10/24/23

Is Adult ADHD the Latest Fad Diagnosis? Part 2

Photo by Tara Winstead: www.pexels.com

Dramatic increases in ADHD diagnoses and prescriptions for ADHD medication noted in Part 1 are not just happening in the U.S. BBC Scotland claimed, “The number of adults receiving an NHS prescription for ADHD had increased seven-fold over the last 10 years.” Data obtained from Public Health Scotland indicated 26,000 patients were prescribed ADHD medications in 2022/23. Almost half were adults. The number of adult prescriptions rose steadily from 1,603 in 2013/14, to 5,920 in 2019/20, and then doubled to 12,182 by 2022/23.

Although ADHD content on social media platforms like TikTok contributes to the current problem of over diagnosis, it didn’t create it. In Saving Normal, Allen Frances, who was the chair for the DSM-IV, said until the mid 1990s ADHD medications had been off patent for decades and could be purchased generically for pennies a pill. There was no advertising to patients or marketing to doctors. Then several newly patented—and expensive—medications ADHD medications came to market. And then drug companies were given the right to advertise to consumers.

The blaring propaganda message was the usual—ADHD is extremely common, often missed, and accounts for why Johnny is a behavioral problem and isn’t learning in school. “Ask your doctor.” Armies of eager sales reps filled the offices of pediatricians, family doctors, and psychiatrists peddling a pill that would magically prevent classroom disruptions and solve home meltdowns. Parents, teachers, and physicians were recruited in an all-out effort to identify and aggressively treat ADHD.

PsychCentral listed the top 25 psychiatric medications in 2020. The top three most expensive medications, making the most money for their manufacturers, were all ADHD medications: methylphenidate (Concerta, $3.28 billion), lisdexamfetamine (Vyvanse, $3.01 billion), and amphetamine/dextroamphetamine (Adderall, $2.35 billion). Adderall had the fourth most prescriptions written with 26.24 million, Concerta was 10th with 18.55 million prescriptions, and Vyvanse was 20th with 8.64 million prescriptions.

Dr. Frances Levin of Columbia University, an internationally recognized expert in adult ADHD, said: “It’s difficult to get a clear picture of how many individuals in this country fit a clinical definition for ADHD, when there are no U.S. guidelines for diagnosis and evaluation of ADHD in adults.” Practice guidelines currently exist only for childhood ADHD. She thought both underdiagnosis and overdiagnosis of ADHD are happening. The American Society of ADHD and Related Disorders (APSARD) recently appointed a special committee to write guidelines for adult ADHD in the U.S. Dr. Levin co-chairs the committee. Her understanding of the rise in overdiagnosis is dramatically different than Dr. Frances.

She said in the early 1990s, there was a belief that ADHD diminished with age as well as concern in the scientific community about the validity of diagnosing ADHD in adults. “Then in the 1990s, the increase in diagnoses of childhood ADHD led to greater public awareness.” More adults recognized and reported symptoms in themselves and adult ADHD was added to the DSM-IV in 1994. Older psychiatrists, she said, weren’t schooled in evaluating and treating adults with ADHD; and now younger clinicians don’t get much training or experience with this population. The creation of uniform standards will address a critical need for healthcare providers and patients.

In Saving Normal, Dr. Frances there was no real reason to think that the prevalence of attentional and hyperactivity problems has actually increased. “We now diagnose as mental disorder attentional and behavioral problems that used to be seen as part of life and of normal individual variation.” He suggested six contributing factors to the increase of diagnosing childhood ADHD. There were: wording changes in DSM-IV; heavy drug company marketing to doctors and advertising to the public; extensive media coverage; pressure from parents and teachers to control unruly children; extra time on tests and extra school services if a child had an ADHD diagnosis. “And finally, the widespread misuse of prescription stimulants for general performance enhancement and recreation.”

Unchastened by the false “epidemic” of ADHD already running rampant among kids, DSM-5 has set the stage for creating a new epidemic of ADHD in adults. As usual, the experts worry so much about missed cases, they fail to consider the much greater risk of overdiagnosis. Attentional problems and restlessness are nonspecific and extremely common among normal adults and in those suffering from any of the other mental disorders. The easy path to adult ADHD suggested by DSM-5 will mislabel many normal people who are dissatisfied with their ability to concentrate and get their work done, especially when they feel bored and don’t like the work they’re doing. It will also misdiagnose those whose problem in concentrating is really caused by something else—e.g., substance abuse, bipolar disorder, depression, all the anxiety disorders, psychotic disorders, and many others. No one should ever get diagnosed or treated for adult ADHD until all of these are first ruled out as the primary cause—lest inappropriate stimulant treatment may worsen their already existing psychiatric problems.

He went on to say adult ADHD was already too easily diagnosed. Symptoms are mostly subjective and based on self-perceptions of poor concentration and task performance. “The DSM-5 lowering of requirements will capture many adults who want to be sharper but don’t have specific or serious enough problems to qualify for a mental disorder.” He said fake adult ADHD would be common in college students, in people with demanding jobs, and in those who struggle to stay awake, like long-haul truck drivers. Remember that Allen Frances was the chair for the DSM-IV.

An article by Allen Frances on Psychtherapy.net thought the numbers given for the prevalence of current adult ADHD were absurdly high. In the general population, the current rate for adult ADHD is reported to be 4.4% (5.4% for males and 3.2% for females). He thought the best guide was that by Keith Conners, considered to be the father of the ADHD diagnosis. Conners thought the rate of childhood ADHD was around 2-3% and about half that number in adults. Frances then gave the following as reasons for the overdiagnosis of adult ADHD.

Almost all mental disorders and almost all substance addictions can perfectly mimic ADHD since they can cause its two classic symptoms — hyperactivity and trouble focusing attention.

  1. Real or imagined attention problems are a very common complaint among perfectly normal people.
  2. Getting an ADHD diagnosis is a gateway to legal speed — desired for performance enhancement, all-nighters for school tests or work assignments, recreational purposes, or for sale into the extensive secondary ADHD pill market.
  3. Careless diagnosis and prescribing by MDs.
  4. An inevitable consequence of overdiagnosing ADHD in kids is overdiagnosing ADHD in adults.
  5. Promotion via drug companies and social networking.

Frances said the risks of overdiagnosing ADHD in adults were:

  1. Meds used for ADHD are usually quite harmful if the person’s symptoms are due to another psychiatric disorder that has been missed — especially bipolar disorder, depression, schizophrenia, eating disorders, or anxiety disorder.
  2. Overdiagnosis of ADHD results in over-medication with drugs that cause harmful side effects and can lead to or worsen addiction.
  3. There is now a huge secondary market for ADHD meds, especially on college campuses.
  4. There is also a nationwide shortage of ADHD meds for patients who really need them — because the meds are so often prescribed for those who don’t or diverted to the illegal market.

His bottom line was that most of what looks like adult ADHD is not adult ADHD. Most of it is normal behavior, sometimes caused by another psychiatric or medical problem or substance use. ADHD drugs are not safe unless carefully used for accurately diagnosed ADHD. Frances thought it was past the time to stop the adult ADHD fad before it gained more traction.

Easy access to legal “speed” has created a large illegal secondary market of diverted pills. ADHD drugs have become the campus recreational drug of choice at parties and the performance-enhancement drug of choice for all-nighters during finals week. Legal speed can cause many medical and psychiatric adverse effects, and emergency room visits for complications are skyrocketing. The Drug Enforcement Agency and the FDA are now trying to contain the epidemic — but their efforts are too little/too late. The adult ADHD fad will be stopped only if clinicians and patients fight against its seduction and insist on more careful diagnosis and cautious treatment.

Writing for Psychiatric Times, Mark Ruffalo and Nassir Ghaemi noted in “The Making of Adult ADHD” that twenty years ago, the consensus view in American academic psychiatry was that ADHD rarely persisted into adulthood. Now, adult ADHD is the “diagnosis du jour.” The rates of diagnosis and the prescriptions for the psychostimulant drugs that treat them are skyrocketing. They thought adult ADHD was a case of disease mongering, rather than psychopathologists and psychiatric nosologists missing the disorder for more than a century. Along with Allen Frances, they also associated the rise in diagnosis of adult ADHD to marketing by the pharmaceutical industry.

The rise in diagnosis of adult ADHD fully coincides with marketing by the pharmaceutical industry when Eli Lilly and Company got the first US Food and Drug Administration indication for this label with atomoxetine (Strattera) in 1996. Since that date, many academics have been promoting the concept of adult ADHD. The adult ADHD market has become a multibillion-dollar industry, with the rise of digital companies specializing in online diagnosis and treatment—some of which have come under legal scrutiny.

They noted retrospective studies, (that look backwards to determine if cases of childhood ADHD continue into adulthood), commonly find 50% to 60% of childhood ADHD persists into adulthood. “However, these data are disproven by prospective studies, which repeatedly show that about 80% of children with ADHD do not continue to have that diagnosable condition, followed prospectively either into young adulthood or even for 33 years into their fourth decade of life.” Ruffalo and Ghaemi don’t think that adult ADHD is a scientifically valid diagnosis. They don’t mean that the symptoms don’t exist. Adults do have problems with attention, concentration, focus, memory and other related abilities. However:

What we mean is that these symptoms have not been shown to be the result of a scientifically valid disease (adult ADHD) and are better explained by more classic and scientifically validated psychiatric conditions, namely diseases or abnormalities of mood, anxiety, and mood temperament.

They concluded the history of psychiatry shows the field has been vulnerable to a host of diagnostic fads. “Adult ADHD is the latest of such fads, and a careful review of the scientific literature reveals that the range of ADHD-like symptoms in adults is more accurately explained by other empirically validated psychiatric disorders.”

10/17/23

Is Adult ADHD the Latest Fad Diagnosis? Part 1

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WebMD has an article on statistics and facts about Adult ADHD, where it estimated adult ADHD affects more than 8 million Americans, with many of them not knowing it. “Several studies suggest less than 20% of adults with ADHD are aware they have it. And only about a fourth of those who do know are getting treatment for it.” Supposedly, every adult with ADHD had symptoms during childhood; and more than 60% of children with ADHD will still have it as adults. This begs the question, why don’t more adults realize they have it?

WebMD said adult ADHD can affect careers, relationships and other aspects of daily life, costing the U.S. economy up to $138 billion a year in lost income and productivity. It tends to occur with other mental health issues, like anxiety, depression or bipolar disorder. “Symptoms of adult ADHD can be mistaken for those conditions.” WebMD seems to presume ADHD is the primary disorder or cause. But what if it is the reverse? Psychiatrist Allen Frances thinks adult ADHD should not be diagnosed until these and other psychiatric problems are first ruled out (see Part 2).

Although researchers don’t know what causes ADHD, it runs in families. Forty percent of children with ADHD have at least one parent with symptoms. “If you have relatives with ADHD, you’re four to six times more likely to have it yourself.” This article ends with a link to the next article, “Do You Have ADHD?”, which then links to, “ADHD Medications and Side Effects.” If you’ve persisted in following the tidbits on adult ADHD, to this point, you’ll read how “Medication is an important part of your ADHD treatment.”

Another source, saying many of the same things, is the CDC, which in “Research on ADHD,” referred to ADHD as a serious public health problem that effects a large number of children and adults. The reader will learn that the criteria used to diagnose ADHD have changed over time. “This has led to different estimates for the number, characteristics, and outcomes of children with the disorder.” Although the exact causes of ADHD are not known, research show that genes play a role, with other factors contributing or making symptoms worse.

This led to the conclusion that there are many unanswered questions about ADHD and how it affects people throughout their life. In “Data and Statistics About ADHD” the CDC used datasets from parent surveys and healthcare claims to understand diagnosis and treatment patterns for ADHD. Concentrating on children, the CDC reported there were 6 million children between 3 and 17 (9.8%) ever diagnosed with ADHD. Many children with ADHD (64%) had at least one other mental, emotional or behavioral disorder. About half had a behavior or conduct problem (52%).

A national parent survey in 2016 reported 62% of children currently with ADHD were taking ADHD medication and 47% received behavior treatment. About 30% were treated with medication alone; 15% received behavior treatment alone. Around 32% received both medication and behavior treatment. And about 23% with ADHD received neither medication treatment nor behavior treatment. Not surprisingly, the American Psychiatric Association reported in November of 2019 that a study, Chung et al, found adult ADHD diagnosis increased 123% between 2007 and 2016.

Chung and colleagues suggest the increase in ADHD among adults may partly reflect an increasing awareness among health care professionals and the public of ADHD in adults. The study authors also address the misuse of ADHD medications particularly among adult-aged students to boost academic performance, noting that “diagnosis seeking to obtain stimulant medication for nonmedical use may be more common among white vs nonwhite patients.” The study found adults who identified as students were at highest risk of ADHD diagnosis.

Chung et al speculated that this increased risk of diagnosis in students could be due to some individuals seeking diagnosis and treatment for the purposes of “cognitive enhancement” with ADHD medications. They said pharmacological cognitive enhancement with prescription and illegal stimulants among individuals not diagnosed with ADHD has been increasing. There has been to be an concern about cognitive enhancement with ADHD medications among college students for some time. See, “Academic Steroids.”

In a related, but nonacademic article, the Guardian described how some tele-health startups have received criticism for their aggressive and misleading advertising campaigns. “These companies offer evaluations in as little as 30 min with no wait lists and prescribe medication, sometimes including controlled stimulant medications like Adderall and Ritalin.” The startups took advantage of an emergency provision established during the pandemic that permitted healthcare providers to prescribe controlled substances (like ADHD medications) via tele-health. While there are guidelines for diagnosing and treating ADHD in children, “There are no guidelines in the US about how to diagnose adult ADHD.”

The CDC reported that while the prevalence of adult ADHD did increase in recent decades and continued during the COVID-19 pandemic, there was a notable upturn during 2020-2021. Improved access to ADHD care through tele-health during the pandemic “introduced the potential for inadequate ADHD evaluations and inappropriate stimulant prescribing.” The significant increase in adults receiving prescription stimulants during the COVID-19 pandemic “draws attention to the need for clinical practice guidelines for ADHD in adults.”

The Guardian noted that the US medical system can’t serve all the people seeking diagnosis and treatment for ADHD, “and social media is filling in those gaps.” This increased demand contributed to an Adderall shortage that began in October of 2022. See, “Bad Things Could Happen with ADHD and the Adderall Shortage.”

A psychologist in Seattle who conducts adult ADHD evaluations said she thought TikTok accounted for at least 50% of her current requests for intakes. Supporting her estimation, a study in the Canadian Journal of Psychiatry, “TikTok and Attention-Deficit/Hyperactivity Disorder,” found that 52% of the most popular TikTok videos about ADHD were misleading if used to determine if you have ADHD.

TikTok videos with titles like “5 signs you have ADHD” and “5 things ADHDers hate,” are driving a lot of interest around adult ADHD. They list symptoms like daydreaming, swaying to avoid things while walking or picking skin for hours. Some videos have disclaimers, informing viewers that they should not replace medical advice, some are from users who list medical credentials, or are from people who have been diagnosed – but it’s not clear how credible each video is.

According to a psychiatrist who specializes in diagnosing and treating ADHD, the average, normal adult has two or three of these so-called “symptoms.” The DSM-5 diagnosis for ADHD requires at least five ADHD diagnostic criteria or symptoms, and those must cause “significant impairment” in at least two settings, like work and home.

TikTok videos facilitating people getting diagnosed for adult HDHD is an alarming trend. The psychologist in Seattle said she was frustrated when patients come to her because they’ve seen some TikTok videos and are hoping to “understand themselves better.” Some of these patients complain she is “invalidating” their experience when they don’t get the ADHD diagnosis they expect. She’s fearful these “patients” are putting pressure on an already overloaded medical system. The trend raises the question if these TikTok videos have led to more people believing they have adult ADHD, how valid of a diagnosis can it be? More on this in Part 2.

 

10/10/23

Goodblend is Closing Its Dispensaries in PA

Medical marijuana customers in Pennsylvania received some disappointing news when Goodblend PA, a subsidiary of Parallel Cannabis, announced the company was closing its operations in the state in order to serve “patients” in other more established markets. The Northside feed and grow operation is scheduled to close by September 15th 2023 and the dispensaries, located in Erie and on Baum Boulevard in Pittsburgh will close sometime in October. A planned dispensary in Cranberry Township will never open. Trib Live reported the company said in an emailed statement, “In connection with a strategic review, we have made the decision to withdraw from the Pennsylvania market in order to serve patients in our other, more established markets.” That could be good news for PA cannabis users in the long run.

Medical marijuana was legalized in Pennsylvania is 2016 and dispensaries began to open in the state in 2018. According to the National Conference of State Legislators, as of April 24, 2023, 38 states have legalized cannabis products for medical use, and 22 states have legalized the recreational use of marijuana. But so far PA has resisted the pressure to join the 22 states who legalized recreational marijuana. I’d encourage the Commonwealth to continue to hold out while research related to the potential problems associated with marijuana use is completed and published.

In PREPARING to Legalize Cannabis, I reviewed two recent studies. One suggested cannabis use had strong associations with adverse mental health and life outcomes in teens. Another one added to the growing evidence of a causal association between cannabis use disorder (CUD) and schizophrenia that was said to be “almost certain.” Now a study published on August 29, 2023, in The Journal of the American Medical Association Network Open, by Lapham et al, found that CUD was commonly found among primary care patients in Washington State. Washington legalized recreational marijuana in 2012.

The New York Times reported that 21 percent of people in the Lapham et al study had some degree of a CUD. These findings were similar to previous research by Leung et al. They quantified the prevalence and risk of CUD as cannabis abuse (CA) or cannabis dependence (CD). Among people who used cannabis, 22% have CUD; 13% have CA (8-18%) and 13% (10-15%) have CD. The risk of developing cannabis dependence increased to 33% (22-44%) among young people who use marijuana weekly or daily.

Cannabis users need to be informed about the risks of developing CUDs and the higher risks among those who initiate early and use frequently during adolescence. Future studies are needed to examine how changes in cannabis policies may affect the risks of CUDs in the population.

The Lapham et al study in Washington State was conducted with data from Kaiser Permanente, a large health system in Washington. 5,000 patients 18 years and older were randomly selected from 108,950 eligible patients with a record of completing a cannabis screen as part of their routine primary care. They were categorized by their stated reason for using cannabis during the past 30 days: medical use only, nonmedical use only, or both. DSM-5 symptoms for CUD were used to assess severity, with 2-3 symptoms = mild, 4-5 symptoms = moderate, and 6-11 = severe.

Patients were asked about all modes of cannabis use as well as the primary mode, including inhalation (ie, smoke, vape, dab), ingestion (ie, eat, drink), application (ie, lotion, ointment), or other modes. Questions also included the frequency of past-year use and typical number of days per week and times per day of cannabis use.

Among cannabis users, 42.4% reported medical use only; 25.1% reported nonmedical use only; and 32.5% reported both recreational and medical use. The prevalence of CUD was 21.3% and interestingly did not differ depending of their reasons for use (i.e., medical use only). The most prevalent CUD symptoms for all groups were tolerance, uncontrolled escalation of use and craving. Patients with nonmedical use only or both reasons for use were more likely to report “withdrawal, use in hazardous situations, continued use despite consequences, time spent on use, interference with obligations, and activities given up.” Patients who reported any nonmedical use were at the greatest risk of moderate to severe CUD, with the lowest risk was among patients reporting medical use only. Lapham et al concluded:

In this study, CUD was common (21%) among primary care patients who use cannabis in a state with legal recreational use, with patients using for nonmedical reasons most at risk of moderate to severe CUD. As legal recreational cannabis use among adults continues to increase across the US, the results here underscore the importance of assessing patient cannabis use and CUD symptoms in medical settings.

So, as legal recreational marijuana use increases across the US, there is a corresponding call to assess people’s cannabis use and symptoms of CUD into standard medical care and practice. Research is also coalescing around a causative connection between using marijuana and schizophrenia. Teenaged use of marijuana leads to future adverse health and life outcomes. But there is a problem between the rapid pace of marijuana legalization and state and federal policy changes. These policy changes are happening faster than the scientific research can be done on the medical benefits and adverse consequences of marijuana.

In October of 2022 President Biden asked the Secretary of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. He also pardoned all people convicted of simple marijuana possession under federal law and urged governors to take similar action. Then on August 29th 2023 Politico reported the HHS Assistant Secretary wrote a letter to the DEA recommending that marijuana be moved from Schedule I to Schedule III. The letter is the last step in the official review process initiated by the President last October. Significantly, the DEA is not required to follow HHS’s recommendation.

The HHS recommendation was the result of an almost yearlong federal review of all available marijuana research. But advocates for the legalization of recreational marijuana and some lawmakers didn’t think the recommendation went far enough. They wanted the president to completely remove cannabis from the Controlled Substances Act. A cannabis advocate told Politico, “Rescheduling cannabis from 1 to 3 does not end criminalization.” However, if approved, the rescheduling would permit cannabis businesses to take tax exemptions for business expenses like salaries and benefits, providing a huge benefit to the financially struggling industry.

The shift in federal cannabis policy would also make it easier to conduct research on the health effects of cannabis consumption and for pharmaceutical companies to bring cannabis-based drugs to market. Researchers have long chafed at restrictions that only allow them to procure cannabis from a single farm at the University of Mississippi that bears little resemblance to the high-potency products many consumers are purchasing in state-legal markets.

Both legalization advocates and anti-legalization advocates are not happy with the HHS recommendation. Pro-marijuana advocates say it does not end criminalization, but anti-legalization advocates see it as potentially detrimental to public health. They say the “addiction profiteers” have been exposed for their lies about the physical, mental and financial benefits of legalization in the wake of the cumulating evidence of the harm being done to millions of Americans. “It is regrettable that the Department of Health and Human Services move now appears to be a nod to those monied interests.”

In August, ABC News did a short, 7-minute video in their Group Chat on how the increase in marijuana use could affect federal legislation, the economy, and national health, “How the legalization of recreational cannabis use is on the rise.” It’s available on YouTube, here. One of the individuals participating in this “Chat” said there is a lot of money at stake here in the marijuana industry. “It’s estimated that the marijuana industry can pump a hundred billion dollars into the overall economy this year.”

The health concerns were mentioned with a reference to a CDC report on its effect on teen health and wellbeing. “There are a lot of unknowns about the long-term risk of any cannabis exposure to developing brains.” According to the CDC marijuana use beginning in teen years or younger can affect brain development, which may impair thinking memory, and learning.” There were mental health issues, including schizophrenia. “The association between marijuana and schizophrenia is stronger in people who start using marijuana frequently at an early age.”

The health expert went on to say he hears from both sides is that “policy changes seem to be happening faster than scientific research. Now potentially rescheduling this from a class one substance can actually help with that research, but there’s a lot more we need to know.” But until then, we know already that several states are growing more cannabis than they can sell because there aren’t enough legal retailers in the market. The impact is that “the illegal marijuana trade is actually stronger and outpacing legal sales in states where it is legal.” In California, where recreational marijuana has been legal for seven years, unlicensed marijuana sales were more than double that of licensed sales.

Returning to Parallel Cannabis closing down its Goodblend facilities in Pennsylvania, there’s more to it than just wanting to serve “patients” in other more established markets. In the Green Market Report, John Schroyer reported the Atlanta-based company Parallel Cannabis is closing its three Goodblend PA facilities and leaving the Pennsylvania medical marijuana market because financial troubles led to a lawsuit from its landlord, Innovative Industrial Properties Inc. Pennsylvania is not the only state Parallel has had problems paying its rent. Parallel also defaulted on its rent for a facility in Texas. Parallel is one of the largest privately held multistate cannabis operators in the US, with additional facilities in Florida, Massachusetts, and Nevada.

Goodblend is struggling to get its own shareholders to agree to liquidate the business, with another pending lawsuit filed by Surterra Holdings, a division of Parallel. That suit alleges that minority owner Medical Bloom, which holds a 25% stake in Goodblend, has refused to agree to a dissolution. Parallel is asking for a court order to force the liquidation in order to pay off Goodblend’s debts, given that the Pennsylvania subsidiary is insolvent, the Post-Gazette reported.

So, in Pennsylvania, let’s not be seduced by the lure of money in legalizing recreational marijuana. The federal government is poised to reschedule marijuana, which will help the cannabis industry without removing marijuana from FDA oversight as a drug. Let’s wait a few more years and see what the scientific research tells us about the benefits and adverse effects from marijuana use before we begin to craft our legalization policy at the state or federal level. And let’s slow down the marijuana lobbyists at the state level who seem to be trying to get a preponderance of states to legalize recreational marijuana before that research has a chance to be done and published. If it means some more companies like Goodblend leave the state for more profitable fields elsewhere—or go bankrupt—good riddance.

10/3/23

Indwelling Sin Weakens Spiritual Strength

In chapter fourteen of Indwelling Sin in Believers, John Owen examined how of the power of Sin can flare-up. In chapter fifteen, he moved on to examine how this power could also be seen in the habitual decline from a state of communion with God. The ways and means by which this decline succeeds in the life of believers are many.

Photo by engin akyurt on Unsplash

When a person is converted, they usually have many refreshing showers of God’s grace bathing their souls. This is produces in them an elevated amount of faith, love, holiness, fruitfulness and obedience. Like a river with many streams running into it, when there is a heavy rain, it overflows its banks. If these streams are not fed continually by showers, “they must needs decay and go backwards.”

The newly converted has a strong sense of God’s pardoning mercy. They are sensible of great forgiveness as was Paul when he said: “of whom I am the foremost” (1 Timothy 1:15). This subdues their hearts to all in God and quickens them to all obedience—that such a poor and cursed sinner should be delivered and pardoned. “The love of God and of Christ, in their forgiveness, highly conquers and constrains them to make it their business to live for God.”

Secondly, the fresh taste of spiritual things has such a savor and relish in their souls, that worldly pleasures are sapless and disagreeable. Having tasted the wine of the gospel, they desire no other. They have such a savor and relish for the grace of Christ upon their souls, that they cannot think of rejecting it. They then see a new guilt and filth in sin that leads to an abhorrence of its old delights and pleasures.

Now, whilst these and the like springs are kept open in the souls of converted sinners, they constrain them to a vigorous active holiness. They can never do enough for God; so that, oftentimes, their zeal, as saints, suffers them not to escape without some blots on their prudence, as men; as might be instanced in many of the martyrs of old.

Indwelling sin attempts to stop or taint these springs. It grooms the individual for decline and decay in grace and obedience by works of sloth and negligence. It prevails the individual to neglect the things that influenced it to strict and fruitful obedience. If diligence and watchfulness are not used, the means appointed by God to keep a quick and living sense of this grace will dry up and decay. And the obedience that springs from this grace will also dry up. Prevailed upon by spiritual sloth, a decay grows insensibly upon the whole soul because of indwelling sin. Thus, God often complained that his people had forgotten him—that they had grown unmindful of his love and grace.

When people begin to become weary of the things of God, those things by which we have communion with him, they deceive themselves by becoming a hearer of the word and not a doer. They look intently at themselves in the mirror of the word, but go away and immediately forget what they were like (James 1:23-24). Owen said it does not make an impression on them; it begets no image of their likeness. They become content with slight and rare thoughts of the things of God. They talk of spiritual things, and perform their religious duties, yet they have poor, starving souls as to any real communion with God.

By the power and subtlety of indwelling sin, they have grown formal, and learned to deal about spiritual things in a careless manner, whereby they have lost all their life, vigour, savour and efficacy towards them. Be always serious in spiritual things, if ever you intent to be bettered by them.

Oftentimes, indwelling sin will stop the springs of gospel obedience by false and foolish opinions, by corrupting the simplicity of the gospel. “False opinions are the works of the flesh.” They proceed from the vanity and darkness in the minds of men, with a mixture of corrupt affections. The apostle Paul was afraid the Corinthians would be led astray from a sincere and pure devotion to Christ (1 Corinthians 11:3) by a decay in faith, love and obedience.

Owen said this is often what happens. He has seen some, who after receiving a sweet taste of the love of God in Christ, and having walked humbly with God for many years, being deceived by false and foolish opinions. They despised their own experiences and rejected all the efficacy of truth. There were innumerable instances then (and now). They put an unspeakable value on the pardon of sin in the blood of Christ and delighted in the gospel discoveries of spiritual things, and walked in obedience on account of them. But they were beguiled and turned aside from the truth in Jesus, to despise the springs of their former obedience.

And this is one way whereby indwelling sin produces this pernicious effect, of drawing men off from the power, purity, and fruitfulness attending their first conversion, and engagements to God, bringing them into habitual declension, at least as to degrees, of their holiness and grace. There is not a thing we ought to be more watchful against, if we intend effectually to deal with this powerful and subtle enemy.

Indwelling sin does this by catching people by surprise in their watch against the return of Satan, who left off from tempting Jesus only until there was a more opportune time (Luke 4:13). It is like this with believers as well. If the person does not stand continually on guard against him, Satan will quickly gain advantage, and disrupt their fruitfulness and obedience. He accomplishes this by having carnal lusts prevail over their convictions, making their soul fit to entertain returning devils.

Satan is a diligent, watchful and crafty adversary. He will not neglect any opportunity or advantage that is offered to him. Where ever our spiritual strength is impaired by sin, or where our lusts press us, Satan aligns with the weakness and presses towards its ruin. “All the actings of the law of sin are subservient to this end of Satan.”

Indwelling sin entangles the soul in the things of the world. And when he discovers that has happened to a person he has been cast out of, he is encouraged to pursue after them. He seeks by his temptations, to impel them by their own lusts. “And oftentimes by this advantage he gets so in upon the souls of men, that they are never free of him more wilst they live.”

“Believers come forth from the spring of new birth with some purity and cleanness.” Yet sometimes they associate with others whose profession may run towards heaven even as their does, but they are muddied with sin and the world. These are often corrupted and so decline from their first purity, faith and holiness. In other words, “in the body of believers, there is a great number of hypocrites.” We cannot say for certain who is or isn’t one, but know for certain there are some. So, take heed how you give yourself up in conformity to the professors you meet with.

Owen continues on with his reflections on how many professors are also sick and wounded. He said sin works by cherishing some secret particular lust. Where indwelling sin has provoked and given strength to a special lust, it proves to be a principal means of a general decline. Just as an infirmity and weakness in any vital part will make the whole body ill, so will the weakness caused by a perplexing lust do to the soul. “It every way weakens spiritual strength.”

It is so with men brought into spiritual decays by any secret perplexing corruptions. It may be they have had a vigorous principle of obedience and holiness; indwelling sin watching its opportunities, by some temptation or other, has kindled and inflamed some particular lust in them. For a while it may be they take notice of it, sometime they complain, but think they will do as in former times, until being insensibly weakened in their spiritual strength, they have work enough to do in keeping alive what remains and is ready to die.

A great sin will certainly give a great turn to the life of a believer. However, “if it be well cured in the blood of Christ, with that humiliation which the gospel requires, it often proves a means of more watchfulness, fruitfulness, humility, and contention, than ever the soul before obtained.” Like a broken bone, if it is well set, it leaves the limb stronger than before. But if not, it makes a man a cripple all his days. “These things we do but briefly name, and sundry other advantages of the like nature, that sin makes use of to produce this effect, might also be instanced in; but these may suffice to our present purpose.”

09/26/23

Don’t Roll the Dice with MDMA, Part 2

Photo by Guillermo Velarde on Unsplash

The psychedelics industry is booming, as companies plan out their patent strategies in order to stake out their future share of the market. In the early days of the industry, nonprofits like MAPS and smalltime startups dominated the psychedelics space. Then the FDA granted breakthrough status to MAPS for MDMA-assisted therapy to treat PTSD in 2017. And in 2018 psilocybin-assisted therapy was approved as a breakthrough therapy for treatment-resistant depression. According to Insider, venture capitalists have now invested $139.8 million into startup psychedelic companies in a few short years.

The Hill noted California was on its way to be the third state to decriminalize psychedelics after its Assembly passed Senate Bill 58 by a 42-11 vote. In addition to decriminalizing personal possession and cultivation, the bill would allow “community-based healing” practices to promote the therapeutic use of psychedelics. Interestingly, the specified substances included psilocybin, psilocin, dimethyltryptamine (DMT) and mescaline, but did not mention MDMA. However, ecstasy or MDMA has been progressively moving through the FDA’s clinical trial gauntlet for approval in MDMA-assisted therapy and MAPS recently published the results of its second Phase 3 clinical trial.

MAPS, the Multidisciplinary Association for Psychedelic Studies, has been advocating for MDMA-assisted therapy to treat PTSD since 1986. In 1985 the DEA classified MDMA as a Schedule I drug, meaning the agency thought it to have no medical use and a high potential for abuse. Rick Doblin, the founder of MAPS said, “The big tragedy to point out is that it was pretty clear in the late 1970s and early 1980s that MDMA had incredible therapeutic potential.” But there is more to know about the history of MDMA and Rick Doblin, who chose PTSD as the disorder to target in his quest to end the government ban on psychedelics.

Doblin said MAPS wanted to help a population that would automatically win public sympathy. “No one’s going to argue against the need to help them [veterans].” When the DEA moved to criminalize MDMA in 1984, Doblin created MAPS and sued the agency, but failed to stop the DEA from permanently classifying it as a Schedule I controlled substance. He realized then psychedelics were seen as too fringe to win public support and decided that both he and the issue needed to go mainstream. So, he applied to the public policy program at Harvard, shaved off his mustache, cut his hair and began to dress more conventionally.

“I used to laugh about how simple it was,” he said. “You put on a suit, and suddenly everyone thinks you’re fine.” Doblin’s dream is to see psychedelic treatment centers in every city, but not simply to treat PTSD. These centers would be where people could go for spiritual experiences, enhanced couples therapy and personal growth. He believes psychedelics can even help homelessness, global warming and world peace: “These drugs are a tool that can make people more compassionate, tolerant, more connected with other humans and the planet itself.”

But this kind of rhetoric makes others nervous. A psychology professor at Swansea University in Wales thinks MDMA’s a dangerous substance. He’s worried FDA approval for the treatment of PTSD will lead many in the public to believe MDMA is safe for recreational use, despite its problematic side effects. See “Give MDMA a Chance?” and “MDMA-Not!” for more information on the history of MAPS and concerns with adverse side effects with MDMA.

Nevertheless, MAPS plans to submit a new drug application (NDA) for MDMA-assisted therapy to the FDA by the end of the year, which brings us to the question posed towards the end of Part 1 of this article: Should the FDA approve MDMA-assisted therapy?

The New York Times described the second Phase 3 clinical trial for MDMA-assisted therapy in “MDMA Therapy [was] Inches Closer to Approval” and said it seemed to be effective in reducing symptoms of PTSD. After giving a brief history of MAPS and Doblin’s efforts towards FDA approval of MDMA-assisted therapy, they gave a summary of MAPP2, the second Phase 3 clinical trial: “MDMA-assisted therapy for moderate to severe PTSD,” published in Nature Medicine. The findings were similar to the results of MAPP1, the first Phase 3 study of MDMA-assisted therapy for PTSD. See Part 1 for a discussion of those findings.

As in previous studies of MDMA-assisted therapy, the treatment was generally well-tolerated, according to the data presented about adverse events. Common side effects, primarily for those in the MDMA group, included muscle tightness, nausea, decreased appetite and sweating.

Two participants in the MDMA group and one in the placebo group experienced serious suicidal ideation during the study, but no suicide attempts were reported.

Allen Frances, a professor emeritus of psychiatry at Duke University and the chair of the DSM-IV, didn’t think the study’s results would meet the FDA’s criteria. He said the benefits in the active group were not much greater than the benefits in the placebo group. The cost of the treatment process would also put it out of the reach of many, if not most, potential patients. “MDMA treatment would add huge costs to the treatment system while providing only a small, specific benefit — and thus result in a massive misallocation of already very scarce resources.”

There is the cost of training therapists for psychedelic-assisted therapy as part of that expense. MAPS already oversees its own therapist education program. But the standards and requirements from the FDA are still not specified for MDMA-assisted therapy. “Drug-assisted therapy hasn’t been approved before, so there’s not a lot of precedent.” Then there is the variability of the price for assisted therapy. MAPS “will not manage how much the therapy component will cost.”

In a Nature news article, “Psychedelic drug MDMA moves closer to US approval,” Eric Turner, a psychiatrist at Oregon Health & Science University (and a former reviewer of psych drugs for the FDA), said while the reported difference between the MDMA and placebo groups was impressive, he doubted it was as big as it seems because it wasn’t a blinded study. “Around 94% of people who received the drug and 75% of those who didn’t correctly guessed which group they were in.” He added that even if MDMA was a safe substance, the study didn’t meet the FDA’s usual criteria for a well-controlled study. Jennifer Mitchell, the lead author for “MDMA-assisted therapy for moderate to severe PTSD,” worried about people trying MDMA on their own, where it could be harmful for those with heart conditions or with a family history of schizophrenia, which could be triggered by the drug.

I’ve been following the MAPS progress with MDMA-assisted therapy since 2016. And I’ve also wondered about the associated proliferation of psychedelic start-ups in “Psychedelics Are Not a Magic Bullet.” With the examination of the rhetoric and published spin on the two studies of the clinical trials for MDMA-assisted therapy, I think it almost appears to be a “con job” of rhetoric instead of the steady, progressive march towards the approval of a novel treatment for PTSD. And it seems I am not alone.

Psychologist James C. Coyne was critical of what he saw as a well-orchestrated publicity campaign by the funders of the MDMA research done by MAPS in “The MDMA-Assisted Therapy for PTSD Study: What You’ll Get Wrong.” He focused his critique initially on an older New York Times article, which he accused of “shilling for the promoters of psychedelics.” He likened the clinics dispensing psychedelics for mental health treatment to “expensive spas where customers can go without a diagnosis of mental disorder and have a guided psychedelic experience.” He said:

Readers, including even experts, are falling for a hard sell job by venture capitalists who launder their funding of the study through a nonprofit foundation [i.e., MAPS] and seek not legalization of psychedelics and related illegal drugs but lucrative control over their use for therapeutic and recreational use.

The potential dangers with MDMA are real and even acknowledged by researchers like Jennifer Mitchell, the lead author of “MDMA-assisted therapy for severe PTSD.” She conceded the expense and time intensity of MDMA-assisted therapy and the concern of addiction. In Psychiatrist.com, she said: “Just like all the other amphetamines, you want to be very careful with them, to not over-administer, and to make sure that somebody doesn’t have an addictive tendency to the amphetamine.” You wouldn’t send it home with people to do in their own living room. “You do it in a good, trained treatment facility and that way, you don’t have to worry as much.”

But people will try it at home in their own living room unless its only dispensed in a treatment setting with trained therapists. But this adds to the expense and time intensity of MDMA-assisted therapy. And also leads to Coyne’s expectation of expensive, spa-like treatment centers.

Mitchell thinks younger generations and the prevalence of psychostimulant use among millennials and Gen Zers with ADHD will make them more accepting of psychedelic, MDMA therapies. She also looks to how MDMA has completely transformed some patients. “That’s typically the kind of change that takes years to occur in psychotherapy.”

But this does not change the fact that there is a lack of research on the impact of MDMA on the entire brain and its long-term effects Psychedelic researchers, including MAPS, don’t allow participants in their studies who suffer with comorbidities. The participants are PTSD without co-occurring like the ones noted previously—substance use disorder, eating disorders, depression, autism, compulsive disorders, schizophrenia and anxiety. Mitchell herself said, “We don’t yet know what these compounds in general—but MDMA in particular—do to those people who have these other disorders.” Could it make the depression worse, increase anxiety, or compound the substance use diagnosis in some participants?

Let’s not roll the dice with MDMA and PTSD. And let’s be sure the research studies are done in a way that clearly demonstrates its potential to heal an individual and not just give them a substance use problem or an intensified mental health disorder. Let’s insist that Phase 3 clinical trials for MDM and other psychedelics have at least the recommended 300 participants and a more credibly double-blinded methodology.

09/19/23

Don’t Roll the Dice with MDMA, Part 1

Photo by lil artsy: pexels.com

Rick Doblin, the founder and Executive Director of MAPS, the Multidisciplinary Association for Psychedelic Studies, was interviewed on Fox Business in January of 2023. He announced that the MAPP2 clinical trial study was completed in November of 2022 and had achieved its objectives. With two confirmatory Phase 3 Trials now completed, Doblin thought it “quite likely” the FDA will approve MDMA-assisted therapy by May of 2024. He predicted the significance FDA approval of MDMA-assisted therapy would be for the “whole field of psychedelic-assisted therapy” (i.e., for psilocybin, ibogaine, ayahuasca, mescaline and others). He added that MDMA was a therapy drug in the 1970s before it became the party and “rave” drug, ecstasy.

In the interview, Doblin emphasized that it was therapy that was main change agent. “It’s not the drug itself; it’s the therapy that is the primary act of treatment. And the MDMA makes the therapy more effective.” Don’t miss what he is saying—the therapeutic process is the primary treatment and the MDMA facilitated the therapy. Nevertheless, the results reported in the MAPS studies were dramatic.

In Mapp1, 67% of the participants in the MDMA-assisted group “no longer qualified for a PTSD diagnosis” after three treatment sessions. Another 21% had a clinically meaningful response, adding up to 88% of participants in the MDMA-assisted therapy group experienced a clinically meaningful reduction in symptoms. These participants also had statistically significant reductions in functional impairment relative to the placebo group with therapy. However, 32% of the placebo with therapy group also no longer met the criteria for PTSD. This percentage of change in the placebo group underscores the importance of the therapy as the primary change agent emphasized by Doblin. See the following graphic.

The results of the MAPP1 clinical trial were published in Nature Medicine, “MDMA-assisted therapy for severe PTSD” and provide a more detailed examination of the data underlying the Phase 3 trail results reported in the above graphic.

The study abstract reported the standard methodology used in the study as “randomized, double-blind, placebo-controlled” and that the placebo itself was inactive. The small number of participants in the study groups was also noted. There were 42 individuals in the MDMA-assisted group and 37 individuals in the placebo group. Turning to the celebrated primary endpoint of the study being met by 67% of the study participants, there were only 28 participants who no longer met the diagnostic criteria for PTSD. The researchers acknowledged that the participant population was smaller than originally planned, which they attributed to the pandemic. They then pointed to the results, saying “given the power noted in the study, it is unlikely that population size was an impediment.” Really?

The FDA described how researchers should design clinical trials to answer specific research questions for a medical product here, saying “Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.” Phase 3 clinical studies, like MAPP1 And MAPP2 were recommended to contain 300 to 3,000 participants who have the condition; and the length of study to be 1 to 4 years. The MAPP1 study only had 79 participants; and the length of the study was only 18 weeks. The Procedural timeline in “MDMA-assisted therapy for severe PTSD” said: “Following the screening procedures and medication taper, participants attended a total of three preparatory sessions, three experimental sessions, nine integration sessions and four endpoint assessments (T1–4) over 18 weeks, concluding with a final study-termination visit.”

The double-blindedness of the study was also neutralized by using an inactive placebo, given the psychoactive properties of MDMA. Participants as well as the researchers and others who assisted in the study (i.e., the trained therapy team) would know in which study group the “blinded” participants were in by observing participant’s behavior after they ingested the supposedly unknown substance. This limitation was acknowledged by the researchers:

Given the subjective effects of MDMA, the blinding of participants was also challenging and possibly led to expectation effects. However, although blinding was not formally assessed during the study, when participants were contacted to be informed of their treatment assignment at the time of study unblinding it became apparent that at least 10% had inaccurately guessed their treatment arm. Although anecdotal, at least 7 of 44 participants in the placebo group (15.9%) inaccurately believed that they had received MDMA, and at least 2 of 46 participants in the MDMA group (4.3%) inaccurately believed that they had received placebo.

Anecdotally then, 95% of the MDMA-assisted group (44 of 46) and 84% of the placebo group (37 of 44) were able to accurately state which research group they were in. The double-blind methodology was clearly ineffective and the dramatic results reported by the study should be understood with this in mind. Emphasizing the differences between the MDMA-assisted group and the placebo group for the lost PTSD diagnosis and a clinically meaningful response draws the readers attention away from these damning limitations for a Phase 3 clinical trial study: the miniscule population size and the failure to use a legitimately double-blinded study methodology.

The MAPP2 Clinical trial was completed on November 2, 2022, and MAPS announced the results on November 17, 2022. The primary and secondary endpoints for the MAPP1 and MAPP2 studies were the same. However, MAPP2 enrolled participants with moderate and severe PTSD, where MAPP1 only enrolled participants with severe PTSD. It had 104 participants.

The results for MAPP2 are expected to be in a peer-reviewed journal sometime in 2023: “The full data from MAPP2, expected to be published in a peer-reviewed journal later this year [2023], will support MAPS PBC’s new drug application to be filed with the U.S. Food and Drug Administration (FDA).” MAPP2 treated its 104 participants “living with PTSD with either MDMA-assisted therapy or placebo with therapy.” The results were said to confirm the findings from MAPP1, with no serious adverse events observed among the participants. Rick Doblin was quoted as saying:

When I first articulated a plan to legitimize a psychedelic-assisted therapy through FDA approval, many people said it was impossible. Thirty-seven years later, we are on the precipice of bringing a novel therapy to the millions of Americans living with PTSD who haven’t found relief through current treatments. The impossible became possible through the bravery of clinical trial participants, the compassion of mental health practitioners, and the generosity of thousands of donors. Today, we can imagine that MDMA-assisted therapy for PTSD may soon be available and accessible to all who could benefit.

MAPS went on to give a brief history of where MDMA had been legally used in therapy for a decade before it was “criminalized” (i.e., classified as a Schedule 1 Controlled Substance) in 1985. MAPS was founded the next year “to fund and facilitate research into the potential of psychedelic-assisted therapies; educate the public about psychedelics for medicine, social, and spiritual use; and advocate for drug policy reform.” The publication of the MAPP1 clinical trial was said to be a major milestone. MDMA-assisted therapies are being planned or conducted to evaluate “conditions closely related to PTSD” such as substance use disorder and eating disorders. Trials of other therapies with couples and group therapy among Veterans are also being planned or conducted.

“These additional Phase 2 trials will determine if MDMA-assisted therapies may be effective for other conditions or with other treatment modalities commonly used to address PTSD.”

Psychiatrist.com echoed these expectations if the FDA approves MDMA-assisted therapy, adding that approval would enable the exploration of the drug’s benefit for depression, anxiety, substance-use disorders, autism spectrum disorder, and compulsive disorders. The lead author of “MDMA-assisted therapy for severe PTSD” described for Psychiatrist.com how MDMA acts on the amygdala, the part of the brain that processes fear-related memories and facilitates memory retrieval. When used in a clinical setting (i.e., with therapy), “they say it helps untangle, consolidate, and release deeply-ingrained memories that may have been suppressed.” MDMA also facilitates the release of oxytocin, a hormone that makes you feel self-compassion and connected to others. The end result is MDMA helps create an environment in which “participants take comfort in their therapy team, approach their memories from a different lens, and ultimately begin to heal.”

This description of MDMA and oxytocin needs to be nuanced, as it glosses over some of the not-so positive connections made with the release of oxytocin. In “The two faces of oxytocin,” the American Psychological Association said recent research has shown that oxytocin is part of a response to social separation and related stress. When it operates during times of low stress, oxytocin physiologically rewards people with good social bonds with feelings of well-being. However, it may “lead people to seek out more and better social contacts” during times of high social stress or pain. This two-faced context for MDMA facilitating the release of oxytocin again underscores the importance of the therapeutic aspect of MDMA-assisted therapy.

Should the FDA approve MDMA-assisted therapy? Should we roll the dice and see what happens? A recent survey noted Americans have mixed feelings. According to the UC Berkeley Psychedelics Survey, 61% of registered American voters support legalizing regulated therapeutic access to psychedelics. Thirty-five percent of those supporters said they strongly support such action.

And yet, there were 35% who opposed it, with 61% also saying they do not see psychedelics as “good for society” and 69% who don’t think psychedelics are something they would personally use. “The data suggested voters are open to policy change but also have significant reservations.”

A reliable answer to whether the FDA should approve MDMA-assisted therapy is hampered by the Schedule I classification of psychedelics, which creates multiple hurdles that researchers have to get over in order to investigate their therapeutic value. And further, it seems supporters of psychedelic-assisted therapies are following a strategy taken from the playbook of legalizing recreational marijuana—focus on the legalization of psychedelics one state at a time. More on this in Part 2.

09/12/23

Bad Things Could Happen with ADHD and the Adderall Shortage

In case you didn’t know, the U.S. has been in the midst of an Adderall shortage since October of 2022 when the FDA announced a shortage of the immediate release formulation. At the time, the FDA said some manufacturers having intermittent manufacturing delays, while others reported they could not meet the increased demand. The agency said it has posted information on the shortage and a list of current manufacturers that are still available, and will continue monitor supply and assist manufacturers “with anything needed to resolve the shortage.” But the shortage problem was still with us.

Kate Underwood reported in Green Matters that as of June 2023, the FDA’s Drug Shortages still listed Adderall as a current shortage. While manufacturing disruptions are the typical issues leading to drug shortages, other concerns such as increased demand for the drug, and shortages of the active ingredient or supplies can also occur. Additionally, drug manufacturers don’t usually make a single drug. So, increasing the production of a drug in short supply could negatively impact the availability of other drugs made in the same facility.

Writing for Vox, Dylan Scott added another factor to the Adderall shortage—it is a stimulant drug with the potential for misuse or addiction. The DEA lists Adderall and other stimulant-based ADHD medications as Schedule II drugs, meaning they are considered to have the same addictive potential as many opioids. “The fear is that Adderall would follow the same path as opioid painkillers: careless overprescribing would lead to an epidemic of drug addiction — this time, to stimulants.”

One of the active ingredients in Adderall is amphetamine, and therefore the drug is regulated as a controlled substance under federal law. Its potential for abuse has long been recognized, with the cliche example being college students taking the drug to help them study. A 2018 study by federal researchers found that about 5 million Americans misused a prescribed stimulant, of which Adderall is the most common, at least once in the past year; about 400,000 misused stimulant drugs frequently enough to be characterized as having a disorder. (About 2.7 million people in the US report they have an opioid use disorder.)

Medical News Today described the medical uses, side effects and misuse of amphetamines. The opening sentence on the page says, “Amphetamine is a powerful stimulator of the central nervous system. It is used to treat some medical conditions, but is also highly addictive, with a history of abuse.” Amphetamines are used today to treat ADHD. In the past it has been used to treat narcolepsy, but concerns with side effects have led to it being increasingly replaced by modafinil.

Physical side effects can include low or high blood pressure, erectile dysfunction, rapid heart rate, blurred vision, dry mouth, tics, nosebleed, and others. Psychological effects may include apprehension, anxiety, irritability and restlessness, mood swings, insomnia, obsessive behaviors and grandiosity, or an exaggerated sense of one’s own importance. “In rare cases, psychosis may occur.”

When used as a recreational drug it can speed up reaction times, increase muscle strength and reduce fatigue. A methamphetamine called Pervitin was used by Hitler’s forces for these benefits during WW II; see “Repeating Past Mistakes.”

The DEA Drug Fact Sheet said the following about amphetamines:

The effects of amphetamines are similar to cocaine, but their onset is slower and their duration is longer. In contrast to cocaine, which is quickly removed from the brain and is almost completely metabolized, methamphetamine remains in the central nervous system longer, and a larger percentage of the drug remains unchanged in the body, producing prolonged stimulant effects.

Chronic abuse produces a psychosis that resembles schizophrenia and is characterized by paranoia, picking at the skin, preoccupation with one’s own thoughts, and auditory and visual hallucinations. Violent and erratic behavior is frequently seen among chronic users of amphetamines.

In order to mitigate the potential for abuse, the DEA sets production limits for the manufacturers of Adderall and its generic competitors. In 2019 the DEA announced it was permitting more production of Adderall, but we still don’t know exactly how much production has been authorized or what limits have been set for individual companies. “We don’t know which company gets how much.” Some companies say they are short, but the DEA replies they haven’t used all their supply, so there’s back-and-forth finger-pointing going on. Listen to the On Point program, “What’s behind the ADHD drug shortage” to hear more discussion of this issue.

However, there also seems to a problem that stems from the opioid crisis. In 2021 there was a settlement with the three largest drug distributors that “flag and sometimes block” pharmacies’ orders of controlled substances like Adderall when they exceed a certain threshold. Bloomberg reported that pharmacists said it restricts their ability to fill many different types of controlled substances in addition to opioids. The rules force some independent pharmacists to use creative workarounds. “Sometimes, they must send patients on frustrating journeys to find pharmacies that haven’t yet exceeded their caps in order to buy prescribed medicines.”

This was illustrated in an article for STAT, written by a “biopharma supply chain specialist” who can’t find the Adderall she’s prescribed. She said she’s been using Adderall for ten years to help her function. Then in February of 2023, she was unable to fill her prescription at the pharmacy down the street. She finally was able to fill it at the 20th pharmacy she called, although it meant a 50-minute drive. She recommended several steps to increase the transparency in the supply chain of Adderall. “This will foster efficiency, reliability, and the ability to identify potential risks before they spiral out of control, as has happened now with not just Adderall but other ADHD medications.”

Money making considerations are also involved in the Adderall shortage. Vox reported that after Adderall was approved in 1996, it quickly became the most commonly prescribed treatment for ADHD, although Ritalin and other drugs are still used. PsychCentral listed Adderall as the fourth most prescribed psychiatric medications, with 26.24 million prescriptions in 2020. Other medications prescribed to treat ADHD within the top 25 most prescribed drugs included: Concerta (10th), Vyvanse (20th), and Focalin (24th). Three of the most expensive medications, making the most money for their manufacturers were Concerta ($3.28 billion), Vyvanse ($3.01 billion), and Adderall ($2.35 billion). ADHD prescriptions accounted for over a third of the prescriptions in 2020.

Axios reported some different statistics for both generic and branded Adderall prescriptions, according to IQVIA, a health research firm. Since 2017, IQVIA reported Adderall prescriptions rose from 32.2 million to 41.4 million. This was up more than 10% from 2020. See the following graph taken from the Axios article.

Axios said prescriptions skyrocketed as it became significantly easier to get a diagnosis of ADHD and a prescription for Adderall during the pandemic. A wave of telemedicine startups emerged on TikTok and Instagram, suggesting people should look into ADHD medication if they felt distracted. The Wall Street Journal reported some startups diagnosed people with ADHD and prescribed stimulants after 30-minute video calls — “entirely remotely, and much faster than a typical diagnosis from an in-person psychiatrist.” The trouble with rapid diagnoses is it can be difficult to tell whether the problem is actually ADHD. “Anxiety can present as ADHD, and depression can present as ADHD.”

This spike in diagnoses raises questions about whether ADHD is being over-diagnosed, but that’s really a question that predates the pandemic. See (“The Tip of the ADHD Iceberg” and “National ADHD Epidemic”) for more information. If supply can’t keep up with demand, experts are warning we could have a public health crisis. Even worse, we could face another movement of people from the pharmaceutical market to the illicit drug market, as what happened with opioids. Leo Beletsky, an epidemiologist at Northwestern University said, “Lots of bad things can happen. … Conditions are very much ripe for that to happen here.”

Overdiagnosis of ADHD

In “Twenty-Year Trend in Diagnosed Attention-Deficit/Hyperactivity Disorder”, Xu et al estimated the prevalence of diagnosed ADHD among US children and adolescents from 1997 to 2016. They estimated the prevalence of diagnosed ADHD among US children and adolescents was 10.2% in 2016. There was a consistent upward trend across subgroups by age, sex, race/ethnicity, family income, and geographic regions. “These findings indicate a continuous increase in the prevalence of diagnosed ADHD among US children and adolescents.” They said the common perception that ADHD overdiagnosed in the US was not supported by the scientific evidence. But that is not the end of the matter.

A 2021 study by Kazda et al, “Overdiagnosis of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents” said that questioning the appropriateness of ADHD diagnosis has grown along with the diagnosis rates. They acknowledged that disagreement continues about how much of the increased diagnoses can be attributed to true increases in frequency, improved detection or diagnostic inflation because of misdiagnosis and/or overdiagnosis. They systematically reviewed the research literature to identify and appraise any evidence of overdiagnosis of ADHD in children and adolescents. They found evidence of overdiagnosis and overtreatment of ADHD.

Of the 12,267 potentially relevant studies retrieved, 334 (2.7%) were included. Of the 334 studies, 61 (18.3%) were secondary and 273 (81.7%) were primary research articles. Substantial evidence of a reservoir of ADHD was found in 104 studies, providing a potential for diagnoses to increase (question 1). Evidence that actual ADHD diagnosis had increased was found in 45 studies (question 2). Twenty-five studies showed that these additional cases may be on the milder end of the ADHD spectrum (question 3), and 83 studies showed that pharmacological treatment of ADHD was increasing (question 4). A total of 151 studies reported on outcomes of diagnosis and pharmacological treatment (question 5). However, only 5 studies evaluated the critical issue of benefits and harms among the additional, milder cases. These studies supported a hypothesis of diminishing returns in which the harms may outweigh the benefits for youths with milder symptoms.

They recommended that practitioners, parents and teachers carefully weigh the potential benefits and harms that can go along with ADHD diagnosis and treatment, particularly when individuals with milder symptoms are identified. “For this group, the benefits of diagnosis and treatment may be considerably reduced or outweighed by harms.”

In his review of the study for Mad in America, Peter Simons said “Each [of the 334 included studies] provided data on at least one of the five conditions. They found that all five conditions were supported by the research.” There was also significant evidence of harm after diagnosis, including how a biomedical view of difficulties was associated with disempowerment. He said the researchers warned that diagnosis “can also deflect from other underlying individual, social, or systemic problems.”

Because there is no biological test for ADHD, and the diagnosis is applied subjectively across age, gender, race, and socioeconomic status, there is room for the diagnosis to expand. Additionally, as the diagnostic criteria are loosened, rates of ADHD have increased. The researchers confirmed that a large proportion of the new cases are on the “mild” end of the spectrum. Rates of stimulant treatment for ADHD have also increased, including those with “mild” or “subclinical” ADHD.

In his book, Saving Normal, Allen Frances, a psychiatrist and the former chair for the DSM-IV, said in retrospect, he wishes there had been cautions in the DSM-IV about overdiagnosis and tips to avoid it. He thought they missed the boat. “No one dreamed that drug company advertising would explode three years after the publication of the DSM-IV or that there would be the huge epidemics of ADHD, autism, and bipolar disorder—and therefore no one felt any urgency to prevent them.” For more on the DSM and overdiagnosis, see “Guild Interests Behind DSM Diagnosis.”

The Demedicalization of ADHD

Not only does it seem ADHD is overdiagnosed, there are some researchers who question whether the diagnosis of ADHD meets the criteria for a disorder set out in the manual used by the medical and psychiatric fields. Freedman and Honkasilta argued that the definition of ADHD relies on subjective cultural values to define “abnormal” behavior. Reviewing their study for Mad in America, Peter Simons said, “The diagnosis thus fails to meet the criteria, as stated in the DSM, that disorders must not be reducible to behavior that violates social norms.” The researchers argued that ADHD should be demedicalized and removed from the DSM, like homosexuality was in 1980.

The British Child and Adolescent Psychiatrist Sami Timimi said in his 2017 article, “Non-diagnostic based approaches to helping children who could be labeled ADHD and their families” that it required little intellectual effort to conclude that the concept and definition of ADHD “is replete with problems around reliability and validity.” The diagnostic guidelines note how ADHD behaviors may be minimal or absent in several settings. These include when the person in under close supervision, engaged in an activity that is particularly interesting to them or in a new, novel setting. Even if a genetic basis for ADHD were found, we’d still have to ask why such behaviors should be treated as disorder rather than differences. “Deciding where to draw the line between what we consider part of the “ordinary” spectrum of behaviours and what we decide is “pathological” is more dependent on cultural than scientific processes.”

He said if he asked the question, “what is ADHD?”, it is not possible for him to reply by referring to a particular known pathological abnormality. Instead, he would have to provide a description ADHD as the presence behaviors like of hyperactivity, impulsivity and poor attention. This was contrasted with answering the question, “what is diabetes?” “Diagnosis in that context sits in a “technical” explanatory framework. In psychiatry what we are calling diagnosis (such as ADHD) will only describe but is unable to explain.”

Timimi concluded that ADHD is then not a medical diagnosis, but rather a descriptive classification. And since it is not a medical diagnosis, “it is not surprising that there has been a failure to find any specific and/or characteristic biological abnormality such as characteristic neuroanatomical, genetic or neurotransmitter abnormalities.” He thought the idea of ADHD as a medical diagnosis was past its use-by date and should be discarded.

ADHD is a cultural construct. It is often argued that the use of categorical constructs like ADHD enables the study of aetiology, treatment and prognosis. Evidence outlined above demonstrates that far from enabling any advancement of knowledge or clinical practice, it has created an illusion of progress and resulted in exposure of possibly millions of children and young people to unnecessary and potentially harmful medications. It has spurred on liberal use of stimulant medication, despite the lack of evidence for improved long term outcomes resulting from this.

We are not at the cultural crossroads with ADHD today that we were with homosexuality in 1980. ADHD will likely continue to be a diagnosable disorder. Yet serious consideration of the above discussion of its overdiagnosis, its future demedicalization and removal from the DSM as a disorder and the lack of improvement in long-term outcomes of individuals taking ADHD prescribed stimulants should be done. In retrospect, the Adderall shortage may not truly be the serious public health crisis that is getting all the press coverage. But if it leads people from the pharmaceutical market to the illicit drug market in search of their amphetamines to help them function, like the person in the STAT article, “Lots of bad things can happen.”

09/5/23

Flesh Eating Tranq Dope

 

Image by Лечение Наркомании from Pixabay

A study published by the CDC , documented a new twist to drug overdose death rates, but it is about a non-opioid veterinary tranquilizer called xylazine. It said xylazine-related overdose deaths in 2021 were 35 times higher than the 2018 rate. The number of drug overdose deaths involving xylazine was 102 in 2018. That rose to 627 in 2019, then 1,499 in 2020 and 3,468 in 2021. Male deaths were double the rates for females over the 2018-2021 period. See the following graph from the study.

An NPR article reported the Biden administration declared illicit xylazine as an emergent threat. Rahul Gupta, the head of the White House Office of National Drug Control Policy said this was the first time a substance has been “designated as an emerging threat by any administration.” Known on the streets as tranq or tranq dope, it was first linked to overdose deaths in the North East, around Philadelphia, but has rapidly spread to Southern and Western states. The DEA reported it has seized xylazine and fentanyl mixtures in 48 of 50 states. See “Tranq Dope and Its Consequences.”

The CDC study indicated the rate of overdose deaths involving xylazine was highest in Region 3 (DC, Delaware, Maryland, Pennsylvania, Virginia and West Virginia), followed by Region 1 (Connecticut, Massachusetts, Maine, New Hampshire, Rhode Island and Vermont) and Region 2 (New Jersey and New York). Between 97.1% and 99.4% of drug overdose deaths involving xylazine also mentioned fentanyl. It has also been co-involved with cocaine, heroin and methamphetamine. See the following map from the CDC study.

Pennsylvania governor Josh Shapiro announced steps his Administration is taking to limit access to xylazine. Among the measures was a notice of intent to temporarily add xylazine to schedule III of Pennsylvania’s Controlled Substance, Drug Device and Cosmetic Act. The Acting Secretary of Health said, “Across the country and here in Pennsylvania we are seeing an alarming increase in the number of overdose deaths in which xylazine was a contributing factor.”

The FDA issued a warning about the risk of xylazine in humans to health care professionals on November 8, 2022. It said xylazine was originally approved in 1972 as a sedative and analgesic for use in veterinary medicine.  Its development for use in humans was discontinued because of adverse effects. Structurally, it is similar to clonidine and causes a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. The effects appear similar to that of opioids, making it difficult to distinguish between opioid toxicity and xylazine.

On March 28, 2023, the Combating Illicit Xylazine Act was introduced with bipartisan, bicameral support. The legislation will address a gap in federal law by:

  1. Classifying its illicit use under Schedule III of the Controlled Substances Act;
  2. Enabling the DEA to track its manufacturing to ensure it is not diverted to the illicit market;
  3. Requiring a report on prevalence, risks, and recommendations to best regulate illicit use of xylazine;
  4. Ensuring all salts and isomers of xylazine are covered when restricting its illicit use;
  5. Declaring xylazine an emerging drug threat.

Unless you are a veterinarian, own large animals—or are familiar with the drug scene in places like the Kensington area of Philadelphia—you probably have not heard of xylazine before. “Xylazine—Medical and Public Health Imperatives” by Gupta et al in The New England Medical Journal said its first illicit use was reported in Puerto Rico around 2001. It began to appear intermittently in the continental U.A. between 2006 and 2018. The drug’s duration of effect is longer than fentanyl. Using them together enhances the euphoria and analgesia induced by fentanyl and seems to reduce the frequency of injections.

Xylazine is not easily detected by routine toxicology screens, and is likely under-detected and underdiagnosed. It is rapidly eliminated from the body, with a half-life of 23-50 minutes. Individuals with repeated use of xylazine can become physically dependent and experience withdrawal. “When xylazine is stopped abruptly, severe withdrawal symptoms may develop.” There are currently no FDA-approved medications to manage xylazine withdrawal. Repeated use also leads to severe, necrotic ulcerations.

Xylazine causes wounds that erupt with a scaly dead tissue called eschar; untreated, they can lead to amputation. It induces a blackout stupor for hours, rendering users vulnerable to rape and robbery. When people come to, the high from the fentanyl has long since faded and they immediately crave more.

The NYT noted that xylazine can cause wounds so severe that some result in amputation. The article said a 38-year-old tattoo artist known as the Hood Grandma rolled her wheelchair in to the exchange check-in for Prevention Point Philadelphia, a 30-year-old health services center in Kensington, the neighborhood at the ‘epicenter’ of Philadelphia’s drug trade. Her mother, sister and partner all died of overdoses. Last year her right leg had to be amputated because of an infection from tranq bore into the bone. She said, “the tranq dope literally eats your flesh.”

She unrolled a bandage from elbow to palm. Beneath patches of blackened tissue, exposed white tendons and pus, the sheared flesh was hot and red. To stave off xylazine’s excruciating withdrawal, she said, she injects tranq dope several times a day. Fearful that injecting in a fresh site could create a new wound, she reluctantly shoots into her festering forearm.

Another woman developed a dependence on pain killers prescribed after a serious car crash. She began using heroin and eventually fentanyl, chasing the cheaper and more potent high. She watched in horror as the bruises she was accustomed to “from injecting fentanyl began hardening into an armor of crusty, blackened tissue.” People told her everyone’s dope was being cut with something that caused the grisly, painful sores. She said, “I’d wake up in the morning crying because my arms were dying.”

STAT News described how Savage Sisters, a harm reduction group in Philadelphia, has increased how often it offers wound care in the community. The executive director of Savage Sisters said she has been jumping up and down for three years, trying to get attention to the danger of xylazine infiltrating heroin and fentanyl. She said, “what we’re doing is a Band-Aid on a bullet hole.”

Drug users are reluctant to seek help until their medical condition had advanced to a dangerous point. One man waited until the wound on his wrist became so swollen and painful, he couldn’t move his hand. “The hospital told him that if he hadn’t come in then, he would have lost his hand.” Another man who had his wounds cleaned and wrapped was reluctant to consider going to a hospital for more advanced care because he was worried about getting “sick” in the hospital and being unable to use when he begins to experience withdrawal.

At this time, there has been minimal study of the xylazine drug scene. “Experts and advocates are still trying to understand just how dangerous xylazine is and how it works.” While presentations with images of the gruesome wounds from necrosis or dead tissue illustrate the serious adverse health effects from xylazine, medical professionals aren’t even sure what’s causing the necrosis, the wounds. Xylazine-related wounds can be healed with proper care, but many doctors aren’t aware that’s possible. It’s also changing what recovering from an overdose looks like after being given naloxone.

Someone who overdoses on tranq dope might start to breathe again after receiving naloxone, but still be unconscious from the sedative effect of xylaxzine. Giving them another dose of naloxone still won’t wake them up. “When it was just fentanyl, it was more straightforward. . . These kinds of unholy mixtures that bring down the level of consciousness in different ways are really making the overdose response picture tricky.” Although there are protocols for easing someone off illicit opioids, there is nothing for xylazine.

Savage Sisters provides drug users with cards they can give to medical providers that say, “Test me for xylazine.” The card also gives suggestions to medical professionals for treating the symptoms of xylazine withdrawal, which include anxiety. See the graphic below, taken from the STAT article.

It seemed that after fentanyl hit the streets, the drug scene couldn’t get any worse. But then drug entrepreneurs discovered xylazine mixed with fentanyl extends the fentanyl high and is cost-effective. Sure, your arms may feel like they’re dying, like tranq dope is eating your flesh. But isn’t the high worth it?

08/8/23

A Misbegotten Stepcousin of Christianity, Part 2

Image by Gerd Altmann from Pixabay

Christian Smith with Melinda Lundquist Denton introduced the term ‘moralistic therapeutic deism’ (MTD) in their 2005 book, “Soul Searching: The Religious and Spiritual Lives of American Teenagers” to describe what they see as the common beliefs among American youths. Yet it seems to echo a distinction between religion and spirituality that can be traced back to the thought of William James in The Varieties of Religious Experience, which has been in print since 1902. In Part 1 of this article, I looked at the meaning of MTD and here will examine how it emerged from the sense of ‘spiritual not religious’ belief in Alcoholics Anonymous that grew out of James’ Gifford Lectures on the psychological study of individual religious and spiritual experience.

In “’Being Religious’ or ‘Being Spiritual’ in America,” Marler and Hadaway looked at five different surveys done between the late 1980s and 2000 that asked respondents whether they considered themselves to be “religious” or “spiritual.” Are Americans less religious and more spiritual? They concluded the studies could not give a definitive answer. “The most significant finding about the relationship between ‘being religious’ and ‘being spiritual’ is that most Americans see themselves as both.” When potential change can be traced by examining successive age groups, or by comparing more with less churched respondents, “the pattern is towards less religious and less spirituality.”

The net effect is that among less churched and younger Americans there is less agreement about religiousness and spirituality, and change is observed more in the decline of those Roof (2000) identifies as ‘strong believers,’ the religious and spiritual, and the increase in ‘secularists.’

Nevertheless, the Pew Research Center said “More Americans now say they’re spiritual but not religious.” In 2017, Pew noted that 27% of U.S. adults think of themselves as spiritual but not religious, an increase of 8% since 2012. This growth was broad-based, increasing among men and women; Republicans and Democrats; across race/ethnicity; and people of different ages and education levels. It seems to have come mainly at the expense of Americans who considered themselves to be spiritual and religious. The percentage of U.S. adults who say they are spiritual and religious fell by 11 points between 2012 and 2017. See the following graphic to the left taken from the Pew article.

While many of U.S. adults are religiously unaffiliated, describing themselves as atheist, agnostic or “nothing in particular”, most actually do identify with a religious group. Many in the “spiritual but not religious” category have low levels of religious observance, saying they seldom or never attend religious services; and that religion is “not too” or “not at all” important in their lives. Yet others say they attend religious services weekly and 27% say religion is very important to them. See the following chart to the right taken from the Pew article.

 

 

 

 

 

 

 

 

 

Smith and Denton acknowledged the widespread sense of “spiritual seeking” by people who consider themselves as “spiritual but not religious.” They are people who have an interest in spiritual matters but are not devoted to one particular historical spiritual faith or denomination. They are reportedly exploring many faiths and spiritualities in order to find what works for them, that meets their needs. They are open to a multiplicity of truths, willing to mix and match traditionally distinct religious beliefs and practices. “And they are suspicious of a commitment to a single religious congregation.”

They operate, whether self-consciously or not, as religious and spiritual consumers by defining themselves as individual seekers, the authoritative judges of truth and relevance in faith according to how things subjectively feel to them. Such consuming seekers are not religiously rooted or settled but are spiritual nomads on a perpetual quest for greater insight and more authentic and fulfilling experiences.

When Smith and Denton looked at whether American teenagers consider themselves to be spiritual but not religious, only 8 percent said it was very true of them. Forty-six percent said it was somewhat true and 43% said it is not true at all. They also presented data that broke this down further by religious tradition. In the following chart, CP stands for conservative Protestant, MP for mainline Protestant, BP for Black Protestant, RC for Catholic, J for Jewish, LDS for Ladder Day Saints/Mormons, OR for other religions, and NR for not religious.

Smith and Denton would likely explain the difference between their research with teenagers and that from the Pew Center with adults as a product of the teens not understanding the meaning of “spiritual but not religious.” The majority of the teens they interviewed for their study said they had never heard the term before. And if they had heard of the term, they had no clue what it meant. “Although the slogan ‘spiritual but not religious’ can be seen on many bookshelves, read in many newspapers, and heard on many talk shows, very few American teenagers have heard of it, much less learned to what beliefs and lifestyles it refers.” So, they coined the term ‘moralistic therapeutic deism’ to capture what they saw as the basics of teen-centered belief system and suggested it operated as a distinct level within American Religion.

While they acknowledged how the thought of Robert Bellah was incorporated into their level of American Civil Religion, they failed to note the correspondence of their levels of Organizational Religion and Individual Religion to William James’ distinction between institutional and personal religion. See the chart for Figure 2 in Part 1.

In VRE, James said worship, sacrifice, ritual, theology, ceremony and ecclesiastical organization were the essentials of institutional religion. He defined personal religion as “the feelings, acts, and experiences of [the] individual . . . in their solitude, so far as they apprehend themselves to stand in relation to whatever they may consider the divine.” James’ sense of institutional religion fits with Smith’s and Denton’s sense of organizational religion (as formal religious institutions and organizations), as his sense of personal religion fits with their sense of individual religion (as the idiosyncratic, eclectic, “lived” beliefs and practices of individuals).

James said that if someone thought the word ‘religion’ should be reserved for the fully organized system of feeling, thought, and institution typically called the church, he invited them to refer to what he called personal religion whatever they wanted. Alcoholics Anonymous began calling it spirituality, where Smith and Denton referred to it as moralistic therapeutic deism.

We live at a time when religious belief in America, particularly Christian religious belief, has been increasingly questioned and challenged as too rigid or doctrinaire. This is especially true for conservative Christians, who are attempting to live by and apply what they see as the teachings of Scripture to their lives during this turbulent time. In “Religious Alcoholics; Anonymous Spirituality” I suggested that the Jamesean distinction of religion and spirituality fails to separate a Christian expression of religion from a non-Christian one, and a biblical sense of spirituality from a nonbiblical one. A richer and nuanced distinction would be between true spirituality and mere spirituality and true religion and mere religion, remembering that “true religion always contains true spirituality.”

In True Spirituality, Francis Schaeffer rejected the possibility that true spirituality could be devoid of biblical content. There cannot be a leap-in-the-dark faith for a Christian; there is no “faith in faith” encounter with the divine. Schaeffer said, “It is believing the specific promises of God, no longer turning our backs on them, no longer calling God a liar, but raising empty hands of faith and accepting that finished work of Christ as it was fulfilled in history on the cross.”

As Smith and Denton said with regard to moralistic therapeutic deism, under the influence of mere religion and mere spirituality, Christianity is degenerating into a pathetic, misbegotten stepcousin of itself. Or worse, it is being displaced by a different religious faith.

I’ve previously described how the sense of ‘spiritual not religious’ found in Alcoholics Anonymous emerged from The Varieties of Religious Experience by William James in several other articles on this website. Search for ‘spiritual not religious,’ on this website. You can start with three related articles, beginning with “What Does Religious Mean?” There are links to the remaining two articles at the end of the article.

07/25/23

A Misbegotten Stepcousin of Christianity, Part 1

Meditation, Pixabay

Until I listened to a five-and-a-half minute excerpt from the podcast Ask Christian Counseling Associates, “Moralistic Therapeutic Deism vs Traditional Christianity,” I had never heard of the term. I was surprised to know it has been around since 2005, when “moralistic therapeutic deism” was introduced by Christian Smith with Melinda Lundquist Denton in, “Soul Searching: The Religious and Spiritual Lives of American Teenagers.” It reminded me of the spiritual, not religious distinction made by Alcoholics Anonymous and the recovery-based support groups that use A.A.’s 12 Steps. Smith’s conclusion in “Soul Searching” was that “a significant part of Christianity in the United States is actually only tenuously Christian” and has “rather substantially morphed into” it’s misbegotten stepcousin, Christian Moralistic Therapeutic Deism. The similarities between being the “spiritual, not religious” sense of the 12 Steps and this misbegotten stepcousin of Christianity are worth unpacking.

“Soul Searching” was the result of the National Study of Youth and Religion (NSYR), a research project on the religious and spiritual lives of American adolescents. It was conducted from 2001 to 2005 at the University of North Carolina at Chapel Hill. The NSYR did a national, randomized telephone survey of U.S. households with at least one teenager. Then 17 trained project researchers organized 267 in-depth, face-to-face interviews with a subsample of these telephone survey respondents in 45 states.

Building upon the thought of Robert Bellah in his 1967 essay, for the journal Daedalus, “Civil Religion in America,” Smith and Denton theorized that Moralistic Therapeutic Deism operated on an analogous, but different level of religion to Bellah’s sense of American civil religion. See Figure 2, scanned from “Soul Searching” below.

The bottom level is the eclectic, idiosyncratic, personal beliefs and practices of Individual Religion. Formal religious institutions and organizations of the more systematized and coherent faiths operate on the plane of Organizational Religion. At the peak is the nationally unifying political faith of American Civil Religion. Smith and Denton see Moralistic Therapeutic Deism (MTD) existing on a plane between Individual and Organizational Religion.

Like American civil religion, Moralistic Therapeutic Deism appropriates, abstracts, and revises doctrinal elements from mostly Christianity and Judaism for its own purpose. But it does so in a downward, apolitical direction. Its social function is not to unify and give purpose to the nation at the level of civic affairs. Rather, it functions to foster subjective well-being in its believers and to lubricate interpersonal relationships in the local public sphere. Moralistic Therapeutic Deism exists, with God’s aid, to help people succeed in life, to make them feel good, and to help them get along with others—who otherwise are different—in school, work, on the team, and in other routine areas of life.

Suggesting that religion in the U.S. operates on those levels includes interaction and influence on each other, according to Smith and Denton. Individual beliefs are shaped in part by the teachings of organized religions, as well as horoscopes, talk shows, etc. American civil religion is affected by both liberal religious activism as well as the Religious Right (or in more current terminology, Christian Nationalism), operating at the level of a formal religious organization. “The same observation about interlevel interaction and influence is also true of Moralistic Therapeutic Deism. It helps organize and harmonize individual religious beliefs below it.”

It also mirrors and may very well interface with American civil religion at the highest level by providing the nation’s inhabitants a parallel and complementary common, unifying, functional faith that operates at a more apolitical, private, and interpersonal level of human life.

Smith and Denton said the “creed” of moralistic therapeutic deism can be codified into five beliefs (pp. 162-63):

  1. A God exists who created and orders the world and watches over human life on earth.
  2. God wants people to be good, nice, and fair to each other, as taught in the bible and by most world religions.
  3. The central goal of life is to be happy and to feel good about oneself.
  4. God does not need to be particularly involved in one’s life except when God is needed to resolve a problem.
  5. Good people go to heaven when they die.

MTD is about instilling a moralistic approach to life. “Central to living a good and happy life is being a good, moral, person.” This includes being nice, kind, pleasant, respectful, responsible, working on self-improvement taking care on one’s health, and doing your best to be successful. MTD is about providing therapeutic benefits. It’s not a religion of repentance from sin, of saying your prayers, of keeping the Sabbath and holy days, “of living as a servant of a sovereign divine”, of building character through suffering.

It is about attaining subjective well-being, being able to resolve problems, and getting along amiably with other people. . . As long as one is happy, why bother with being able to talk about the belief content of one’s faith? Lastly, MTD is about a particular understanding about God. God exists, created the world and defines our general moral order, but is not one who is particularly personally involved in one’s affairs—especially affairs in which one would prefer not to have God involved. Most of the time, the God of this faith keeps a safe distance.

Anyone familiar with the teachings and beliefs of conservative, biblical, Christianity can see the problems with this so-called “creed.” It seems to equate biblical teaching and that of other religions, blurring an important distinction between special and common grace. It has a self-centered focus, ignoring that humanity’s “chief end” (according to the Westminster Shorter Catechism) is to glorify God, and enjoy him forever. He is not the Divine Butler and Cosmic Therapist.

This God is not demanding. He actually can’t be, because his job is to solve our problems and make people feel good. In short, God is something like a combination Divine Butler and Cosmic Therapist; he is always on call, takes care of any problems that arise, professionally helps his people feel better about themselves, and does not become too personally involved in the process.

Ultimately, it is Christless. The self-sacrifice of Christ in order to sanctify and cleanse us is not necessary. Saying he was the way, the truth and the life; that no one comes to the Father except through him (John 14:6) was a misstatement. In their Conclusion for chapter four, “God, Religion, Whatever,” Smith and Denton said:

We have come with some confidence to believe that a significant part of Christianity in the United States is actually only tenuously Christian in any sense that is seriously connected to the actual historical Christian tradition, but has rather substantially morphed into Christianity’s misbegotten stepcousin, Christian Moralistic Therapeutic Deism. This has happened in the minds and hearts on many individual believers and, it also appears, within the structures of at least some Christian organizations and institutions. The language, and therefore the experience, of Trinity, holiness, sin, grace, justification, sanctification, church, Eucharist, and heaven and hell appear, at the very least, to be supplanted by the language of happiness, niceness, and an earned heavenly reward. It is not so much that U.S. Christianity is being secularized. Rather more subtly, Christianity is either degenerating into a pathetic version of itself or, more significantly, Christianity is actively being colonized and displaced by a quite different religious faith.

A Google search of the term found over 35,000 references to “moralistic therapeutic deism.” There have been many different reflections on the implications of MTD. It is more than simply a problem in youth ministry. Writing for The Gospel Coalition, Brian Cosby said MTD runs counter to the gospel of Jesus Christ. God is not the divine genie, dispensing wishes, but Immanuel—he became human “to seek and save his bride.” By faith alone, through his life, death, and resurrection Jesus Christ has accomplished everything God has required of us. And only those who come through him will see the Father in heaven.

Albert Mohler said the radical transformation of Christian theology and Christian belief in MTD replaced the sovereignty of God with the sovereignty of self. Human problems are reduced to pathologies in need of a treatment plan. “Sin is simply excluded from the picture, and doctrines as central as the wrath and justice of God are discarded as out of step with the times and unhelpful to the project of self-actualization.”

We now face the challenge of evangelizing a nation that largely considers itself Christian, overwhelmingly believes in some deity, considers itself fervently religious, but has virtually no connection to historic Christianity. Christian Smith and his colleagues have performed an enormous service for the church of the Lord Jesus Christ in identifying Moralistic Therapeutic Deism as the dominant religion of this American age. Our responsibility is to prepare the church to respond to this new religion, understanding that it represents the greatest competitor to biblical Christianity.

I would disagree with Dr. Mohler that MTD is a new religion in the sense that it has existed with individuals saying they are spiritual, not religious which can be traced back to the thought of William James over 100 years ago. He distinguished institutional religion from personal religion in his seminal work, The Varieties of Religious Experience. See part 2 for how MTD emerged from the sense of spiritual, not religious belief.