Tag Archives: Allen Frances

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

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!

12/18/18

The Death of Grief

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The field of psychiatric diagnosis suffered a significant loss in the spring of 2013 with the death of the bereavement exclusion. It was not a peaceful ending, as several experts fought desperately to keep it alive within DSM-5. But the efforts of psychologists like Joann Cacciatore and psychiatrists such as Allen Frances were not successful. The American Psychiatric Association published the DSM-5 without the bereavement exclusion and effectively eliminated any diagnostic distinction between bereavement and major depression. Grief, for all intensive purposes, was dead.

Dr. Joann Cacciatore, a psychologist who specializes in counseling individuals affected by traumatic death, lamented this passing in her article, “The Death of Grief, the Birth of Mental Illness.” She said: “Grief is not a disease, it is not an illness, it is not depression. It is in fact, an expression of love. Grief can only be a disease if love is.” She noted how the change increased the likelihood that grief would be misdiagnosed as Major Depressive Disorder and then mistakenly treated with psychotropic medications. “There is no sound evidence that they are effective for grief. Research shows that bereaved parents are already medicated earlier than can be justified by current evidence.”

We are saddened and disappointed by the recent announcement that the DSM-5 task force has finalized the decision to eliminate the bereavement exclusion from the Major Depressive Disorder diagnosis in the upcoming edition of the manual. This move will allow clinicians, including counselors, general physicians, social workers, and psychiatrists, to diagnose a major mental disorder in bereaved parents and other grieving individuals as early as two weeks following the death of a loved one should they meet the DSM-5’s criteria for depression. Importantly, many of you will recognize these criteria which include sadness, feelings of emptiness, crying, sleep and weight changes, guilt and regrets, and loss of interest or energy. Yet, all of these symptoms are quite common in grief, and particularly after the death of a baby or child which evokes enduring and intense reactions in parents.

Allen Frances, a psychiatrist and chair of the DSM-IV, repeatedly pleaded with the APA to not medicalize grief in “Last Plea to DSM 5: Save Grief from the Drug Companies.” He even ranked it as the second worst mistake within the DSM-5. He noted it would be a “bonanza for drug companies, but a disaster for grievers.” Frances referenced and quoted the concerns of Joann Cacciatore, Russell Friedman (the co-founder of The Grief Recovery Institute Educational Foundation) and Jerry Wakefield, a professor of Social Work. Frances said: “The DSM 5 medicalization of grief has been opposed by editorials and scientific papers in the major medical and scientific journals, by hundreds of newspaper  articles.”

After 40 years and lots of clinical experience, I can’t distinguish at two weeks between the symptoms of normal grief and the symptoms of mild depression- and I challenge anyone else to do so. This is an inherently unreliable distinction. And I know damn well that primary care doctors can’t do it in a 7 minute visit. This should have been the most crucial point in DSM 5 decision making because primary care docs prescribe 80% of all antidepressants and will be most likely to misuse the DSM 5 in mislabeling grievers. . . . Grief is a normal and inescapable part of the human condition, not to be confused with psychiatric illness. Let us respect the dignity of mourning and treat it medically only when it becomes melancholia.

Another eminent psychiatrist, Ronald Pies, disagreed with Allen Frances. He believes eliminating the bereavement exclusion was a reasonable decision. Pies said grief and depression are distinct constructs and bereavement does not “immunize” the person from major depression. He said the bereavement exclusion was removed from the DSM-5 for two main reasons: 1) major depression is potentially a lethal disorder, “with an overall suicide rate of about four percent”; and 2) there is no clinical or scientific evidence to distinguish bereavement-related grief from major depression. “Disqualifying a patient from a diagnosis of major depression” after the death of a loved one “closes the door on potentially life-saving interventions” (meaning medication).

It is important to understand that the DSM-5 criteria merely allow the diagnosis of MDD when the recently bereaved person meets all required symptom, severity, duration, and impairment criteria for MDD. Nothing in the manual compels a diagnosis of MDD shortly after bereavement.

In conclusion, Pies said while normal grief should not be medicalized, neither should major depression be normalized simply because it occurred “in the context of recent bereavement.” Dr. Pies seems to be arguing that the problems of a “falsely positive” in diagnosis of major depression in the context of bereavement are outweighed by the dangers from a “false negative” in diagnosis. Yet there are some who would strongly dispute this conclusion. Instead they see removing the bereavement exclusion as an example of how psychiatry relentlessly seeks to expand its reach.

In “Elimination of the Bereavement Exclusion: History and Implications,” psychologist Philip Hickey gave a history of the DSM and how the bereavement exclusion was first added, then whittled away over time. He noted how the DSM-I did not suggest its “disorders” were chemical imbalances or “illnesses-just-like-diabetes.” Rather, the “disorders” were conceived as reactions of the personality and believed to be of  “psychogenic origin.” Hickey then gave a couple of quotes from the DSM-I illustrating his point.

The emphasis on psychological explanations was not merely a reflection of Adolf Meyer’s influence, but a reflection of the fact that a great many psychiatrists at that time (1952) subscribed to this position and were entirely comfortable with these types of psychoanalytic explanations.

But the introduction of antipsychotic and antidepressant medications in the 1950’s changed things. They offered a pathway to “prima facie medical legitimacy.” What was needed was a label that posed as a diagnosis; time for a 15-minute med check; and a quickly-written prescription. “No longer would it be necessary to delve collaboratively and time-consumingly into a client’s childhood conflicts, current fears, or counter-productive relationships.” Don’t be too quick to dismiss Hickey’s rhetoric. In an address to the American College of Neuropsychopharmacology in 2000, Allen Frances said the DSM system and psychopharmacology grew up together “and have had a strong influence upon one another.”

The psychopharmacological revolution required that there be a method of more systematic and reliable psychiatric diagnosis. This provided the major impetus for the development of the structured assessments and the research diagnostic criteria that were the immediate forerunners of DSM-III. In turn, the availability of well-defined psychiatric diagnoses stimulated the development of specific treatments and increasingly sophisticated psychopharmacological studies.

Hickey said as more psychiatric drugs came to market in the 1960s, “it became increasingly clear the psychogenic framework of the DSM-I had to go.” Thus a movement to develop a cause-neutral diagnostic system began with the DSM-II and continued on through the DSM-III under the guidance of Robert Spitzer.  The concept of cause-neutrality, according to Hickey, meant that: “regardless of why a person is despondent, if he scores five or more yeses on the checklist, he has major depression, the ‘illness,’ and therefore needs medical treatment.” Over time, as the use of DSM diagnostic criteria became central to the conceptualization of depression and grief, the bereavement exclusion included by Robert Spitzer in the DSM-III seemed more and more problematic for mainline psychiatry. And bereavement as a cause of grief-related depression became increasingly irrelevant.

The death of grief is inversely related to the birth and growth of what Hickey called the biological-pathology perspective. The bereavement exclusion was finally pronounced dead with the publication of DSM-5 in 2013. “The bogus cause-neutral perspective (in reality the bogus biological-pathology perspective) was now the de facto psychiatric position, with no exceptions.”

The notion that one can gain an understanding of a person’s sadness by ignoring its causes and contexts, and simply bumping his superficial presentation against a fabricated checklist, and seeing if he scores hits on at least five, is simply inane. It’s like trying to understand a poem by counting the words. Anyone with the slightest compassion or understanding of human experience can see this.

For more on the concerns with psychiatric diagnosis see: “Where There’s Smoke …” and “Psychiatric Huffing and Puffing.” For more on the APA actions on bereavement, see: “Pathologizing Grief.”

 

08/3/18

Lies, Damn Lies and Autism Statistics

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The Center for Disease Control and Prevention (CDC) recently published a study, “Prevalence of Autism Spectrum Disorder,” that said the overall prevalence rate for Autism Spectrum Disorder (ASD) in the US was 16.8 per 1,000 (one in 59) children who were 8 years old in 2014. Estimates of ASD increased from one in 150 children during 2000-2002 to one in 68 during 2010-2012. This means the prevalence of ASD doubled in the twelve years between 2000 and 2012; then it increased another 16% between 2012 and 2014. One autism expert said those rapid increases were not believable, and even “preposterous.”

Darold Treffert made the above comments in his article for Scientific American, “We Need to Stop Moving the Goalposts for Autism.” Dr. Treffert is an expert on savant syndrome and wrote two books on the topic. He was also a consultant for the movie Rain Man. He believes the reported increases in ASD were the result of moving the goalposts in diagnosis by diluting the condition and expanding the definition of ASD.

Problems he pointed to in the CDC study included the fact that figures included what he called “educational autism,” meaning a diagnosis made by teachers or educational specialists; and “medical autism,” a diagnosis based on review of available medical records. “There are no actual in-person evaluations.” Another issue he pointed out was the extremes of prevalence reported between states within the Autism and Developmental Disabilities Monitoring (ADDM) Network used for the CDC study. New Jersey, one of the eleven ADDM sites in the US, reported a prevalence of 2.93 percent for ASD, more than double that of Arkansas at 1.31 percent.

From my perspective as an observer of “autism” for over 60 years, I do believe there is an actual increase in the number of cases of autistic disorder, but it is not an epidemic. And it has not been an increase of 31 percent in two years here in Wisconsin, for example, or a more than 150 percent increase in the U.S. in the past decade. That is simply not believable. Instead much of that “epidemic” is a dilution of the rigor of the criteria for autism.

He noted some examples of misdiagnosis, and said the first step is to make a correct diagnosis. The broader and less precise the diagnosis becomes, the less chance of finding subgroups “among increasingly heterogeneous, diluted diagnostic groups.” He believes autism is a group of disorders, rather than a single disorder. In order to detect autism with precision Treffert said we need to start calling things by their right names. “The present method of assessing prevalence in the U.S. is not doing that well since we keep moving the goalposts.”

Treffert referred to another Scientific American article by Simon Baron-Cohen, “Is It Time to Give Up on a Single Diagnostic Label for Autism?” When reviewing the rationale for a single diagnostic label for ASD, Baron-Cohen said the term spectrum in ASD refers to the heterogeneity in autism. Although all autistic individuals share certain core features, “there are huge disparities in many areas.” This heterogeneity is part of the meaning of the term “spectrum.” He then pointed to other benefits of the ASD label:

It allows the clinician to describe the person without shoehorning them into a rigid subgroup. Its flexibility also allows for individuals who previously transitioned between different subgroups. And it reduced the risk that service providers might exclude a person because they didn’t meet the eligibility criteria based on a rigid subtype. So, the consensus among clinicians is that the addition of the word “spectrum” was helpful and long overdue. Most clinicians therefore find it useful to have the flexibility of the very broad single diagnostic label.

He then turned to the downside of a single diagnostic label. The American Psychiatric Association combined what had been Asperger Syndrome (AS) with classic autism in the DSM-5, believing the diagnosis of AS was unreliable. Hindsight suggests that wasn’t the problem. Rather, the contrast between AS and classic autism had value and “perhaps should have been retained.” He suggested using a typology of subtypes within ASD. “Under this approach, we could keep the single umbrella category called the autism spectrum and within this have type 1, type 2, etc.”

Treffert commented that the search for a reliable, consistent measure of autism prevalence occurred outside the U.S., as well. He referred to a different set of researchers in “Global Data on Autism Spectrum Disorders Prevalence” whose data for ASDs suggested the global rate was around 1.7 per 1,000 (one in 588), not the 16.8 per 1,000 (one in 59) reported by the CDC study. The authors noted in many developing countries the reported rates of ASD are significantly lower than in developed countries. “Whether this truly reflects an absolute low prevalence, deficits in diagnostic skills, maladaptation of diagnostic criteria as it relates to cultural differences in behaviour, or under sampling are issues that continue to be discussed.” Treffert added there is also an inconsistency between how the DSM-5 and the World Health Organization’s International Classification of Diseases (ICD) define ASD.

Allen Frances, the chair for the DSM-IV, added another perspective into the autism “epidemic” in his book, Saving Normal. He said before the DSM-IV, the diagnosis of autism was extremely rare. But the DSM-IV broadened the concept of autism by introducing Asperger’s disorder. And prevalence rates are extremely sensitive to any change in how a psychiatric disorder is defined. “The twentyfold increase in just twenty years occurred because diagnostic habits had changed radically, not because kids were suddenly becoming more autistic.”

As chair of the DSM-IV Task Force, I deserve blame for not having anticipated the rush to overdiagnose Asperger’s. It would have been useful in advance to predict the changes in diagnostic rates and to explain their causes. We should have proactively taken steps to educate the public and the media about what the labels mean and what they don’t mean—that kids hadn’t changed, just the way they were being diagnosed. It’s a lot easier to trigger a fad then end one.

The prevalence of autism surely came from improved surveillance and identification by doctors, teachers, families and patients. Some of the increase was also because of the introduction of Asperger’s disorder, “a new diagnosis that greatly broadened the concept of autism.” But Frances estimated that about half of the increase was due to the service opening provided—“children get the diagnosis incorrectly because it is the ticket to more attention in the school system and more intense mental health treatment.”

It would be better if school decisions were not so closely coupled to a psychiatric diagnosis that was developed originally only for clinical, not for educational, purposes. Many of the mislabeled kids do get special attention; they just don’t need the extra added stigma that comes with an incorrect diagnosis of autism.

Frances also pointed out another issue leading to the drastically high prevalence rate found by the CDC study: epidemiological miscount. He said every so often we hear about the climbing rates of some psychiatric disorder, which in this case is autism. These rates are generated by a psychiatric epidemiologist, “using a method that is inherently flawed and systematically biased in the direction of overreporting.” Epidemiological studies, like that conducted by the Autism and Developmental Disabilities Monitoring (ADDM) Network, rely on lay interviewers with no clinical experience and no ability to determine whether symptoms are clinically meaningful or not. “They make their diagnoses of psychiatric disorders based upon symptoms counts alone with no consideration of whether the symptoms are severe or enduring enough to really warrant diagnosis or treatment.”

The ADDM study, as Treffert pointed out, had no in-person interviews. The ADDM staff reviewed records and abstracted information from “comprehensive evaluations” that were completed in the local communities. A child was considered to meet the case definition for ASD,

If he or she displays behaviors, as described on one or more comprehensive evaluations completed by community-based professional providers, consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autistic disorder; pervasive developmental disorder–not otherwise specified (PDD-NOS, including atypical autism); or Asperger disorder.

Allen Frances noted where this always results in greatly inflated rates. Psychiatric symptoms in mild form are widely distributed in the general population. From time to time almost everyone will experience isolated or mild symptoms of a psychiatric disorder. “But isolated or mild symptoms alone do not define psychiatric disorder—they must cohere over time in a specified way and also cause significant distress or impairment.” Epidemiological studies, Frances said, regularly disregard these factors. “They mistakenly diagnose as psychiatric disorder symptoms that are mild, transient, and lacking in clinical significance.”

Results generated in this rough-and-ready way are no more than an upper limit on the prevalence of any given mental disorder. They should never be taken at face value as a true reflection of the real extent of illness in the community. Unfortunately, the exaggerated rates are always reported without proper caveat and are accepted as if they are an accurate reflection of the real prevalence of psychiatric disorder. Disraeli exaggerated only a tad when he said: “There are three kinds of lies: lies, damned lies, and statistics.”

09/26/17

Demolishing ADHD Diagnosis

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The Harvard psychologist, Jerome Kagan, sees ADHD as more of an invented condition than a serious illness. Further, he thinks it was invented for “money-making reasons” by the pharmaceutical industry and pro-ADHD researchers. He believes the drastic increase in the number of children diagnosed with ADHD has more to do with “fuzzy diagnostic practices” and relabeling. Fifty years ago, a 7-year-old child who was bored and disruptive in class was seen as “lazy.” Today he is seen as suffering from ADHD.

Every child who’s not doing well in school is sent to see a pediatrician, and the pediatrician says: “It’s ADHD; here’s Ritalin.” In fact, 90 percent of these 5.4 million kids don’t have an abnormal dopamine metabolism. The problem is, if a drug is available to doctors, they’ll make the corresponding diagnosis.

In his interview with Spiegel Online, Kagan went on to say that the inflated diagnosis of ADHD and other so-called childhood mental health disorders means more money for the pharmaceutical industry, psychiatrists and the people doing research. “We’re up against an enormously powerful alliance: pharmaceutical companies that are making billions, and a profession that is self-interested.” As he said, he’s not the only psychologist who is saying this.

Parenting expert and family psychologist, John Rosemond, agrees with Kagan. In 2009 he co-authored The Diseasing of American’s Children where they argued that ADHD and other childhood behavior disorders “were inventions of the psychological-psychiatric-pharmaceutical industry.” They went further than Kagan in saying that ADHD does not exist; that it is a fiction. In his April 9, 2017 article, “ADHD Simply Does Not Exist,” Rosemond referred to Kagan’s declaration on ADHD, noting that he and other psychologists studied Kagan’s books and research papers on children and child development when they were in graduate school. In The Diseasing America’s Children, Rosemond said:

Science depends on verifiable, objective evidence and experimental results that can be replicated by other scientists. Where ADHD is concerned, neither verifiable, objective evidence nor replicable experimental results exist to support the claims of the ADHD establishment.”

Rosemond and his co-author, Bose Ravenel, believe that childhood behavior disorders like ADHD are manifestations of “dysfunctions of discipline and lifestyle” endemic to modern family culture. Once these problems are identified, they can be easily corrected. And once corrected, the errant behavior “usually recovers to a state of normalcy within a relatively short period of time.” They believe children do not need a psychologist when they misbehave, they need discipline—“firm, calm and loving discipline.”

In Debunking ADHD, educational psychologist Michael Corrigan said ADHD is a negative label that does not exist. “Not unlike the many wonderful stories about unicorns, fairies, and leprechauns, the diagnosis of ADHD is a brilliant work of fiction.” He noted that many of the common childhood behaviors (or supposed symptoms) associated with ADHD are also used to identify giftedness in children. When these behaviors are harnessed and focused, they can help children become “incredibly creative, insightful, and successful individuals in adulthood.” If children don’t learn to harness the power of the behaviors ADHD and giftedness have in common, “such behaviors when displayed might seem annoying and immature.” He said:

My biggest reason for writing this book is my desire to show you that the practice of medicating children for acting like children in the name of ADHD is, in two words, wrong and dangerous. Despite the grandiose claims of the mega-pharmaceutical companies selling ADHD drugs to concerned parents, prescribing pills to young children trying to learn how to become young adults is just a quick fix void of any long-term benefits.

Corrigan described eating lunch with a group of children who had just taken their ADHD medication at school. They were now supposedly “good to go” (sufficiently medicated) for an afternoon of learning. It was the longest lunch period he had ever experienced. “Comparing the kids at my table to others in the cafeteria, and slowly watching these playful, creative, energetic, and funny children go from kids being kids to near expressionless robot-like entities, made me sick to my stomach.”

The total number of children on ADHD medication “skyrocketed” from 1.5 million in 1995 to 3.5 million in 2011. “Sales of prescription stimulants quintupled from 2005 to 2015.” The rising rate of ADHD diagnosis has been described as “an unreal epidemic” and a “national disaster of dangerous proportions” by well-known professionals like Allen Frances and Keith Conners. Frances was the chair of the DSM-IV. Conners, now an emeritus professor of medical psychology at Duke University, “spent much of his career in legitimizing the diagnosis of ADHD.”

Allen Frances was one of four authors of an article in the International Journal of Qualitative Studies on Health and Well-Being, “ADHD: A Critical Update for Educational Professionals.” When the DSM-IV was published in 1994, the prevalence of ADHD was estimated to be 3%. Since then, parent-reported ADHD diagnosis increased to 7.8% in 2003; 9.5% in 2007; and to 11% in 2011. Nearly one in five high school boys had been diagnosed with ADHD and around 13.3% of 11-year-old boys were medicated for ADHD.

Teachers and other school personnel are often the first to suggest a child might be “ADHD.” Research suggested teachers felt insecure about dealing with behavioral problems and hesitated to accept responsibility for students with special needs. Frances and his coauthors described six scientifically grounded issues that educational professionals should be aware of when they are confronted with inattention and hyperactivity in the classroom.

First: birth order matters. Several studies have shown “That relative age is a significant determinant of ADHD diagnosis and treatment.” The youngest children in the classroom are twice as likely to be diagnosed with ADHD and receive medication. They suggest teachers take the child’s relative age into account when judging the child’s behavior. “Seeing ADHD as the cause of inattention and hyperactivity is in fact a logical fallacy as it is circular.”

Second, there is no single cause of ADHD. “There are no measurable biological markers or objective tests to establish the presence or absence of ADHD (or any other given DSM syndrome).” ADHD is a description of behavior and is based on “criteria that are sensitive to subjectivity and cognitive biases.” Multiple factors have been associated with ADHD, without necessarily implying causality. Those factors include: divorce, poverty, parenting styles, lone parenthood, sexual abuse, lack of sleep, artificial food additives, mobile phone use and growing up in areas with low solar intensity. “All these factors and more may play a role when a particular child exhibits impairing hyperactive and inattentive behaviours, and there is no conclusive cause of ADHD.”

Third, most children exhibiting “ADHD behavior” have normal-looking brains. Studies that do show small differences in terms of brain anatomy do not apply to all children diagnosed with ADHD. Individual differences refer to slower anatomical development. “They do not reveal any innate defect as is illustrated by the fact that many people with an unusual anatomy or physiology do not experience ADHD related problems.” Also, the test subjects in many brain-related studies are rigorously screened and don’t represent all individuals diagnosed with ADHD.

The samples do not comprise an accurate representation of their respective populations, meaning an average child with a diagnosis of ADHD and an average “normal” child. This problem is particularly urgent since the DSM 5 has lowered the age of onset criterion, as well as the impairment criterion compared to the previous version, the DSM-IV. Alongside the lowered threshold, the potential to generalize earlier research findings has lowered as well.

Fourth, the claims of ADHD being inherited may be overestimated.  The claims vary widely and are subject to debate because of methodological issues used in calculating the heritability coefficient in twin, familial and adoption studies. There is significant difficulty separating genetic influences from environmental ones, such as poverty, parenting styles and divorce, in these studies. “In genetic association studies that really analyse genetic material and that are more powerful when separating the influence of genetics from other etiologic sources, associated genes show only very small effects.” When combined, they explain less than 10% of variance.

This means they occur only slightly more often in diagnosed individuals than in controls, and they do not explain nor predict ADHD behaviours. For educational professionals, this is important to consider as an ADHD label might give a false sense of security with regard to the alleged (genetic) cause of a child’s behaviour and the preferred cure (medication).

Fifth, medication does not benefit most children in the long run. Follow up studies of the long-term effects of the MTA (Multimodal Treatment of Attention Deficit Hyperactivity Disorder) study showed a convergence of outcomes over time between medicated and non-medicated children. Other studies also report either no long-term benefits, or even worse benefits. “While medication may help a small group of children in the long run, most will not benefit from long-term pharmaceutical treatment.”

The sixth and final issue that educational professionals should be aware of when confronted with inattention and hyperactivity in the classroom is the reality that a diagnosis can be harmful to children. A CDC MMWR Report indicated only 13.8% had severe ADHD, with 86.2% having mild (46.7%) or moderate (39.5%) ADHD. The authors pointed out a DSM diagnosis opened the door for additional reimbursement to the school for treatment and school services, perhaps promoting a search for pathology in relatively mild cases. “The question is whether in these mild cases the merits of a confirmed diagnosis—such as acknowledgement of problems and access to help—outweigh possible demerits.” Some known disadvantages of a diagnosis are: lower teacher and parent expectations that turn into self-fulfilling prophecies, prejudice and stigmatization of diagnosed children, a more passive role towards problems, difficulties getting life and disability insurances later on in life, and others.

The Allen Frances article linked above was the most accepting of ADHD as a legitimate “neuro-developmental disorder.” Yet it cautioned there was no single cause for ADHD, medications to “treat” ADHD did not have long-term benefits, and there was a problem with its over diagnosis. Jerome Kagan thought 90% children were wrongly diagnosed with ADHD because of “fuzzy diagnostic practices and relabeling.” Michael Corrigan, John Rosemond and questioned the validity of ADHD as a neuro-developmental disorder. Corrigan said it pathologized normal childhood behavior; and medicating these children was wrong and evil. It’s time to demolish the ADHD treatment empire.

Additional articles on ADHD can be found on this website here: “National ADHD Epidemic,” “Misleading Info on ADHD,” “Tip of the ADHD Iceberg,” and “Is ADHD Simply a Case of the Fidgets?” You can also read a longer paper: “ADHD: An Imbalance of Fire Over Water of a Case of the Fidgets?”

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.

10/18/16

Dancing with the Devil

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I once knew a woman who had an anxiety disorder. She also abused benzodiazepines. She was able to conjure up a panic attack in a doctor’s office and walk out with a prescription for the benzo of her choice. At one time, she had four concurrent prescriptions for these anti-anxiety medications. Another person I know of has a ten-year history of using benzodiazepines at close to the maximum recommended dose. When he had an unexpected short-term hospital stay, the treating physicians were reluctant to continue prescribing benodiazepines at such a high level while he was in the hospital. When he returned home, in case his medical issue resulted in another unexpected stay, he put together an emergency hospital kit with various things—including extra benzodiazepines.

A study published in the American Journal of Public Health in April of 2016 found that benzodiazepines were the second most common drug in prescription overdose deaths for 2013. Given the common knowledge of the potential dangers of benzodiazepines and people becoming more aware of opioids, Marcus Bachhuber and a team of researchers thought that their study would show a steady of declining pattern for prescribing benzodiazepines. But they found exactly the opposite. Between 1999 and 2013 there was an increase of 30% among adult Americans who filled a benzodiazepine prescription. In addition, the amount of medication within a prescription doubled over the same time period.

Bachhuber was quoted by CNN as saying the study’s findings were very concerning. The risk of overdose and death from benzodiazepines alone is said to be generally lower in otherwise healthy adults. But in combination with other drugs like alcohol or opioids, they can be lethal.

Future research should examine the roles of these potential mechanisms to identify effective policy interventions to improve benzodiazepine safety. In particular, as underscored by several recent reports, interventions to reduce concurrent use of opioid analgesics or alcohol with benzodiazepines are needed.

The overdose problem with benzos has been overshadowed by the problems with prescription opioids. Writing for CNN, Carina Storrs said: “The current study could help shine a light on the problem of benzodiazepine abuse and overdose.” Dr. Gary Reisfield, a professor of psychiatry at the University of Florida, referred to the problem with benozdiazepines as a “shadow epidemic”:

Much attention has been paid to the explosion of prescription opioid prescribing and the associated morbidity and mortality. Much less attention has been paid to the shadow epidemic of benzodiazepine prescribing and its consequences.

A 2015 study by Jones and McAninch found that emergency department visits and overdose deaths involving opioids and benzodiazepines increased significantly between 2004 and 2011. Overdose deaths from combining the two classes of drugs rose each year from 18% in 2004 to 31% in 2011. This rate increased faster than the percentages of people filling prescriptions and the quantity of pills in the prescriptions.

As Dr. Indra Cidambi wrote in “Are We Ignoring an Escalating Benzodiazepine Epidemic?”,  she observed with increasing alarm the rising rate of concurrent use/abuse of benzos among opiate users. She pointed to two possible factors driving this trend. First, some opiate abusers use benzos to “spike” the euphoria from their opiates. Second, patients often receive their prescriptions from two different physicians. She said that it is “notoriously difficult” for doctors to refuse to prescribe these two medications.

Unfortunately, and ironically, pain and anxiety are neither verifiable nor quantifiable through medical testing! Consequently, self-reported symptoms by patients are the sole basis on which prescriptions for these medications are written, enabling individuals addicted to these medications to obtain them fairly easily.

Dr. Cidambi recommended the establishment of a national database for physicians to verify whether or not a patient has been prescribed one of these medications before prescribing or filling a prescription for the other. Second, she said physicians should develop limited, short-term treatment plans from the beginning to treat noncancerous pain with opiates and anxiety with benzodiazepines.

Studies have shown the decreasing efficacy of long-term treatment for pain with opioid medications, and evidence-based treatment protocols for benzodiazepines clearly indicate that long-term use of benzodiazepines is not recommended.

In “Benzos: A Dance with the Devil,” Psychiatrist Kelly Brogan described some of her work helping patients taper off of benzodiazepines. A woman who had been placed on Remeron (an antidepressant) and Klonopin (a benzodiazepine) for eight years said of her original prescriber: “He never once told me there might be an issue with taking these meds long-term. In fact, he told me I probably needed them after I tried stopping them cold turkey and felt so sick I thought I was dying.” Brogan said no one ever discussed with this woman or her patients the true risks, benefits and alternatives to psychiatric medications like benzodiazepines, “perhaps because we as clinicians are not told the full story in our training.”

She went on to quote from a paper by another psychiatrist, Peter Breggin, on the risks of benzodiazepines, which include: cognitive dysfunction that can range from short-term memory impairment and confusion to delirium; “disinhibition or loss of impulse control, with violence toward self or others, as well as agitation, psychosis, paranoia and depression.” There can also be severe withdrawal symptoms, ranging from anxiety and insomnia to psychosis and seizures after abruptly stopping long-term larger doses. The person can re-experience their pre-drug symptoms as they taper. These so-called rebound symptoms of anxiety, insomnia and others serious emotional reactions can be more intense than they were before drug treatment began. And don’t forget dependency or abuse.

Psychiatrist Allen Frances, the former chair of the DSM-IV, recently wrote: “Yes, Benzos Are Bad for You.” He introduced his article by saying that he was going to say some very negative things about benzodiazepines in the hope that doctors think twice before prescribing them and patients are discouraged from taking them. Benzos were wonder drugs in the 1960s. Anyone remember the 1966 song, “Mother’s Little Helper,” by the Rolling Stones? These drugs were reputed to be safe, and so were used for a variety of “ills,” such as anxiety, alcohol use disorders (yes, really), to take the edge off of agitation in dementia, and to help people sleep. “Initially we were pretty oblivious to the risk of addiction.” So benzodiazepines quickly became the most prescribed medications in America.

A second craze began in the 1980s with the release of Xanax. Frances said the dose to treat panic disorder was “dangerously close” to the dose leading to addiction. “This should have scared off everyone from using Xanax, but it didn’t.” It remains a best seller, with its own “brand” that now leads to fentanyl be pressed into counterfeit Xanax pills. See “Buyer Beware Drugs” and Paul Gaita’s article on fake Xanax laced with fentanyl.

The real wonder of the benzos is that sales continue to boom, despite their having so little utility and no push from pharma marketeering (because patents have run out – thereby decreasing costs and profits.) Between 1996 and 2013, the percentage of people in the U.S. using benzos jumped more than one-third from an already remarkable 4.1 to 5.6 percent. Especially troubling is that benzo use is ridiculously high (nearly one out of ten) in the elderly, the group most likely to be harmed by them.

Frances said the beneficial uses of benzodiazepines can be counted on the fingers of one hand: short-term agitation in psychosis, mania and depression; catatonia; “as needed” use for times of special stress, like fear of flying, or for sleep. While they should be used very short term, in real life most people take them long term—“in doses high enough to be addicting, and for the wrong reasons. . . . Benzos are very easy to get on, almost impossible to get off.”

In addition to the harm from overdoses, Frances described the painful and dangerous withdrawal symptoms, which he said are a “beast.” Common symptoms are irritability, insomnia, tremors, distractibility, sweating and confusion. “The anxiety and panic experienced by people stopping benzos is usually much worse than the anxiety and panic that initially led to their use.”  Concurrent use or abuse of alcohol or other drugs, like opioids, complicates withdrawal even further.

The most insidious issues with benzos for Frances, is how they effect brain functioning. Especially with the elderly, ongoing benzo use can be devastating. Many elderly begin their downward spiral to death and disability from falls—that happen from their benzo use! He said: “If you meet an elderly patient who seems dopey, confused, has memory loss, slurred speech, and poor balance, your first thought should be benzo side effects — not Alzheimer’s disease or dementia.” See “Sedating Seniors” for more information on this topic. It’s been over 30 years since he last prescribed a benzo for anxiety.

The tough question is what to recommend for those many unfortunates already suffering the tyranny of benzo addiction. Should they stay the course to avoid the rigors and risks of withdrawal or should they make the great effort to detox? This is an individual decision that can’t be forced on someone. But the longer you are on them, the harder it gets to stop, and the cognitive side effects of benzos create more and more dysfunction as your brain ages. The best bet is to stick with a determined effort to detox, however long and difficult, under close medical supervision. On a hopeful note, some of the happiest people I have known are those who have overcome their dependence on benzos.

So it was encouraging to see that the FDA will require class-wide changes in drug labeling to bring attention to the dangers of combining opioids and benzodiazepines. The changes will include boxed warnings on nearly 400 products with information on the risks of combining these medications. The FDA Commissioner, Robert Califf said: “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together.” He implored health care professionals to carefully and thoroughly evaluate on a patient-by-patient basis whether the benefits outweigh the risks when using these drug classes together.

Used alone or in conjunction with opiates, benzodiazepines are potentially lethal and addictive. A too sudden withdrawal from benzodiazepines can be fatal, where the same is rarely true with opiates. They work quickly and effectively for anxiety and sleep problems and yet they can have a multitude of side effects, including addiction. Did I say they are addictive? Using benzodiazepines has become a dance with the devil for too many unsuspecting individuals … those that are still alive to regret it, that is.

This article previously appeared on the addiction and recovery website “The Fix” under the title of “Dangerous Dance.”

05/31/16

To Be or Not to Be Bipolar

53409894_sOn The Oprah Winfrey Show in October 2007, Sinéad O’Connor disclosed that she had been diagnosed with bipolar disorder in 2003. The website, “Famous Bipolar People,” said Sinéad had suffered from depression and had thoughts of suicide since the age of 23. She also experienced voices urging her to harm herself. The voices got so loud, she said, she took herself to hospital. She was put on antidepressants, which helped. “These all confirmed that she had bipolar disorder.” Then a few years ago, she went public with an announcement that she had been misdiagnosed with bipolar disorder for eight years.

During her interview with Oprah, she said she didn’t think she was born with bipolar disorder. She thought her illness was caused by a number of outside pressures. “I believe it was created as a result of the violence I experienced.” She was scared to take the medication at first. But she realized that she had nothing to lose, so she tried them. “It was brilliant because I felt this huge hole. And when I took the meds, within half an hour, it was literally like I felt concrete coming in to fill the hole.” She said she thought she had died and then was ‘born again’ as a result of taking the meds.

But after spending eight years on the medications, she realized her depression was still there. Additionally, “some of the same problems she’d had before being medicated were persisting.” And she received complaints about her weight from people in the music business. By the way, weight gain is one of the side effects from antipsychotic medication. When she mentioned her weight problem to her doctors, they suggested taking her off of the bipolar meds as a remedy.

Writing for About Health, Angel Rouse said O’Connor was alarmed with the casualness of the suggestion and aware that simply stopping meds could be dangerous. So she sought outside opinions, eventually getting three additional ones. Their conclusion was that she was not bipolar. Rather, she actually suffered from PTSD. She revealed that when she cancelled her tour in 2012, she had tried to stop taking her medication cold turkey. Ironically, as a result of that attempt, she struggled with bipolar problems of mania and depression for nearly a year. Interviewed for the Irish Mirror, she said:

The illness was in fact what happens when you don’t go about coming off these meds properly. I’m delighted to be able to say that after ten years of poisoning myself with these drugs and having to live with the extremely difficult side-effects of them I can shortly begin the very, very slow indeed, process of getting them out of my system and my life and getting my life back.

Sinéad O’Connor is not a unique case. The NAMI (National Alliance on Mental Illness) website claims that 2.6% or 6.1 million American adults have a bipolar disorder. NAMI referenced this “mental health fact” on data they took from the National Institute of Mental Health (NIMH), which in turn cited this article by Kessler et al. from JAMA Psychiatry on the prevalence, severity and comorbidity of DSM-IV disorders. See Table 1 in the article for the reported percentage. But if Sinéad O’Connor could be misdiagnosed as having a bipolar disorder and mistakenly placed on potentially harmful medications that are seen as necessary to stabilize and control the bipolar ‘illness,’ how many others are similarly misdiagnosed? Regarding the medications she was on, O’Connor told the Irish Mirror:

They are extremely debilitating drugs. Tiring to the extreme. Ironically, extremely depressing. They can cause suicidal or self-harm type thinking. They can mess up your menstrual cycle very badly and cause you to be incapacitated for a week before. . . . [They] f**k up your liver, your kidneys, your eyes, your appetite, your entire way of thinking and generally your entire life.

Within his seminal book, Anatomy of an Epidemic, Robert Whitaker described “The Bipolar Boom” in chapter nine. He related a talk given by Fredrick Goodwin at the 2008 annual meeting of the American Psychiatric Association (APA). Goodwin said the illness has been altered since 1990. There was more rapid cycling; more mixed states; more lithium treatment failures than when he’d coauthored Manic-Depressive Illness. “The illness is not what Kraepelin described anymore, and the biggest factor, I think, is that most patients who have the illness get an antidepressant before they ever get exposed to a mood stabilizer.” Whitaker said not everyone speaking agreed that antidepressants had been disastrous for bipolar patients, but no one questioned Goodwin’s assessment that bipolar outcomes had noticeably worsened since 1990.

On his website, Whitaker noted that before 1955, bipolar illness had been a rare disorder. Only 12,750 people were hospitalized with the disorder that year. There were only about 2,400 “first admissions” that year in the country’s mental hospitals. Outcomes were fairly optimistic. Seventy-five percent of these first-admissions were projected to recover within 12 months. And only 15% of first-time admissions were expected to become chronically ill. And at least 70% were projected to return to work and have active social lives.

Today, bipolar illness is said to affect one in every 40 adults in the United States. A rare disorder has become a very common diagnosis. There are several reasons for this. First, many drugs–both illicit and legal–can stir manic episodes, and thus usage of those drugs leads many to a bipolar diagnosis. Second, the diagnostic boundaries of bipolar illness have been greatly broadened.

Allen Frances is a psychiatrist and the author of Saving Normal. He was also the chair for the DSM-IV, which expanded the criteria in diagnosing bipolar diagnosis by adding the bipolar II category. In Saving Normal, he described a dilemma when the APA was revising bipolar diagnosis for the fourth edition of the DSM. Patients with “hypomania,” less-than-full-manic episodes, didn’t fit neatly into the unipolar or bipolar depression categories. The bipolar II category was seen as a compromise that would lessen the dangers of classifying them as having unipolar depression and treating them with antidepressant medication that could trigger a manic episode.

We knew that bipolar II would expand the bipolar category somewhat into unipolar territory, but we did not think that it would double. Undoubtedly, our decision resulted in more accurate diagnosis and safer treatment for many previously missed truly bipolar patients. But like all fads, it overshot and had led to unnecessary medication for many unipolar patients who have been misdiagnosed as bipolar on very flimsy grounds and are now receiving unnecessary mood stabilizing drugs.

Whether you agree with Frances’ assessment that adding bipolar II resulted in more accurate diagnosis and safer treatment for many, don’t miss that he also said it led to misdiagnosis and unnecessary medication.  If you follow this link, also given above, to Robert Whitaker’s website, Mad in America, you will find a series of journal articles describing how substance abuse can be related to developing bipolar disorder; the effects of antidepressant use on bipolar disorder and how these drugs can worsen long-term bipolar outcomes; and the deterioration of bipolar outcomes in the modern era.

For a postscript, I want to return to note one last piece of information on Sinéad O’Connor. While she has cast off her diagnosis of bipolar disorder, it isn’t finished with her. Many websites, like that of “Famous Bipolar People” mentioned above, still list her as one of their own. There was a concluding note in the “About Health” article on Sinéad O’Connor that said: “In spite of her having stated clearly on several occasions that she does not have bipolar disorder, O’Connor continues to be included at many sites that compile lists of famous bipolar people.”

Famous Bipolar People, if Sinéad had said it’s over between the two of you, accept it and move on. There are plenty of more fish in the sea. You still have Kay Redfield Jamison. She’s written two books that touch on bipolar disorder, An Unquiet Mind and Touched with Fire. And both have been made into movies. The movie, Touched with Fire, is a fictional love story about two people with bipolar disorder who meet in a psychiatric hospital and fall in love. The trailer has a slight Romeo and Juliet feel to it; two young lovers who family and friends try to keep apart. So there will be plenty of new discussions about who is and who isn’t bipolar related to the movie. Just let go of Sinéad; let her go and move on.

12/31/15

Medieval Alchemy

© algolonline | 123rf.com

© algolonline | 123rf.com

Three years after the publication of the fourth edition of the DSM in 1994, the US became the only country in the world to allow direct to the consumer advertising of pharmaceuticals. Now there’s New Zealand. Soon after the approval, pharmaceutical advertising was everywhere in the US. Over the next decade, from 1997 to 2007, drug companies tripled their spending on marketing. Everyday problems were being portrayed as unrecognized psychiatric disorders. The chair of the DSM-IV, Allen Frances, admitted they had failed to anticipate how easily their manual could be utilized to promote pharmaceutical sales. They were not able to stem the flood of “false demand” instigated by the marketing done by drug companies. “Within a few years, it was clear the drug companies had won and we had lost.”

We should have been far more active in educating the field and prospective patients about the risks of overdiagnosis. There should have been prominent cautions in DSM-IV warning about overdiagnosis and providing tips on how to avoid it. We should have organized professional and public conferences and educational campaigns 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. (Allen Frances, Saving Normal, p. 74)

Frances said the evidence for this diagnostic inflation is clear. There has been a fortyfold increase in childhood bipolar disorder. Autism diagnoses have increased twentyfold. “Attention deficit/hyperactivity has tripled; and adult bipolar disorder doubled.” The result has been huge profits for the drug companies.

At the very top of the Pharma hit parade are the antipsychotics at a resounding $18 billion a year. Antidepressants produce a hardy $12 billion a year, despite the fact that many are now off  patent and sold in cheaper generic versions. Fifteen years ago, stimulants were a rounding error in drug company sales at a measly $59 million a year. Now with direct-to-consumer advertising and heavy marketing to doctors, sales have been juiced up to a hefty $8 billion a year. And because primary care doctors love to prescribe them, antianxiety agents are eight in sales among drug classes—even though they probably do much more harm than good. (Saving Normal, p. 105)

Patients regularly misdiagnosed themselves and asked their doctor for “the magic pill that would correct their chemical imbalance,” just as the advertisements suggested. And as requested, doctors prescribed the medications. “Patients who requested a drug they had seen advertised were seventeen times more likely to walk out of the office with a prescription.” Primary care physicians (PCPs), such as general practitioners, obstetrician-gynecologists and pediatricians, now prescribe most of the psychiatric drugs in the US.

Using data from August 2006 to July 2007, Ryan DuBosar noted in “Psychotropic drug prescriptions by medical specialty” that 59% of the psychotropic prescriptions were written by PCPs. Breaking down the drug by class, PCPs prescribed 37% of the antipsychotics, 52% of the stimulants, 62% of the antidepressants and 65% of the anxiolytics (anti-anxiety meds). Frances said: “Too often, drugs are used promiscuously in a way that approximates the quackish practice of medieval alchemists.”

On November 17, 2015, the American Medical Association (AMA) adopted a new policy that calls for a ban on direct to the consumer advertising of prescription drugs. The new policy calls for a physician task force and launching an advocacy campaign to promote prescription drug affordability.

The AMA Board Chair-elect, Patrice Harris, said the vote reflects concerns among physicians about Pharma’s commercially-driven promotions and the impact of marketing costs in escalating drug prices. She said direct-to-consumer advertising also created a demand for new and more expensive drugs, even when these drugs may not be appropriate. “Patient care can be compromised and delayed when prescription drugs are unaffordable and subject to coverage limitations by the patient’s health plan. In a worst-case scenario, patients forego necessary treatments when drugs are too expensive.”

Reporting for Reuters, Susan Kelly noted that the AMA did not say how the ban could be overturned. There have been a series of court decisions determining that the ads are a form of commercial speech protected by the U.S. Constitution. PhRMA, the largest trade group for the pharmaceutical industry in the US, said the ads increase consumer awareness of available treatments for diseases. PhRMa spokesperson, Tine Stow said: “Providing scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer pharmaceutical advertising about prescription medicines.” REALLY?

Allen Frances said that Big Pharma seems to feel it is above the law. “Almost all of the companies have absorbed huge fines and even criminal penalties as punishment for their illegal sales practices. He published a chart in Saving Normal that he referred to as the drug company hall of shame. It contained information on fines and settlements by Pharma for off-label promotion (which is illegal at this time) as well as shady marketing and fraudulent misbranding. The sum total of the fines between 2004 and 2012 was $12.06 billion.

Yet a Pharma company has been in court attempting to assert that it has “a constitutional right to share certain information about its products with doctors.” The drug companies have been increasing their pressure on the FDA to relax its guidelines around off-label marketing. See “Pharma Goes to Court” for more on this issue.

Frances said it is our fault that we allowed drug companies to prey on our weakness. “Diagnostic questions should be decided by what is best for the patient, not what is best for the doctor or the APA [American Psychiatric Association] or Pharma or the consumer group.” All this could be reversed if we had the political will to do so. He proposed fourteen ways to tame Pharma. The top six were:

  • No more direct-to-consumer advertising on TV, in magazines, or on the internet.
  • No more drug company-sponsored junkets, dinners, promotional gifts, or continuing medical education for doctors or medical students.
  • No more financial support for medical professional organizations.
  •  No more beautiful salespeople congregating in the doctors’ waiting room.
  • No more free samples.
  • No more off-label marketing.

These changes strike at the heart of Pharma’s marketing strategy, so it won’t be easy to get Congress to approve the changes. Pharma outspends all other industries in its lobbying efforts. Since 1998, the pharmaceutical industry has spent $3,716,474,293 lobbying Congress. In 2017 Pharma has spent $209,395,967. Annually they outspend all other industries. See OpenSecrets.org for more information on this issue. The OpenSecrets data was updated to reflect spending since this article was originally published in 2015.

10/14/15

Antipsychotic Big Bang

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© sakkmesterke | 123rf.com

Duff Wilson wrote in “Side Effects May Include Lawsuits” that antipsychotics were a niche product for decades. Yet they have recently generated sales that have surpassed that of “blockbusters like heart-protective statins.” In the 1990s, pharmaceutical companies began marketing them for much broader uses than the original FDA approved uses for more serious mental illnesses, like schizophrenia and bipolar disorder. A Scientific American article reported that pediatric prescriptions for atypical antipsychotics rose 65%—from 2.9 million to 4.8 million—between 2002 and 2009. And a New York Times article noted that federal investigators have found widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease.

There are two more facts to introduce you to about neuroleptics or atypical antipsychotics. First, in 2008, antipsychotics sales reached $14.6 billion, making them the biggest selling therapeutic class of drugs in the U.S. Second, each of the following pharmaceutical companies that marketed antipsychotics has been investigated for misleading marketing under the False claims Act. All their neuroleptics—Risperdal (risperidone; Johnson & Johnson), Zyprexa (olanzapine; Eli Lilly), Seroquel (quetiapine; AstraZeneca), Geodon (ziprasidone; Pfizer), and Abilify (aripiprazole; Bristol-Myers Squibb and Otsuka)—are now off patent.

The primary use off-label use of neuroleptics for the elderly and with children has been for behavioral control. A recent study commissioned by the Pennsylvania Department of Human Services found that children between the ages of 6 and 18 who were in foster care was four times higher than other youth in Medicaid. More than half of these youth had a diagnosis of ADHD. “This is concerning, as the majority of these youth did not have another diagnosis that clinically indicated the use of antipsychotics.” Risperidone was the most frequently prescribed antipsychotic medication among the youth. However, Abilify and Seroquel grew to exceed risperodone over the course of the study. Zyprexa was the least commonly used antipsychotic among all youth.

A trade group for nursing homes, The American Health Care Association, indicated that while antipsychotics helped some dementia patients who have hallucinations or delusions, “They also increase the risk of death, falls with fractures, hospitalizations and other complications.” The American Psychiatric Association, among others pointed to a JAMA Psychiatry study that showed mortality risks increased in patients given antipsychotics to reduce their symptoms of dementia. Another study published in Health Policy said the benefits and harms of using antipsychotic medications in nursing homes should be reviewed.

Antipsychotic medication use in nursing home residents was found to have variable efficacy when used off-label with an increased risk of many adverse events, including mortality, hip fractures, thrombotic events, cardiovascular events and hospitalizations.

Another “add on” area for neuroleptic use is when it is used with an antidepressant for “treatment resistant” depression. On BuzzFeed, Cat Ferguson reported how the sale of antipsychotics such as Abilify, and Zyprexa “skyrocketed” as they were approved to treat depression as an add-on medication. Seroquel is not FDA approved to treat major depression, but along with Abilify and Zyprexa is approved to treat bipolar depression in adults. Zyprexa and Seroquel are approved for some indications of bipolar disorder in adolsecents, but Abilify is only used off label with bipolar children, having “low or very low evidence of efficacy.” See the Psychopharmacology Institute for more information on these drugs and their approved and off-label uses.

Ferguson quoted a few psychiatrists expressing concern about the antipsychotic boom, and there are some surprises given other stands they’ve taken. Allen Frances, the former chair for the DSM-IV, agreed there has been heavy marketing of antipsychotics. He thought they are prescribed too quickly for depression and without clear indication of their efficacy. He added there seemed to be pressure from the pharmaceutical companies. He said: “These drugs should have a narrow indication, and instead they’ve become the highest revenue-producing drugs in America.”

Over the past few years Allen Frances has become an outspoken critic of some psychiatric practices, including the overuse of antipsychotics and antidepressants. He’s also been critical of the DSM-5. He’s even written Saving Normal to address his concerns with psychiatry and psychiatric practice. Search for his name here to find several articles where he is mentioned.

I was surprised and encouraged to see Jeffrey Lieberman, the chair of psychiatry at the Columbia University College of Physicians and Surgeons express concern with the over prescribing of antipsychotics. Lieberman has positioned himself as defender of psychiatry and psychiatric practice, recently publishing Shrinks. You can also search his name here to see other articles interacting with his book and position on psychiatry. Lieberman said that antipsychotic medication should be used sparingly in treating nonpsychotic disorder, including depression. He said: “I think there’s the possibility that antipsychotics are overprescribed, not just for depression, but in other areas.”

My point is that when two prominent psychiatrists with opposing views on many areas of psychiatry and psychiatric practice agree that antipsychotics are overused, pay attention. Both Frances and Lieberman have pointed out elsewhere how pharmaceutical marketing strategies contribute to this problem, but some pharma companies and representatives put the blame back on doctors. An Eli Lilly spokesperson said pharmaceutical companies aren’t responsible for how their drugs are used by doctors. “Physicians make prescribing decisions, not pharmaceutical companies. . . . While certainly we inform doctors of the benefits and risks of our medicine, it’s really up to physicians to prescribe the right medicine.”

But this attempt to deflect responsibility onto physicians is a cop out when you consider the marketing done by pharmaceutical companies for their products. In this YouTube advertisement for Abilify as an antidepressant add-on, you see how Bristol-Myers Squibb actively encouraged individuals to “ask your doctor if Abilify is right for you.” Pay attention to the fact that the first thirty seconds verbally describes how Abilify can help, while the rest of the 90-second commercial has the woman and her family going on a picnic while the adverse side effects are described.

Another problem is that all clinical trials for drug approval are done over short periods of time—six or eight weeks—antipsychotics included. But what are the long-term consequences of antipsychotics? As Dan Iosifescu, the director of the Mood and Anxiety Disorders Program at Ichan School of Medicine at Mount Sinai Hospital said, “It’s just a fallacy to take short-term data and extrapolate it for long term.” His bottom line is that antipsychotics tend to be helpful in the short term, but can have major consequences in the long term.

Thomas Glasen, writing in Schizophrenic Bulletin, weighed the pros and cons of medication treatment for psychosis. In the case for medication, he noted that the benefits of medication were profound. The therapeutic power of antipsychotic medication had been validated in countless studies and was now the primary treatment of schizophrenia. “In today’s climate, treating schizophrenia without medication mobilizes high anxiety among treaters for the safety of their patients from irrationality and for the safety of themselves from litigation.” However, in the case against medication, Glasen said:

Antipsychotics obscure the pathophysiology of psychosis by altering the neurobiology of the brain and the natural history of [the] disorder. . . . Medication can be lifesaving in a crisis, but it may render the patient more psychosis-prone should it be stopped and more deficit-ridden should it be maintained.

So how do individuals on long-term antipsychotics do? In Anatomy of an Epidemic, Robert Whitaker described Martin Harrow’s presentation of a long-term study funded by NIMH on sixty-four individuals diagnosed as schizophrenic between 1975 and 1983. Whitaker had just reviewed a series of studies questioning whether there was a long-term benefit to the use of antidepressants before discussing the Harrow study. He then said: “If the conventional wisdom is to be believed, then those who stayed on antipsychotics should have had better outcomes.” Harrow found that after two years, there was evidence that the off-med group was doing slightly better than the group on drugs.

Then, over the next thirty months, the collective fates of the two groups began to dramatically diverge. The off-med group began to improve significantly, and by the end of 4.5 years, 39 percent were “in recovery” and more than 60 percent working.

The outcomes for the medication group worsened and this divergence continued. At the fifteen-year follow up, 40 percent of those off drugs were in recovery and more than half were working; only 28 percent suffered from psychotic symptoms. “In contrast, only 5 percent of those taking antipsychotics were in recovery, and 64 percent were actively psychotic.” The 2007 Harrow study can be found here. Harrow said that not only was there a significant difference in global functioning between the two groups, 19 of the 23 (83%) schizophrenic patients with uniformly poor outcome after fifteen years were on antipsychotics.

symptomsHarrow et al. (2014) continued his study and reported data in Psychological Medicine at the twenty-year stage of his follow-up schedule. Here he investigated whether multi-year treatment with antipsychotics reduced or eliminated psychosis; and whether the results were superior to individuals in the non-medicated group. The data showed that the pattern noted above by Whitaker in Harrow’s 2007 report continued: “A surprisingly high percentage of SZ prescribed antipsychotic medications experienced either mild or more severe psychotic activity.”  The figure to the left, originally from the 2014 Harrow et al. report, shows that 68% of the medication group experienced psychotic activity, while only 8% of the off-med group experienced any psychotic activity. The source of the figure was a slide reproducing the Harrow data in a presentation by Robert Whitaker at the “More Harm than Good” conference sponsored by the Council for Evidence-Based Psychiatry (CEP). The slides and videos of the presentation can be found here.

Harrow et al. thought the high percentage of the medication group experiencing psychotic activity was influenced by two factors. One was the high vulnerability to psychosis of many schizophrenic patients, leading to a high risk of psychosis. But that begs the question of how the medication group in the study had such a high number of patients “at risk of psychosis.” Given the above data, their second factor seems to have been the more important factor: prolonged use of antipsychotics (or partial dopamine blockers) may produce a medication-generated build-up of supersensitive dopamine receptors or excess dopamine receptors.

The production of excess or supersensitive dopamine receptors would then be an iatrogenic, drug induced effect from the long-term use of antipsychotics. The brain increases or sensitizes the receptors, thus compensating for the blockade of original receptors in the postsynaptic neuron. Again, drawing from Whitaker’s presentation slides at the CEP conference, it would look like this:

dopamine

The above presentation of Harrow’s data and the discussion from Whitaker’s CEP presentation seem to affirm Glasen’s thesis that antipsychotics could alter the neurobiology of the brain. Antipsychotics reduce the activity of dopamine systems, stimulating the increase of receptors. When the antipsychotic is tapered or withdrawn, this would not immediately diminish the number of additional dopamine receptors produced by the brain to compensate for the dopamine blocking action of the antidepressant. With decreased antipsychotic levels, the result would be increased activation of the postsynaptic neurons because of the greater number receptors to absorb dopamine.

The person’s symptoms could intensify through the increased absorption of dopamine because of this disregulation of the dopamine system. In other words, tapering off of antipsychotics could activate symptoms like mania, paranoia and hallucinations because of the chemical imbalance produced by the medication. The experience of mania from a too sudden withdrawal of an antipsychotic is in this view, likely a withdrawal or discontinuation symptom instead of proof that the person needs to remain on an antipsychotic because they have a chemical imbalance. Robert Whitaker’s conclusion in Anatomy of an Epidemic was:

What the scientific literature reveals is that once a person is on an antipsychotic, it can be very difficult and risky to withdraw from the medication, and that many people suffer severe relapses. But the literature also reveals that there are people who can successfully withdraw from the medications and that it is this group that fares best in the long term.