychiatry’s Mythical Phoenix.

10/30/18

When Gaming Gets Disorderly

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In August of 2016 in his New York Post article, Nicholas Kardaras told an anecdotal story about a six-year old boy and an iPad that read like a Stephen King novel. His mother bought the boy an iPad when he was in first grade, thinking she was helping him “get a jump on things.” He discovered the game Minecraft, which the technology teacher likened to electronic Lego. “Some mornings he would wake up and tell her that he could see the cube shapes in his dreams.” When his behavior worsened and she tried to take the game away from him, he threw temper tantrums. “Then, one night, she realized that something was seriously wrong.”

She went into his room to check on him—he was supposed to be sleeping—and found him sitting up in his bed, seemingly in a trance. “His bloodshot eyes looking into the distance as his glowing iPad lay next to him.” In a panic, she had to shake him several times to snap him out of it. “Distraught, she could not understand how her once-healthy and happy little boy had become so addicted to the game that he wound up in a catatonic stupor.” Kardaras said:

We now know that those iPads, smartphones and Xboxes are a form of digital drug. Recent brain imaging research is showing that they affect the brain’s frontal cortex — which controls executive functioning, including impulse control — in exactly the same way that cocaine does. Technology is so hyper-arousing that it raises dopamine levels — the feel-good neurotransmitter most involved in the addiction dynamic — as much as sex.

Peter Gray was more balanced in his article for Psychology Today, “Sense and Nonsense About Video Game Addiction.” Gray said that Kardaras claiming that “your kid’s brain on Minecraft looks like a brain on drugs” was utter nonsense. He cited gaming researchers who said video gaming doubles dopamine levels in the brain—about the same as eating a slice of pepperoni pizza. “Drugs like heroin, cocaine, or amphetamine raise dopamine by roughly ten times that much.” He went on to say video gaming can positively alter your brain, but did acknowledge research shows that a small percentage of gamers “are suffering psychologically in ways that at least are not helped by gaming and maybe are worsened.”

When the DSM-5, the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders was published in 2013 it did not christen gaming as a distinct behavioral addiction. It did, however, include “Internet Gaming Disorder” in a section called “Conditions for Further Study.” In contrast, the World Health Organization (WHO) included “Gaming Disorder” as a distinct behavioral disorder.

The proposed diagnosis of Internet Gaming Disorder would mean “Persistent and recurrent use of the internet to engage in games, often with other players, leading to clinically significant impairment or distress as indicated by five (or more) of the following in a 12-month period.”  Then the following diagnostic criteria were given: 1) preoccupation with internet games; 2) withdrawal symptoms when gaming is taken away; 3) tolerance—the need to spend increasing amounts of time engaged in gaming; 4) unsuccessful attempts to control participation in gaming; 5) loss of interest in previous hobbies and entertainment activities other than gaming; 6) continued excessive use of gaming despite knowledge of psychosocial problems; 7) deception of family members, therapists or others about the amount of gaming; 8) use of gaming to escape or relieve a negative mood (like feelings of helplessness, guilt or anxiety); 9) gaming that jeopardized or led to the loss of a significant relationship, job, or either an educational or career opportunity.

Gray pointed out that preoccupation, tolerance, loss of interest in previous activities, deception, using to escape or relieve a negative mood could apply to anyone intensely interested in a hobby. “What I’m suggesting here is that a person who has a quite healthy passion for video gaming, who is not at all suffering, could very well check off these five “symptoms” and thereby get a diagnosis of IGD.” The other four seemed to him to be more indicative that something was wrong: withdrawal symptoms, unsuccessful attempts at control; continued excessive gaming despite psychosocial problems; risks of losing significant relationships or employment because of gaming.  He then briefly reviewed several studies of gaming addiction with a wide range of findings. Look at “Sense and Nonsense About Video Game Addiction” for his discussion of and citation of these studies. Here I’ll give an overview of a couple additional studies.

Torres-Rodriguez et al. wrote of their case study of four different types of adolescent problematic gamers in the International Journal of Mental Health and Addiction. The primary objective was to evaluate the effects of PIPATIC, a 22-session specialized treatment for adolescents with Internet Gaming Disorder (IGD). Given that all four cases had different etiologies leading to their problematic gaming, is was interesting that “the PIPATIC treatment was able to significantly reduce the negative symptoms and effects of IGD irrespective of the patients’ pathway and predispositions.” Three of the adolescents had comorbid disorders: autistic spectrum disorder, ADHD with depression and social phobia with depression.

In the American Journal of Men’s Health, Chen et al. examined how Internet Gaming Disorder was an emerging health issue for men. The authors observed where adolescent and adult males “demonstrate far more addictive internet gaming use in terms of screen hours, craving, and negative impacts on health, which have, in isolated incidents, also caused death.” They sought to do a literature review on IGD to raise awareness about IGD as an emergent men’s health issue. An intriguing section looked at studies seeking to conceptualize IGD through neuroscience. Conceived as a behavioral addiction, “a strong neurobiological link to addictive patterns has also been demonstrated in IGD.”

Although IGD is not recognized as an official mental health disorder, it is a significant emergent men’s health issue. If left untreated, IGD can lead to detrimental psychosocial impacts, affecting gamers and their families. PCPs can play an important role in providing early intervention, by knowing how to assess and treat men’s IGD; however, more research is needed to fully understand, accurately diagnose, and effectively treat this mental health condition.

The World Health Organization went further than the APA and classified Gaming Disorder in their eleventh edition of the International Classification of Diseases (ICD-11). When comparing the two descriptions, there are strong similarities, with the WHO definition being a more elegant and readable definition.

The ICD-11 said gaming disorder was defined as a pattern of gaming behavior “characterized by impaired control over gaming, increasing priority given to gaming over other activities to the extent that gaming takes precedence over other interests and daily activities, and continuation or escalation of gaming despite the occurrence of negative consequences.” For diagnosis, the behavior pattern must be severe enough to result in “significant impairment in personal, family, social, educational occupational or other important areas of functioning and would normally have been evident for at least 12 months.”

Writing for Medical News Today, in “What is gaming disorder?” Jayne Leonard reviewed the new ICD-11 disorder and explored what the classification could mean for gamers. She also noted the similarities between IGD and Gaming Disorder. There are also multiple links to additional studies, noting for example, how gaming may co-occur with anxiety, depression or stress. “People who remain physically inactive for extended periods due to gaming may also have a higher risk of obesity, sleep problems, and other health issues.”

Looking at what this could mean for gamers, Leonard said there was no doubt that some gaming behaviors were problematic. “But the majority of people who play computer and video games do not need to worry.” According to research into IGD assessed in a 2017 study by Przybylski et al., only .3-1.0 percent of people are likely to meet the criteria for an IGD diagnosis. More than 2/3 of individuals did not report any symptoms of IGD. Another study found individuals who did meet the criteria for IGD tended to have poorer emotional, physical, mental and social health.

Even though gaming disorder is not widespread, people should be aware of the amount of time that they spend playing games. They should also monitor the effect that gaming has on their other activities, their physical and mental health, and their relationships with others.

It doesn’t appear that like opioids, a gaming disorder epidemic will emerge. But it is wise to monitor gaming for impairment in some area of your life or the life of your children. And if a problem does emerge, there are gaming self help groups, like: “On-Line Gamers Anonymous. Look for the four diagnostic behaviors Peter Gray pointed out.

Do you feel restless when unable to play games (withdrawal)? Do you feel you should play less, but are unable to (unsuccessful attempts at control)? Do you continue gaming despite knowing it has a negative effect on your life (continued excessive gaming despite psychosocial problems)? And have you risked losing significant relationships or employment because of gaming?

04/17/18

Digital Addiction & Diagnosis

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The World Health Organization (WHO) plans to include Gaming Disorder as a mental health disorder in the next edition of their diagnostic manual, the ICD-11, the International Classification of Diseases, 11th edition. It will be classified under the section “Disorders due to addictive behaviours,” along with Gambling Disorder.  At this point, the ICD-11 is a “beta draft,” so the description and diagnostic criteria for Gaming Disorder may change before it is finally published, sometime in 2018. Parents, you may be dealing with a soon-to-be “addictive behavior” when your teen threatens to jump out a second story window if you take their cell phone off of them.

Dr. Richard Graham, an addiction specialist at the Nightingale Hospital in London, told the BBC he welcomed the proposed diagnosis. “It is significant because it creates the opportunity for more specialised services. It puts it on the map as something to take seriously.” He added he was also sympathetic to those who questioned whether the condition should be medicalised. “It could lead to confused parents whose children are just enthusiastic gamers.” He said in his practice, he sees about fifty new cases of digital addiction each year.

He looks for whether the digital activity is affecting basic things like sleep, eating, socializing and education. He asks himself, “Is the addiction taking up neurological real-estate, dominating thinking and preoccupation?” Commenting on the proposed classification, Psychology Today said: “Whether this provides clinical benefits over treating problematic gaming as a generic addiction disorder remains to be seen, but this move acknowledges the prominent psychological role that computing, and gaming in particular, can have in people’s lives.”

The DSM-5, which is the psychiatric diagnostic manual most used in the US, only listed internet gaming disorder as a “condition for further study” when it was published in 2013. However, many other countries have already begun to take steps to restrict the amount of time children and teens can spend gaming. South Korea introduced a law banning access for children under the age of 16 from online games between midnight and 6 am. In China, the online company Tencent limited the amount of time children can play its most popular games. In Japan players are alerted if they spend more than a specified amount on time each month playing games.

Here is a link to a description of Gaming Disorder for the ICD-11. It says: Gaming disorder is characterised by a pattern of persistent or recurrent gaming behaviour (‘digital gaming’ or ‘video-gaming’), which may be online (i.e., over the internet) or offline.” Symptoms or diagnostic criteria include: 1) impaired control over gaming that includes “onset, frequency, intensity, duration, termination, context;” 2) increased priority given to gaming so that “gaming takes precedence over other life interests and daily activities;” and 3) continuing or escalating gaming despite there being negative consequences.

The pattern of gaming behaviour results in marked distress or significant impairment in personal, family, social, educational, occupational, or other important areas of functioning. The gaming behaviour and other features are normally evident over a period of at least 12 months in order for a diagnosis to be assigned, although the required duration may be shortened if all diagnostic requirements are met and symptoms are severe.

There is an exclusion to diagnosing Gaming Disorder in the ICD-11, the presence of Hazardous Gaming. It refers to “a pattern of gaming, either online or offline that appreciably increases the risk of harmful physical or mental health consequences to the individual or to others around this individual.” The increased risk could be from the frequency of gaming, from the amount of time spent gaming, from neglecting other activities and priorities, from risky behaviors associated with gaming, or from the adverse consequences of gaming. It could also be a combination of these symptoms. “The pattern of gaming is often persists in spite of awareness of increased risk of harm to the individual or to others.”

This may seem like a bizarre claim, but it’s been happening since the 1980s, when a man died playing an arcade game in a bar, according to Simon Parkin in Death by Video Game. According to “Video game addiction” on Wikipedia, in 2007 a Chinese man died after playing video games for three days straight. A New Mexico woman was convicted of second-degree murder and child abandonment for allowing her 3 ½-year-old daughter to die of malnutrition and dehydration while she was playing World of Warcraft online. She received 25 years in prison. An Ohio teen shot his parents, killing his mother, when they took away his copy of Halo 3. He received 23 years to life. Here’s a YouTube video referencing 10 real life deaths associated with video games.

Researchers in a South Korean study found an imbalance in the brain chemistry of young people “addicted” to smartphones and the Internet. Nineteen young people with internet or smartphone addiction and 19 gender- and age-matched healthy controls took part in the study. In order to assess the severity of this addiction, standardized internet and smartphone addiction tests were used to measure the severity of internet addiction. “The addicted teenagers had significantly higher scores in depression, anxiety, insomnia severity and impulsivity.”

MRS (magnetic resonance spectroscopy) exams showed that “the ratios of GABA to creatine and GABA to glutamate were significantly correlated to clinical scales of internet and smartphone addictions, depression and anxiety.” GABA (gamma aminobutyric acid) is a neurotransmitter in the brain that inhibits or slows down brain signals. Glutamate-glutamine (Glx), causes neurons to be more electrically excited. “Previous studies have found GABA to be involved in vision and motor control and the regulation of various brain functions, including anxiety.”

More study is needed to understand the clinical implications of the findings, but Dr. Seo believes that increased GABA in the anterior cingulate gyrus in internet and smartphone addiction may be related to the functional loss of integration and regulation of processing in the cognitive and emotional neural network.

However, after cognitive behavioral therapy, GABA to Gix ratios were significantly decreased or normalized. “The increased GABA levels and disrupted balance between GABA and glutamate in the anterior cingulate cortex may contribute to our understanding the pathophysiology of and treatment for addictions.”

The possibility of internet addiction was investigated as far back as 1998 in a paper for CyberPsychology & Behavior by Kimberly Young, “Internet Addiction: The Emergence of a New Clinical Disorder.” Young found that there were “significant behavioral and functional usage differences” between participants who met her criteria for dependent internet users and nondependent internet users. Kwon et al. developed a self-diagnostic scale called the Smartphone Addiction Scale (SAS). The authors said further research should look at the relationship between smartphone addiction and anxiety, depression, loneliness, low self-esteem and social maladjustment. They hoped the development of their scale would serve as an opening for the clinical diagnosis of smartphone addiction.

It’s not really surprising that some people would become “addicted” to something as reinforcing as video or online games. Compulsive smartphone use is also understandable, given how easily humans develop compulsive behavior patterns. But formally entrenching them as psychiatric disorders in the ICD or the DSM is going too far. Richard Graham’s observation that it could lead to confusion is to the point. Where does the diagnostic, disordering impulse stop? When does the medicalisation of so-called addictive behaviors end? Gambling, and now gaming—why not working or shopping—or pick your own favorite compulsive behavior.

A scale to assess problematic smartphone use or digital gaming has its uses. But adding another diagnostic label isn’t necessary … unless, perhaps, we might want to add something that quantifies the compulsion to create new diagnoses. How does Diagnostic Disorder sound as a label? Its symptoms could be: 1) impaired control over creating diagnoses, including the frequency, intensity and duration of their identification; 2) an increased emphasis on generating diagnoses to the point they take precedence over other psychiatric interests and daily activities; 3) continued or escalating diagnostic generation despite the negative consequences to others of such behavior.

02/24/17

Misdiagnosing Substance Use

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Allen Frances doesn’t like the DSM-5 and you can hear him say so here.  He said our mental health system was in a mess. And he is afraid that with DSM-5, it will get even worse. “People who are essentially normal are being diagnosed with mental disorders they don’t have.” Small changes in the diagnostic system can result in tens of millions of normal people qualifying for a diagnosis. He used himself as an example, stating how he would qualify for several of the DSM-5 disorders. Typical symptoms of grief over his wife’s death, lasting beyond two weeks, would have signified him as having a Major Depressive Disorder.

Anther mistake was combining what had been two different diagnoses of substance use in the DSM-IV—Substance Abuse and Substance Dependence—into one: Substance Use Disorder. Substance Abuse was when someone had recurrent, but intermittent, trouble from recreational binges. Substance Dependence was a continuous and compulsive pattern of use, often with tolerance and withdrawal. The majority of substance abusers “never become addicted in any meaningful sense.”

The two DSM IV diagnoses have radically different implications for treatment planning and for prognosis. Artificially lumping them together in DSM-5 forces inaccurate diagnosis, loses critical clinical information, and stigmatizes as addicts, people whose substance problem is often temporary and influenced by contextual and developmental factors.

Hasin et al., “DSM-5 Criteria for Substance Use Disorders: Recommendations and Rationale,” presents the rationale used by the DSM-5 workgroup for substance use disorders for its changes, particularly combining abuse and dependence into one disorder. They recommended the combination as well as dropping one diagnostic criteria (legal problems) and adding one (craving). Two criteria are required to diagnose a Substance Use Disorder. The number of criteria met will indicate mild (2 to 3 criteria), moderate (4 to 5), and severe disorders (6 or more). The following chart, taken from the article, illustrates the changes from DSM-IV to DSM-5.

Frances is not alone in seeing value with two distinct types of substance use disorder. Carleton Erickson in The Science of Addiction noted how the distinction allowed for the differentiation between individuals with drug-related problems who could stop using when they wished (substance abusers), and others who had the disease of chemical dependence. Chemically dependent people have a dysregulation of the mesolimbic dopamine system and generally cannot stop using drugs without intensive intervention into their drug use problems. “According to these criteria, drug abuse in intentional, ‘conscious,’ or voluntary. Drug dependence is pathological and unintended.”

In his article, “DSM-5 Made a Mistake Eliminating Substance Abuse,” Allen Frances indicated the DSM-5 workgroup for substance use disorders based its rationale for dropping Substance Abuse on studies suggesting the distinction was hard to make. He said the results of the studies were not definitive. Moreover, their interpretation was flawed by what he said was a basic DSM-5 misunderstanding of the nature of psychiatric diagnosis. “All DSM disorder overlap with other DSM disorders and also frequently with normality.” Fuzzy boundaries among near diagnostic neighbors are common and not a sufficient excuse to collapse clinically valuable distinctions.

Carleton Erickson’s discussion of the degrees of severity with drug problems helps to illustrate this misunderstanding. He indicated there were mild, moderate and severe forms of both drug abuse and drug dependence. Most people don’t think in terms of severity with substance use problems. You either have a problem or you don’t; you either abuse drugs or you don’t. He then illustrated their relationship to drug-seeking behavior as follows.

Drug Abuse

Drug Dependence

Drug-Seeking

Mild

Little/None

Moderate

Some

Severe

Mild

A Lot

Moderate

Even more

Severe

All the Time

The overlap referred to by Frances occurs between severe drug abuse and mild drug dependence. The inability of psychiatric diagnosis to make a clear distinction here seems to have led to the decision to collapse the abuse and dependence diagnoses into one category in the DSM-5.

I think another overlap between drug abuse and drug dependence happens with regards to self-control. A distinction is necessary between self-control of thoughts, feelings and behavior when drinking and control of the drug intake itself. Any substance use can lead to a loss of self-control over an individual’s thoughts, feelings and behavior. When that loss of control results in recurrent, intermittent trouble, there is a drug abuse problem. The severity of this type of loss of self-control and the related intermittent trouble varies.

Not everyone who abuses a drug experiences the classic sense of losing of control over how much of the drug they use. A loss of control over drug intake—a continuous and compulsive pattern of use—is only evident within drug dependence. And again, the severity of this loss of control over drug intake varies. So I’d adopt Erickson’s degrees of severity with drug abuse and dependence problems as seen below.

Loss of Self-Control in Abuse

Loss of Control over Drug Intake in Dependence

Mild

Moderate

Severe

Mild

Moderate

Severe

A substance abuse problem with severe trouble related to loss of self-control may be indistinguishable from a substance dependence problem with mild loss of control over drug intake. Both people would look at their severe “trouble” and attribute it to drinking or drugging too much. Given an equal motivation to avoid further “trouble,” the substance abuser would likely have an easier time maintaining abstinence. Carleton Erickson said chemical dependence is not a “too much, too often, withdrawal” disease; it’s a “I can’t stop without help disease.” There is a pathological, compulsive pattern to substance use.

There does seem to be a “fuzzy boundary” between Substance Abuse and Substance Dependence. Nevertheless, the distinction still carries some clinical and diagnostic value. I agree with what Allen Frances said: “The change was radical, creates obvious harms, and provides no apparent benefit.” What should clinicians do? Frances suggested they simply ignore the DSM-5 change. He said it was appropriate and clinically preferable to continue making the distinction.

There is nothing sacred or official about the DSM-5 choices — I know because I made the choices for DSM-IV. The ICD coding system is official; the DSM codes are just one groups’ fallible adaptation of them. It is of great significance that the official coding in ICD-10-CM does not follow the DSM-5 decision to eliminate Substance Abuse. Instead, ICD-10-CM retains the DSM-IV terminology and continues to provide separate Substance Abuse and Substance Dependence codes for each of the major classes of substances.

The ICD-11 workgroup, currently in the final stage of development before field tests, will continue to separate Substance Dependence and Harmful Substance Use. The guidelines for dependence are revised and simplified into three diagnostic features: impaired control over substance use; increasing priority in life and physiological features. Severity qualifiers were suggested only for alcohol intoxication. They also introduced a new diagnostic category, with no equivalents in ICD-10 or DSM-5: single episode of harmful use. Frances commented:

The DSM-5 mistake thus places it out of line with ICD-10, ICD-11, previous DSM’s, and well established clinical practice. Clinicians remain truer both to clinical reality and to ICD coding when they ignore the new DSM-5 lumping of substance use disorders and instead continue to distinguish Substance Abuse from Substance Dependence. DSM’s are explicitly meant to be used only as guides, not worshiped as bibles. Clinicians are free to ignore DSM whenever it makes mistakes that go against clinical common sense and the International coding system.

01/24/17

Herding Pharma “Cats”

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The Chinese government released a report in September of 2016 by the State Food and Drug Administration (SFDA) that found fraudulent clinical trial practices on a massive scale. The SFDA concluded that over 80% of clinical trial data was fabricated. The scandal was the result of a “breach of duty by supervision departments and malpractice by pharmaceutical companies, intermediary agents and medical staff.” More than 80% of the applications for the mass production of new medications have been cancelled, with warnings by the SFDA that further evidence of malpractice might still emerge.

Radio Free Asia also reported the SFDA indicated much of the clinical trail data was incomplete at best. But it also failed to meet basic analysis requirements or was untraceable. “Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.” Apparently, this came as no surprise to industry insiders. “Clinical data fabrication was an open secret even before the inspection.”

Many of the new drugs were combinations of existing ones. Clinical trial outcomes were written beforehand, and their data presented so it agreed with the fabricated outcomes. A doctor at a top Chinese hospital said the problem lay with the failure to implement regulations governing clinical trial data. “Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country.” Reporting for Pharmafile, Ben Hargreaves said:

The root of the issue is then not regulation, with regulation for clinical trials running on similar lines to Western practises, but in the lack of adherence to them. China’s generic drug industry has struggled with quality problems and therefore there is a temptation for companies to manipulate data to meet standards. The report found that many of the new drugs were found to be a combination of existing drugs, with clinical trials outcomes written beforehand and the data tweaked to fit in with the desire outcomes.

Sadly, clinical trial problems are not unique to China. An editorial published in the British journal The Lancet Psychiatry described multiple issues beginning with how subjects are recruited, moving on to determining what the control group should be, and ultimately defining meaningful outcome measures. Sometimes, trial recruits receive “care” they didn’t agree to. “Researchers and ethics review boards need to examine the ethical arguments and practical procedures from other areas of medicine where consent is problematic.” If such trials are done, regular and rigorous monitoring is essential. Patient safety and autonomy needs to be a priority.

In his discussion of the editorial, Justin Carter elaborated on one of the problems with recruiting subjects. An individual was recruited into a study on three antipsychotics while under a forced commitment order from a judge. “The psychiatrist who recruited him was in charge of the study and was his treatment provider and was also empowered to report on the patient’s progress to the judge.” The individual died by suicide during the drug trial.

The work of Irving Kirsch and others has shown the problem with inert placebos (sugar pills). The side effects from medication make it easy for participants to guess which study group they are in.

And when the trial is over and the data in, do the outcome measures really provide something meaningful for people’s lives? If the ultimate goal is for people to fell better and resume their prior level of functioning, should outcome measures by primarily patient self-reports, clinical assessment, or differences shown by imaging or the as-yet-to-be-clearly-identified biomarkers?

Given the problems running and interpreting psychiatry trials, it is essential to learn how even the most successfully tested interventions work in real clinics with the broad patient population. Implementation, uptake, and effectiveness in real-life settings must be analysed, and delivery of new innovations modified accordingly. Future research should be thought of not as a plain linear process from innovation to trial to implementation, but as a virtuous circle where research feeds into the clinic and vice versa.

Another issue pointed to by Carter was the validity and reliability of the diagnosis or classification system used to determine who to include and who to exclude from the trials. The DSM system, now in its fifth edition (DSM-5), is the current “bible” for assessing and diagnosing problems the psychiatric medications in clinical trials are supposed to “treat” in the U.S. Yet there have been questions about the reliability and validity of the DSM dating from an argument raised by Robert Spitzer and others in the 1970s that ushered in changes still embedded in the DSM-5. Rachel Cooper gave a brief history of the reliability questions with the DSM in “How Reliable is the DSM-5?” You can also refer to “Psychiatry Has No Clothes,” “Where There’s Smoke …”, and  “The Quest for Psychiatric Dragons,” Parts 1 and 2.

A few weeks before the release of the DSM-5, Thomas Insel, then the NIMH Director, announced the NIMH would be “reorienting” its research away from DSM categories. The agency’s new approach is called the Research Domain Criteria (RDoC) project. For now, RDoC is a research framework and not a clinical tool. But NIMH has high hopes for it: “RDoC is nothing less than a plan to transform clinical practice by bringing a new generation of research to inform how we diagnose and treat mental disorders.” While Tom Insel has moved on to work for Alphabet (Google), RDoC is alive and well within NIMH. You can keep up with news about RDoC on the “Science News About RDoC.”

The Science Update for February 16, 2016 noted the March 2016 issue of the journal Psychophysiology would be devoted to the RDoC initiative. Dr. Bruce Cuthbert said the special issue was a unique opportunity for researchers to engage with one another and reflect on work being done in various laboratories throughout the country. He thought it was encouraging to see many investigators already engaged in the kind of work RDoC advocates. “What this shows is that while the RDoC acronym may be new, the principles behind RDoC are certainly not new to psychiatric research.”

If the principles behind RDoC are not new to psychiatric research, how can it bring “a new generation of research to inform how we diagnose and treat mental disorders” in order to transform clinical practice? It sounds a lot like using the same deck of cards to just play a new card game. RDoC may not be the transformative framework it’s touted to become.

Added to these issues is the failure of pharmaceutical companies to publically report the results of clinical trials, as they are required by law to do. New reporting rules will take effect on January 18, 2017. But advocates for transparency in clinical research have cautioned the success of the new rules will depend upon the willingness and vigor of government enforcement of those rules. The failure to enforce the existing rules, which went into effect in 2008, led to widespread noncompliance with reporting requirements. If the FDA had fined the violators, they could have collected an estimated $25 billion.

Reporting for STAT News, Charles Piller said studies have indicated only a small fraction of trials will comply with the law. Yet there are no current plans to increase enforcement staffing at the FDA and NIH. That’s a big problem, according to Ben Goldacre, an advocate for full disclosure in clinical research. Francis Collins, the NIH director said they are serious about this and will withhold funds, if needed. “It’s hard to herd cats, but you can move their food, or take their food away.”

The legislation that created ClinicalTrials.gov emerged from numerous cases of drug manufacturers withholding negative trial results, making drugs look more effective and less harmful. Efforts to market the antidepressant Paxil for teenagers more than a decade ago stimulated the push for better reporting. A recent analysis in the journal BMJ found that GlaxoSmithKline, Paxil’s manufacturer, failed to disclose 2001 data showing the drug to be no more effective than a placebo, and was linked to increased suicide attempts by teens.

Writing for Time, Alexandra Sifferlin reported on a new study that suggested many of the medical reviewers for the FDA go to work for the drug companies they oversaw while working for the government. One of the study’s authors said: “I don’t think there is overt collusion going on, but if you know in the back of your mind that a major career opportunity after the FDA is going to work on the other side of the table, I worry it can make you less likely to put your foot down.”

Returning to the Francis Collins metaphor, it seems that the willingness to try and herd Pharma cats is dependent on whether or not you are afraid they will scratch you in the attempt.

09/2/16

Antidepressant Scapegoat

5169097 - goat. photo based illustation. the scapegoat was a goat that was driven off into the wilderness as part of the ceremonies of yom kippur, the day of atonement, in judaism during the times of the temple in jerusalem. the rite is described in leviticus 16.

© Elena Ray | 123rf

The Hamilton Depression Rating Scale (Ham-D) is the most widely used clinician-administered assessment scale. In use since the 1960s, it is seen as the “gold standard” for assessing depression. As such, it was the assessment tool of choice when antidepressant clinical trials were being done. The only problem was many, if not most, of the antidepressants that came to market had a statistically significant effect on the Ham-D that was not observable clinically. Irving Kirsch called this a “dirty little secret.” Both the pharmaceutical companies bringing the drugs to market and the FDA knew there was essentially no difference between the effects of the drug and the placebo used in the clinical trial.

Kirsch’s research into the placebo effect with antidepressants has been established and repeatedly replicated; it wasn’t a fluke, one-and-done study. Search his name in Google or start here with “Dirty Little Secret,” “Modern Alchemy with Antidepressants,” or “Do No Harm with Antidepressants.” Kirsch showed clearly that study participants were able to regularly break the double blind methodology of the clinical trials because the researchers continually used inert placebos. The real drugs given to study participants produced side effects; the inert placebo pills didn’t. All you had to do was pay attention to any side effects you may or may not exhibit to have about a 75% chance of accurately predicting whether you were in the experimental group of the control group.

But Swedish researchers suggested that the reason SSRI antidepressants haven’t performed better than placebo was because they were measured incorrectly. Heironymus et al. said that if 16 of the 17 items in the Ham-D were ignored and only the single item assessing depressed mood was utilized, “scientifically valid support for the tested drug being antidepressant” could be shown. They said their decision to focus on depressed mood was because it was one of the two key symptoms required by the DSM-IV definition of depression; and it is given particular importance by the FDA when the agency evaluates the efficacy of an antidepressant.

While not claiming that assessing depressed mood only is the optimal way of recording symptom severity, or that other symptoms are irrelevant, we do suggest that a treatment faithfully outperforming placebo in reducing depressed mood can hardly be regarded as ineffective.

Perceived flaws with the Ham-D have been pointed out by previous researchers. In 2004, Bagby et al. looked at the psychometric properties of the Ham-D and found the internal, interrater, and retest reliability estimates overall were mostly good. However, many of the individual scale items were poor contributors when measuring the severity of depression. Some had poor interrater and retest reliability. “For many items, the format for response options is not optimal.” They concluded that:

Evidence suggests that the Hamilton depression scale is psychometrically and conceptually flawed. The breadth and severity of the problems militate against efforts to revise the current instrument. After more than 40 years, it is time to embrace a new gold standard for assessment of depression.

They said many of the individual items were poorly designed and add up to a total score whose meaning was unclear. At the very least, they thought the Ham-D needed a complete overhaul of its items. The researchers thought it was time to retire the Ham-D, as it is measuring a conception of depression that is several decades old. “The field needs to move forward and embrace a new gold standard that incorporates modern psychometric methods and contemporary definitions of depression.” In other words, the new gold standard needs to include current DSM symptoms.

I wonder if the Bagby et al. study may be suggesting we set aside the Ham-D prematurely. A cursory comparison of the Ham-D and the current edition of the DSM, the DSM-5, suggested there is a good bit of overlap. An article by Michael Schreiner, “Major Depressive Disorder DSM 5 Criteria,” gives the DSM-5 diagnostic criteria; the Ham-D is described here in a NIH document.

The DSM-5 lists nine potential symptoms of depression, five of which are required to exist within a two-week period of time for a diagnosis of major depression. The symptoms have to cause clinically significant distress or impairment in social, occupational or other important areas of functioning. Every one of the nine symptoms is mentioned one way or another within the Ham-D.

The nine DSM-5 symptoms are:

1. Depressed mood most of the day, almost every day, indicated by your own subjective report or by the report of others. This mood might be characterized by sadness, emptiness, or hopelessness.
2. Markedly diminished interest or pleasure in all or almost all activities most of the day nearly every day.
3. Significant weight loss when not dieting or weight gain.
4. Inability to sleep or oversleeping nearly every day.
5. Psychomotor agitation or retardation nearly every day.
6. Fatigue or loss of energy nearly every day.
7. Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day.
8. Diminished ability to think or concentrate, or indecisiveness, nearly every day.
9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a   specific plan for committing suicide.

There are clear differences between them as well. The Ham-D scale devoted three items to sleep disturbance; the DSM-5, only one. Some items in the Ham-D, like agitation and retardation (slowness of thought and speech) were mixed into two different symptoms in the DSM-5. Hypocondriasis was in the Ham-D, but not the DSM-5. The Ham-D item on “work and activities” was broken into a symptom of fatigue and also appeared in a separate category B: “Symptoms cause clinically significant distress or impairment in social, occupational or other important areas of functioning.”

The case for a more psychometrically sensitive depression scale, one that has a greater correspondence to how depression is currently diagnosed, makes some sense. But is the problem really that a more effective diagnostic scale needs to be developed? Perhaps the issue is that the Ham-D hasn’t had a very good track record in demonstrating the effectiveness of antidepressant drugs. So researchers and pharmaceutical companies would like a scale that more clearly demonstrates efficacy with medications than the Ham-D. Or maybe the Ham-D is being scapegoated for the failures of antidepressant drugs. Then again, maybe the problem is trying to “treat” a complex human condition like depression by manipulating one or two neurotransmitters with antidepressants.