01/18/22

Safety Concerns with Esketamine

It is approaching the three-year mark since the FDA approved Janssen’s Spravato (esketamine), in conjunction with an oral antidepressant to treat adults with treatment-resistant depression. The acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said at the time, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.” Esketamine was later approved to treat adults with major depressive disorder with suicidal thoughts. Despite the approval, Janssen said it is not known if esketamine is “safe and effective for use in preventing suicide or in reducing suicidal thoughts.”

Joanna Moncrieff and Mark Horowitz originally expressed concern in “Esketamine for treatment resistant depression” that history was repeating itself, that “a known drug of abuse, associated with significant harm, with scant evidence of efficacy, is being submitted for licensing, without adequate long-term safety studies.” In their 2019 article, they said they were surprised to see an article in the BMJ endorsing esketamine, as they thought it had been approved on “flimsy evidence.” Only one of three trials of acute treatment was positive and “the difference between esketamine and placebo was not large.” Particularly when compared to the large placebo effect. They acknowledged that serious adverse effects could take time to come to light, and concluded their article with the following warning:

Leaving this crucial research until after the drug is licenced, as the FDA has done in the United States … puts the public at risk and sets depressed patients up as unwitting guinea pigs in a huge and unregulated pharmaceutical experiment.

Peter Gøtzsche et al thought the safety and efficacy of esketamine was exaggerated. They thought the available evidence found that esketamine was “more likely to harm than benefit patients with resistant depression.” They thought esketamine should not be used in clinical practice. “But only as an experimental drug in randomised trials of adequate length, with long-term follow up, and with patient relevant outcomes assessing both harms and benefits.”

Horowitz and Moncrieff have updated their previous analysis in “Esketamine: uncertain safety and efficacy data in depression.” By June 2021, six 4-week efficacy trials have been published, with only one reporting a statistically significant difference between placebo nasal spray and esketamine. The one trial finding a statistically significant effect of four points, was not clinically significant given the large effect size (15.8 points) in the placebo plus antidepressant section of the study. It was also less than the 6.5-point difference used by Janssen in their sample size calculation; and had no long-term efficacy data. “The time point of four weeks in all these studies means the data are rather uninformative, since treatment-resistant depression in usually treated for months or years.”

They noted how other national health service organizations such as NICE (National Institute for Health Care Excellence) have examined the same evidence as the FDA and did not approve the drug for treatment resistant depression. However, NICE has launched a second consultation on the use of esketamine for treatment resistant depression after receiving feedback that it could benefit some patients. The results of that consultation have not been released yet. Horowitz has been critical of NICE’s delay of their decision on Twitter, saying: “Janssen’s antidepressant might not be much good, but their marketing spin is second to none. Hats off. I wonder whether NICE is in the spin room as they have been persuaded to delay their decision on esketamine for 10 months.”

Horowitz and Moncrieff compiled a table (see below) of withdrawal symptoms 4 weeks after stopping esketamine. They acknowledged the table did not establish a causal attribution between the symptoms and stopping esketamine. The large numbers in the esketamine group and longer duration of treatment also may have inflated suicides in that group.

In the safety study, one in seven patients developed ‘treatment-emergent’ suicidal ideations and six attempted suicides occurred in a group “selected for not being actively suicidal.” Using the FDA Adverse Event Reporting System (FAERS) database, Gastaldon et al found a disproportionate number of suicides could be attributed to esketamine in the first year of its use in the USA. Their conclusion was, “Esketamine may carry a clear potential for serious AEs [adverse events], which deserves urgent clarification by means of further prospective studies.”

The doses of esketamine were similar to recreational doses of ketamine, which causes tolerance, dependence and withdrawal. The FDA and Janssen said withdrawal symptoms were probably not relevant in the relapse prevention study. Yet Janssen did not report data from the Physician Withdrawal Checklist to support this conclusion.

Although it is difficult to be definitive about the nature of experiences that occur following drug discontinuation, the possibility that withdrawal effects were mistaken for relapse requires consideration, as withdrawal effects overlap with most items on the Montgomery–Åsberg Depression Rating Scale. NICE concluded that “any withdrawal effect would be difficult to distinguish from a change in depressive symptoms.”

The Janssen trial studies were also not representative of all individuals with major depression. They only included individuals who had failed two antidepressants (representing 44% of patients with depression). The studies excluded people with a recent history of suicidal intention, psychiatric comorbidity, drug and alcohol problems, vagal nerve stimulation (VNS) and deep brain stimulation (DBS).

Another confounding effect in the efficacy with esketamine is the known fact that ketamine, like other anesthetics, cause a pleasurable ‘high’ for some users. It is not clear how this drug induced euphoria and the antidepressant effects can be distinguished. Horowitz and Moncrieff concluded that:

Overall, the central points of our Analysis remain: esketamine has a clinically uncertain effect at 4 weeks, and there are no studies with longer follow-up periods more relevant for the care of people with depression. The discontinuation trial potentially conflates relapse and withdrawal and there are concerning safety signals.

Successful suicides that occurred during the clinical trials were glossed over or presented as unrelated to esketamine. The FDA “Briefing Document” for the committee indicated there were three successful suicides; all were esketamine-treated subjects. After parsing the differences between the three cases, the Briefing Document said: “Given the small number of cases, the severity of the patients’ underlying illness, and the lack of a consistent pattern among these cases, it is difficult to consider these deaths as drug-related.” In “Nasal Spray for Depression? Not So Fast,” Kim Witzcak said: “In my opinion, we need more information on the potential link to suicide before an assumption can be made that it’s safe.”

The adverse events identified in the Briefing Document of the greatest concern were sedation, dissociation, and increased blood pressure; most of which occurred within the first two hours of administration. In order to minimize the risk of misuse and abuse of esketamine, the committee proposed following a Risk Evaluation Mitigation Strategies (REMS). The FDA can require REMS for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. “REMS are not designed to mitigate adverse events of a medication, rather, it focuses on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.”

How did a drug with all of these concerns get approved by the FDA? There were exceptions made in the FDA approval process for esketamine as a “breakthrough therapy.” Witczak said the term treatment resistant depression (TRD) is the buzzword that allows drug companies to obtain FDA fast tracking:

Such designation gives the pharmaceutical company the ability to present smaller, fewer clinical trials in order to get their drug to market quicker. While most approved antidepressants currently on the market had to show effectiveness data from at least two positive short-term trials, Janssen only presented one positive short-term trial and the second is an incomplete picture as it is from a withdrawal trial. Janssen’s other trials failed to meet their primary endpoints for efficacy.

Janssen is persisting in its efforts to expand the market for Spravato/esketamine. It appears to me they convinced NICE to delay announcing their decision on esketamine for 10 months in order for the company to spin some additional information. And perhaps to convince NICE to reverse its rejection of esketamine. For more on esketamine, see: “Esketamine Craze,” “Hype and Concern with Esketamine,” “Evaluating the Risks With Esketamine,” and “Doublethink with Spravato?”

12/28/21

Don’t Use Marijuana If You’re Pregnant

Should you use marijuana if you are pregnant? As a growing number of states legalize the medical and recreational use of marijuana, it’s reasonable to assume there will be an increase of women using marijuana while they’re pregnant. The American College of Obstetricians and Gynecologists (ACOG) estimates between 2 and 5 percent of women use marijuana while they are pregnant. Several studies found that increases to 15-28% among young, urban, socioeconomically disadvantaged women. So, what are the potential consequences to prenatal exposure to marijuana?

A Healthline article, “Cannabis Use During Pregnancy,” said research has linked neurodevelopmental issues such as ADHD and higher levels of stress and anxiety in children whose mothers used marijuana while pregnant. A study published in the Proceedings of the National Academy of Science (PNAS) found a relationship between maternal cannabis use and a higher potential risk for anxiety, aggression and hyperactivity in early childhood. This corresponded with pervasive reductions in immune-related gene expression in the placenta, which has been associated with anxiety and hyperactivity. “Future studies are needed to examine the effects of cannabis on immune function during pregnancy as a potential regulatory mechanism shaping neurobehavioral development.”

Commenting on the study to Healthline, Dr. Jordan Tishler, president of the Association of Cannabinoid Specialists, said: “It surely contributes to our growing knowledge of the risks associated with cannabis use during pregnancy, and further supports the take-home message to women that, at present, our understanding leads us to recommend not using cannabis during pregnancy and breastfeeding.” Dr. Scott Krakower, a child and adolescent psychiatrist, agreed there is a strong correlation between anxiety and marijuana use. However, he said it’s unclear why marijuana users have more anxiety.

That is either because, A, you’re more anxious and you’re more likely to use marijuana, or B, using marijuana is possibly worsening the anxiety over the long run.

A 2011 study, “Lasting impacts of prenatal cannabis exposure,” examined human longitudinal studies that showed the long-term influence of prenatal exposure to marijuana. The researchers concluded that prenatally cannabis-exposed children had cognitive deficits, suggesting that maternal use had interfered with the proper maturation of the brain.

Cannabis consumption during pregnancy has profound but variable effects on offspring in several areas of cognitive development. Most of the information on the long-term consequences of prenatal exposure to cannabis comes from longitudinal studies of the OPPS [Ottawa Prenatal Prospective Study] and MHPCD [Maternal Health Practices and Child Development Study] cohorts. By comparing data from the cohorts, a pattern emerges where maternal cannabis use is associated with impaired high-order cognitive function in the offspring, including attention deficits and impaired visuoperceptual integration.

In Marijuana Use During Pregnancy and Lactation,” the Committee on Obstetric Practice of the ACOG said because of concerns about impaired neurodevelopment, as well as maternal and fetal exposure to the adverse effects of smoking, “women who are pregnant or contemplating pregnancy should be encouraged to discontinue marijuana use.”

Obstetrician–gynecologists should be discouraged from prescribing or suggesting the use of marijuana for medicinal purposes during preconception, pregnancy, and lactation. Pregnant women or women contemplating pregnancy should be encouraged to discontinue use of marijuana for medicinal purposes in favor of an alternative therapy for which there are better pregnancy-specific safety data. There are insufficient data to evaluate the effects of marijuana use on infants during lactation and breastfeeding, and in the absence of such data, marijuana use is discouraged.

Many women who use marijuana continue to do so when they are pregnant (34-60%). A study, “Prevalence and patterns of marijuana use among pregnant and nonpregnant women of reproductive age,” found that 18.1% of pregnant women reporting marijuana use in the past year met the criteria for a substance use disorder. Certainty about the effects of marijuana on pregnancy and the developing fetus is difficult in part because users often use other drugs and in part because of other confounding variables. Marijuana smoke contains many of the same carcinogenic toxins as tobacco smoke. Adverse socioeconomic conditions like poverty and malnutrition can result in outcomes otherwise attributable to marijuana.

Marijuana use alone was not associated with an increased risk of lower birth weight. However, women who used marijuana at least weekly during their pregnancy were at increased risk of giving birth to a newborn weighing less than 5.5 pounds. Several studies noted statistically significant smaller birth lengths and lower birth weights. “These findings were more pronounced among women who used more marijuana, particularly during the first and second trimesters.” The clinical significance of these findings is still uncertain.

Because of concerns of impaired neurodevelopment and maternal and fetal exposure to the adverse effects of smoking, women who are pregnant or considering pregnancy should be encouraged to stop using marijuana. The ACOG gave the following recommendations:

Before pregnancy and in early pregnancy, all women should be asked about their use of tobacco, alcohol, and other drugs, including marijuana and other medications used for nonmedical reasons.
Women reporting marijuana use should be counseled about concerns regarding potential adverse health consequences of continued use during pregnancy.
Women who are pregnant or contemplating pregnancy should be encouraged to discontinue marijuana use.
Pregnant women or women contemplating pregnancy should be encouraged to discontinue use of marijuana for medicinal purposes in favor of an alternative therapy for which there are better pregnancy-specific safety data.
There are insufficient data to evaluate the effects of marijuana use on infants during lactation and breastfeeding, and in the absence of such data, marijuana use is discouraged.

In “Cannabis Use in Pregnancy May Lead to a More Anxious, Aggressive Child,” The New York Times noted the findings of the PNAS study added weight to a growing body of evidence linking cannabis use during pregnancy to psychiatric problems in children. A behavioral neuroscientist at Queens College said, “We have a long way to go to educate pregnant women, policymaker and even OB-GYN doctors in this issue.”

Studies have shown that THC can pass through the mother’s bloodstream to the placenta and then to the fetus. This is the case no matter how the cannabis is consumed, whether from smoking it, eating it or being exposed to it through vapors, oils or creams. If they contain THC, “they’re all going to pass through to the baby,” Dr. El-Chaâr said.

Many questions about marijuana use during pregnancy don’t yet have clear answers. For now, Dr. El-Chaâr urged caution. “What I would tell patients is that there’s no known safe amount.”

12/7/21

Misrepresentation in Biological Psychiatry

An intriguing article, “Medicine and the Mind,” by psychiatrists Caleb Gardner and Arthur Kleinman was published in The New England Medical Journal in October of 2019. They said that something has gone wrong with academic and clinical psychiatry. “Checklist-style amalgamations of symptoms have taken the place of thoughtful diagnosis, and trial-and-error ‘medication management’ has taken over practice to an alarming degree.” While facing less and less time to work with patients, they thought psychiatry was facing the “stark limitations” of biologic treatments.

While these limitations are widely recognized by experts in the field, the dominant message to the public—and the rest of medicine—continues to be that the solution to psychological problems means making the correct diagnosis and then matching it with the right medication. As a result, psychiatric diagnoses and medications flourish in the name of scientific medicine. Yet, “there is no comprehensive biologic understanding of either the causes or the treatments of psychiatric disorders.”

Psychiatry is plagued with three things, according to Gardner and Kleinman. First is the over-prescription of medications for a large segment of the population. Second, there has been the abandonment and incarceration of individuals with chronic, severe mental illness. Third, diagnostic systems have become increasingly unwieldy with their overlapping checklists of symptoms.

The problem is not simply one of scientific and intellectual integrity. This state of affairs influences training and reimbursement and does a great disservice to patients, practicing psychiatrists, and our medical colleagues who are striving to provide the best and most humane care to people with medically and psychologically complicated conditions.

Psychiatry should be uniquely positioned to help through example, scholarship and consultation. “Yet the field seems to have largely abandoned its social, interpersonal, and psychodynamic foundations, with little to show for these sacrifices.” Science historian Anne Harrington proposed that psychiatry limit its scope to only severe, mostly psychotic disorders. In her 2019 book, Mind Fixers, she said, “Today one is hard-pressed to find anyone knowledgeable who believes that the so-called biological revolution of the 1980s made good on most or even any of its therapeutic and scientific promises.”

We believe that a fundamental rethinking of psychiatric knowledge creation and training is in order. If only the highest-quality biologic research were supported, substantial funding could be redirected to psychosocial, cultural, public health, and community studies that directly support the work of practicing psychiatrists responding to the needs of patients, families, and communities. The most pressing work is research on addiction, elder care, community care programs, consultation aimed at improving the quality of care in medical clinics and hospitals, child and adolescent psychiatry, and global mental health, as well as cultural studies of vulnerable populations.

Misrepresenting the Truth

In “Messaging in Biological Psychiatry” for the Harvard Review of Psychiatry, researchers Estelle Dumas-Mallet and Francois Gonon noted the article by Gardner and Kleiman was the first time that psychiatrists acknowledged in a prestigious biomedical journal that they have been misrepresenting the truth of biological psychiatry to their non-psychiatric peers in medicine and to laypeople. Dumas-Mallet and Gonon believe that most psychiatrists do not intentionally deceive patients or the public. They are not aware they contribute to the doublespeak or recognize how they passively accept it. “Therefore, in the absence of convincing evidence supported by observational studies, they might miss Gardner and Kleinman’s important message.”

In their article, Dumas-Mallet and Gonon sought to review the academic literature that described the misrepresentation of biological psychiatry, what its sources were, how it is diffused through mass media, and what the social consequences have been. As documented in several academic studies, there is often a huge gap between the observations reported in biomedical publications and their presentation in mass media. Focusing on psychiatry, they described the misrepresentations of the scientific observations in the biomedical literature that were spread through the media. They reviewed academic works that examined how mass media covered biomedical research. Lastly, they discussed the possible reasons why journalists, scientists, and scientific institutions “contribute to the misrepresentation of biological psychiatry.”

The percentage of scientific articles that confirmed researchers’ initial hypotheses increased from 70% in 1990 to 86% in 2007. Dumas-Mallet and Gonon thought the preferential publication of positive biomedical findings could be the result of two tendencies. First, researchers could choose to not publish their negative results. Second, journal editors have increasingly rejected articles reporting negative findings. These tendencies can be illustrated by looking at how clinical trials reporting a beneficial effect to the FDA are more often published than those reporting no effect.

Among a total of 74 randomized, controlled trials of antidepressants registered with the FDA, 37 of the 38 trials reporting a positive effect were published in peer-reviewed journals. By contrast, among the 36 trials judged as negative by the FDA, 22 had not been published, 11 were published but reported positive outcomes, and only 3 trials published results in agreement with the FDA’s judgments.

Many articles reporting a correlational relationship between a pathology and a risk factor improperly suggested it to be causative. When this wrong interpretation is reported in press releases of the research, it is likely to appear in media reports covering the study. They gave an example with a brain-imaging study that said a link between brain abnormalities and ADHD confirmed that ADHD was a brain disorder. The authors themselves acknowledged that “structural changes in certain brain areas are not necessarily the cause of mental disorders.” A large international study suggested the modest atrophy of the hippocampus could be the result of chronic depression rather than the cause.

Since positive findings are preferentially published in biomedical journals, the first study on a new subject often reports a larger effect size than subsequent studies. Dumas-Mallet and Gonon conducted a large comparative study of initial studies. They found that an average of one in two initial studies was either contradicted or significantly weakened by the corresponding meta-analysis. They observed how the public was seldom informed of research that disproved initial studies. In a second illustration, they said “only 4 of 50 newspapers covering a story on genetic susceptibility to depression also reported a later meta-analysis that disconfirmed its results.”

This example illustrates a general observation: newspapers strongly favor studies published by prestigious scientific journals, even though the initial studies that they publish are as often disconfirmed by subsequent studies, as are the initial studies published by journals with lower impact factors. Newspapers preferentially cover these initial studies because these prestigious journals also produce press releases highlighting the studies they publish. Indeed, these press releases are the direct source of more than 80% of the press articles reporting biomedical findings.Moreover, most newspaper articles are very closely inspired by these press releases and take up their biases and exaggerations without criticism. Finally, newspapers further accentuate publication biases by almost exclusively covering studies reporting a positive effect.

Misrepresenting the results of biological psychiatry to the public reinforces the view that mental disorders are biomedical diseases. The percentage of Americans who believe that schizophrenia and depression are genetic brain diseases increased from 61% in 1996 to 71% in 2006. Patients that hold this view are more pessimistic about their recovery and focus their hopes on psychotropic medications. While it needs further investigation, some studies show that patients with less endorsement of biogenetic beliefs about depression appear more likely to recover, while other studies find no relationship.

Possible Causes

A scientist’s career primarily depends on the number and quality of their publications. Getting a study published in a prestigious journal ensures the author a lasting reputation, and increases the likelihood their grant applications will be funded. In order to gain publication in a prestigious journal like The Lancet or The New England Medical Journal, researchers may be tempted to exaggerate the interest of their work. On the publication side, editors of prestigious journals will select the most exciting results likely to interest a large audience. “In fact, mass media preferentially cover studies published by prestigious journals because they believe them to be the most reliable, although many of them are disconfirmed by subsequent studies.”

Scientific institutions favor researchers who publish in prestigious journals. They also encourage researchers to communicate with journalists and the public. Institutions have also strengthened their press services and are flooding national journalists with press releases. National newspapers also seem to preferentially cover biomedical publications whose authors are working in that nation. Since research is mainly funded on project-based proposals, researchers are encouraged to over-promise in their grant applications, and then to embellish their results in order to continue receiving grants.

Journalists may unwittingly worsen the distortions already present in the biomedical literature. Biomedical observations in scientific publications are frequently altered by different forms of distortion, including: partially falsified results, data spin or embellishment, improper interpretation, exaggerated conclusions. Press releases by biomedical journals and scientific institutions often aggravate these distortions. While journalists are not the main source of these distortions, they boost their distribution by preferentially covering initial studies and those reporting positive results. “Consequently, the journalistic ideal of independent and objective investigation of the facts seems to apply poorly to the media coverage of biomedical findings.”

All these observations illustrate why mass media almost never informs the public when a study they covered is contradicted by subsequent studies. To illustrate this, Dumas-Mallet and Gonon pointed to Caspi et al, “Influence of Life Stress on Depression,” where the authors suggested there was a genetic susceptibility to depression. This was covered by 50 newspapers during the week after its publication. Yet when later studies contradicted Caspi et al, there was essentially no media attention. “Only four newspapers covered the meta-analysis published in 2009.” They concluded that the psychosocial understanding of mental disorders was at least as important as the biological one to guide mental health professionals.

Dumas-Mallet and Ganon told Mad in America they were motivated to write their article because they were seeing signals that academic psychiatry was prepared to reflect on these misrepresentations and change course (See “If Not Psychiatry, What Then?”). They affirmed there is a doublespeak done with biological psychiatry that negatively effects patient care. The publication of the Gardner and Kleinman article prompted them to write theirs. “For the first time in a prestigious medical journal, the doublespeak of psychiatry was acknowledged.” The Mad in America author, Emaline Friedman, said:

The existing literature makes a compelling case that a psycho-social understanding of mental disorders is at least as important as a neuro-biological understanding. Such a shift in the dominant narrative has the potential to influence mental health treatments as well as the mental health literacy of the public, which impacts how mental health patients are treated by those around them.

11/16/21

If Not Psychiatry, What Then?

In June of 2021, the World Health Organization published a document, “Guidance on Community Mental Health Services.” The WHO document is seeking to provide quality care and support for person-centered, human rights-based and recovery-oriented mental health care and services worldwide. In a video launch of the event, Sir Norman Lamb said: “Our collective aim must be to end coercive practices, including seclusion and restraint, forced admission and treatment. And we must combat violence, abuse and neglect. This is an urgent imperative for all countries. It’s a global human rights priority.”

Reports from around the world highlight the need to address discrimination and promote human rights in mental health care settings. This includes eliminating the use of coercive practices such as forced admission and forced treatment, as well as manual, physical or chemical restraint and seclusion and tackling the power imbalances that exist between health staff and people using the services. Sector-wide solutions are required not only in low-income countries, but also in middle- and high-income countries.

The Executive Summary of the WHO report said global mental health services often face substantial restriction of resources, and operated with outdated legal and regulatory frameworks. There was an overreliance on the biomedical model, where the predominant focus of care was on diagnosis, medication and symptom reduction. Overlooked were the social determinants that impact people’s mental health, hindering progress towards a fuller realization of a human rights-based approach. “As a result, many people with mental health conditions and psychosocial disabilities worldwide are subject to violations of their human rights – including in care services where adequate care and support are lacking.” Key messages of the Guidance said:

According to the WHO Mental Health Atlas 2017, the global median government expenditure on mental health is less than 2% of total government health expenditure. In order to develop quality mental health systems with enough human resources to provide the services and provide adequate support of people’s needs, allocating adequate financial resources is essential. But the problems with mental health provision cannot be dealt with by simply increasing resources. “In fact, in many services across the world, current forms of mental health provision are considered to be part of the problem.”

The majority of existing funding is invested in the renovation and expansion of residential psychiatric and social care institutions. This represents over 80% of total government expenditure on mental health for low- and middle-income countries. “Mental health systems based on psychiatric and social care institutions are often associated with social exclusion and a wide range of human rights violations.” While some countries have taken steps towards closing psychiatric and social institutions, this action has not automatically led to dramatic improvements in care. The history of closing psychiatric hospitals in the U.S. illustrates this point.

The predominant focus of care in many contexts continues to be on diagnosis, medication and symptom reduction. Critical social determinants that impact on people’s mental health such as violence, discrimination, poverty, exclusion, isolation, job insecurity or unemployment, lack of access to housing, social safety nets, and health services, are often overlooked or excluded from mental health concepts and practice. This leads to an over-diagnosis of human distress and over-reliance on psychotropic drugs to the detriment of psychosocial interventions – a phenomenon which has been well documented, particularly in high-income countries. It also creates a situation where a person’s mental health is predominantly addressed within health systems, without sufficient interface with the necessary social services and structures to address the abovementioned determinants. As such, this approach therefore is limited in its consideration of a person in the context of their entire life and experiences. In addition, the stigmatizing attitudes and mindsets that exist among the general population, policy makers and others concerning people with psychosocial disabilities and mental health conditions – for example, that they are at risk of harming themselves or others, or that they need medical treatment to keep them safe – also leads to an over-emphasis on biomedical treatment options and a general acceptance of coercive practices such as involuntary admission and treatment or seclusion and restraint.

Reports from countries in all income brackets around the world highlight extensive and wide-ranging human rights violations that exist in mental health care settings. These violations include the use of coercive practices such as forced admission and forced treatment (as with Britney Spears), as well as manual, physical and chemical restraint and seclusion. In many services, people are exposed to poor, inhuman living conditions, neglect, and in some cases, physical emotional and sexual abuse. People with mental health conditions are also excluded from community life and discriminated against in employment, education, housing and social welfare. These violations further marginalize them from society, “denying them the opportunity to live and be included in their own communities on an equal basis with everyone else.”

A fundamental shift within the mental health field is required, in order to end this current situation. This means rethinking policies, laws, systems, services and practices across the different sectors which negatively affect people with mental health conditions and psychosocial disabilities, ensuring that human rights underpin all actions in the field of mental health. In the mental health service context specifically, this means a move towards more balanced, person-centred, holistic, and recovery-oriented practices that consider people in the context of their whole lives, respecting their will and preferences in treatment, implementing alternatives to coercion, and promoting people’s right to participation and community inclusion.

The End of Psychiatry as We Know it?

In Western society, this means challenging the biologically centered, medical model approach to psychiatry. Writing for Psychology Today, John Read noted how global critics of an overly biological approach to understanding and helping distressed people is often dismissed as radical or extremist. Critics of the dominant medical model approach, promoted by the drug companies and biological psychiatry, are often labeled as “anti-psychiatry.” However, Read replied, “We, however, view ourselves as anti-bad and anti-ineffective, unsafe treatments.” He then quoted Steven Sharfstein, then president of the American Psychiatric Association, who said in 2005:

If we are seen as mere pill pushers and employees of the pharmaceutical industry, our credibility as a profession is compromised. As we address these Big Pharma issues, we must examine the fact that as a profession, we have allowed the bio-psycho-social model to become the bio-bio-bio model.

Read also cited Robert Whitaker, who thought the WHO report was a landmark event. There is a global rethinking of how to treat and think about mental health. Whitaker said, “Model programs highlighted in this WHO publication, most of which are of fairly recent origin, tell of real-world initiatives that are springing up everywhere.” Read said it will be become harder for defenders of the medical model to dismiss organizations like the UN or the WHO as extremist, anti-psychiatry radicals. This can be illustrated by looking at how Psychiatric Times launched “Conversations in Critical Psychiatry,” a series of articles and conversations with prominent individuals who are critical of various aspects of psychiatry.

Dr. Awais Aftab, who is a psychiatrist, not only interviews other psychiatrists such as Dr. Ronald Pies, Dr. Giovanni Fava and Dr. Allen Frances, he also talks with individuals from the critical, so-called anti-psychiatry side of the debate, namely Dr. Joanna Moncrieff, Lucy Johnstone and Dr. Sami Timmi. His first interview in 2019 was with Dr. Frances, the Chair of the DSM-IV Task Force and a vocal critic of the DSM-5, over diagnosis and the state of mental health treatment in the U.S. Follow Drs. Frances and Aftab on Twitter to see what they have to say about the current state of psychiatry. One of the concerns for Dr. Fava has been how the psychiatric establishment uses the term “discontinuation syndrome” to describe “antidepressant withdrawal.” In “The Impoverishment of Psychiatric Knowledge,” he said:

If you teach a psychiatric resident that symptoms that occur during tapering cannot be due to withdrawal, he/she is likely to interpret them as signs of relapse and to go back to treatment (exactly what “Big Pharma” likes). In the UK, the NICE guidelines are changing to reflect the potentially malignant outcome with SSRI and SNRI discontinuation. I do not see anything similar happening in the US.

One of the staunchest defenders against so called anti-psychiatry has been Dr. Ronald Pies, professor emeritus of psychiatry, SUNY Upstate Medical University; and Editor in Chief emeritus of Psychiatric Times. Among the many articles Dr. Pies has written over the years defending establishment psychiatry and psychiatric practice are these on Psychiatric Times from the past year: “What Kind of Science is Psychiatry?”, “Do Psychiatrists Treat Diseases?,” and “Why Thomas Szasz Did Not Write The Myth of the Migraine.” He also wrote “Is Depression a Disease?”, about a report from the British Psychological Society whose central argument was that depression is best thought of as an experience rather than a disease; and “Poor DSM-5—So Misunderstood!”, which challenges the claim that the DSM-5 “offers a biomedical framing of people’s experiences and distress and impairment.”

In “The Battle for the Soul of Psychiatry,” Dr. Aftab and Dr. Pies talked about various issues he’s faced over his career. Dr. Pies agreed with Dr. Aftab that they could have done a better job of counteracting “the so-called ‘chemical imbalance’ trope.” Pies wished he had tackled that issue earlier than 2011. He acknowledged the field of psychiatry took a “fairly sharp turn” toward the biological from roughly 1978 to 1998, “which, to a considerable degree, persists to this day.” Dr. Pies thought the movement toward the biological/biochemical was heavily influenced by the pharmaceutical industry.

His hope for the future of psychiatry was to recover its pluralistic core. He said his department at SUNY Upstate Medical University emphasized the integration of psychopharmacology and psychotherapy, and explicitly endorsed “the biopsychosocial approach.” He supported constructive critics of psychiatry, whose aim was to improve the profession’s concepts, methods, ethics, and treatments. He rejected the “anti-psychiatry” critics, saying their rhetoric was clearly aimed at discrediting psychiatry as a medical discipline. This last charge by Pies seems to be true to a degree.

In their book, Psychiatry Under the Influence, Robert Whitaker and Lisa Cosgrove (two of the anti-psychiatry critics) said the time was ripe for a paradigm shift. Many Americans are seeking alternatives to psychiatry’s medication-centered care. Disagreeing with Dr. Pies, they believed psychiatry was facing a legitimacy crisis from a scientific standpoint. Second generation psychiatric drugs are no better than the first, belying the claim psychiatry is progressing in its somatic treatment of psychiatric diseases. “The disease model paradigm embraced by psychiatry in 1980 has clearly failed, which presents society with a challenge: what should we do instead?”

10/26/21

Pseudoscience of the MBTI and Personality Testing, Part 2

Today, the Myers-Briggs Type Indicator (MBTI) is one of hundreds of assessments that people use to think about themselves in new, if not entirely serious ways. The MBTI was developed by a mother and daughter with no formal training in psychology or statistics, Katherine Briggs and Isabel Briggs Myers. However, they believed that their experiences as mothers and wives taught them about the innate power of personality types. “But in the mid-20^th century, businesses used it as a powerful tool in hiring and management, changing the trajectories of many workers’ lives.” What business executives didn’t realize then was how arbitrary the “science” of the MBTI was.

In “The Capitalist Origins of the Myers-Briggs Personality Test,” Merve Emre said Katherine Briggs always had an interest in personality. She became a minor celebrity from writing parenting columns in the 1920s about how she educated her daughter Isabel. But when Isabel left for college, Katherine fell into a serious depression. Then Katherine discovered the writings of Carl Jung. After reading his book, Psychological Types, she burned the book she had begun to write on personality. Jung became her “savior” and the “author of her life.”

She developed a way of categorizing personalities by using Jung’s theory of psychological types: introversion/extraversion, intuition/sensing, feeling/thinking. To these three dichotomies she added perception/judging. Katherine’s system never caught on until her daughter Isabel Briggs Myers developed an “indicator” after reading a Readers’ Digest article on personality testing in 1941 and wondered if she could develop one with no good or bad types; without judgment or criticism. In 1943 she sold the MBTI to Edward Hay and became a part time employee of Hay and Associates. Hay was one of the first personnel consultants in the U.S.

With the rise of the labor force during and after World War II, newly established consultancies like Hay’s were warming to the idea of using cheap, standardized tests to fit workers to the jobs that were “right for them,” a match made under the watchful eyes of executives eager to keep both profits and morale high.

At the end of World War II interest in the MBTI began to accelerate. Isabel started to pick up accounts that began to double and even triple in size from their initial order. She took large orders from colleges, government bureaus and pharmaceutical companies. Some of her early clients included: Swarthmore College, the National Bureau of Standards, Bell Telephone and the First National Bank of Boston. “By the mid 1950s, Isabel’s clients were the largest utilities and insurance companies in the United States.”

It was through a client of Hay and Associates that she met Oliver Ohmann, an assistant to the vice president of the Standard Oil Company and head of its industrial relations department. Ohmann was a strong conceptual ally of Isabel and he purchased the MBTI from Hay in 1949. Ohmann thought it offered the perfect solution for “introducing people to their true selves and convincing them that the work they were doing was a natural extension of how God had created them.” Ohmann told Hay and Isabel that the MBTI in its primordial form was a bargain struck between God and mammon—“the ideal marriage of ‘higher and more enduring spiritual values’ to the material realities of work.”

But Isabel did not share Ohmann’s vision when it came to type’s spiritual reach. She did not think the benefits of knowing one’s type accrued to all workers equally. She discouraged companies from spending too much money evaluating their workers if they employed mainly unskilled laborers. She said, “The type differences show principally in the more intelligent and highly developed half of the population.” Company executives revealed a high degree of type development while blue-collar workers were the weakest type, their personalities falling “in the no-man’s-land between the indicator’s dichotomies.”

Of course, there existed no controlled study, and thus no real evidence, to validate Isabel’s belief in the inverse relationship between intelligence and the strength of one’s type preferences. But as was the case for the most famous test of the 1940s, the intelligence quotient (IQ) test, evidence mattered less than the indicator’s ability to justify as “natural” or “normal” the divisions that already existed in the world; a world where wealthier, whiter, and more upwardly mobile men were decreed more self-aware than everyone else. It did not occur to anyone, even Isabel, as unusual that the strongest preferences were always expressed by successful, self-assured men with ready access to power. Often it was these men who paid her to manage the personnel dilemmas they found unsavory or tedious. Hiring, firing, promotion, and attrition were all easier to talk about when employers were shielded from the lives of their employees by the abstract, pseudoscientific language of type.

Sometimes subjects she tested and then retested seemed to change their type overnight. “Thinkers became feelers, judgers became perceivers.” From rereading Psychological Types, Isabel discovered this was a phenomenon called “enantidromia.” Jung defined enantidromia as “The emergence of the unconscious opposite in the course of time.” She was confident that the inability of the MBTI to be validated—to produce consistent results for test subjects over time—was based in Jungian psychology.

The Fantasy of the X-Rays of Personality

Sociologist William Whyte became alarmed as corporations were increasingly seen as the answer to post-WW II life with their introduction of new technologies such as television, the availability of affordable cars, and space travel. He was concerned that the American belief in the perfectibility of society was shifting from that of individual initiative to one that could be achieved at the expense of the individual. So, he wrote The Organization Man, which quickly became a bestseller. Inside was an appendix titled, “How to Cheat on Personality Tests.”

Whyte’s belief was that the more a test insisted it was for the individual, and that it promoted objective self-discovery, it hid the total integration of the individual within the organization’s culture. Whyte believed personality tests were tests of potential loyalty. Neither the questions nor the evaluation of them were neutral. They were loaded with organizational values and set a yardstick that rewards the conformist at the expense of the nonconformist person, “without whom no society, organization or otherwise, can flourish.” Whyte encouraged his readers to develop a test-taking persona—a hybrid of your true self, the values of the test maker and the values of the company.

Personality tests spoke for more than just an individual person or company; they represented an emergent culture of white-collar work. Isabel’s language of type helped give rise to a new spirit of capitalism: one in which the worker would be matched to the job that was divinely right for him. The job that would permit him to do his best and most creative work, afford him the greatest sense of personal satisfaction, endear him to his bosses and colleagues, and this encouraged him to lodge his sense of self even deeper into his nine-to-five occupation.

That spirit is alive today in the MBTI and other tools used by corporations and organizations to “Support your personal well-being and professional performance goals by providing you with a deeper understanding of what makes you you.” The Myers-Briggs Company said the MBTI is one of the world’s most popular personality tools because it works. It is used by 88% of Fortune 500 companies in 115 countries, and is available in 29 languages. “It has become the go-to framework for people development globally.” It claims to have helped thousands of organizations and millions of people around the world “improve how they communicate, learn, and work.”

Yet the popularity of the MBTI has waned with what is called the “Big Five,” the five-factor model (FFM) set of personality traits derived from a statistical study of words commonly used to describe psychological characteristics across cultures and languages. The categories are: openness to experience, conscientiousness, extraversion, agreeableness, and neuroticism. The FFM is an open-source data set and has several assessment tools derived from it, including the NEO Personality Inventory, developed by two of the creators of the five-factor model. “Unlike the MBTI, assessments based on the Big Five can reliably predict job performance, studies show.”

Examples of other modern personality tests include: the Rorschach inkblot test, the Thematic Apperception test, the MMPI or Minnesota Multiphasic Personality Inventory (MMPI), the Keirsey Temperament Sorter, the DISC assessment, the Predictive Index, StrengthFinders 2.0, the Birkman Method, and various kinds of the Five Factor Model (FFM).

In The Cult of Personality Testing, Anne Murphy Paul said since the early days of personality tests, they have been referred to as x-rays of personality. “And yet this metaphor had never been more than an alluring fantasy, or perhaps a willful delusion.” The reality is personality tests cannot even begin to capture the complexities of human beings. They cannot predict how we will act in particular roles or situations. They cannot predict how we will change over time. Many tests, like the MMPI, look for and find dysfunction rather than health and strength.

Many others fail to meet basic scientific standards of validity and reliability. The consequences of these failures are real. Our society is making crucial decisions—whether a parent should receive custody of a child, whether a worker should be offered a job, whether a student should be admitted to a school or special program—on the basis of deeply flawed information. If these tests serve anyone well, it is not individuals but institutions, which purchase efficiency and convenience at the price of our privacy and dignity. Personality tests do their dirty work, asking intrusive questions and assigning limiting labels, providing an ostensibly objective rationale to which testers can point with an apologetic shrug.

Perhaps the most insidious effect of personality testing, according to Paul, is its influence on the way we understand others and even ourselves. “The tests substitute a tidy abstraction for a real, rumpled human being, a sterile idea for a flesh-and-blood individual.” While these formularies are easier to understand than actual people, Ultimately, they only diminish our recognition and appreciation of the other’s full humanity.

For more on the MBTI and personality testing, see “Pseudoscience of the MBTI and Personality Testing, Part 1.”

10/19/21

Pseudoscience of the MBTI and Personality Testing, Part 1

In 1849, a young man arrived at the offices of Fowler & Wells in lower Manhattan. He was there to have the bumps on his skull measured in order to determine his personality traits. The man paid three dollars and sat still as Lorenzo Fowler began running his fingers over his head. A stenographer recorded every word Fowler pronounced during his reading. The young man was Walt Whitman and the procedure he submitted to was known as phrenology.

Phrenology is a process that entails observing and/or feeling a person’s skull for enlargements or indentations to determine their psychological attributes. “From absolute and relative sizes of the skull the phrenologist would assess the character and temperament of the patient. . . Phrenologists believed the head revealed natural tendencies but not absolute limitations of strengths of character.” While it was seen as a science and even had an influence on psychiatry and psychology in the 1800s, phrenology has been long recognized as a pseudoscience.

In The Cult of Personality Testing, Anne Murphy Paul observed that humans have long searched for some way to make sense out of “the unruly variety of our own natures.” In Whitman’s time phrenology was seen as a scientific answer to a problem that had unsuccessfully tried many previous ways to make sense of human nature. Today, these solutions, like phrenology, seem utterly implausible to most people. However, at the time they served a deeply ‘felt need’ of people.

They allow predictions to be made and advice to be dispensed. They permit swift judgments about strangers. They authorize the assignment of individuals, ourselves included, to the comforting confines of a group. They often justify social arrangements as they are, extending a reassuring (to some) sense of stability. Most important, they explain why we are the way we are.

The earliest such system was astrology, which is the idea that the order of the stars and planets at the time of our birth give a suggestion of the person we will become. Hippocrates (460 BC to 370 BC) developed the humoral system of medicine, believing that certain moods and emotions were caused by an excess of body fluids, called humors. These fluids were: blood, yellow bile, black bile and phlegm. Galen (129 AD to 216 AD) claimed the balance of the humors determined our typical mood or temperament. He named four temperamental categories: sanguine, choleric, melancholic and phlegmatic. A gloomy melancholic had an excess of black bile; a sluggish phlegmatic had an excess of phlegm; and an irritable choleric, of yellow bile.

Modern science has rejected the theories of the four temperaments. Nevertheless, the Christian author Tim LaHaye attempted to resurrect the temperament personality theory in a series of books like The Spirit-Controlled Temperament, which was originally published in 1966. Today there are many personality tests, some of which are clinical instruments administered and interpreted by psychologists and other trained personnel. There are also many online “personality tests” constructed to help you discover things such as which Star Wars character you are like.

Briggs, Myers and the Birth of Personality Testing

In The Personality Brokers, Merve Emre noted how days after the Japanese bombed Pearl Harbor Isabel Myers gathered her mother’s preliminary materials on personality typing together. She had just read a Reader’s Digest article on personality testing that showed her how she could use her mother’s work to develop a personality test. She learned there were hundreds of personality tests classifying workers as normal or abnormal. This distinction helped employers avoid assigning an anxious worker or a depressed person to a high-pressure job. A growing industry of hundreds of consulting firms administering these tests also provided employers a means of protecting themselves from resentful employees because employers could say their management decisions were based upon the tests.

But Myers wondered what would happen “if she could design a test that generated only positive results?” She thought she would call it an “indicator,” not a test. Her instrument would provide information about the individual’s personality without judgment or criticism. The Myers-Briggs Type Indicator (MBTI) was born. Today it is given to two million people a year. Nearly all the Fortune 500 companies and U.S. colleges and universities, the army, the navy, community centers and churches continue to use the type indicator and defend its credibility to answer fundamental questions such as: What is a personality? Who am I?

Katherine Briggs had been developing and writing a book on her personal theory of types when she first read Carl Jung’s book Psychological Types in 1923. So awe-struck was she by Jung’s type theory that she set aside her notes and book, eventually burning them. Around that time, Jung appeared to her in a dream. “Dr. Jung symbolized a psychological reality—something within me, something that actually has called upon me!” She spent the next five years trying to understand how Jung’s dichotomies (i.e., introvert-extravert) explained the various aspects of her life. Jung became her ‘personal God’ who walked in the world beyond the conscious world, where “the unknown, shapeless material of the mind flowed in dreams and fantasies.”

For five years, five of the most exciting and interesting years of my life, friends laughingly referred to Jung’s Types as my Bible . . . And indeed I did use it much as my father and mother used the Good Book—as a means of salvation—always understanding my life a little better because of what I read, and my reading a little better because of what I lived.

The American psychologist John B. Watson, who popularized the theory of behaviorism, wrote a review of Jung’s Psychological Types. He said the book sought to reinstate the psychoanalyst as a spiritual healer, “a god among mortals.” In his attempt to do so, Jung invented the opaque notions of “type” and type pairs,” suggesting that the souls of humans could be classified along three binaries: extraverted and introverted types, intuitive and sensing types, and thinking and feeling types. Watson dismissed Jung’s types as nonsense; a metaphysical ruse that defied serious critique because it was so flimsy.

Watson claimed he could not critique Jung’s psychology. It was what a “religious mystic” would write in order to justify certain factors his training forced him to believe existed. Watson thought Psychological Types was borne of “unproven assumptions about inborn dispositions and inherited constitutions.” He concluded Psychological Types offered no tools for the scientific study of personality.

Jung himself did not believe his conjectures in type theory could be validated by modern science. He thought objective psychology could only go a little way toward giving an adequate picture of the human soul. And yet, the MBTI is still in use and popular in corporate America. Despite the popularity of the Myers-Briggs, it is regularly criticized by psychologists as unscientific, meaningless or bogus.

“How Accurate Is the Myers-Briggs Personality Test?” said the main problem psychologists have with the MBTI is its lack of scientific support. Adam Grant, a University of Pennsylvania professor of psychology, said in social science there are four standards: Are the categories reliable, valid, independent and comprehensive? “For the MBTI, the evidence says not very, no, no, and not really.” Some research indicates the MBTI is unreliable because the same person can get different results when they retake the test. Other studies question its validity, and the ability of the MBTI to link “types” to real world outcomes—such as how well certain types will perform in a given job.

There are some additional limitations of the test resulting from the conceptual design of the MBTI. Personality “types” are treated as black-and-white, categorical variables, placing the person into distinct groups. You are either an extravert or introvert. But people don’t fall neatly into categories on any personality dimension; there are many different degrees within a dimension. Personality is on a continuum—a continuous sequence whose adjacent elements are not noticeably different from each other, while the extremes are quite distinct. Most people are closer to the average measure of a dimension, with relatively few individuals at either extreme. Placing people in categorical boxes separates individuals who are in reality more like each other than they are different.

Another shortcoming comes from the complex, messy nature of human personality. “Neat categories of MBTI make personality look clearer and more stable than it really is.” Finally, the MBTI is missing additional nuances by assessing only four aspects of personality differences. Michael Ashton, a professor of psychology said, “Several decades ago, personality researchers had determined that there were at least five major personality dimensions, and more recent evidence has shown that there are six.”

We’ll take a look in Part 2 of this article at what personality researchers believe the MBTI missed and reflect on how personality tests can lead to the miseducation of children, the mismanagement of companies and the misunderstanding of ourselves.

09/14/21

ACEs and Eights

“Patty” was 28 years-old and weighed 409 pounds when she enrolled in a radical year-long weight loss program supervised by Vincent Felitti in 1985. Patients did not eat any food; they would drink five glasses of water a day plus a nutritional supplement called Optifast. After 51 weeks on the diet, Patty’s weight was down to 132 pounds. She remained at that weight for three weeks, but then gained 39 pounds over the next three weeks. In “Adverse Childhood Experiences,” Felitti said he was puzzled, “and so was Patty.”

Then Patty admitted she was a sleep walker who binged on food as she wandered about at night. When she woke up in the morning, she would find open cans and boxes of food. “She would also cook at night.” When Felitti asked her what she thought was happening with her, she said the men at work were saying she looked attractive. Still confused, Felitti asked what those comments might have to do with her eating at night. “She told me that she began overeating at 11, about a half a year after her grandfather began sexually abusing her.”

Soon after Patti confided in him, Felitti and his colleagues at Kaiser Permanente in San Diego began to ask other obese patients about whether they also had a history of sexual abuse. “We were shocked. Of the first 286 patients we asked, 55% reported a history of abuse.”

In 1990, Felitti traveled to Atlanta for a national conference on obesity where he shared his findings on Patty and others who were struggling with the long-term effects of sexual abuse. David Williamson, a researcher at the CDC, thought Felitti’s work had enormous importance for the country, and said he would need to conduct a large epidemiological study in the general population. This led to a twenty-year collaboration with Williamson on the ACE study.

From 1992 to 1994, Felitti regularly interviewed patients to see what other early traumas they might have experienced besides sexual abuse. That’s when he came up with a list of the ten most common adverse child events, which in addition to sexual abuse include such experiences as physical abuse, parental alcoholism, and parental mental illness. He turned this list into a questionnaire, which he could use to conduct a formal study.

The Adverse Childhood Experiences (ACE) study began in 1995 and was first published in The American Journal of Preventive Medicine in 1998: “Relationship of Childhood Abuse and Household Dysfunction to Manty of the Leading Causes of Death in Adults.” Seven categories of adverse childhood experiences were compared to measures of adult risk behavior, health status and disease. Felitti et al found that more than half of respondents reported at least one, and 25% reported 2 or more categories of adverse experiences. There was a graded relationship between the number of adverse childhood experiences and “each of the adult health risk behaviors and diseases that were studied.”

Persons who had experienced four or more categories of childhood exposure, compared to those who had experienced none, had 4- to 12-fold increased health risks for alcoholism, drug abuse, depression, and suicide attempt; a 2- to 4-fold increase in smoking, poor self-rated health, ≥50 sexual intercourse partners, and sexually transmitted disease; and a 1.4- to 1.6-fold increase in physical inactivity and severe obesity. The number of categories of adverse childhood exposures showed a graded relationship to the presence of adult diseases including ischemic heart disease, cancer, chronic lung disease, skeletal fractures, and liver disease. The seven categories of adverse childhood experiences were strongly interrelated and persons with multiple categories of childhood exposure were likely to have multiple health risk factors later in life.

Among their findings the researchers reported that adults with four or more ACEs were four times more likely to have a depressive episode and twelve times more likely to have attempted suicide in the past year than participants with no ACEs. Other psychiatric issues in adulthood similarly rose with the frequency of adverse child experiences for chronic depression, suicide attempts and hallucinations. See the following graphs taken from “Adverse Childhood Experiences.”

Over the past two decades, over 100 papers in leading medical journals have followed Felitti’s original paper. In 2017, Huges et al published a metanalysis of the harmful effects of ACEs on health, “The effect of multiple adverse childhood experiences on health ” in The Lancet Public Health. There were moderate associations of increased risk among individuals with at least four ACEs for smoking, heavy alcohol use, cancer, heart disease, poor self-rated health, and respiratory disease; strong associations with sexual risk taking, mental health issues and problematic alcohol use. The strongest associations were for problematic drug use and interpersonal and self-directed violence.

Despite accumulating knowledge about the lifelong effects of ACEs, their prevention and the development of resilience and support for those affected have been slow to move up political agendas. International attention is increasingly focusing on prevention of violence against children, often emphasizing protection of girls. Although girls are especially vulnerable to certain ACEs (eg, sexual abuse), both sexes are routinely victims of multiple ACEs and both feel their long-term effects. In fact, the high prevalence of ACEs combined with their effect on life-course health suggests a substantial but largely hidden contribution to Global Burden of Disease estimates, which include childhood sexual abuse, yet not many other ACEs. Thus, smoking and alcohol use are leading risk factors for burden of disease, and in this study, individuals who had had at least four ACEs were more than twice as likely to be current smokers or heavy drinkers and almost six times as likely to drink problematically than were those who had had no ACEs. Consistent with such elevated risks, NCDs [non-communicable diseases] including respiratory disease, diabetes, cancers, and heart disease (the leading cause of death globally), were also substantially more likely in those with at least four ACEs than in those with none.

The ACE study led by Felitti closed in 2015; Ferlitti and his original collaborators have all retired. But he still speaks around the world, advocating for people to use the data from the ACE study. He lamented that there remains a lot of resistance. He thinks there is a pressing need for increased investments in policies that strive to prevent child abuse and improve parenting skills. This should be combined with efforts “to identify and treat individuals at high risk for developing numerous debilitating health problems, physical and psychological, related to adverse childhood experiences.” Although most health professionals are familiar with the ACE study, few doctors screen for ACEs.

The CDC has continued the struggle to inform the public about ACEs. Sixty-one percent of all adults reported they have experienced at least one type of ACE. Nearly 1 in 6 reported they had experienced four or more types of ACEs. Under “Fast Facts,” the CDC noted how environmental factors like growing up in a household with substance use problems, mental health problems or instability from parental separation of household members being in jail or prison undermined a child’s sense of safety, stability and bonding. ACEs were linked to chronic health problems, mental illness, and substance use problems as adults.

In “Risk and Protective Factors,” it was acknowledged there are many risk and protective factors beyond the original ten. ACEs are categorized into three groups: abuse, neglect and household challenges. Then each category is further divided into ten subcategories. Some additional adverse childhood traumas include homelessness, losing a caregiver, watching a sibling be abused, bullying, teen dating violence, community violence, and others. See the following graphic for the most commonly mentioned adverse experiences of the original ACE Study.

What happened to Patty? Her story ended tragically, as if she had been holding a dead man’s hand of aces and eights. She eventually regained all of her weight and then disappeared from Felitti’s clinic for twelve years. When she returned, she got bariatric surgery and lost 94 pounds, but then she struggled with chronic depression. She said it felt as if her will was crumbling. “Patty eventually had five stays in psych hospitals, during which she underwent three courses of ECT. In the end, nothing seemed to help her, and she died a few years ago.” Let’s see if we can change the outcome for future Pattys.

08/24/21

Homelessness and COVID-19

©james63/123rf.com

The findings for the 2020 Annual Homeless Assessment Report (AHAR) to Congress were published in January of 2021 and it contained some disturbing information. In a single night in 2020, approximately 580,000 people experienced homelessness in the U.S. Sixty-one percent stayed in sheltered locations, while 39% were “living rough” on the street, in abandoned buildings, or wherever they could pitch a tent. For the fourth year in a row, homelessness increased nationwide. The number of people who were homeless increased by 2% between 2019 and 2020. Almost 60% experienced homelessness in an urban area and 53% of all unsheltered people were counted in the nation’s 50 largest cities.

The 2020 AHAR count reflects a 7% increase of individuals staying outdoors with the number of sheltered individuals remained largely unchanged, with a 0.6% decline. “Increases in the unsheltered population occurred across all geographic categories.” The key factor was a sizeable increase (21%) in the number of unsheltered people with chronic patterns of homelessness. This means being homeless for more four times in the past 3 years, or continuously homeless for at least one year.

Unsheltered families with children also increased for the first time since data collection began. In 2020, just under 172,000 people in families with children were homeless. While most of these homeless families (90%) were in sheltered locations, there was an increase of unsheltered families by 13%.

People identifying as black or African American accounted for 39 percent of all people experiencing homelessness and 53 percent of people experiencing homelessness as members of families with children but are 12 percent of the total U.S. population. Together, American Indian, Alaska Native, Pacific Islander and Native Hawaiian populations account for one percent of the U.S. population, but five percent of the homeless population and seven percent of the unsheltered population. In contrast, 48 percent of all people experiencing homelessness were white compared with 74 percent of the U.S. population. People identifying as Hispanic or Latino (who can be of any race) are about 23 percent of the homeless population but only 16 percent of the population overall. [See the following graphic]

Psychological Services published a special issue on homelessness in 2017, “Homelessness as a Public Mental Health and Social Problem.” The authors said after deinstitutionalization in the 1960s, thousands of patients moved out of mental institutions into community-based care became homeless. Under the Bush administration, the federal government began requiring communities to conduct and report annual point-in-time counts of homeless individuals to track the scope of the problem. An epidemiological study found that 4.2% of Americans have experienced homelessness for over one month sometime in their lives and 1.5% experienced homelessness in the past year. “From both epidemiological studies and PIT counts, it is clear that homelessness remains a major problem in the country.”

Risk factors that are strongly associated with homelessness include adverse childhood experiences, mental illness and substance abuse. Most research on homelessness has focused on homeless, single, middle-aged men. “But there is increasing study on the growing number of homeless women and families who may have different needs.”

While there have been efforts to provide housing for the homeless or those at risk of homelessness, such as the HUD Exchange, many people who enter supported housing return to homelessness. Comprehensive primary care and behavioral health services have been intentionally integrated into many homeless organizations. Unfortunately, there continues to be limited access to mental health and substance use services available for many in supportive housing.

Nan Roman, the President and CEO of the National Alliance to End Homelessness, said the 2020 report gave a deeply troubling picture of homelessness in the U.S. on the eve of the COVID-19 pandemic. She said these results show an under-resourced system supposed to meet the needs of people at risk of and experiencing homelessness. While the Alliance was encouraged by the investments federal leaders have made in homelessness and housing resources during the pandemic, “the numbers make it clear that these investments are tragically overdue.”

COVID-19 and Homelessness

The pandemic was a major disruption for homeless system operations. The yearly Point-in-Time (PIT) survey for 2021 of persons who are homeless received new guidance that allowed for flexibility when counting people who were unsheltered. There were allowances made for observation-only counts, samplings, abbreviated surveys, and longer times permitted for the process. There was even a report published to guide those conducting a street-based PIT count that maintained the health and safety of those performing the count as well as those individuals who were homeless during the COVID-19 pandemic. See the National Alliance to End Homelessness for a webinar on “Conducting the 2021 PIT in the Age of COVID-19” and other resources.

In “COVID-19 and the State of Homelessness,” the National Alliance to End Homelessness reported how the pandemic significantly complicated efforts to end homelessness. One expert predicted there would be an increase of 250,000 new people homeless over the course of the year. Consider that before the pandemic, systems were not able to serve everyone experiencing homelessness. “Providers only had capacity to offer an emergency shelter bed to 1 in 2 individuals experiencing homelessness in 2019.” Limited resources resulted in overcrowded shelters and social distancing was difficult, if not impossible. “Unsheltered people lack consistent access to water, soap, and hand sanitizers that help prevent the spread of the virus.”

In “People experiencing homelessness: Their potential exposure to COVID-19,” Lima et al noted how many homeless people already have a diminished health condition, higher rates of chronic illnesses or compromised immune systems, “all of which are risk factors for developing a more serious manifestation of the coronavirus infection.” Those suffering from mental illness potentially struggle recognizing and responding to threats of infection. They also have less access to health care providers who could order diagnostic testing, and if confirmed, isolate them from others in coordination with local. Health departments.

In “Data for: People experiencing homelessness: Their potential exposure to COVID-19,” Neto et al said homeless organizations warned the coronavirus could cause catastrophic harm to unhoused communities. People who sleep in shelters or on the streets already have a lower life expectancy, as well as struggles with addiction and underlying health conditions that put them at greater risk should they develop the virus. Experts say the chronically ill homeless have a unique vulnerability to the coronavirus. “If exposed, people experiencing homelessness might be more susceptible to illness or death due to the prevalence of underlying physical and mental medical conditions and a lack of reliable and affordable health care.”

People experiencing homelessness are increasingly older and sicker. Many have underlying health conditions but lack access to primary-care physicians or preventive health screenings. They struggle to find public bathrooms to maintain their basic hygiene. Those who live in tent encampments or crowded shelters might be unable to keep their distance from others or self-isolate if they show symptoms.

A CDC Morbidity and Mortality Weekly Report (MMWR) for May 1, 2020 assessed the infection prevalence of COVID in five homeless shelters for residents and staff members in four U.S. cities—Boston, San Francisco, Seattle and Atlanta. They found that when COVID clusters (two or more cases in the preceding two weeks) occurred, “high proportions of residents and staff members had positive test results for SARS-CoV-2.” Community incidence (the average number of reported cases in the count per 100,000 persons per day during the testing period) varied, with Boston having the highest incidence and San Francisco the lowest.

To protect homeless shelter residents and staff members, CDC recommends that homeless service providers implement recommended infection control practices, apply social distancing measures including ensuring residents’ heads are at least 6 feet (2 meters) apart while sleeping, and promote use of cloth face coverings among all residents. These measures become especially important once ongoing COVID-19 transmission is identified within communities where shelters are located. Given the high proportion of positive tests in the shelters with identified clusters and evidence for presymptomatic and asymptomatic transmission of SARS-CoV-2, testing of all residents and staff members regardless of symptoms at shelters where clusters have been detected should be considered. If testing is easily accessible, regular testing in shelters before identifying clusters should also be considered. Testing all persons can facilitate isolation of those who are infected to minimize ongoing transmission in these settings.

In the Journal of Internal Medicine, “Addressing the COVID-19 Pandemic Among Persons Experiencing Homelessness,” Barocas et al noted that at least 1 in 5 of 13.8 million adults in rental housing say they are behind in rent. Coupled with an end to the federal eviction moratorium, this could mean an increase of more than 2.7 million newly homeless or unstably housed people in the U.S. Medical conditions such as heart and lung disease disproportionately effect the unsheltered and place them at risk for high morbidity and mortality from COVID-19. “A sudden increase in the number of people without housing or infections in the existing homeless population combined with COVID-19’s current strain on our health care system will greatly reduce our ability to care for this vulnerable population.”

Barocas et al recommended four changes. First, immediate improvements to and expansion of the national shelter system are needed. They believe the situation will become more dire if the federal eviction moratorium is not extended. Federal and state relief plans need to allocate funds for more shelters that are properly staffed and resourced.

Second, there needs to be an improvement with ongoing surveillance to prevent outbreaks among homeless individuals. One of the suggestions was to increase the use of waste water-based epidemiology, the practice measuring biomarkers in wastewater. “Active surveillance of municipal wastewater mapped to homeless shelters could be used to identify insipient outbreaks.” This seems to be a potentially low-cost COVID-19 surveillance method that could be used in low-resource settings such as shelters.

The third recommendation is to develop a universal approach to testing and contact tracing. A lack of testing supplies has led to a disproportionate allocation of tests across society, with more socially disadvantaged individuals encountering challenges when accessing tests. New methods of contact tracing rely on the assumption of stable housing, secure internet, or cell phones with application abilities. While most homeless people own or have access to a mobile phone, they often do not have smartphones that support app-based programs. “We need a dedicated investment in contact tracing in this population; otherwise, expanded testing will be for naught.”

The fourth and final recommendation is to provide places for persons with inadequate housing and without a permanent home to isolate once they are diagnosed with COVID-19 and do not meet criteria for skilled nursing care. Shelters are usually not equipped to convert entire floors into quarantine units. Innovative approaches to help this vulnerable population attain a space to recuperate and limit the spread of COVID-19, such as using hotels or college dormitories for temporary housing, were suggested.

As a nation, we have, thus far, done little to protect persons experiencing homelessness from COVID-19 disease. In the short term, we need funding for the expansion and improvement of our shelter systems, development and implementation of innovative strategies for active surveillance of outbreaks, rapid deployment of more COVID-19 tests coupled with a comprehensive contact tracing strategy, and expanded space for recuperation for this population. For a long-term effect, we need to extend the eviction moratoria and to use the pandemic as an opportunity to expand affordable and low-income housing and establish pathways to regain housing. Continued neglect of this vulnerable population will most certainly lead to considerable strain on the already stretched healthcare system during times of SARS-CoV-2 surge, increased transmission and mortality from SARS-CoV-2, and a widening health disparity gap.

The 2021 Annual Homeless Assessment Report will not be completed and published until 2022. The 2020 AHAR was published in March of 2021 and already showed a 2% increase from 2019 to 2020. What will the 2021 AHAR reveal?

08/3/21

Psychedelics Are Not a Magic Bullet

The Society for Cultural Anthropology published a series of articles, “The Psychedelic Revival,” which noted that psychedelics were making a comeback in modern science, public discourse, and cultural significance. Popular books and mainstream media have highlighted seemingly promising research with drugs such as MDMA, psilocybin and ayahuasca. The medicalization of psychedelics has stimulated the expansion of institutional research and private investment as these new treatments move towards the market. The New York Times published, “How MDMA and Psilocybin Became Hot Investments.” There is even a webpage for Psychedelic Investors, where you can “find financial backing for your psychedelic-driven idea.”

The NYT noted how the nation’s top universities are setting up psychedelic research centers. Investors are giving millions of dollars to an ever-increasing group of start-ups with psychedelic-driven ideas. Michael Pollan, the author of the best selling How to Change your Mind, said there has been a sea change in receptiveness about what had been considered fringe science. “Given the mental health crisis in this country, there’s great curiosity and hope about psychedelics and a recognition that we need new therapeutic tools.”

The two leading psychedelic candidates being developed as therapeutic tools are MDMA and psilocybin. The journal Nature Medicine published the results of the ongoing quest of Rick Doblin and his organization MAPS (Multidisciplinary Association for Psychedelic Studies) to bring MDMA to market as an FDA treatment for PTSD. The New England Medical Journal just published the findings of a British group of researchers, most notably Robin Carhart-Harris and David Nutt, and their desire to treat depression with psilocybin. Scientists, psychotherapists and entrepreneurs in the rapidly growing field of psychedelic medicine believe it is only a matter of time before the FDA gives approval for these drugs to be used therapeutically.

The question for many is how far — and how fast — the pendulum should swing. Even researchers who champion psychedelic-assisted therapy say the drive to commercialize the drugs, combined with a growing movement to liberalize existing prohibitions, could prove risky, especially for those with severe psychiatric disorders, and derail the field’s slow, methodical return to mainstream acceptance.

Psychedelic research is now swimming in money. Rick Doblin can remember when research money was scarce. But MAPS has raised $44 million over the past two years. “I spend a lot of my time saying no to investors,” said Doblin. John Hopkins, The University of California Berkley, and Mount Sinai Hospital in New York have or soon will have psychedelic research programs funded by private donors.

There are over a dozen psychedelic start-ups and a handful of companies that have gone public. Compass Pathways is a Nasdaq-listed health care company that has raised $240 million and is conducting 22 clinical trials across 10 countries of psilocybin therapy for treatment-resistant depression. Field Trip Health is a two-year old Canadian company trading on the Canadian stock Exchange that raised $150 million to finance dozens of ketamine clinics in North American cities like Chicago, Los Angeles and Houston. Oregon became the first state to legalize the therapeutic use of psilocybin last year. So far, the Justice Department has taken a hand-off approach to enforcing the fact that psychedelics are still illegal under federal law.

Field Trip got its start opening cannabis clinics across Canada. This summer the company plans to test psilocybin therapy in Amsterdam, where psilocybin mushrooms are legal. They are also developing a new psychedelic with the same therapeutic effects of psilocybin, but it works in half the time—about two or three hours. This would reduce the staffing costs of supervised sessions. More importantly, it would give the company propriety control of the new drug. Other biotech companies are doing the same.

Ronan Levy, Field Trip’s executive chairman said, “We are riding the forefront of what I think is going to be a significant cultural and business wave.” This corporate interest is both thrilling and troubling. Potential missteps could undo the progress of recent years. Veteran psychedelic scientists like Charles Grob of UCLA worry that commercialization and the rush toward the recreational use of psychedelics will trigger a public backlash again, “especially if increased availability of the drugs leads to a wave of troubling psychotic reactions.”

Rigorous protocols and a system to train and credential psychedelic medicine professional is needed, according to Grob. They have to be meticulously attentive to safety conditions. If these conditions are not maintained, there is a risk that some people will become psychologically unstable. “And if the primary motivator is extracting profit, I feel the field is more vulnerable to mishaps.” Rick Doblin shares some of those concerns. “I realize we could screw things up at the last minute so I’m not planning to celebrate any time soon.”

The Pollan Effect

Since the publication of How to Change Your Mind the expectations of participants in the research trials of what’s going to occur have skyrocketed. In “The Pollan Effect,” a psychedelic trial researcher said it was a big problem, but there’s not much they can do about it. The promising results are published and describe an 80 percent success rate and mystical experiences. Then a participant has a session where they don’t feel anything and are hugely disappointed; and sometimes feel like failures. “You want people coming into this with some openness, and typically once you have all these preconceived ideas, they think they know what they want. That doesn’t always work out well.”

For my part I definitely think this issue is a big problem, and my guess is that it will only be getting worse in the near-term. I actually just drew up a slide for a talk at APA [American Psychological Association] next month with the title in bold, PSYCHEDELICS ARE NOT A MAGIC BULLET. I’ll also be talking about . . . this mythology that with psychedelics they can take this brief trip to a faraway place (like Disneyland) and come back magically transformed/cured, whereas the reality is much more complex.

But these warnings don’t seem to discourage the so-called “psychonauts” (someone who explores altered states of consciousness, particularly through hallucinatory drugs). On the maps.org home page is the statement: “Together, we can cross the finish line and make MDMA a medicine.” It adds that if successful, the treatment could transform the lives of millions of people living with complex trauma. Rick Doblin is quoted as saying, “Psychedelics, when used wisely, have the potential to heal us, help inspire us, and perhaps even save us.” And this appears to be the goal behind what MAPS is presenting as MDMA-assisted therapy for PTSD—MDMA-assisted therapy for everyone.

On May 11, 2021, MAPS won an appeal to do a phase 1 trial of MDMA-assisted therapy with healthy volunteer therapists to measure the “development of self-compassion, professional quality of life, and professional burnout among clinicians.” The FDA had placed a clinical hold on the proposed study in 2019 due to concerns regarding the scientific merit of the study, the risk-to-benefit ratio for healthy participants, and the credentials of the clinical investigators. “Personal experience is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.” If the appeal had not been granted, the Lead Facilitator in each two-person facilitator team would be required to hold an M.D., Ph.D. or equivalent degree and be on-site instead of on-call during treatment sessions.

The hoped-for process would seem to be something like this once there is FDA approval for MDMA-assisted therapy for PTSD. Once allowed by the FDA, MDMA-assisted therapy for PTSD would be linked with FDA approval of MDMA-assisted therapy for healthy volunteer therapists; and then followed by FDA approval of MDMA-assisted therapy for any interested, healthy party. Rick Doblin implied as much when he said:

For three decades, we have sought to educate the FDA in our novel approach rather than simply accept FDA requirements that are unjustified by the evidence. The dedicated work and incisive strategy of our Clinical Development team continues to improve the regulatory landscape for all future patients of psychedelic-assisted medicines.

Since 2010, MAPS has organized a series of Psychedelic Science conferences. In 2013, it was a three-day conference with over 1,900 international attendees. The 2017 conference was a six-day global gathering with three days of conference programming. In 2019, the conference became a Psychedelic Science Summit. The 2023 Psychedelic Science Conference expects an estimated 10,000 attendees, “At the world’s largest psychonaut gathering.”

In 2014, Scientific American republished a brief article on the resurgence of in psychedelics as therapeutic agents, which said: “Psychedelic drugs are poised to be the next major breakthrough in mental health care.” The hype is accelerating and the enthusiasm is growing for psychedelic-assisted therapies. But let’s wait and see what the open science and total transparency of MAPS shows us with MDMA. Remember psychedelics are not a magic bullet, whether they are used to heal or inspire us. They certainly won’t save us and may not be as efficacious as claimed.

In “Trial of Psilocybin versus Escitalopram for Depression,” researchers sought to compare psilocybin-assisted therapy with escitalopram assisted therapy in a randomized, blinded study. The Mental Elf website reviewed and commented on the study. There were no statistically different differences in the primary outcome measure between the psilocybin and escitalopram groups at six weeks, but no conclusions could be drawn from the data. “In both trial groups, the scores on the depression scales at week 6 were numerically lower than the baseline scores, but the absence of a placebo group in the trial limits conclusions about the effect of either agent alone.”

Writing for The Mental Elf, James Rucker and Sameer Jauhar commented how the lack of a placebo control condition made it difficult to differentiate between the two drug treatments and the psychological therapy that went along with these. They noted the six week follow up may not have been long enough to effectively evaluate the escitalopram condition. “Positive and negative expectancy effects are likely to have affected the results in this trial and are liable to bias results in favour of psilocybin.” Given that participants likely received extensive psychological support, “The results of this trial may reflect more the therapeutic efficacy of attentive psychological therapy than to psilocybin or escitalopram.” (emphasis in the original)

07/13/21

The Long, Strange Trip of Psychedelic Psychiatry

There seems to be a full court press of articles on the renaissance of clinical research into psychedelic substances. NPR had a segment on their program Short Wave. Salon published an article on how researchers are studying psychedelics all wrong. The New York Times published an article describing a new study that showed where MDMA-assisted therapy resulted in 67% of the participants no longer qualified for a diagnosis of PTSD. You can even find receptive discussions of psychedelics by H. Steven Moffic and Tiago Merques on Psychiatric Times and an article on a presentation of this research at the 2021 APA Annual Meeting. Welcome to psychedelic psychiatry.

The takeaway from the NPR broadcast, “The Resurgence of Psychedelic Psychiatry” was that we are “at the beginning of a new era.” Dr. Moffic presented a breezy history of research with psychedelics in “The Trip Resumes for Psychedelics, Psychiatry, and Society” and said the topic required more careful study. Merques noted the trial was testing the drug plus assisted psychotherapy. He acknowledged this was very different from normal FDA studies.

The NYT article, “Looking to the Future of MDMA-Assisted Psychotherapy,” highlighted the work of Rick Doblin and MAPS, the Multidisciplinary Association for Psychedelic Studies, in bringing MDMA-assisted therapy through the FDA approval process. Doblin was the senior author of “MDMA-assisted therapy for severe PTSD,” recently published in the prestigious journal, Nature Medicine. The presentation at the 2021 APA Annual Meeting, “Looking to the Future of MDMA-Assisted Psychotherapy,” reviewed the results described in the Rick Doblin article and quoted one of the presenters as saying, “The future is here.”

The MAPS efforts with MDMA-assisted therapy to treat PTSD is getting the most press and interest at this time. Jennifer Mitchell, who was the lead author of “MDMA-assisted therapy for severe PTSD,” said in the NYT article, “This is a wonderful, fruitful time for discovery, because people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years.” Doblin added that it wasn’t the MDMA that produced the therapeutic effect, “it’s the therapy enhanced by the drug.” MDMA combined with therapy was thought to allow the brain to process painful memories and heal itself.

For this process to work, a person must be primed to engage with their trauma. Participants first undertook preparatory sessions with two trained therapists. Then in three sessions of eight-hours each, spaced a month apart, they received either an inactive placebo or MDMA. Neither the participants nor the therapists knew which. While most participants correctly guessed whether they received a placebo or MDMA, this did not undermine the study’s results or its methodology, which was agreed to in advance by the F.D.A.

“MDMA-assisted therapy for severe PTSD,” concluded from their results that MDMA-assisted therapy could be a potential breakthrough therapy. The authors speculated that the pharmacological properties of MDMA, when combined with therapy, could produce a ‘window of tolerance,’ where participants could revisit and then process traumatic events without becoming overwhelmed. The acute prosocial and interpersonal effects of MDMA seem to support the quality of the therapeutic alliance, “a potentially important factor relating to PTSD treatment adherence and outcome.” They even found it effective with comorbid issues such as childhood trauma, depression and dissociation.

PTSD is a particularly persistent and incapacitating condition when expressed in conjunction with other disorders of mood and affect. In the present study, perhaps most compelling are the data indicating efficacy in participants with chronic and severe PTSD, and the associated comorbidities including childhood trauma, depression, suicidality, history of alcohol and substance use disorders, and dissociation, because these groups are all typically considered treatment resistant. Given that more than 80% of those assigned a PTSD diagnosis have at least one comorbid disorder, the identification of a therapy that is effective in those with complicated PTSD and dual diagnoses could greatly improve PTSD treatment. Additional studies should therefore be conducted to evaluate the safety and efficacy of MDMA-assisted therapy for PTSD in those with specific comorbidities.

The Salon article, “Why mental health researchers are studying psychedelics all wrong,” was written by two psychedelic advocates who said they have worked for decades with thousands of people. They questioned whether the current mental health industry was the place for psychedelic drugs. There is a history of supposed breakthrough modalities that would bring psychiatry into the realm of medical science. “Yet none of these claims have demonstrated a high benchmark of legitimate authority, and many have even been harmful.” The authors thought there would be a substantial loss when psychedelics were medicalized.

The model for introducing psychedelics into a medical framework is being defined by the Multidisciplinary Association for Psychedelic Studies (MAPS), the most visible and politically connected psychedelic organization. Their flagship research project is using MDMA, a psychostimulant, to treat Post Traumatic Stress Disorder (PTSD), a diagnosis that has become increasingly common. Its public association with war vets and sexual abuse survivors makes PTSD the perfect public relations focus for psychedelics as the next medical breakthrough.

If psychedelics hold promise, the authors said, it may be a result of the drugs not working in a linear fashion or providing overnight results. They can lead people on paths of self-inquiry and growth that don’t become evident until years later. As Robert Whitaker pointed out, this doesn’t fit with a medical model that gets FDA approval. The reductive research of the FDA process requires a strict protocol that leads to replicable changes for anyone with a given diagnosis. “Why do you need a doctor for that? Why do you go to medical school for that?”

There is a need for research into psychedelics as they present an opportunity to recontextualize how we think about and experience suffering. However, drowned in the media hype of psychedelic advocacy organizations and the mental health industry, there is little public discourse about the potential implications of moving psychedelics into a system with such a problematic history.

The medicalization of psychedelics raises several questions about psychopharmacology and psychiatry. With psychedelics, their sensitivity to set and setting—the psychological and physical environments of their consumption—has been known for a long time. This compels researchers to consider the context as a variable when measuring the effectiveness of psychedelic substances. Does this mean that the FDA is moving away from its essentialist methodology for drug approval? A double-blind methodology can’t be implemented, effectively neutralizing this “gold standard” of scientific investigation embedded in the FDA’s methodology. Rick Doblin acknowledged this above when he admitted that most participants correctly guessed whether or not they received a placebo or MDMA.

If MDMA-assisted therapy ever achieves FDA approval to treat PTSD, it will challenge the scientific foundation upon which Western drug testing has depended for decades. Assuming the FDA ultimately approves MDMA-assisted therapy, does this signal the agency’s willingness to modify its clinical trial protocols for other potential “breakthrough” therapies? Will we be able to trust that the findings of a flexible methodology are truly scientific? In its pursuit of the next breakthrough therapy, is psychiatry moving away from a consistently scientific evaluation of its effectiveness? Michael Pollan, in his best-selling book, How to Change Your Mind, made similar observations:

Western science and modern drug testing depend on the ability to isolate a single variable, but it isn’t clear that the effects of a psychedelic drug can ever be isolated, whether from the context in which it is administered, the presence of the therapists involved, or the volunteer’s expectations. Any of these factors can muddy the waters of causality. And how is Western medicine to evaluate a psychiatric drug that appears to work not by means of any strictly pharmacological effect but by administering a certain kind of experience in the minds of people who take it?

For one future psychiatrist, his youthful LSD trip led to an insight that focused his attention on psychopharmacology. Jeffrey Lieberman is the Chairman of the Department of Psychiatry at Columbia University, and a former president of the American Psychiatric Association. In his book Shrinks: The Untold Story of Psychiatry, he described how an LSD trip played a role in his professional development. In 1968, as a junior at Miami University in Oxford Ohio, Lieberman decided to try LSD.

He jotted down notes on his insights while tripping, expecting to revisit “these profound pearls of wisdom” once the drug wore off. Afterwards, he found his notes either “boringly mundane” or “ludicrously nonsensical.” He learned that “Just because a person believes he is having a cosmic encounter—whether because of drug or mental illness—it doesn’t mean he is.” However, there was one lasting insight for which he is still grateful.

Though my LSD-fueled reverie dissipated with the light of the morning, I marveled at the fact that such an incredibly minute amount of a chemical—50 to 100 micrograms, a fraction of a grain of salt—could so profoundly affect my perceptions and emotions. It struck me that if LSD could so dramatically alter my cognition, the chemistry of the brain must be susceptible to pharmacologic manipulation in other ways, including ways that could be therapeutic.

Lieberman’s LSD experience led him to become a biological psychiatrist and not a surgeon or neurologist. Yet, his generation of psychiatrists has failed to discover the underlying causes of mental illnesses. And now it seems psychiatrists are turning back to see if psychedelics can be used as medicine. What a long, strange trip it has been for psychedelic psychiatry.

Faith Seeking Understanding

Charles Sigler, D.Phil.

Category Archives: Counseling Issues