02/6/24

Psychedelics as the Newest Psychiatric Craze, Part 1

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In October California Governor Gavin Newsom vetoed a bill that would have decriminalized the possession and personal use of several plant-based hallucinogens, including psilocybin, mescaline and dimethyltryptamine (DMT), saying more work needed to be done on treatment guidelines. The legislation would have decriminalized possession before setting up regulatory treatment guidelines, with the California Health and Human Services Agency supposed to make recommendations to lawmakers after the consequences of decriminalization. The bill would not have arrested or prosecuted individuals who possessed limited amounts of plant-based hallucinogens. Also, the bill did not legalize the sale of these psychedelics. They are still illegal under federal law.

Public opinion was said to have shifted on using psychedelics to treat trauma and other disorders such as depression, and alcohol use disorder. There has been a significant amount of interest in the potential of psychedelics for mental health that includes encouragement and discouragement of treating psychiatric conditions with them. Sandy Cohen opened her article “Do psychedelics have a role in psychiatric treatment?” for UCLA Health, with the provocative question, “What if there was a medication that could significantly reduce symptoms of treatment-resistant depression in a single dose?” A UCLA Health psychiatrist, Walter Dunn, described two studies where psilocybin was found to have a significant reduction in symptoms of treatment-resistant depression. He said these results were unprecedented: “We have nothing that works this well.”

Dunn said the coverage in mainstream media and books aimed at lay audiences (such as Michael Pollan’s book, How to Change Your Mind) have raised interest and curiosity in psychedelics. He said when he goes to dinner parties and people discover his work is with psychedelic drugs, “I’m talking about them for the rest of the evening.” According to a 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. But there were 35% who opposed it and 69% did not see it as something “for people like me.”

We are in a historic moment in the space for psychedelic science, research and also mental health in general. . . There hasn’t been any time in modern psychiatry where there has been so much interest, awareness and discussion around a potential mental health treatment.

Dunn acknowledged the drugs come with risks, which was one of the reasons the FDA has been cautious about the trials being run. “These are not benign medicines. Anything that can help you can harm you.” He discussed how the FDA was set to consider MDMA-assisted therapy for PTSD in 2024. It’s still unclear whether or not the FDA will want a Risk Evaluation and Mitigation Strategy (REMS), if these treatments are approved. A REMS could require psychedelic-assisted therapy to included two specially trained and certified clinicians during the psychedelic experience. If a REMS is required by the FDA for MDMA-assisted therapy, it would reduce the pool of therapists who could administer the treatment and decrease access even as it enhances safety.

Joanna Moncrieff, a British psychiatrist, noted in “Psychedelics—The New Psychiatric Craze” where they were viewed as an increasingly fashionable medical treatment. But she wondered if they had any objective health benefits and were they safe. She noted where psilocybin, LSD, MDMA and ketamine were some of the psychedelics being recommended for an ever-lengthening list of problems that include depression, anxiety, addiction, and PTSD. She acknowledged some people might learn important about themselves through the effects of psychedelic drugs.

But these benefits are not medical or health effects. They are akin to the personal development people achieve through other sorts of activities and life experiences. . . And although the concept of drug-assisted psychotherapy acknowledges that it is the way the psychoactive effects of the drugs are used to promote a process of personal learning that is relevant, why not employ other, safer and cheaper methods? Why not nature-assisted psychotherapy (a walk in the park), for example?

Yet, the use of these drugs is portrayed as if they work by targeting underlying dysfunctional brain processes. Moncrieff is concerned that when psychedelics get a medical license, psychotherapy will be dropped or minimized. “As with ketamine, the tendency of all psychedelic treatment will be towards the provision of the drug in the cheapest possible way, which means the minimum of supervision and therapy.” Presciently, Moncrieff wrote her article two years ago, before the accidental death of Matthew Perry from the acute effects of unsupervised ketamine use.

She said most psychedelic research ignores the way the immediate psychoactive effects of the drugs impact people’s feelings and behavior in a way that will influence mood symptom ratings and may produce the impression of improvement.  She singled out the American Psychiatric Association’s report on ketamine treatment, which said there was compelling evidence the antidepressant effects of ketamine infusion are rapid and robust. While the APA acknowledged the antidepressant effects were transitory, they did not explain how they could be distinguished from the euphoria and other mental alterations associated with acute ketamine intoxication. “If ketamine’s effects are ‘antidepressant’ then so are the effects of all the other drugs that produce short-term euphoria including alcohol, cocaine, heroin, amphetamines, etc.”

Any powerful mind-altering drug will likely have ‘placebo’ effects. Drug-induced experience will lead people to expect they will improve or think they have improved. Psychedelic research also neglects the hours of medical supervision and professional attention associated with psychedelic treatment. Clinical contact improves people’s outcomes in depression, as was seen in esketamine trials, where a high level of professional contact seems to have exerted a powerful effect on some people.

The current craze for psychedelics also means the adverse effects are being minimised or overlooked. The ‘bad trip’ is a well-recognised phenomenon, and may not be that uncommon. Psychiatrist Rick Strassman, author of DMT: the Spirit Molecule, described how half of the 60 volunteers he injected with the powerful hallucinogen, DMT (N,N-dimethyltryptamine), experienced terrifying hallucinations and anxiety, and he discontinued his research, in part because of these effects. Science journalist John Horgan describes months of depression and flashbacks following a ‘bad trip’, and also reminds us that Albert Hofmann, who first synthesised LSD, also had doubts about it, calling his 1981 memoir LSD: My problem child.

Moncrieff ended her article by noting that while one or two doses of any drug is unlikely to do much harm, the tendency for treating mental health concerns is for long-term use. And repeated use of psychedelics is unlikely to be completely harmless. “As with so many other medical treatments, they have become popular through the potent mixture of financial interests and desperation.” There are many safer routes to promote personal development through an unusual experience. But we will be faced with a decision to legalize psychedelic-assisted treatment sooner rather than later, as MDMA-assisted therapy is expected to be submitted to the FDA for review for approval in early 2024. See Part 2 of this article for more information on the approval process for MDMA-assisted therapy.

01/30/24

Continue to Keep Marijuana Medical in PA

Photo by Alesia Kozik: https://www.pexels.com/

Medical marijuana has been available in Pennsylvania since February of 2018. Fortunately, progress to the legalization of recreational marijuana has not occurred yet. I’ve been urging for almost six years that we wait for the research into the risks and benefits of marijuana use can be reliably researched. Here are three recently published research articles to reflect on that suggest going ‘full Colorado’ in Pennsylvania may not be a good idea.

In August of 2023, The British Medical Journal (BMJ) published “Balancing risks and benefits of cannabis use” by Solmi et al. Their research was an umbrella review of 101 meta-analyses that have reported on the safety of cannabis, cannabinoids or cannabis-based medicines. According to the 2019 Global Burden of Disease Study, Solmi et al said more than 23.8 million people have cannabis use disorder (CUD). In the U.S., the prevalence of CUD was estimated at around 6.3% in a lifetime. In Europe, around 15% of people aged 15 to 35 reported using cannabis in the past year.

In Europe, over the past decade, self-reported use of cannabis within the past month has increased by almost 25% in people aged 15-34 years, and more than 80% in people who are 55-64 years. Cannabis or products containing tetrahydrocannabinol (cannabinoids) are widely available and have increasingly high tetrahydrocannabinol content. For instance, in Europe, tetrahydrocannabinol content increased from 6.9% to 10.6% from 2010 to 2019. Evidence has suggested that cannabis may be harmful, for mental and physical health, as well as driving safety, across observational studies but also in experimental settings. Conversely, more than a decade ago, cannabidiol was proposed as a candidate drug for the treatment of neurological disorders such as treatment-resistant childhood epilepsy. Furthermore, it has been proposed that this substance might be useful for anxiety and sleep disorders, and even as an adjuvant treatment for psychosis. Moreover, cannabis-based medications (ie, medications that contain cannabis components) have been investigated as putative treatments for several different conditions and symptoms.

There was converging evidence of an increased risk of psychosis in adolescents and adults, and with psychosis relapse in people with a psychotic disorder. There was an association between cannabis and general psychiatric symptoms such as depression and mania; and detrimental effects on memory, verbal delayed recall, verbal learning and visual immediate recall. “Across different clinical and non-clinical populations, observational evidence suggests an association between cannabis use and motor vehicle accidents.” There was also evidence of an association with somnolence (drowsiness) with cannabinoids and cannabidiol. Cannabis-based medicines were associated with visual impairment, disorientation, dizziness, sedation and vertigo.

In addition to the association of cannabis and psychosis, cannabis use is associated with a worse outcome after onset, including poorer cognition, lower adherence to antipsychotics and a higher risk of relapse. “In other words, use of cannabis when no psychotic disorder has already occurred increases the risk of its onset, and using cannabis after its onset, worsens clinical outcomes.” Mood disorders have their peak of onset close to that for cannabis use, raising concern because of the associations noted in this study between cannabis and depression, mania and suicide attempt. High THC content cannabis is thought to serve at a gateway to other substances, especially in younger people.

With regard to the therapeutic potential of cannabis-based medicines, cannabidiol was beneficial in reducing seizures in certain forms of epilepsy. They were also beneficial for pain and spasticity in multiple sclerosis, as well as for chronic pain in various conditions. In patients with chronic pain, the effects of prolonged use of cannabinoids needs to be tested “because current findings only come from short term randomized controlled trials.” Active comparisons between cannabidiol and available options for epilepsy, cannabis-based medicines and other pain medications, other treatments for muscle spasticity in multiple sclerosis are needed with a focus on efficacy and safety to inform future guidelines.

In conclusion, Solmi et al said converging and convincing evidence supported the association of marijuana use with poor mental health and cognition and the increased risk of car crashes. Cannabis use should be avoided in adolescents and young adults when neurodevelopment is still occurring, when mental health disorders begin and cognition is important for optimizing academic performance and learning. Cannabidiol could be considered as a potential treatment option in epilepsy. Cannabis-based medicines could be considered for chronic pain across different conditions, and for nausea and vomiting and for sleep in cancer.

Law and public health policy makers and researchers should consider this evidence synthesis when making policy decisions on cannabinoids use regulation, and when planning a future epidemiological or experimental research agenda, with particular attention to the tetrahydrocannabinol content of cannabinoids. Future guidelines are needed to translate current findings into clinical practice.

The 2022 National Survey on Drug Use and Health (NSDUH) released in November of 2023, 22% of people 12 or older reported using marijuana in various ways (smoking, vaping, dabbing, eating or drinking, lotion or cream, taking pills or some other way). The percentage was highest among young adults, 18 to 25 (38.2% or 13.3 million people), followed by adults over 26 (20.6%, 45.7 million people), then adolescents 12 to 17 (11.5%, 2.9 million people). Among people 12 or older in 2022, 6.7% or 19 million people, has a CUD (cannabis use disorder) in the past year. The percentage of young adults 18 to 25 with CUD was 16.5% or 5.7 million people. Adolescents aged 12 to 17 with CUD was 5.1%, or 1.3 million people. These figures were higher than the data reported in the following article, “Cannabis-Related Disorders and toxic Effects,” perhaps reflecting more recent data.

In December on 2023, The New England Journal of Medicine published “Cannabis-Related Disorders and Toxic Effects” by Daniel Gorelick. The article reviewed the seven cannabis-related disorders defined in the DSM-5-TR. The author said worldwide, an estimated 209 million persons between 15 and 64 used cannabis in 2020. In the U.S., an estimated 52.4 million people 12 and older used cannabis in 2021, representing 18.7% of that age group. And 16.2 million persons met the diagnostic criteria for CUD.

Cannabis use disorder occurs in all age groups but is primarily a disease of young adults. The median age at onset is 22 years (interquartile range, 19 to 29). In the United States, the percentage of 18-to-25-year-old persons with current (past-year) cannabis use disorder in 2021 was 14.4%. Younger age at initiation of cannabis use is associated with faster development of cannabis use disorder and more severe cannabis use disorder.

The major risk factors for developing CUD are the frequency and duration of cannabis use. And the core feature is loss of control, reflected in persistent use despite adverse consequences. The potency and amount of cannabis are also risk factors, but they have not been well studied because of the difficulty in quantifying the amount and potency of the THC content of products. “The potency of cannabis has doubled over the past 2 decades, according to analyses of samples seized by U.S. law enforcement, which may contribute to the increased risk of cannabis use disorder and cannabis-induced psychosis.” The risk of CUD increases with the frequency of use: 3.5% prevalence of CUD with yearly use (less than 12 days per year); 8.0% with monthly use (up to 4 days per month); 16.8% with weekly use (up to 5 days per week); and 36% with daily or near daily use.

Several clinical and sociodemographic factors are associated with an increased risk of cannabis use disorder, including the use of other psychoactive substances such as alcohol and tobacco; having had adverse childhood experiences (such as physical, emotional, or sexual abuse); having a history of a psychiatric disorder or conduct problems as a child or adolescent; depressed mood, anxiety, or abnormal regulation of negative mood; stressful life events (such as job loss, financial difficulties, and divorce); and parental cannabis use. These significant associations do not necessarily indicate a direct causal influence on cannabis use disorder, because many of these factors are also highly associated with both cannabis use and frequent cannabis use.

Gorelick told Medical Xpress almost 50% of people with CUD have another diagnosable psychiatric disorder such as major depression, PTSD or generalized anxiety disorder. He said: “There is a lot of misinformation in the public sphere about cannabis and its effects on psychological health with many assuming that this drug is safe to use with no side effects.” About 1 in 10 people who use cannabis will become addicted and if you start using before the age of 18 the risk rises to one in six. Cannabis use accounts for 10% of all drug-related emergency room visits and is associated with a 30 to 40 percent increased risk of car accidents.

He concluded that CUD and heavy or long-term cannabis use have clear adverse effects on physical and psychological health. He thought research on the endocannabinoid system is needed to better explain the pathophysiology of these effects and to develop treatments. In other words, continue to keep marijuana medical in PA until we have reliable research to determine whether or not recreational marijuana should be legalized. So far, it’s not looking to be a wise move.

For more information on marijuana and the concerns with legalization, search for “marijuana” or “cannabis” on this website or see, PREPARING to Legalize Cannabis.” For more information on marijuana legalization in Pennsylvania, see “Keep Marijuana Medical in PA,” “Waiting Before Pennsylvania Goes ‘Full Colorado’” and others.

01/23/24

Life, Liberty, and the Pursuit of Christian Nationalism

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After reading Paul Miller’s book, The Religion of American Greatness, I became aware of the problems of thinking of America as a “Christian Nation.” Simply put, it is a political ideology with a Christian gloss. I was relatively unaware of Christian nationalism until then, but was persuaded by his arguments. He wrote an article for Christianity Today, “What Is Christian Nationalism” where he noted that many of the rioters on January 6th, 2021 had Christian signs, slogans or symbols. “But none of this should be confused with the Christian’s identity in the transnational family of God, and no national political agenda or ideal can take priority over God’s global mandate and mission for his people.” It takes the name of Christ as a fig leaf to cover its political program, “treating the message of Jesus as a tool of political propaganda and the church as the handmaiden and cheerleader of the state.”

As Miller noted in his article, the term “Christian Nationalism” is a relatively new term, one which it seems many Americans are not familiar with. Slate said the term was “in the air” after January 6th rioters came to the Capitol waving Christian symbols and banners. But it has been embraced by others, including Marjorie Taylor Greene. She even hocked a Proud Christian Nationalist tee shirt in her Official MTG Shop. She also posted on X, formerly known as Twitter, that she was honored to meet Jake Chansley, the infamous QAnon shaman from January 6th.

The Pew Research Center also noted growing numbers of Americans were embracing the Christian Nationalist label, while others still saw it as a danger. Pew said their survey found most American adults believed the founding fathers intended the country to be a Christian nation (60%), with many affirming (45%) it should be a Christian nation today. When the survey’s respondents were separated into those who think the U.S. should be a Christian nation and those who did not, some interesting difference emerged. Among those who thought the U.S. should be a Christian nation, only 28% thought the country should openly declare it. Fifty-two percent thought no religion should be the official religion of the country.

Among those who thought the U.S. should not be a Christian nation, 1% thought the U.S should openly declare it, and 88% rejected the idea. Similar differences were found with whether the state should advocate for Christian religious values, or moral value shared by people of many faiths. And whether or not to enforce or stop enforcing the separation of church and state. See the Pew link for a graphic. Those who want the U.S. to be a Christian nation tended to want the Bible to have a great deal or some influence on U.S. laws (78%), while those opposed to the idea soundly rejected the idea (79%). See the chart below, found in the Pew article.

The Pew survey results disturbingly resonate with what Paul Schreiner called the “bad form” of Christian nationalism. This is a fusion of Christianity and civil life, where instead of persuasion, adherents seek to enact and enforce laws. This is attempting to bring about the kingdom of God by power and command, not by the Spirit of God. Schreiner acknowledged the distinctly Christian history of America, but noted how this sense of Christian nationalism goes against key features of the American experiment, namely pluralism and religious liberty.

Eliminating all dissent might sound attractive, and it certainly would allow governing authorities to get things done more quickly. But squashing dissent violates human liberty, equality, and the vision of the founding fathers. It requires coercion of and change from those who dissent. If taken to its logical conclusion, this Nationalism undermines the foundation of a free society. Should such a fusion dominate American civil life, it would divide the nation rather than unify it. Uniformity in some aspects of national life isn’t all bad, but that must always exist beside diversity.

See “What’s Wrong with Christian Nationalism?” or Paul Schreiner’s article, “The Good, the Bad, and the Ugly of Christian Nationalism” for a more through critique and discussion of this point.

Perhaps many of the Pew survey participants didn’t have a well-thought-out understanding of the nuances within so-called “Christian nationalism.” This seems to have been the case. Half of the Pew survey respondents were asked if they have heard the term “Christian nationalism.” Overall, 54% of Americans said they had never heard it. Non-Christians tended to be more familiar with the term (55%). But atheists (78%) and agnostics (63%) were most familiar. See the table below, found in the Pew article.

Schreiner warned that the “bad” form of Christian Nationalism becomes “ugly” when it “idealizes and advocates for a fusion of Christianity with American life and does so by dominion. This is the type of Christian Nationalism exhibited by some on January 6.” This conflates God and country, confusing the categories of Christian faith and nation-state and advocates for its goals by force or violence when deemed necessary. “No nation-state can be a Christian nation-state, because Christianity doesn’t work that way.” Here, the fig leaf referred to in the opening paragraph comes off and Christian nationalism is exposed as a political program of nationalism.

Jake Chansley, the infamous QAnon shaman from January 6th was sentenced and imprisoned for 27 months. At his parole hearing, he expressed remorse for his actions and said he no longer wanted to be known as the QAon Shaman, saying he was wrong to enter the Capitol . He was released into a Phoenix halfway house for ex-offenders. Seemingly unrepentant for his actions, he is now running for Congress in the state of Arizona as a Libertarian and has again embraced his role as the QAnon Shaman. Look at the link to “X” above where Marjorie Taylor Greene said she was honored to meet him. Also see his own Twitter feed.

In “What Is Christian Nationalism?” Paul Miller distinguished between Christian nationalism and nationalism. Miller said nationalism is the belief that humanity is divisible into mutually distinct culture group defined by shared language, religion, ethnicity, or culture. They should have their own governments; the governments should promote and protect a nation’s cultural identity. Sovereign national groups then provide meaning and purpose for human beings.

The problem is, humanity is not easily divisible into mutually distinct cultural groups. “Cultures overlap and their borders are fuzzy.” They make a poor fit as the foundation for political order. Whereas cultural identities are fluid and hard to draw boundaries around, political boundaries are hard and semipermanent. “Cultural pluralism is essentially inevitable in every nation.” Attempts to found political legitimacy on cultural likeness means the political order will consistently be felt to be illegitimate by some group.

In the absence of moral authority, nationalists can only hope to establish themselves by force. “Scholars are almost unanimous that nationalist governments tend to become authoritarian and oppressive in practice.” Miller observed that when Protestantism was a “quasi-official religion” in the U.S., “it did not respect true religious freedom.” Christianity was also used by the U.S. and many individual states to support slavery and segregation.

Miller thought Christian nationalism was the belief that the American nation is defined by Christianity; and the government should take steps to keep it that way and continue to be so in the future—to promote a specific cultural template as the “official” culture of the country. There may be some who want an amendment to the Constitution to recognize America’s Christian heritage. They strive to enshrine a Christian nationalist interpretation of American history in school curricula; that America has a special relationship with God; that it was chosen by him to carry out a special mission on earth. Others advocate for immigration restrictions to prevent changes to American ethnic demographics or a change to American culture. Others want to empower the government to take stronger action against immoral behavior.

Christian nationalism tends to treat other Americans as second-class citizens. If it were fully implemented, it would not respect the full religious liberty of all Americans. Empowering the state through “morals legislation” to regulate conduct always carries the risk of overreaching, setting a bad precedent, and creating governing powers that could be used later be used against Christians. Additionally, Christian nationalism is an ideology held overwhelmingly by white Americans, and it thus tends to exacerbate racial and ethnic cleavages. In recent years, the movement has grown increasingly characterized by fear and by a belief that Christians are victims of persecution. Some are beginning to argue that American Christians need to prepare to fight, physically, to preserve America’s identity, an argument that played into the January 6 riot.

Christianity is a religion focused on the person and work of Jesus Christ as defined by the Christian Bible and the Apostles’ and Nicene Creeds. It is the gathering of people “from every nation and tribe and people and language,” who worship Jesus (Revelation 7:9), a faith that unites Jews and Greeks, Americans and non-Americans together. Christianity is political, in the sense that its adherents have always understood their faith to challenge, affect, and transcend their worldly loyalties—but there is no single view on what political implications flow from Christian faith other than that we should “fear God, honor the king” (1 Peter 2:17), pay our taxes, love our neighbors, and seek justice.

Miller said normal Christian political engagement is humble, loving and sacrificial. It rejects the idea that Christians are entitled to primacy of place in the public square or that Christians have a presumptive right to continue their historical predominance in American culture. Christians should seek to love their neighbors by pursuing justice in the public square, which includes working against abortion, promoting religious liberty, furthering racial justice, protecting the rule of law, and honoring constitutional processes. “That agenda is different from promoting Christian culture, Western heritage, or Anglo-Protestant values.”

There is a “good” sense of Christian Nationalism, meaning simply that “Christianity has influenced and should continue to influence the nation.” The Declaration of Independence affirmed that all men (and women) are created equal. They are endowed “by their Creator with certain unalienable rights, that among these are life, liberty, and the pursuit of happiness.” Schreiner noted that such a principle was worthy of Christian advocacy alongside biblical views of marriage, sexuality, and abortion. “Our nation would be improved by affirming the goodness of natural law principles.”

In the best sense, this form of Christian Nationalism doesn’t attempt to dominate the political process or to make the nation completely Christian but seeks instead to bring change by persuasion. Rather than trying to overthrow the government, adherents advocate their cause by supporting laws, electing candidates, podcasting, writing, and developing think tanks. They won’t force their opinions, but they also won’t back down from arguing for them.

For further reflections on nationalism, see the link “Christian Nationalism” on this website.

01/16/24

Doubling Down on STAR*D Outcomes

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In January of 2006, the NIMH announced the results of Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study, the largest and longest study ever done to evaluate depression treatment. Its purpose was to determine the effectiveness of different treatments for people with Major Depression Disorder (MDD) who did not respond initial treatment with an antidepressant. The startling STAR*D results reported that almost 70 percent of those who did not withdraw from the study became symptom-free. “For the first time, doctors and people with depression now have extensive data on antidepressant treatments from a federally funded, large-scale, long-term study directly comparing treatment strategies.” However, the true remission rate turned out to be 35%, around half of what was reported.

In August of 2023 Ed Pigott and other researchers reanalyzed and published the patient-level data set from the STAR*D study in the British Medical Journal (BMJ), keeping their analysis to the original research protocol. They discovered the STAR*D investigators did not use did not use the STAR*D protocol-stipulated HRSD (Hamilton Rating Scale for Depression), but instead used a non-blinded clinic-administrated assessment, known as the QIDS-C, the Quick Inventory of Depressive Symptomatology. They also included 99 patients who scored as remitted on the HRSD at the outset of the study as well as 125 who scored as remitted when initiating their next-level treatment. “This inflated their report of outcomes.”

Unfortunately, the STAR*D investigators’ assertion of a 67% cumulative remission rate had already become accepted clinical wisdom. The NIMH’s director at the time, Thomas Insel, and an editorial in the American Journal of Psychiatry both claimed STAR*D participants achieved a 70% remission rate. “Our reanalysis found that in step 1, STAR*D’s remission and extent of improvement rates were substantially less than those reported in other open-label antidepressant comparator trials and then grew worse in steps 2-4.” The remission rate in step 1 was 25.5%; by step 4, it was only 10.4%.

Robert Whitaker further reported that Pigott and others discovered only 3% of the participants who entered the trial remitted and stayed well in the trial to its end in one year. One of the STAR*D investigators thought Pigott’s analysis was “reasonable and not incompatible with what we had reported.” That was 13 years ago and as of yet, there hasn’t been a public acknowledgement that these protocol violations were a form of scientific misconduct.

Yet, there has been no public acknowledgement by the American Psychiatric Association (APA) of this scientific misconduct. There has been no call by the APA—or academic psychiatrists in the United States—to retract the studies that reported the inflated remission rates. There has been no censure of the STAR*D investigators for their scientific misconduct. Instead, they have, for the most part, retained their status as leaders in the field.

Thus, given the documented record of scientific misconduct, in the largest and most important trial of antidepressants ever conducted, there is only one conclusion to draw: In American psychiatry, scientific misconduct is an accepted practice.

Whitaker said this presented a challenge to American citizens. If the American Psychiatric Association would not police its own research, it was up to the public to demand the STAR*D paper be withdrawn from the American Journal of Psychiatry. “As STAR*D was designed to guide clinical care, it is of great public health importance that this be done.”

He persuasively argued that there had been an intent to deceive. He said once Pigott and colleagues identified the deviations from the STAR*D protocol (which they did initially in 2010), “the STAR*D investigators’ ‘intent to deceive’ was evident.” After Pigott made the protocol and other key documents available in 2011 on two blogs for the Mad in America website, the scientific community could see the deception.

Their recent RIAT publication [in August of 2023] makes it possible to put together a precise numerical accounting of how the STAR*D investigators’ research misconduct, which unfolded step by step as they published three articles in 2006, served to inflate the reported remission rate. This MIA Report lays out that chronology of deceit. Indeed, readers might think of this MIA Report as a presentation to a jury. Does the evidence show that the STAR*D’s summary finding of a 67% cumulative remission rate was a fabrication, with this research misconduct born from a desire to preserve societal belief in the effectiveness of antidepressants?

In Psychiatry Under the Influence Whitaker and his coauthor Lisa Cosgrove wrote about how the STAR*D trial was an example of institutional corruption. They said there were two forms of institutional corruption, or economies of influence, driving that corruption: psychiatry’s guild interests and the extensive financial ties the STAR*D investigators had with the pharmaceutical industry. They said:

Although this was a NIMH-funded trial, industry influence was indirectly present during the trial. Rush and at least seven other STAR*D investigators had financial ties to Forest Laboratories, the manufacturer of Celexa. The investigators’ collective disclosure statement revealed hundreds of ties to pharmaceutical companies, with many investigators reporting that they had served as both consultants and speakers. Yet, given that this was a NIMH-funded trial, STAR*D couldn’t be blamed on the drug companies, and it could be argued that the “corruption” seen here far outstripped anything seen in a commercial trial of the SSRI antidepressants. (p. 129)

Whitaker said the American Psychiatric Association is best understood as a trade association that promotes the financial and professional interests of its members. The APA has long touted antidepressants as effective and safe treatment. He thought if the STAR*D results has been accurately reported, they would have derailed society’s belief in the safety and efficacy of antidepressants. The STAR*D investigators were, in a business sense, protecting one of their primary “products.” And they were safeguarding the public image of their profession.

This research misconduct has done extraordinary harm to the American public, and, it can be argued, to the global public. As this was the study designed to assess outcomes in real-world patients and guide future clinical care, if the outcomes had been honestly reported, consistent with accepted scientific standards, the public would have had reason to question the effectiveness of antidepressants and thus, at the very least, been cautious about their use. But the fraud created a soundbite—a 67% remission rate in real-world patients—that provided reason for the public to believe in their effectiveness, and a soundbite for media to trot out when new questions were raised about this class of drugs.

This, of course, is fraud that violates informed consent principles in medicine. The NIMH and the STAR*D investigators, with their promotion of a false remission rate, were committing an act that, if a doctor knowingly misled his or her patient in this way, would constitute medical battery.

This cataloging of harm done extends to those who prescribe antidepressants. Primary care physicians, psychiatrists, and others in the mental health field who want to do right by their patients have been misled about their effectiveness in real-world patients by this fraud.

The harm also extends to psychiatry’s reputation with the public. The STAR*D scandal, as it becomes known, fuels the public criticism of psychiatry that the field so resents.

Believing this to be a matter of great importance to public health, Mad in America put up a petition on change.org urging the American Journal of Psychiatry to retract the November 2006 article on the STAR*D results. Their hope is that the petition will circulate widely on social media and produce a public call for retraction that will grow too loud for the American Journal of Psychiatry to ignore. Whitaker hoped the publication of the August 2023 article by Pigott and others linked above in the prestigious journal British Medical Journal will lead the American Journal of Psychiatry to retract a paper that told a fabricated story about the outcome of the STAR*D study.

On December 1, 2023 the American Journal of Psychiatry published a letter from John Rush and four other STAR*D researchers, “The STAR*D Data Remain Strong: Reply to Pigott et al.” The researchers claimed the analytic approach by Pigott et al. had significant methodological flaws and stood by their results and methodology in STAR*D. They further said the effectiveness trials of their study were designed “to be more inclusive and representative of the real world than efficacy trials.” Pigott et al failed to recognize this rationale for the inclusion of the 941 patients in the original analyses that were eliminated from their reanalyses by Pigott et al.

The rationale for removing these participants from the longitudinal analysis appears to reflect a studious misunderstanding of the aims of the Rush et al. paper, with the resulting large difference in remission rates most likely the result of exclusion by Pigott et al. of hundreds of patients with low symptoms scores at the time of study exit.

Robert Whitaker responded to the letter in “After MIA Calls for Retraction of STAR*D Article, Study Authors Double Down.” He said the STAR*D investigators had inflated the “cumulative remission rate” in four principal ways. First by including ineligible patients in their tally of remitted patients. Second, by switching outcome measures. Third, by categorizing early dropouts as non-evaluable patients. Fourth, by calculating a “theoretical” remission rate.

By the end of their letter, they again affirmed the 67% cumulative remission rate. Whitaker thought they had “doubled-down on the fraud they committed in their 2006 summary report of STAR*D outcomes.”

Now that the STAR*D authors have “defended” their work, all the public really needs to know is this: The STAR*D investigators, by including 931 patients who weren’t eligible for the study in their final tally of cumulative remissions, greatly inflated that bottom-line outcome. That is research fraud, and in their letter to the editor, rather than admit that these patients weren’t eligible for the study, they instead falsely accused Pigott and colleagues of “creating” their own “post-hoc” criteria to remove those with “large improvements” in symptom scores from their re-analysis.

Whitaker said the STAR*D scandal evolved into a litmus test for psychiatry. Would they acknowledge the research misconduct and inform the public of how the STAR*S study had been compromised? Was it okay to deceive the public in this way? “And now, with this letter to the editor, we know the answer to that litmus test.”

01/9/24

Dimming the Experience of Pleasure and Addiction

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Neuroscience News reported on a recent study led by researchers from the National Institute on Drug Abuse (NIDA) and other federal agencies that found the brain’s ‘salience network’ was only activated when drugs were taken intravenously or smoked, but not ingested orally. “When drugs enter the brain quickly, such as through injection or smoking, they are more addictive than when they enter the brain more slowly, such as when they are taken orally.” The study suggests there’s new information on what may be behind the difference.

Nora Volkow, senior author of the study said, “We’ve known for a long time that the faster a drug enters the brain, the more addictive it is – but we haven’t known exactly why.” Using new imaging technology, the researchers believe they may now have an understanding of why this is. “Understanding the brain mechanisms that underlie addiction is crucial for informing prevention interventions, developing new therapies for substance use disorders, and addressing the overdose crisis.”

The researchers conducted a double-blind, randomized, counterbalanced clinical trial that used simultaneous PET/fMRI imaging. There were twenty adults who participated in the trial. Over three separate sessions, they received either a small dose of placebo or methylphenidate (Ritalin), orally or intravenously. After the participants received the study drug or placebo, the researchers looked at the differences in dopamine levels (through PET imaging) and brain activity (through fMRI imaging). The participants also reported their subjective experience of euphoria in response to the drug.

Consistent with previous research, the PET scan showed when participants received the methylphenidate orally, their dopamine rate peaked more than an hour after administration. However, participants who received methylphenidate intravenously, peaked within 5 to 10 minutes of administration. The fMRI of the participants indicated the ventromedial prefrontal cortex (where we process risk and fear) was less active after both oral and intravenous drug use. “However, two brain regions, the dorsal anterior cingulate cortex [associated with learning and self-control] and the insula [linked with salience detection and addiction], which are part of the brain’s salience network, were activated only after receiving the injection of methylphenidate, the more addictive route of drug administration.” The same areas of the brain were not activated after taking methylphenidate orally.

The salience network of the brain attributes value to things in our environment. It is important for recognizing and translating internal bodily sensations, like the euphoric effects of drugs. “This research adds to a growing body of evidence documenting the important role that the salience network appears to play in substance use and addiction.” Interestingly, other studies have shown when people experience damage to their insula (part of the brain’s salience network), they may have a complete remission of their addiction.

After receiving the drug intravenously, researchers noticed that the activity and connectivity of the salience network, observed via fMRI imaging, very closely paralleled almost every participant’s subjective experience of feeling high. When the imaging showed increased activity in this part of the brain, participants’ reports of feeling high increased.

When the imaging showed decreasing activity in the salience network, participants’ reports of feeling high decreased. Researchers theorize that the network identified in this study is relevant not just for the chemical action of the drug, but also the conscious experience of drug reward.

The authors indicated a next step would be to see whether inhibiting the salience network when someone takes a drug effectively blocks the feeling of being high. This would further support the salience network as a target for the treatment of substance use disorders. The lead author of the study said, “I’ve been doing imaging research for over a decade now, and I have never seen such consistent and clear fMRI results across all participants in one of our studies.”

Manza et al, the study reported in Neuroscience and discussed above, said: “Together, these findings provide insight into how the salience network is critically linked to the pathophysiology of substance use disorder.” Among the considerations to note in the study, participants were naïve to stimulant drugs. The participants were also administered methylphenidate in a laboratory environment, which tends to inhibit the results. For example, other studies have shown adult males will drink significantly more alcohol when they are exposed to a simulated bar environment relative to a neutral laboratory setting. Manza et al further said:

Notably, our study identified two distinct circuits similar to the pattern of brain lesions leading to clinical remission of addiction. Patients who suffered stroke lesions to brain regions that had positive functional connectivity with dACC [dorsal anterior cinugulate] and insula (where we observed activation with fast dopamine increases), and lesions to brain regions that had negative functional connectivity with ventromedial prefrontal cortex (where we observed deactivation both with slow and fast dopamine increases) led to remission. Therefore, both studies support interventions to inhibit the dACC and insula and interventions to stimulate the ventromedial prefrontal cortex as strategies for the treatment of substance use disorder. Indeed, the dACC is being tested as a neuromodulation target to combat compulsive drug use with preliminary findings showing decreases in cocaine self-administration, cue-induced alcohol craving, and heavy drinking days. Critically, in the latter study, successful stimulation effects were associated with decreased connectivity between dACC and caudate. A key next step is to evaluate if inhibition of this circuit during drug administration blocks the subjective experience of drug reward, which could open new avenues to treat substance use disorders.

The Reward Pathway and Addiction

The significance of the above-described study demonstrating the importance of fast or slow dopamine increases in the develop of a substance use disorder can be understood by reviewing Carleton Erickson’s description of the Reward Pathway of the brain in his book, The Science of Addiction. Erickson capitalizes the word “Addiction” to represent when addiction progresses to the stage of physical dependence.

Drugs produce “Addiction” in the mesolimbic dopamine system (MDS), the pleasure pathway located in the middle of the brain. It is believed that addiction problems develop when the function of these MDS neurotransmitter systems are disrupted due to genetic problems, long-term exposure to a drug, or a combination of these with environmental influences. The MDS generates signals in the part of the brain known as the ventral tegmental area (VTA), which releases dopamine (DA) into the nucleus accumbens (NAc). This release of DA into the NAc causes the feelings of pleasure, but not only from drugs. Other areas of the brain, like the basal ganglia, create a lasting record or memory that associates the good feelings with the from the drug use with the circumstances and environment in which they occur. See the figure below.

Release of DA in the NAc produces the sensation of pleasure. The anticipation of obtaining the drugs activates the limbic pathways in a way that leads to chemical dependence, to Addiction. This is why the above discussed study is significant and as the researchers speculated, opens “new avenues to treat substance use disorders.” But there is a potential problem with inhibiting connectivity between the dACC and insula in the treatment of substance use disorder as suggested.

In Never Enough, the neuroscientist Judith Grisel explained when activity in the mesolimbic pathway is prevented, the person is unable to experience pleasure. If activity in the mesolimbic pathway was prevented before a person used drugs, she said they’d “think the drugs were a complete waste of money.”

This might look like a cure, but … it is ethically problematic. Such an intervention would prevent pleasure from all sources, including things like food and sex. Most of the world has prohibited this sort of surgical intervention, although some nations, including China and the Soviet Union, are reportedly reducing relapse rates by employing this strategy. However, it doesn’t work all that well for seasoned addicts who use mainly to avoid unpleasant symptoms associated with withdrawal rather than seeking a high.

Addicts who are clearly suffering from their addiction are generally not willing to voluntarily undergo a procedure that would produce this form of anhedonia, a global deficit in their experience of pleasure. Most would rather go to prison or suffer other severe consequences, because then they could still experience transient pleasures. “Without dopamine in the nucleus accumbens, nothing, a letter from a friend, an especially beautiful sunset or piece of music, or even chocolate, would alleviate a persistently bleak existence.”

The research of Manza et al, reported by Neuroscience and discussed above is interesting. And when it’s replicated, it will become even more important to our growing knowledge of addiction. I would hope as we pursue the association of dopamine and addiction, that future research won’t dim the person’s experience of pleasure as it tries to cure their addiction.

01/2/24

When Nationalism Gets a Christian Gloss

Image by Q K from Pixabay

In The Religion of American Greatness, Paul Miller said his book was primarily an examination of the ideology of nationalism, particularly the kind of American nationalism that uses Christian symbols and rhetoric. He said nationalism has been increasing in its popularity around the world today. He said it is an “irresistible political tool” for leaders looking to stir up enthusiasm and support within their base. “Nationalism is almost always idolatrous in the sense of becoming a substitute religion.” When nationalism is given a Christian gloss, it conflicts with core American ideals of liberty and equality for all people and “amounts to the pursuit of Christian power at the expense of Christian ideals.”

Miller quoted Clifford Geertz’s definition of religion from Interpretation of Cultures and argued that nationalism fulfilled all the criteria of a religion. Geertz said religion was a system of symbols that acted to establish powerful, pervasive, and long-lasting moods by formulating conceptions of a general order of existence. These conceptions are clothed with such an aura of factuality that the “moods and motivations seem uniquely realistic.”

Nationalism fulfills all the criteria of a religion. It is a set of symbols that establishes powerful moods that last for centuries. It describes a general order for life, an orienting framework with a standard of right and wrong, a sense of purpose and direction. And it roots this general order in an “aura of factuality,” a story about the nation’s ancient roots and primal existence which seems feasible because the nation preexists us and outlives us.

However, Miller didn’t originate the idea of a secular or civil “religion.” Robert Bellah wrote about it in “Civil Religion in America in 1967. Bellah attributed the phrase “civil religion” to Rousseau in The Social Contract. He acknowledged the phrase was not used by America’s founding fathers, but similar ideas were “to be found among the Americans.” Bellah said:

While some have argued that Christianity is the national faith, and others that church and synagogue celebrate only the generalized religion of “the American Way of life,” few have realized that there actually exists alongside of and rather clearly differentiated from the churches an elaborate and well-institutionalized civil religion in America. This article argues not only that there is such a thing, but also that this religion—or perhaps better, this religious dimension—has its own seriousness and integrity and requires the same care in understanding that any other religion does.

Nationalists say they want to preserve their nation’s heritage. They want to honor the past, to preserve what came before. They claim nationalism simply means being patriotic, the love of country. However, Miller said the word can mean much more than mere patriotism. He agreed that the love of country is generally a good thing, but we need to be on our guard “against some common temptations to ensure our love is rightly ordered.”

Miller then turned to C.S. Lewis in his book, The Four Loves, where Lewis looked at the love of one’s country. He commented that we all now know that love of country can become a demon when it becomes a god. Seemingly, Lewis here made a reference to Nazi Germany during the Second World War. He said when this kind of love becomes demonic, it will produce wicked acts. Demonic patriotism when it exists within the citizens of a nation, makes it easier for its rulers to act wickedly; healthy patriotism may make it harder.

When they are wicked, they may by propaganda encourage a demonic condition of our sentiments in order to secure our acquiescence in their wickedness. If they are good, they could do the opposite. This is one reason why we private persons should keep a wary eye on the health or disease of our own love for our country.

Lewis seems to agree with Miller that nationalism can become a substitute religion. But when it does, it should not be called “Christian” in any sense of the term.  He also said Christendom needed to make a full confession of the extent to which it contributed to the sum of human cruelty and treachery. Large areas of “the World” won’t listen to us until we have publicly disowned much of our past. “Why should they? We have shouted the name of Christ and enacted the service of Molech.”

Miller said nationalism is a totalistic political religion that is inconsistent with orthodox Christianity. It is “a false religion that places the nation in the place of the church and the leader in place of God.” He said the ideal type of Christian nationalism can’t fit with Christianity. “They are separate, rival, mutually exclusive religions.” Yes, Christians should be patriots, but true patriotism sometimes means rebuking your country for its sin; or even working against it, “as Bonhoeffer worked against the Nazi government of his German homeland.”

C.S. Lewis taught at Oxford throughout the Second World War and like others at the time, he reflected on ultimate issues such as life and death, good and evil, suffering and eternity, and the nature of reality. Among his writings of this time were “The Weight of Glory,” “Evil and God” and the initial series of talks on the BBC which later became part of his book Mere Christianity.

In his essay, “C. S. Lewis & Three Wars: 1941,” Joel Heck wrote there were some at the time who were advocating for the formulation of a Christian political party through letters to The Guardian, a British daily newspaper. In response to those letters, Lewis wrote “Meditation on the Third Commandment” for the January 10, 1941 edition of The Guardian. It is available in writing within God in the Dock. The title is a subtle allusion to the idolatry and consequences of which he wrote. The third commandment is: “You shall not take the name of the Lord your God in vain, for the Lord will not hold him guiltless who takes his name in vain.”

Lewis said, “Nothing is so earnestly to be wished as a real assault by Christianity on the politics of the world.” He pointed out there were some problems with forming a Christian party or a Christian platform in politics. First, Christians were not united on the means to accomplish their various ends. Some saw democracy as a monster (fascism), while others saw it as the only hope, with still others saw the need for a revolution (communism).

The three types represented by these three Christians presumably come together to form a Christian party. Either a deadlock ensues and there the history of the Christian party ends; or else one of the three succeeds in floating a party and driving the other two with their followers out of its ranks. The new party, being probably a minority of the Christians, who are themselves a minority of the citizens, will be too small to be effective. In practice, it will have to attach itself to the unchristian party nearest to it in beliefs about means . . . It remains to ask how the resulting situation will differ from that in which Christians find themselves today.

Whatever the party calls itself, it will not represent Christendom, but only a part of Christendom. “The principle which divides it from its brethren and unites it to its political allies will not be theological. It will have no authority to speak for Christianity. It will have no more power than the political its members give it to control the behavior of its unbelieving allies.” Lewis said there will be a real and disastrous novelty because it will not be simply a part of Christendom, but a part claiming to be the whole.

By the mere act of calling itself the ‘Christian party,’ it implicitly accuses all Christians who do not join it of apostasy and betrayal. It will be exposed in an aggravated degree to that temptation which the devil spares none of us at any time—the temptation of claiming for our favorite opinions that kind of degree of certainty and authority which really belongs only to our faith. The danger of mistaking our merely natural, though perhaps legitimate, enthusiasms for holy zeal, is always great. Can any more expedient be devised for increasing it than that of dubbing a small band of fascists, communists, or democrats the Christian party? The demon inherent in every party is at all time ready enough to disguise himself as the Holy Ghost. The formation of a Christian party means handing over to him the most efficient makeup we can find. And when once the disguise has succeeded, his commands will presently be taken to abrogate all moral laws and to justify whatever the unbelieving allies of the Christian party wish to do. If ever Christian men can be brought to think treachery and murder the lawful means of establishing the regime they desire, and fake trials, religious persecution and organized hooliganism, the lawful means of maintaining it, it will surely be by just such a process as this. The history of the late medieval pseudo-Crusaders, of the Covenanters, of the Orangemen, should be remembered. On those who add, “thus said the Lord” to their merely human utterances, descends the doom of a conscience, which seems clearer and clearer the more it is loaded with sin. All this come from pretending that God has spoken when He has not spoken.

C.S. Lewis thought that by natural light God has shown us which means are lawful. To discover which one is efficacious, “He has given us brains. The rest he has left to us.”

Miller concludes “The Religion of American Greatness” by saying churches must take a role in challenging Christian nationalism. He said there was no more credible voice to confront an unhealthy Christian political witness than the healthy kind. Jesus gave his church the authority to proclaim his message and represent his name (Matthew 28:18-20). And when his name and message are misrepresented, “the church must be at the forefront of saying so and correcting the record.”

For further reflections on nationalism, see the link “Christian Nationalism” on this website.

12/26/23

The Sackler Cartel Goes Before the Supreme Court

Photo by Sigmund on Unsplash

The Sackler family’s legal maneuverings to avoid financial consequences from their privately-owned company, Purdue Pharma, just had another development. In August of 2023 the U.S. Supreme Court temporarily blocked the bankruptcy deal for Purdue Pharma that would have shielded members of the Sackler family from additional lawsuits and cap the Sacklers’ personal liability at $6 billion. This was in response to a Justice Department objection that said the settlement would allow the Sackler family to take advantage of legal protections meant for debtors in financial distress, while the Sackler family is reportedly worth $11 billion. The New York Times and SCOTUSblog reported on the Supreme Court arguments on Monday, December 4th over the bankruptcy deal.

The case could have far-reaching implications for similar lawsuits. If the court approves the deal, it would affirm a litigation tactic that has become popular in resolving lawsuits where people claim similar injuries from the same entity, whether that is a drug or a consumer product. “By turning to the bankruptcy courts as a tool to resolve those claims, businesses aim to free themselves from civil liability and prevent future lawsuits.” If the Supreme Court were to block the use of such a mechanism in this case, the Sackler family would no longer be shielded from civil lawsuits. Additionally, the Purdue Pharma bankruptcy settlement deal would be in jeopardy as the Sackler family previously threatened to walk away from the settlement if the bankruptcy protections were not included in the agreement. See “Carrot-and Stick Tactics of Purdue and the Sacklers” and “Supreme Court considers $6bn deal that shields Sacklers.”

The NYT said it was rare for the Supreme Court to hear a bankruptcy dispute, but this one was precipitated when a watchdog office of the Justice Department, the U.S. Trustee Program, petitioned the court to review the deal. Additionally, the opioid crisis is a nationally important issue. Allowing third parties to be shielded without declaring bankruptcy themselves has become an increasingly popular tactic for avoiding liability. And these rulings have divided lower courts.  The objection by the U.S. Trustee Program was, if approved, the Sacklers would get the benefits of bankruptcy without its costs.

Individuals who may want to sue individual Sackler family members—the ones actively involved in decisions made by Purdue Pharma—in civil court would be prevented from doing so. “The U.S. trustee argued that their constitutional due process rights would be summarily extinguished.” While the Justice Department and a few other plaintiffs are challenging the settlement, most others are concerned about the potential loss of funds to initiatives intended to address the opioid crisis.

Under the deal, Purdue would pay $1.2 billion toward the settlement immediately upon emerging from bankruptcy, with millions more expected in the years to come. The Sacklers would pay up to $6 billion over 18 years, with almost $4.5 billion due in the first nine years.

According to an agreement with tribal plaintiffs, all 574 federally recognized Native American tribes are eligible for payouts from a trust worth about $161 million.

Each state has devised a formula with its local governments for distributing the Purdue money. But all must follow the guidance for using it: that it be largely applied to initiatives intended to ease the opioid crisis, including addiction treatment and prevention.

If the agreement is upheld, about 138,000 plaintiffs, individuals and family members of victims who died from overdoses, would be able to file claims to a trust that would hold $700 to $750 million. Payments are expected to range from $3,500 to $48,000. “Though the payouts are small, the Purdue plan is one of only very few opioid settlements across the nation that set aside money for individuals.”

Purdue Pharma would cease to exist. A new company, Knoa Pharma, would receive the assets from Purdue. Knoa would be owned by creditors, and would manufacture addiction treatment and opioid reversal medicines at no profit. See “The Bondage of Buprenorphine” for a potential new product already developed by a Sackler. Knoa would continue to make opioids like OxyContin as well as nonopioid drugs, with the profits going towards the settlement funds. The Sacklers have been off the Purdue board since 2018, so why it there such resistance to members of the Sackler family avoiding further financial liability?

CNN reported members of the Sackler family withdrew more than $10 billion from Purdue Pharma and placed the money in family trusts and holding companies as pressure built over the nation’s opioid epidemic. An audit of Purdue related to its filing for bankruptcy in September 2020 showed that from 2008 to 2018 the family withdrew more than eight times as much money from the company as the previous 13 years. “From 1995 through 2007, the Sacklers received $1.3 billion from Purdue; but from 2008 through 2018, those payments amounted to $10.7 billion.” The larger withdrawals came after Purdue’s 2007 plea deal with the Justice Department to pay a $600 million penalty on a felony charge of misleading and defrauding physicians and consumers over OxyContin.

The withdrawals came during a time when Purdue Pharma was accused of fueling the nation’s opioid epidemic and amid growing concerns from many states that a significant amount of the family’s wealth may be held overseas; therefore unavailable to plaintiffs seeking relief through the courts.

According to StatNews, political appointees at the Justice Department refused to approve felony charges for Purdue executives, letting the company off with a $600 million fine. Richard Sackler admitted he never bothered to read the entire 2007 plea deal document where prosecutors gave guidelines for Purdue’s future behavior. Instead, they doubled down on marketing OxyContin. The important result of the ruling was there was no trial. “A trial would have exposed the company’s OxyContin profits to forfeiture or prompted one of the executives to expose the magnitude of OxyContin scion Richard Sackler’s participation in the admitted crimes.”

An attorney for the Raymond Sackler family said the amount the family withdrew was publicly known. ““These distribution numbers were known at the time the proposed settlement was agreed to by two dozen attorneys general and thousands of local governments.” But Letitia James, the New York Attorney General said the audit showed the need for even more information:

The fact that the Sackler family removed more than $10 billion when Purdue’s OxyContin was directly causing countless addictions, hundreds of thousands of deaths, and tearing apart millions of families is further reason that we must see detailed financial records showing how much the Sacklers profited from the nation’s deadly opioid epidemic.

CNN said a spokesperson for the Sackler family defended the withdrawals, saying: “Members of the Sackler family who served on Purdue’s board of directors acted ethically and lawfully, and the upcoming release of company documents will prove that fact in detail.” The statement of the Purdue audit said the family’s ownership interest of Purdue Pharma had been valued at between $10 billion to $12 billion.

In his testimony for federal bankruptcy court, Dr. Richard Sackler, a former president and co-chairman of the bord of directors of Purdue Pharma said he, the Sackler family and Purdue Pharma did not have any responsibility for the opioid crisis in the United States. Yet during his tenure, Purdue pleaded guilty twice to federal criminal charges related to marketing and sales of OxyContin. In an email he wrote in 2001, he said “We have to hammer on abusers in every way possible… They are the culprits and the problem. They are reckless criminals.”

A congressional committee investigating the Sacklers, released a statement saying the Sackler family, who owned a controlling interest in Purdue Pharma since 1952, were collectively worth $11 billion. See the statement for a listing of the Sackler family’s assets. The chairperson of the committee said the family built its enormous fortune in large part through sales of OxyContin:

Members of the Sackler family pushed Purdue to use deceptive marketing practices to flood communities with this dangerous painkiller, and now the Sackler family is attempting to use Purdue’s bankruptcy proceedings to evade individual responsibility for their role in fueling the opioid epidemic.

Untangling the contributions of the Sackler family from executives for Purdue Pharma in order to get a clear picture of exactly what individual family members were responsible for may be an impossible task. But looking at how family members contributed to the opioid epidemic and Purdue Pharma’s facilitation of the opioid epidemic is easily done.

Arthur Sackler’s marketing strategies were applied to OxyContin after his death, and Mortimer Sackler transferred millions of dollars from trust companies to himself as early as 2009. Records show approximately $1 billion in wire transfers between the Sacklers, entities they control, and different financial institutions—including funds placed in Swiss bank accounts.

According to StatNews, the evidence of callous greed by Purdue was chilling. The privately-held company fired employees who tried to blow the whistle on its activities and maneuvered to have reporters working on the story of fraud at Purdue fired or removed from their beats. Sales reps were encouraged to allow doctors to believe morphine was stronger than OxyContin; it wasn’t. Executives at Purdue knew the opposite was true.

The 2007 plea deal document discussed above didn’t slow them down. It allowed Purdue Pharma to continue marketing and selling OxyContin. Now with the assistance of consultants at McKinsey & Co., they “turbocharged” their sales, concentrating on known pill mill operators, pushing the highest-dosage pills, “and banning together with other opioid makers to pull end-runs around FDA regulators.”

For more information on the Sacklers and OxyContin, read Pain Killer, by Barry Meier, which “exposes the roots of the opioid epidemic at the hands of Purdue Pharma and Raymond and Mortimer Sackler.”  Also see: “What Purdue and the Sackler Family Treasure,” “It’s Strictly Business,” and “Giving an Opioid Devil Its Due.” Read “The Tale of the OxyContin Lie” and watch PainKiller on Netflix if you think the Sackler family should get a pass by the Supreme Court.

12/19/23

Health Effects of Vaping

Photo by Itay Kabalo on Unsplash

The American Heart Association recently published a scientific statement on the use of e-cigarettes, “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products.” It describes the latest usage trends, the current scientific evidence about e-cigarettes and identifies current health impacts. It noted that vaping and e-cigarette use has grown exponentially over the past ten years, particularly among youth and young adults. They have been touted as safer alternatives to tobacco cigarettes, and even as potential tobacco-cessation products. However, e-cigarettes in 2019 led to more than 2,800 hospitalizations.

The CDC reported that as of February 18, 2020, a total of 2,807 hospitalized EVALI (e-cigarette or vaping product use-associated lung injury) cases or deaths were reported. Laboratory data showed that vitamin E acetate, an additive in some THC-containing products, was strongly linked to the EVALI outbreak. The CDC and FDA recommended that people not use THC-containing ENDS—electronic nicotine delivery system. After the identification of the primary cause of EVALI, and a significant decline in EVALI cases, the CDC stopped collecting data from states as of February 2020, the beginning of the COVID pandemic.

By 2019 in the U.S., 27.5% of high school students said they used e-cigarettes or ENDS. These products are the most commonly used tobacco products among youth, a growing number of whom reported never smoking combustible cigarettes. Data from the National Youth Tobacco Survey (NYTS) indicated current use in the past 30 days of ENDS increased from 1.5% in 2011 to 20.8% in 2018, an estimated 3.1 million students. Among middle school students, current e-cigarette use increased from .6% in 2011 to 4.9% in 2018, an estimated 570,000 students. See the following figure from “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products.”

Data from the 2019 NYTS indicated 25.5% of 12th graders reported current e-cigarette use compared to 11% in 2017. Current THC (cannabis) vaping increased in 12th graders from 4.9% in 2017 to 14.0% in 2019, 4.3% to 12.6% with 10th graders, and 1.6% to 3.9% with 8th graders. The prevalence of ENDS use among youth remained stable despite the pandemic. Data from 2020 showed ENDS use declined to 19.6% among high school students and to 4.7% among middle school students. “Whether this is an artifact of the great societal disruptions from the global pandemic or represents a decreased trend remains to be seen.”

Because of the rapid evolution of ENDS, it is important to examine prevalence rates with other vaping products besides e-cigarettes such as e-hookahs (e-waterpipes). E-hookahs are a new category of vaping devices, introduced in 2014 and recently patented by Philip Morris [the tobacco company], that are marketed as healthier alternatives to traditional hookah fruit-flavored tobacco smoking. Findings from the nationally represented PATH study (Population Assessment of Tobacco and Health; 2014–2015) in children 12 to 17 years of age indicated that 7.7% were identified as ever-users of e-hookahs compared with 14.26% who were ever-users of ENDS products.

Studies in the U.S. indicate a rapid increase in ever and current ENDS use among adults since 2010, “with the vast majority of users being current or former cigarette smokers.” Recent analysis of NHIS (National Health Interview Survey) data from 2014 to 2018 showed young adults 18 to 24 years of age are using ENDS at high rates. Current use increased from 5.1% to 7.6%. There were large increases among never-smokers (1.5% to 4.6%) and former smokers (10.4% to 36.5%).

See “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products” for a detailed discussion of the acute health effects and toxicity of e-cigarettes and vaping products.

Chronic Health Effects and Toxicity of E-Cigarettes and Vaping Products

E-cigarettes were created in China in the early 2000s and introduced to the US market in 2007. The basic mechanism heats or atomizes a liquid solution or e-liquid that generally contains a humectant (a substance used to keep things moist), nicotine and flavoring agents. The e-liquid formulations can contain other drugs beside nicotine, including THC, methamphetamine and methadone. The FDA attempted to stop the importation of these products, recognizing they could be used as drug-delivery devices. But a 2010 court ruling, Smoking Everywhere, Inc. vs US Food and Drug Administration deemed e-cigarettes should be considered tobacco products, and fall under the 2009 Family Smoking Prevention and Tobacco Control Act.

E-cigarettes and vaping were introduced in the US 16 years ago, and only saw widespread adoption in the past ten years. “We do not yet know the long-term health effects of these products.” Tobacco use was not recognized as a major preventable cause of death until many years after cigarette smoking became widespread. An increasing incidence of lung cancer was not noted until 1930. Definite scientific evidence associating cigarette smoking and lung cancer was not reported until the 1950s.

In 1964, the US Surgeon General report on tobacco and health attributed the increase in lung cancer to cigarette smoking. Only then did cigarette smoking per capita begin to decline. With the delayed development of chronic disease from smoking, lung cancer deaths did not begin to fall accordingly until decades after the 1964 report.

See the following figure taken from “Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products.”

In 2018 an evidence-based summary of the health concerns with ENDS found no available evidence that ENDS use was associated with coronary heart disease, stroke, and peripheral artery disease. There was insufficient evidence that ENDS use was associated with long-term effects on heart rate, blood pressure and cardiac function. There was also no available evidence on whether ENDS use causes respiratory diseases in humans. There was only moderate evidence ENDS use is associated with increased asthma problems, and limited evidence of adverse effects of ENDS exposure on the respiratory system.

There have been few studies of the chronic cardiovascular effects of ENDS because they have only been available for the past 16 years! Assuming similar time delays for the appearance of chronic disease from cigarettes and for ENDS, “epidemiological increases in disease prevalence would not be expected to be observed for years.”

Vaping devices have not been shown to be safe for long-term use. The short- and long-term toxicities of inhaling aerosols generated from liquids containing vegetable glycerin, propylene glycol, nicotine, or flavors are unknown. Inhaling aerosols generated from THC- or CBD-containing liquids, which often contain additional chemical components, also have unknown health effects. Thus, elucidating their long-term respiratory, cardiac, and cancer health effects is a public health priority.

E-Cigarette and Vaping Products as Cigarette-Cessation Products

The Cochrane Review found that nicotine e-cigarettes can be effective in helping people stop smoking for at least six months. They were found to be more effective than nicotine replacement therapy and cessation with e-cigarettes without nicotine. And yet, they strongly discouraged those who have never smoked from using e-cigarettes, especially young people. “This is because they are a relatively new product and we don’t yet know the long-term health effects.”

“Cardiopulmonary Impact of Electronic Cigarettes and Vaping Products” said in the Cochrane Review adverse events were higher at 12 weeks to 6 months in ENDS users when compared to no support or behavioral support only. One study compared e-cigarettes with varenicline (Chantix), finding e-cigarettes were less effective than varenicline. Four of 27 e-cigarette users versus 13 of 27 varenicline users stopped smoking. The main study results assessed smoking cessation and not complete product cessation. “This could mean that participants who quit smoking continued ENDS use.”

Another study compared nicotine ENDS plus a nicotine patch (NRT) with NRT alone and NRT plus nicotine-free ENDS. The patch alone has a 2% abstinence rate. The patch and nicotine-free ENDS had a 4% abstinence rate and the nicotine patch and nicotine ENDS had a 7% abstinence rate. “No current ENDS products have FDA approval as a tobacco-cessation aid. There is only low to moderate confidence of improved cessation with nicotine-containing ENDS products compared with NRT or behavioral interventions.”

There are few empirically tested prevention and cessation programs for youth ENDS use. Using novel technology—text messages, social media—that have been used extensively to advertise ENDS products to youth, as wells as educational efforts targeting parents and health educators, and other methods have been shown to promote smoking cessation among youth. But further work is needed to develop and test effective interventions.

Conclusion

ENDS products have undeniably been increasing in popularity, particularly among young adults and teens, in the past decade. The constituents of these products often include nicotine, which is well established to have negative health effects and strong addictive properties. Other ingredients, particularly in flavored products, have known health risks. Because ENDS products are not regulated as classic therapeutic drugs or devices, there are no dedicated long-term safety studies. Critical questions remain unanswered about the short-term and, in particular, long-term health effects of ENDS products. Because the products have only recently gained widespread use, decades of prospective or retrospective data are not yet available to examine the long-term health effects of cigarettes. Early analysis suggests some utility of ENDS as a smoking cessation product; however, any benefit needs to be juxtaposed with a clear understanding of the health risks of the ENDS products themselves and the risks of product availability leading to nonsmokers initiating ENDS use.

12/12/23

The One and Only True Christian Nation

Photo by Debby Hudson on Unsplash

In “What Is Christian Nationalism?”, Paul Miller said Christian Nationalism was the belief that the American nation was defined by Christianity, and that the American government should take steps to keep it that way. “Christian nationalists want to define America as a Christian nation and they want the government to promote a specific cultural template as the official culture of the country.” Some want to amend the Constitution to acknowledge America’s Christian heritage. Others want the government to promote specific a cultural template and take stronger action to circumscribe immoral behavior. Still others believe America has a unique relationship with God and has been chosen by him to carry out a special mission on earth.

Christian Nationalists believe the American nation is defined by Christianity and the government should take active steps to preserve this cultural sense in the future. They believe America must remain a so-called “Christian nation” and appropriate the name of Christ for its worldly political agenda. Miller said when this happens, the name of Christ is used as a fig leaf to cover its political program. The message of Jesus becomes a tool of political propaganda and the church a cheerleader of the state. The movement commonly called Christian Nationalism is better understood as Religious Nationalism, a false religion that substitutes the nation for the church.

As citizens of the kingdom of God, Jesus is our Immanuel, the embodiment of the kingdom of God (See “So-Called ‘Christian’ Nationalism and the Kingdom of God”). This kingdom is associated with the church and cannot not be said to apply to any particular nation, making it difficult to be a Christian Nationalist if you believe you belong to Jesus. Herman Ridderbos said there is a connection between the kingdom of God and the church, but they are not identical. “The kingdom is the whole of God’s redeeming activity in Christ in this world; the church is the assembly of those who belong to Jesus Christ.” He suggested to think of the relationship between the church and the kingdom as two concentric circles, with the church as the smaller one and the kingdom of God as the larger, with Christ as the center of both.

The church, as the organ of the kingdom, is called to confess Jesus as the Christ, to the missionary task of preaching the gospel in the world; she is also the community of those who wait for the coming of the kingdom in glory, the servants who have received their Lord’s talents in prospect of his return. The church receives her whole constitution from the kingdom, on all sides she is beset and directed by the revelation, the progress, the future coming of the kingdom of God, without at any time being the kingdom herself or even being identified with it.

Richard Gaffin said the church alone has been entrusted with the ‘the keys of the kingdom’ (Matthew 16:18, 19) and has been commissioned to preach ‘the gospel of the kingdom’ (Matthew 24:14). Citizens of the kingdom of God are only found in the church, and are “those who by repentance and faith submit to the redemptive lordship of Christ.” All things, the entirety of creation, are subject to him (Matthew 28:18; 1 Corinthians 15:27; Hebrews 2:8). The Father of glory, the God of our Lord Jesus Christ, has put all things under his feet and gave him as “head over all things” for the church (Ephesians 1:22).

In contrast to this sense of the kingdom of God, Christian Nationalism adopts the name of Christ for a worldly political agenda and claims that its political program is the program for every true believer. In other words, if you belong to the kingdom of God, you should support a Christian Nationalist agenda. Paul Miller said this is wrong, regardless of what the agenda is, “because only the church is authorized to proclaim the name of Jesus and carry his standard in the world.” In his book, The Religion of America’s Greatness, Miller said when nationalists say they have a divine commission to accomplish God’s purpose in the world, “they are reading their secular polities into the biblical narrative, substituting their nation for God’s people, a frank admission that nationalism is a religion.”

Regrettably, Americans have long thought of themselves as a chosen people. Miller said in the 18th and 19th centuries Americans regularly referred to themselves as a “new Israel.” Today, many Americans will cite 2 Chronicles 7:14 in support of this: “If my people, which are called by my name, shall humble themselves, and pray, and seek my face, and turn from their wicked ways, then I will hear from heaven, and will forgive their sin, and will heal their land.” President Dwight Eisenhower took the oath of office on a Bible opened to this passage in 1953. Ronald Reagan once said his favorite verse was 2 Chronicles 7:14. Like Eisenhower he took the oath of office on Bibles opened to the verse in 1981 and 1985.

At least as far back as the civil war, there was a similar trend, using Psalm 33:12 in addition to 2 Chronicles 7:14: “Blessed is the nation whose God is the Lord.” In 1864 a group of clergymen advocated amending the US Constitution to explicitly acknowledge Jesus Christ “and declare the nation’s Christian identity.” The group invoked Psalm 33:12, calling on those who loved their country to sign their petition and support the constitutional amendment.

The use of these verses in reference to the United States is part of a broader tendency among some American Christians to view the United States as a divinely chosen nation in a unique relationship with God to carry out his mission on earth. In this most extreme form, Christian nationalism treats loyalty to America as the national implication of Christian piety. It conflates American identity with Christian identity and treats the good of one as the good of the other. Past generations very clearly argued that our Christian identity gave America a unique moral status, or that the United States was specially privileged by God for a unique mission or destiny.

These two Scripture verses, Second Chronicles 7:14 and Psalm 33:12 are not about the United States or any other secular polity. The “nation whose God is the Lord,” and the people “who are called by my name” refer to Israel and in the new covenant, the church. According to Paul Miller, “To apply them to the United States is hermeneutically indefensible, theologically irresponsible, intellectually sloppy, politically dangerous, and borderline heretical.” The divine mission of God’s chosen people is to spread the gospel of Jesus Christ, not political liberty, national sovereignty, and capitalism. “The church is the one and only true Christian nation.”

The discussion of the kingdom of God here draws from the thought of Herman Ridderbos on “Kingdom of God, Kingdom of Heaven” in the New Bible Dictionary; and the thought of Richard Gaffin on “Kingdom of God” in the New Dictionary of Theology.

For further reflections on nationalism, see the link “Christian Nationalism” on the website.

12/5/23

Xanax Is Not the Way Out of Anxiety

Image by Pete Linforth from Pixabay

In November of 2022 Maria Shriver and her daughter Christina Schwarzenegger released a documentary on Netflix titled, Take Your Pills: Xanax. Their film looked at both the cure and curse Xanax has become for so many people. In their interview Maria said we are in the midst of widespread anxiety for which people want a quick fix. Now individuals are asking, “What is the effect of taking this pill on my brain, or on my body?” What impact might this have if I want to stop taking Xanax down the road?

Xanax was originally approved by the FDA as in 1981 to treat anxiety associated with depression. The patent expired in September of 1993. On January 17, 2003 the FDA approved Xanax XR, an extended-release form, to treat panic disorder, with or without agoraphobia. The patent for Xanax XR will expire on April 8, 2028. FDA Approved Labeling for Xanax-XR says its longer-term efficacy has not been systematically evaluated. “Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.”

Xanax, alprazolam, is the most widely prescribed benzodiazepine on the market today. PsychCentral said it was the nineth most prescribed psychiatric medication with 16.78 million prescriptions in 2020. “A Review of Alprazolam Use, Misuse, and Withdrawal” said its clinical use has become a point of contention as addiction specialists consider it to be highly addictive, while primary care doctors prescribe it for much longer time periods than recommended. And it has been shown to have a more severe withdrawal syndrome than other benzodiazepines, “even when tapered according to manufacturer guidelines.” Data on national emergency department (ED) visits indicated alprazolam is the 2nd most common prescription medication and the most common benzodiazepine involved in ED visits related to drug misuse.

Alprazolam has a high misuse liability, particularly when prescribed to individuals with a history of some type of substance use disorder. Individuals with a history of alcohol or opiate use seem to prefer it to other benzodiazepines like Serax (oxazepam) because they found it to be more rewarding. CDC prescription death rate data indicated alprazolam was used with another drug over 96% of the time, usually with fentanyl. Heroin was the second most frequent concomitant drug. See Table D taken from the CDC report.

The above cited review of alprazolam said, “All benzodiazepines carry a risk of misuse, diversion tolerance and physical dependence.” Withdrawal symptoms seem to be more severe with Xanax because of its shorter half-life and high potency causing severe rebound anxiety. Alprazolam is also more toxic than other benzodiazepines in cases of overdose, and should not be prescribed to patients at increased risk of suicide, or who use alcohol, opioids, or other sedating drugs. The use of benzodiazepines with opioids doubles the risk of death and respiratory depression, and should be avoided. “Alprazolam should be prescribed primarily in its extended-release formulation for a short duration to minimize misuse liability and only to those with no prior substance use history.”

Well-designed human studies addressing alprazolam’s reinforcing effects and the discontinuation syndrome [withdrawal] are needed, and must consider important issues such as selection of appropriate comparison drug, dose, formulation, and population. Future research should also further investigate the misuse liability of alprazolam XR, and should attempt to clarify the role of carbamazepine, clonidine, other anticonvulsant drugs, and related compounds in the treatment of the alprazolam withdrawal syndrome.

A new study published online on October 19, 2023 examined both the published and unpublished data from five FDA-reviewed trials for Xanax XR. Only three of the five trials were ever published, and all published trials claimed the results of their respective studies were positive. The researchers compared the overall trial results according to the FDA, to the corresponding published literature of the 3 published trials and found only one of the trials was positive. “Publication bias substantially inflates the apparent efficacy of alprazolam XR.”

We found that alprazolam XR may be less effective than the published literature would suggest. According to the published literature, every trial of alprazolam XR found it to be effective. By contrast, according to the FDA, only one of five trials was positive.

The researchers noted where selective reporting of clinical trials undermines the integrity of the evidence base “and deprives clinicians, patients, researchers, and policymakers of accurate data critical for decision-making.” Their study highlighted the value of regulatory data for public health. It brought to light unpublished trial data and provided a more balanced and realistic view of the efficacy of alprazolam XR, compared to what was previously reported. Neuroscience News indicated that publication bias inflated alprazolam’s effectiveness by over 40%!

The senior author of the study, Eric Turner, who is a former FDA reviewer, said clinicians were well aware of the safety issues with alprazolam, but didn’t question its effectiveness. “Our study throws some cold water on the efficacy of this drug. It shows it may be less effective than people have assumed.” He concluded how the study reinforced caution before starting a prescription for alprazolam.

The documentary Take Your Pills: Xanax said after 9/11, prescriptions for antianxiety drugs increased 23% in New York City and 8% nationally. Even before COVID-19, anxiety had overtaken depression as the “diagnosis du jour.” One of the psychiatrists in the documentary said drugs like Xanax were meant to taken short-term—no longer than about a month. But the fact is many people who begin taking a benzodiazepine “will continue to take that for years or even decades.” This is despite that the medication guide for Xanax says it is not known if Xanax is safe and effective to treat anxiety for longer than 4 months or to treat panic disorder for longer than 10 weeks. And it warns you to not stop benzodiazepines suddenly, or you may have “symptoms that can last several weeks to more than 12 months.”

Since direct-to-consumer advertising was approved for prescription drugs and medical devices, patients have come to their doctors telling them what medications they want. And doctors write the prescriptions to avoid a poor evaluation when the patient doesn’t get the drug they were told to “ask your doctor” about. “Medicine has become industrialized to the point where doctors kind of function like workers on an assembly line.” There is also a problem when training doctors about prescribing and using these medications “is not always as robust as one would hope.” Additionally, the typical consumer who asks their doctor for a certain medication is changing.

That typical profile of a patient who might be prescribed benzodiazepine is widening. So, whereas it might have been, typically, you know 30 years ago, a middle-aged woman, now we’re seeing younger and younger age groups. We’re seeing very old people are not only being prescribed benzodiazepines, but being kept on them for much longer periods of time.

I’ve written about concerns with the use of benzodiazepine for a while and was pleased to see the Ashton Method for benzodiazepine withdrawal mentioned in Take Your Pills: Xanax. There is a World Benzodiazepine Awareness Day (W-BAD) on July 11th that seeks to raise awareness about iatrogenic, medically caused, benzodiazepine dependence and adverse effects of benzo withdrawal. There is another documentary by Holly Hardman, As Prescribed, which also promotes awareness of benzodiazepine harm: “People don’t realize when they’re given benzodiazepines what’s going to come of it in the end.” Also see, “It Takes Away Your Soul” and Are Benzos Worth it?”

One person in Take Your Pills: Xanax said the only way out of anxiety is to go through it. “What’s going to get you on the other side of the anxiety is to actually go through it and experience it and understand it and make some sort of peace with it.” Another person thought that benzodiazepines like Xanax “erode the resilience that we must rely upon at some point in our lives to manage distress, anxiety, difficult situations.” What is so seductive about benzodiazepines like Xanax is how well they work. We need to remember, “the only way out is through” the anxiety.