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.

11/28/23

Counterfeit Pills, Snapchat and Overdose Deaths

Image by Hasty Words from Pixabay

WPVI-TV, channel 6 in Philadelphia told a story about a new legal battle over drugs available on social media. More than 60 families are suing Snapchat, arguing the overdose deaths of their children were due to the social media app. They are demanding changes to protect their children, claiming they died after buying illegal drugs sold by dealers on the app. One parent said, “Snapchat is the largest open-air drug market we have in the United States when it comes to our kids.”

CNN reported the number of drug overdose deaths is still increasing, but seems to be slowing. New estimates from the CDC estimates were 112,024 people died from a drug overdose in the 12-month period ending in May of 2023. This was a 2.5% increase over the 12-month period ending in May of 2022 (109,261). Dr. Katherine Keyes, a professor of epidemiology, said, “There were extraordinary increases in 2020 and 2021 that have started to flatten out in 2022 – now going into 2023. They’re not declining yet. But the pace of the increase is certainly slowing.”

However, certain states have seen steep increases in overdose deaths in comparison to national totals. For example, overdose deaths in Washington increased more than 37%, from 2,373 to 3,254. Fentanyl and other synthetic opioids were involved in most overdose deaths, followed by psychostimulants like methamphetamine. Washington’s dramatic increase in overdose deaths may have been fueled by the availability of counterfeit pills, which we will look at below.

A CDC report said more than 1 million people died between 1999 from and 2021 of a drug overdose. Synthetic opioids other than methadone seem to be the main driver of drug overdose deaths. “Nearly 88% of opioid-involved overdose deaths involved synthetic opioids.” Opioid were involved in 75.4% of all drug overdose deaths.

A NCHS data brief released in December of 2022 indicated drug overdose deaths were stable from 2006 through 2013, but then increased from 13.8 per 100,000 in 2013 to 32.4 in 2021. From 2020 to 2021, the rate increased 14% from 28.3 to 32.4 per 100,000. For each year from 2001 through 2021, the rate for males was higher than females. Notice from the following figure the dramatic increase in overdose deaths that begins in 2019, the year before the COVID pandemic.

Despite the concerns of parents with Snapchat making it easy for dealers to connect with teenagers seeking drugs, there were four other age groups with higher rates of overdose deaths.  Among adults aged 25 and older, the rate of drug overdose deaths was higher in 2021 compared to 2020. The rates were highest for adults aged 35-44 (53.4 and 62.0 per 100,000 respectively) and lowest for people 65 and older. See Figure 2 below.

The drug overdose deaths involving synthetic opioids other than methadone (fentanyl, fentanyl analogs, and tramadol) increased at different rates from 2001 through 2021. Natural and semisynthetic opioid overdose deaths (i.e., oxycodone and hydrocodone) increased from 1.2 to 3.5 per 100,000 in 2010 and then leveled off, reaching 4.0 per 100,000 in 2020 and 2021. The rate of overdose death involving methadone increased from 0.5 in 2001 to 1.8 in 2006. Then it decreased through 2019 to 0.8, and remained stable through 2021 (1.1). “Of the drugs examined, only drug overdose deaths involving heroin had a lower rate in 2021 than in 2020 (2.8 and 4.1, respectively).” See figure 4 below.

Overdose deaths from cocaine and stimulants were also on the rise. Cocaine-related overdose deaths was a bit of a roller coaster ride, increasing from 1.3 per 100,000 in 2001 to 2.5 in 2006, then decreasing to 1.5 in 2001, and then increasing to 7.1 in 2021. “The rate in 2021 was 22% higher than in 2020 (6.0).” The rate of overdose deaths involving psychostimulants (i.e., amphetamine, methamphetamine and methylphenidate) increased from 0.2 in 2001 to 0.5 in 2005, remaining stable through 2008. Then it increased from 0.4 in 2008 to 10.0 in 2021. The rate in 2021 was 33% higher than the rate in 2020 (7.5). See Figure 5 below.

Drug overdose deaths have risen fivefold over the past 20 years. The rate for males increased from 39.5 to 45.1 and the rate for females increased from 17.1 to 19.6, from 2020 to 2021. For both sexes, the highest rates were for adult between 35 and 44. The rates of drug overdose deaths involving opioids and stimulants increased from 2020 to 2021.

Counterfeit Pills

One disturbing trend that seems to be driving that increase in overdose deaths is the evidence of counterfeit pill use in the U.S. In a September CDC Morbidity and Mortality Report (MMWR), the CDC said these pills are not manufactured by pharmaceutical companies, but are made to look like legitimate drugs, frequently oxycodone and alprazolam (Xanax). Counterfeit pills often contain illicitly manufactured fentanyls and illicit benzodiazepines like bromazolam, etizolam and fluaprazolam. They increase the risk of overdose by exposing individual users to drugs they did not intend to use and did not know they were in the pills they were buying.

The overall increase of overdose deaths with evidence of counterfeit pill use increased from 2% to 4.7%, driven by an increase from 4.7% to 14.7% in Western states. More than half of overdose deaths with evidence of counterfeit pills (55.8%) occurred in Western states such as Washington. See the following table reproduced from data in Table 1 of the above CDC MMWR report.

The report had these key findings. First, the overall percentage of overdose deaths with evidence of counterfeit pills remained under 6%, but more than doubled from 2.0% in the third quarter of 2019 (July-September) to 4.7% in the fourth quarter of 2021 (October-December). The percentage more than tripled in Western states. Second, the percentage of deaths with evidence of counterfeit pills using illegally manufactured fentanyl (IMF) was more than double the percentage of deaths without evidence of counterfeit pill use.

Evidence of counterfeit pill use more than tripled in western jurisdictions, indicating IMFs, which are frequently present in counterfeit pills, are infiltrating drug markets in western U.S. states. Historically, white-powder IMFs have been less prevalent in western states because of difficulty mixing with predominantly black tar heroin prevalent in that region. The highest percentages of deaths with evidence of counterfeit oxycodone use (both alone and with counterfeit alprazolam) were in western jurisdictions, whereas nearly one half of deaths with evidence of counterfeit alprazolam use only were in southern jurisdictions. This finding suggests that exposure to different types of counterfeit pills and drugs might vary by region. Prevention and education materials that incorporate local drug seizure data and information about regional drug markets might be particularly effective at highlighting relevant counterfeit pill types and reducing deaths.

Those who died from counterfeit pills were significantly younger and more often Hispanic. Counterfeit pills have been marketed towards younger persons, where they may also exhibit more risk-taking behaviors than do older persons. The higher percentage of Hispanic persons could reflect the has implications for access to and use of prevention messaging materials and harm reduction services. “It is important to ensure that prevention messaging and harm reduction outreach are tailored to younger persons and the Hispanic population to address potential engagement, language, or other barriers.”

The DEA reported their lab testing revealed that 4 out of 10 counterfeit pills contain at least 2 mg of fentanyl, a potentially lethal dose. Criminal networks are mass producing counterfeit pills and marketing them as legitimate prescription pills. They’re often sold on social media and e-commerce platforms, which make them widely available to anyone. In 2021, the DEA seized 20 million fake pills, more than the 2 previous years combined. They’ve been identified in all 50 states.

In “Overdosing,” I wrote of the overdose problem as it existed in 2016, before fentanyl, counterfeit pills and Snapchat had become part of the problem. There I referred to “Melanie,” the first person I worked with who eventually became a heroin overdose statistic in the late 1980s. In that article is a map of Pennsylvania showing the drug-related overdose deaths by county in 2014. Philadelphia County even then had the most reported deaths, followed by Allegheny County, where I live. Legislation allowing first responders to carry naloxone to reverse an overdose had just been passed. Let’s continue to fight against the everchanging and adapting drug trade and never forget those who were taken too soon by overdose like Melanie.

11/21/23

So-Called “Christian” Nationalism and the Kingdom of God

Photo by Ben White on Unsplash

In The Religion of America’s Greatness: What’s Wrong with Christian Nationalism, Paul Miller said nationalism was often a fig leaf for authoritarian governments to hide behind. It is a form of cultural determinism, trivializing the ideals for which our founding fathers fought, sacrificed and died. “Independence was hardly necessary to preserve a Christian culture, which was not threatened by the Christian monarch of Protestant Britain.” They sought to gain independence for one Christian people (Americans) from another Christian nation (England) because they valued political liberty enough to fight and die for it. “Christian nationalism has the perverse implication of insulting the founders by minimizing the importance of the ideals for which they fought.”

Not only does it trivialize the ideals our founding fathers fought for, it is a false religion that places the nation in the place of the church and the authoritarian leader in the place of God. It misdirects the attention of Christians from where we should focus our attention—the kingdom of God—onto an idolatrous, false religion (See “What’s Wrong with Christian Nationalism?”). We are residents of the kingdom of God and should seek first that kingdom (Matthew 6:33), which is not of this world (John 18:36). This kingdom is associated with the church; not any particular nation—even modern-day Israel. The universal church alone contains citizens of the kingdom of God.

The kingdom of God or the kingdom of heaven is the central theme of Jesus’ preaching in the Synoptic Gospels of Matthew, Mark and Luke. The terms are interchangeable. Matthew alone speaks of the ‘kingdom of heaven’ because he was writing to a Jewish audience, who tended to avoid direct reference to God. Even in modern Judaism, the name of G-d is handled with caution and respect. Mark and Luke speak of the ‘kingdom of God’ because it was more intelligible to non-Jews. Neither phrase is found in the Old Testament and only the ‘kingdom of God’ is found in the New Testament outside of the gospel of Matthew.

Although the phrase ‘kingdom of God’ is not in the OT, the ideas of God as king and his kingly rule are inescapable. He is “the great king over all the earth” (Psalm 47:2)  and “his kingdom rules over all” (Psalm 103:19). It is an everlasting kingdom, ruling over past, present and future: “Your kingdom is an everlasting kingdom, and your dominion endures throughout all generations” (Psalm 145:13). This great future reign will be realized through the ministry of the Messiah (Isaiah 11, 49), and will mean salvation and blessing for Israel and all the nations (Isaiah 2:1-4; Micah 4:1-5). It is the fulfillment of the covenantal promise made to Abraham in Genesis 12:3, where all people on earth will be blessed through him.

Herman Ridderbos said the coming of the kingdom was ardently expected by the Jews, “to restore his people’s fortunes and liberate them from the power of their enemies.” The coming of the Messiah was to pave the way for the kingdom of God. By the time of Jesus, this hope had a prominent cosmic and apocalyptic sense concerning both the restoration of David’s throne and the coming of God to renew the world. “Although the OT has nothing to say of the eschatological kingdom of heaven in so many words, yet in the Psalms and prophets the future manifestation of God’s royal sovereignty belongs to the most central concepts of OT faith and hope.”

The misinterpretation of God’s redemptive purpose, expressed in the Old Testament Scriptures, was a stumbling block to Jesus’ disciples, to John the Baptist, Nicodemus and other Jews at the time of Jesus’ ministry. Richard Gaffin captured this succinctly in his article on “The Kingdom of God” for the New Dictionary of Theology:

This covenantal kingship, in turn, gives rise to the hope which is at the heart of the prophetic expectation of the entire Old Testament. In the midst of national decline and even exile, the prophets announce the time when God will manifest himself as king, when in a climactic and unprecedented fashion, ‘the Sovereign  Lord comes with power, and his arm rules for him’ (Isaiah 40:10), and when for Zion the proclamation at last holds true in the eschatological sense: ‘Your God reigns’ (Isaiah 52:7; cf. Deuteronomy 2:44; 7:14, 27). This great future, realized through the ministry of the Messiah (e.g. Isaiah 11, 49), will mean salvation and blessing, not only for Israel but for all the nations (e.g. Isaiah 2:1–4; 49:7; Micah 4.1–5); it is the fulfilment of the primal covenantal promise made to Abraham: ‘and all peoples on earth will be blessed through you’ (Genesis 12:3).

In the New Testament, John the Baptist announced the kingdom of heaven was at hand (Matthew 3:2) and Jesus began his preaching with the same message (Matthew 4:17). But they both gave it a sense that was at odds with the legalistic and nationalistic concerns in the apocalyptic and rabbinic materials of their time. In John’s preaching, the announcement of divine judgment was prominent. The axe was already laid to the root of the trees. Every tree that didn’t bear good fruit would be torn down and thrown into the fire.

Yet John said he was not the promised Messiah, who would come after him. The Messiah would hold the winnowing fork in his hand, and would baptize them with the Holy Spirit and fire. Therefore, the people must repent and submit to baptism for the washing away of their sins, in order to escape the coming wrath. God’s coming as King was above all else to purify, sift and judge and no one could evade this judgment. “The coming of the kingdom is the great perspective of the future, prepared by the coming of the Messiah, which paves the way for the kingdom of God.”

In view of his coming the people must repent and submit to baptism for the washing away of sins, so as to escape the coming wrath and participate in the salvation of the kingdom and the baptism with the Holy Spirit which will be poured out when it comes.

It seems from the beginning of his ministry, Jesus wasn’t acting like the Jews expected their Messiah would act. Remember, the kingdom was commonly thought to be the restoration of the Davidic kingdom and the (political?) liberation of the Jewish people from their enemies. After a while, even John the Baptist began question whether Jesus was the Messiah. So, John sent his disciples to ask Jesus if he was the one who is to come. Jesus told John’s disciples to tell John what they have seen and heard: that the blind see, the lame walk, lepers are cleansed, the deaf hear, the dead are raised and the poor have good news preached to them (Matthew 11:5; Luke 7:22).

With their own eyes they saw that God sent the Messiah. The kingdom of God was present in the words and deeds of Jesus, but the Jews did not believe. In John 10:24-26, the Jews confronted Jesus in the temple and demanded of him to plainly tell them if he was the Christ. “Jesus answered them, ‘I told you, and you do not believe. The works that I do in my Father’s name bear witness about me, but you do not believe because you are not my sheep.’”

This present aspect of the kingdom of God is seen more specifically when Jesus casts out demons. In Matthew 12, Jesus is accused by the Pharisees of casting out demons by Beelzebul, the prince of demons. He replied if he casts out demons by Beelzebul, then by whom do their sons cast him out? “But if it is by the Spirit of God that I cast out demons, then the kingdom of God has come upon you” (Matthew 12:28). When healing the demon-possessed, it is evident Jesus has entered the house of the ‘strong man’ and bound him fast.

The kingdom of heaven breaks into the domain of the evil one. The power of Satan is broken. Jesus sees him fall like lightning from heaven. He possesses and bestows power to trample on the dominion of the enemy. Nothing can be impossible for those who go forth into the world, invested with Jesus’ power, as witnesses of the kingdom (Luke. 10:18f.). The entirety of Jesus’ miraculous ministry is the proof of the coming of the kingdom.

Herman Ridderbos goes on to say in the Gospels how Jesus’ Messiahship is present in the here and now. Not only is he proclaimed as such on the Mount of Transfiguration, but he is also endowed with the Holy Spirit (Matthew 3:16). He came to fulfill what the prophets foretold; to seek and save the lost; to serve others and give his life for a ransom for many (Mark 10:45). “The secret of belonging to the kingdom lies in belonging to him” (Matthew 7:23; 25:41).

At the same time the kingdom of God is in the here and now of the gospel, it is also future. The miracles and healings described above are a foretaste of what is to come. They are tokens of a future order of reality, not the present one.  It is not yet the time when demons will be delivered into the eternal fire prepared for the devil and all his ‘angels’ (Matthew 8:29; 25:41).

In the Olivet Discourse (Mark 13), Jesus told his disciples that before the end, to be aware there will be false christs and false prophets performing signs and wonders to attempt to lead astray the elect. But “in those days,” which was a reference to the last days (Jeremiah 3:16; Joel 3:1; Zechariah 8:23), they will see the Son of Man coming in clouds with great power and glory. In the New Dictionary of Theology, Richard Gaffin said these present and future aspects of the kingdom of God are not two kingdoms, but one eschatological kingdom coming in successive stages: “a. the period of Jesus’ earthly ministry, b. the period from his exaltation to his return (the time of the church), and c. the period beyond his return.”  The kingdom of God is thoroughly messianic, “shaped by the unique demands of Christ’s work.” Jesus is therefore autobasileia, the kingdom in person.

Jesus is the Christ, the embodiment of the kingdom of God. He is Immanuel, God with us. His one entrance into space and time is evident in three successive stages: the time of his earthly ministry, the time of the church (between his exaltation and return), and the time after his triumphant return in space and time. We have the privilege of living out and provisionally manifesting the reality of that kingdom as the church, the body of Christ, until the time of his return.

As residents of the kingdom of God in the church age, we should seek first the kingdom of God (Matthew 6:33), which is not of this world (John 18:36). This kingdom has Christ as its head and the church as his body (Ephesians 5:23), and does not align with any particular nation. In the Sermon on the Mount, Jesus said no one can serve two masters. You will hate the one and love the other, or you will be devoted to the one and despise the other (Matthew 6:24). If you truly belong to Jesus in the kingdom of God, you can’t be a Christian Nationalist.

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.

11/14/23

Voyages on the Starship Ketamine

On October 10, 2023, the FDA issued a warning about the potential risks of compounded ketamine products for the treatment of psychiatric disorders such as depression, anxiety, OCD and PTSD. The concern seems to center on the at-home use of ketamine compounds from a multitude of online sources, dispensing oral formulations such as ketamine lozenges or tablets. Not only is ketamine not FDA approved for the treatment of any psychiatric disorder, it has known safety concerns such as abuse and misuse, increased blood pressure, slowed breathing and “psychiatric events.” The FDA said these compounds should only be used “under the care of a health care provider.”

Ketamine is a Schedule III controlled substance approved by the FDA as an intravenous or intramuscular injection to induce and maintain general anesthesia. It is not FDA-approved to treat any psychiatric disorder. It is a mixture of two-mirror-image molecules, R-ketamine and S-ketamine—arketamine and esketamine, respectively. The “S” form of ketamine (esketamine), known as Spravato, was approved by the FDA as a nasal spray for the treatment of major depression and adults with acute suicidal ideation or behavior in 2019. See “Red Flags with Spravato,” “Doublethink with Spravato?,” “Repeating Past Mistakes with Esketamine” and other articles on this website expressing concerns with esketamine/Spravato.

Spravato is also a Schedule III controlled substance and like ketamine, and has similar risks of adverse events. This led the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) with esketamine, meaning that esketamine is required to be “dispensed and administered in medically supervised health care settings that are certified in the REMS and agree to monitor patients for a minimum of two hours following administration because of possible sedation and disassociation and the potential for misuse and abuse.” But ketamine and ketamine compounds can be legally prescribed off label to treat psychiatric disorders and do not have to have a FDA required REMS.

However, on February 16, 2022 the FDA published an alert describing the risks associated with the use of compounded ketamine nasal spray products. The FDA Adverse Event Reporting system (FAERS) and the medical literature identified five cases (reported between 2016 and 2021) of compounded ketamine nasal spray that resulted in psychiatric events “such as delusion, dissociation, visual hallucination, and panic attack as well as abuse and misuse.”

The reported concentrations of compounded ketamine nasal spray ranged from 125 – 200 mg/ml. Frequency of use varied from three sprays three times a day to six sprays eight times a day. The amount of medication administered to the patients with each spray is unknown. In most case reports, the patients self-administered the product at home, and it is unknown whether they were observed or monitored by a healthcare professional.

Because compounded ketamine nasal spray products are not FDA-approved, there is no FDA-approved dosing regimen for these products. There are also no data to support dosing conversion between Spravato (esketamine) nasal spray and compounded ketamine nasal spray.

The New York Times said the October 2023 alert sought to differentiate between the supervised use of ketamine as a therapy administered at clinics, and the “wellness centers” or online marketers that prescribe the drug via telemedicine so that buyers can take the drug at home. The alert included a caution that individuals receiving ketamine products from compounders and telemedicine platforms may not receive information about the potential risks associated with the product. “At-home administration of compounded ketamine presents additional risks because a health care provider is not available onsite to monitor for serious adverse outcomes resulting from sedation and dissociation.”

The pandemic-related boom in telehealth has given rise to a legion of online prescribers that dispense inexpensive ketamine lozenges, tablets or nasal sprays following a brief video interview. Some companies provide as many as 30 doses after one session, which experts say can lead to misuse.

Company executives in the compounding industry say they’d welcome government oversight. But they are concerned that a lack of flexibility in the FDA’s guidance could result in overly aggressive enforcement by state regulators. The manager of a compounding pharmacy in San Francisco said he is concerned these online sellers will ruin it for everyone. “Our fear is that regulators, if they perceive a threat to public health, will move to take this amazing medicine away and leave patients at risk.”

Psychiatric Times also expressed concerns with at-home ketamine therapy. They described a report by the All Points North Treatment Center in Edwards Colorado of 2,000 adults where 64% said they thought ketamine helped with their mental health symptoms. But 55% who tried at-home ketamine therapy also admitted accidentally or purposely using more than the recommended dose. The Editor in Chief of Psychiatric Times said, “Esketamine has to be administered in person by a trained health care provider. The use of at-home ketamine bypasses this safety net and puts individuals at risk, undermining the FDA’s REMS protocol to minimize risk and maximize safety and prevent diversion and abuse/misuse.”

There were reservations in 2019 with the approval process for esketamine, Spravato  (see “Hype and Concern with Esketamine” and “Evaluating the Risks with Esketamine”). A NPR interview BEFORE the FDA approved esketamine predicted the problem the FDA is now attempting to address in its alert for “compounded ketamine products.” A doctor who prescribed ketamine to his patients said doctors would continue to offer a generic version of ketamine for depression because it would be cheaper than the cost of Spravato with its REMS. The generic form of ketamine was cheap, and could be taken at home with the assistance of a nasal spray, he said. “Any psychiatrist or physician can prescribe [it] without the restrictions that are going to be applied to esketamine.”

A Cunning Methodology

In a new study, Stanford researchers devised a cunning workaround to disguise the dissociative properties of ketamine. A major difficulty with doing clinical trials on psychedelic drugs like ketamine is the difficulty of providing a satisfactorily double blinded methodology. Participants can usually tell whether or not they were given ketamine or a placebo. The researchers “recruited 40 participants with moderate to severe depression who were scheduled for routine surgery, then administered a dose of ketamine or placebo when the participants were in surgery and under general anesthesia.”

They were surprised to find that both groups experienced the large improvement in depressive symptoms usually seen with ketamine. The senior author of the study he was surprised to see the result. He quoted some participants as saying their life was changed; they never felt like that before. “But they were in the placebo group.” Both the ketamine and placebo groups saw their depression rating scores drop by half and stayed roughly the same throughout the two-week follow-up of the study.

The researchers thought it was unlikely the surgeries and general anesthesia accounted for the improvement. They theorized the positive expectations of the participants played a key role in the effectiveness reported by them. “Those who had improved more in their depression scores were more likely to think they received ketamine, even when they didn’t, implying some preexisting positive expectations for ketamine.” The senior author said this was nothing new.

Placebo is probably the single most effective, consistent intervention in medicine, full stop. It’s seen in every trial, and we should probably be paying more attention to the factors that give rise to it.

However, he said the takeaway shouldn’t be that ketamine “is just a placebo.” He thought that was a disservice to placebos. He hypothesized there may be a physiological resonance between the placebo effect and how ketamine works. “There is most definitely a physiological mechanism, something that happens between your ears, when you instill hope.” He added that the results also suggest the psychedelic experience may not be crucial to the drug’s benefits, although it likely encourages more positive expectations.

Maybe with a non-hallucinogenic psychedelic analog you can get the same benefits without having to, you know, go to outer space.

11/7/23

Emerging Threat with Captagon

Bekaa Valley, Lebanon; photo by Maya Babti on Unsplash

The Hamas-Israeli conflict currently dominates the news of what’s happening in the Middle East. There’s even been speculation that Hezbollah could join Hamas in it fight against Israel. However, there is a quieter, nonmilitary struggle coming out of Syria with the potential to spread havoc on a wide scale beyond the Middle East—the fight against the drug captagon. While the drug is not widely known outside the Middle East, CNN said it has become a “financial lifeline” to the Assad regime of Syria to the tune of an estimated $57 billion in 2022. Captagon smuggling is worth approximately three times the combined trade of the Mexican drug cartels.

Captagon or fenethylline was first synthesized by the German company Degussa Pharma Gruppe in 1961. It was used as a milder alternative to amphetamine and related compounds in the treatment of what we now refer to ADHD until it was listed as a Schedule I controlled substance in the U.S. in 1981. It became illegal in most countries when the World Health Organization listed it under the Convention on Psychotropic Substances in 1986. It is a synthetic drug of the phenethylamine family, which also contains amphetamine, methamphetamine and MDMA (known as ecstasy).

Counterfeit “Captagon” tablets containing other amphetamine derivatives that are easier to produce are pressed and stamped to look like Captagon pills. These knockoffs often contain a mixture of amphetamines, caffeine and various fillers and are sometimes referred to as “captagon” with a lower case “c.”

The BBC reported there have been an increasing number of drug busts involving captagon across the Middle East, with the Persian Gulf region being its main destination. Police in the United Arab Emirates seized 13 tons of captagon pills (worth $1 billion), smuggled in furniture. In 2020, 14 tons of captagon (worth over $1 billion) were seized in Italy. In 2022, Saudi Arabia seized 46 million captagon pills smuggled in a shipment of flour at a warehouse in the capital Riyadh. CNN said millions more pills have been intercepted since.

Captagon has become a bargaining chip for Syria, as it tries to normalize ties with neighboring Arab states. Although Syria’s neighbors are now in talks to normalize relations with Syria and President Bashar al-Assad, Saudi Arabia is still not on board because it is the biggest market for Syrian drugs. According to New Lines Institute, the Syrian regime has leveraged its agency over the captagon trade, suggesting they could reduce captagon trafficking “as a good will gesture.” Syrian state media regularly reports how the interior ministry is cracking down on captagon and other narcotics.

New Lines Institute published a 55-page report “The Captagon Threat,” that investigated the available information about captagon trade efforts to expand its market beyond the Persian Gulf region. Recent seizures point to southern Europe and North Africa as “new transit points and sites of interest.” It remains unclear whether these are intended transit areas for other markets, or if they are emerging as new consumer markets. “Regions beyond are also potentially at risk for increased captagon trafficking from Syria and neighboring states.” See the following map from New Lines Institute.

Captagon production in Syria has shifted from smaller outfits to industrial, containerized operations in rebel-held areas held by the regime of President Bashar al-Assad. Parts of the Syrian government are key drivers for the captagon trade. After the international economic isolation that occurred as a result of the 2011 civil war in Syria, captagon smuggling helped turn Syria into a narco-state. The BBC said at the height of the civil war armed groups supplied the drug to fighters in order to boost their courage and keep them awake. The growth of the captagon industry led the US to introduce the 2022 US Captagon Act, which linked the trade to Syria and called it a “transnational security threat;” but the legislation was never enacted. See the following map from New Lines Institute.

Elements of the Syrian government are key drivers of the captagon trade, with ministerial-level complicity in production and smuggling, using the trade as a means for political and economic survival amid international sanctions. The Syrian government appears to use local alliance structures with other armed groups such as Hezbollah for technical and logistical support in captagon production and trafficking.

Al-Assad and the Syrian government denies that it profits from the drug trade, and Hezbollah denies any ties to it. Nevertheless, in March of 2023, the U.S. and the European Union imposed sanctions on a list of people that included two of President Assad’s cousins suspected of involvement in the captagon trade, as well as prominent businessmen and militia leaders. The militia leaders are associated with drug smuggling and production. One is known as the ‘king of captagon’ and is associated with Hezbollah. Another uses his militia headquarters to facilitate captagon production.

The Assad regime, Hizballah, and other Iranian-backed militia all facilitate the captagon industry, and in doing so fuel regional instability and creating a growing addiction crisis across the region.

The BBC reported a soldier said many soldiers became drug dealers to supplement their incomes. He said they were not allowed to go to the factory. “They would pick a meeting place and we would buy from Hezbollah. We would receive the goods and co-ordinate with the Fourth Division to facilitate our movement.”

The Fourth Division, an elite Syrian army unit tasked with protecting the government from internal and external threats, is heavily involved in the captagon trade. Since 2018, it has been led by Maher al-Assad, the younger brother of President Assad. A former officer who defected from the Syrian army said it because of difficult financial conditions that many members of the Fourth Division have resorted to smuggling. “So the cars of the Fourth Division’s officers started to be used to carry extremists, weapons, drugs, since it was the only body able to move across checkpoints in Syria.”

In “The Captagon Threat,” New Lines Institute said there was some evidence that the Fourth Division was cooperating with loyal elements of Syria’s industries over protection, smuggling and distribution of captagon in and outside of Syria. “These elements appear to be using military or commercial vehicles to transport captagon from distribution centers at militia headquarters and checkpoints under the guise of security missions or business activities.” There is also some evidence that Fourth Division officials use a series of state-owned ports in the Latakia and Tartus region to dispatch captagon shipments.  The Fourth Division’s 42nd Brigade has allegedly been used to guard a captagon manufacturing center close to the Syrian-Jordanian border.

Hezbollah’s fighters played a crucial role in helping the Syrian government turn the tide in the civil war and now have a presence throughout the country. They have been repeatedly accused of involvement in drug trafficking, but have always denied it. A Syrian journalist said, “Hezbollah is involved but is very careful not to have its members playing key roles in transporting and smuggling the merchandise.” However, Hezbollah has a known history of controlling Lebanese cannabis production and smuggling it out of the southern Bekaa Valley. In 2016, the UN estimated that Lebanon was the third-largest cannabis producing country in the world.

Hezbollah’s technical expertise in drug smuggling, along with the number of potential partner criminal organizations in the Middle East, Europe, and North Africa, has aided the Syrian government’s efforts to run an industrial-sized captagon market. The relationship builds upon a dynamic that has existed since the Lebanese civil war, where Syrian political, military, and intelligence officials collaborated with Hezbollah in cannabis cultivation and production, activities that led the U.S. Department of State to designate Syria as a narco-state until the Pax Syriana era.

This expertise and its partner organizations has meant Hezbollah could support smuggling efforts, helping dispatch captagon shipments from Lebanese ports in Tripoli and Beirut. Hezbollah has protected transit routes between Syria and Lebanon, and uses its political leverage and security networks within Lebanon to facilitate uninterrupted illicit commerce. Hezbollah fighters have been seen assisting the Fourth Division in controlling and securing key areas of captagon production and smuggling at key checkpoints along the Damascus-Amman highway and other smuggling routes. They have also been seen visiting captagon factories in Syria.

Yet given Hezbollah’s political imperative to preserve its conservative image, particularly amid increasing domestic backlash with political protests and anti-corruption calls, Hezbollah Secretary-General Hassan Nasrallah and other political leaders have publicly denied direct involvement in the narcotics trade, shifting blame to local tribal leaders and political barons with proven ties to the captagon trade and to Syria.

Aljazeera recently reported on the role captagon is playing in Syria and President Bashar al-Assad’s attempt to return to the Arab fold. Al-Assad, of course, denies any organized governmental efforts to profit from the drug. So, it came as no surprise in May of 2023 that he did not discuss the drug trade during the Arab League’s 32nd summit in Jeddah, Saudi Arabia. Following a meeting of foreign ministers after the summit, Syria agreed to address drug trafficking and within days an air raid on Syrian soil killed a reputed Syrian drug kingpin.

A director at New Lines Institute told Aljazeera how the Syrian regime had already conducted a series of “cosmetic” seizures in order to build good will with Arab governments. “They want to be seen as a country that could interdict Captagon if they are persuaded and incentivised to, particularly with sanctions relief and economic packages.” She thought they would give up traffickers that are not closely aligned to the regime, but are named as potential contributors to the drug trade. She does not believe Syrian authorities will touch any of the core backers of the trade named on the U.S. and the European Union list noted above.

I also think the regime is very much using this as their own political card in normalisation discussions, essentially owning up to the fact that they have agency over the trade and using that as a main tactic to encourage countries to pay them off in exchange for them cracking down.

The director of the SOAS Middle East Institute said she believes al-Assad was unlikely to give up captagon and other Arab states have little leverage over al-Assad to persuade him to do so. Revenue from the drug trade, which is Syria’s largest export, will require the restoration of legitimate trade. Al-Assad will demand the lifting of sanctions and the return of his territory. “The most Arab countries can hope for in this regard is that those regime elements involved in the Captagon trade might divert some of it to markets outside the Arab world so as to reduce the flow of the drug to Arab countries.”

So, begin to look for Captagon to come to a drug market near you.

10/31/23

What’s Wrong with Christian Nationalism?

Image by SEspider from Pixabay

In a video for The Gospel Coalition—“Why America Is Not a Christian Nation”—Michael Horton said, “The misuse of Scripture for civil religion has plagued churches across the political spectrum for centuries. The problem isn’t new in our generation, but recent events remind us that Christians must speak clearly against the problematic concept of Christian Nationalism.” He was referring to the events of January 6, 2021. Horton referenced seeing a wooden cross “propped up outside the U.S. capitol, surrounded by a mob of people, hoisting up American flags” and not far from a platform and noose seemingly intended for the vice president. “The January 6th attack on the U.S. capitol, which included insurrectionists praying Christian prayers once they infiltrated the Senate chamber, has prompted a renewed conversation about what’s called ‘Christian Nationalism.’”

Horton is not the only Christian to raise concerns about this sense of Christian Nationalism. In “The Good, the Bad, and the Ugly of Christian Nationalism,” Patrick Schreiner said Christian Nationalism has become a junk box into which everyone piles their own conceptions of what they think it means. Some, like Michael Horton, equate it with rioting at the U.S. capitol. Others see it as attempting to enforce God’s law in our country, while still others see it as advocating for Christian moral values on issues like abortion. “How you view the movement depends almost entirely on your circles.”

Schreiner went on to unpack his understanding of three forms of Christian Nationalism as Good, Bad and Ugly. The good form of Christian Nationalism meant that “Christianity has influenced and should continue to influence the nation.” This sense of Christian Nationalism doesn’t attempt to dictate the political process or make the nation completely Christian by force, “but seeks instead to bring change by persuasion.” The adherents don’t force their opinions, but advocate their views by supporting laws, electing candidates, writing, podcasting, etc. In other words, they seek to make known God’s will providentially (Romans 1:19-20). “But this isn’t what most people mean by Christian Nationalism.”

Like theonomy, the bad form of Christian Nationalism wants a fusion of Christianity with American civil life, meaning the “laws of the United States should be explicitly Christian.” Instead of persuading by the word of our testimony (Revelation 12:11), adherents seek to enact and enforce laws. For them, the kingdom of God is brought about by command and power, not by the Spirit. Failed efforts of bringing about the kingdom of God by power exist throughout history. Christian conversion must occur by the compelling of the Spirit, not by instituting human law.

We conquer not by fighting the culture war but by embodying Jesus’s cross-shaped victory. His blood declares him the King of the universe, and our blood speaks to our solidarity with him. We continue to speak of and demonstrate Jesus’s cross in our own lives and so remain faithful in a pagan society.

While America does have a distinctly Christian past, the bad sense of Christian Nationalism overlooks key features of the American experiment, religious liberty and pluralism. The First Amendment says, “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof.” Squashing dissent by law violates human liberty, and the vision of the founding fathers. It coerces those who dissent. In The Religion of American Greatness, Paul Miller said the First Amendment rightly protects religious freedom for all people, “including Muslims, atheists, and even progressives.”

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.

At this time in history, we live between Christ’s resurrection and his second coming. Making explicitly Christian laws perverts this distinction by our human attempts to institute Christ’s rule in the present age. In this age, religious freedom, diversity and pluralism are blessings to God’s people who want to live a peaceful and quiet life (1 Timothy 2:2). But we can’t codify or institute God’s law completely in this age. That is for Christ to do when he returns.  “As citizens of the kingdom of God, we point forward to the [coming] kingdom but never forget the age we inhabit.”

Some will argue that nationality is a biblical idea, and point to the table of nations in Genesis 10, where God separates humanity into distinct groups. They will cite Deuteronomy 32:8, where it says when God gave the nations their inheritance, he divided mankind, “he fixed the borders of the peoples.” But they neglect Genesis 11, where mankind sought to build a city and tower with its top in the heavens to make a name for themselves, not God. When God saw what they had done, he confused their language and dispersed them over the face of the earth.

When Christian Nationalism turns ugly, it becomes a cultural framework that idealizes and advocates for the fusion of Christianity and American civil life and pursues it by dominion—by force or violence when necessary. It is a conflation of God and country—as Michael Horton said—into a civil religion. “The misuse of Scripture for civil religion has plagued churches across the political spectrum for centuries. The problem isn’t new in our generation, but recent events remind us that Christians must speak clearly against the problematic concept of Christian Nationalism.”

Although Christianity played a role in American history, America can never be honestly described as a Christian nation. “No nation-state can be a Christian nation-state, because Christianity doesn’t work that way.” Christianity and nation-states are two very different entities and to claim America is a Christian nation confuses the categories and forms a civil religion. However, there is nothing wrong with Christians getting involved with politics and political advocacy. It’s okay for Christians to participate in nonreligious and nonviolent protests of public policies.

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. . . . The worldwide church is Christ’s Kingdom.

In an article for Christianity Today, “What Is Christian Nationalism?”, Paul Miller explained how Christian Nationalism differed from other forms of nationalism, patriotism, and Christianity. Patriotism is the love of country, where nationalism is an argument about how to define a country. “All of God’s creation is good and patriotism helps us appreciate our particular place in it.” We should love our country and work to improve it by holding it up for critique and work for justice when it errs. Here, Miller seems to echo what Schreiner called “good” Christian Nationalism.

Nationalism begins with a belief that humanity is divisible into mutually distinct, internally coherent cultural groups. These groups are defined by shared traits like language, religion, ethnicity, or culture. Nationalists believe these groups should have their own governments. These governments should then promote and protect the nations’ cultural identity. And sovereign national groups should provide meaning and purpose for human beings.

Christian Nationalism is the belief that the American nation is defined by Christianity, “and that the government should take active steps to keep it that way.” Miller said this is not just an observation about American history, but an inflexible program for what America must do. They want the government to promote a specific cultural template for the country. This is a reflection of Schreiner’s “bad” Christian Nationalism.

Some have advocated for an amendment to the Constitution to recognize America’s Christian heritage, others to reinstitute prayer in public schools. Some work to enshrine a Christian nationalist interpretation of American history in school curricula, including that America has a special relationship with God or has been “chosen” by him to carry out a special mission on earth. Others advocate for immigration restrictions specifically to prevent a change to American religious and ethnic demographics or a change to American culture. Some want to empower the government to take stronger action to circumscribe immoral behavior.

Miller said this presumption that Christians are heirs of the true heritage of American culture tends to treat other Americans as second-class citizens.  If implemented, it would not respect the full religious freedom of all Americans. Empowering the state through so-called “morals legislation” to regulate conduct carries the risk of overreaching “and creating governing powers that could be used later against Christianity.” Now we reach Schreiner’s “ugly” Christian Nationalism.

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.

Christian nationalism misappropriates the name of Christ for a worldly political power (nationalism), when Jesus said his kingdom is not of this world (John 18:36). It proclaims that its program is “the political program for every true believer.” In reality, it is a political ideology focused on the national identity of the United States. It includes a distorted understanding of American history and American government that is extrabiblical, while claiming to be biblical. While it generalizes from biblical ideas and principles, at its worst, it is contradictory to them.

In The Religion of America’s Greatness, Paul Miller said you can either be a Christian nationalist or a Christian; you can’t be both. Yes, Christians should be patriots, but true patriotism sometimes means rebuking our country for its sin, as we do when advocating for prolife. And it may mean working against it, as Dietrich Bonhoeffer did against the Nazi government of his German homeland. Perhaps so-called Christian nationalism is better referred to as religious nationalism.

We should not be trying to “Make America Great Again.” We should be striving to “seek first the kingdom of God and his righteousness” (Matthew 6:33). Christian Nationalism in the extreme is “a totalistic political religion that is inconsistent with orthodox Christianity, a false religion that places the nation in the place of the church and the leader in the place of God.”

We are called to be residents of the kingdom of God, which is not of this world.

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

10/24/23

Is Adult ADHD the Latest Fad Diagnosis? Part 2

Photo by Tara Winstead: www.pexels.com

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

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

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

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

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

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

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

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

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

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

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

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

Frances said the risks of overdiagnosing ADHD in adults were:

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

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

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

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

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

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

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

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