Anti-Anti-Black Box Warning

395675_sThe New England Journal of Medicine recently published two very different articles on the 2004 black box warnings the FDA put on antidepressants because of their relationship to suicidality. They illustrate the truth that there are no brute, utterly uninterpreted facts. “The modern scientist, pretending to be merely a describer of facts, is in reality, a maker of facts” (Cornelius Van Til).

Richard Freidman concluded from his review of the literature that the black box warnings led to less treatment for depression. Not only had prescription rates for antidepressants fallen, so had the rate of diagnosing new cases of depression. He acknowledged that data indicating these trends were only correlational and could not establish a causal link between the warning and these changes. Yet he thought it plausible that in the face of the debate over FDA warning and resultant media coverage, “patients might be reluctant to disclose symptoms that could lead to a diagnosis of depression and subsequent antidepressant treatment, and physicians might be hesitant to prescribe these drugs.”

He also noted a study by Lu et al. that found there was a statistically significant increase in psychotropic-drug poisonings after the FDA warning.  This measure was used by the study as a proxy measure for suicide attempts. “Insofar as such poisonings represent a reasonable proxy for suicide attempts, it’s possible that the downward trend in antidepressant use resulted in an increase in such attempts.” He qualified that statement by saying that we cannot be certain that any given poisoning was intentional or accidental. Then he pointed to a gradual increase in suicide rates among 10 to 34 year olds between 1999 and 2010. “So there is little evidence that actual suicide rates have changed in the wake of the advisory.”

In his opinion, the “very small risk associated with antidepressant treatment” is offset by the far greater risk posed by untreated depression. Given that the 2007 modification of the black-box warning was not enough to prevent “a chilling effect on depression treatment,” he did not think further modifications would be helpful. He recommended that the FDA consider removing the warnings entirely.

I believe we cannot ignore the weight of these epidemiologic data or the very real possibility that the FDA advisory has unintentionally discouraged depressed patients from seeking treatment and doctors from prescribing antidepressants.

However, as Mad in America pointed out, Dr. Marc Stone challenged virtually all of the interpretations made by Dr. Freidman in his article. Stone meticulously demonstrated how the investigators in the reported studies failed to distinguish the alleged effect of “the boxed warning from the effect of general public awareness of the suicidality issue.” He further noted that it cannot be assumed that 2005 decreases in antidepressant prescription rates were a reaction to the warning and resultant controversy.

While the number of prescriptions did decrease in every age group up to 54 years of age, they increased in every older subgroup. “Why were prescribing trends unaffected among adults 55 or older?” Stone suggested that the time period was a transitional one, where several popular antidepressants went off patent, while generics sharply increased. From 2004 through 2008, promotional expenditures for antidepressants decreased by 35%.

It is possible that the modest reduction in antidepressant prescribing reflected drug makers’ reduced marketing of brand-name antidepressants to everyone except patients who would soon be eligible for the new Medicare prescription-drug benefit.

Stone also noted that the Lu et al. study cited by Freidman rested its claim that “poisoning by psychotropic agents” could be a proxy measure for suicide attempts on an invalid application of another study: “That study did not investigate whether the relationship between proxy and attempted suicide remained stable over time.” Superior data from the CDC indicated that incidents of attempted suicide from poisoning and all other causes peaked in 2003 or 2004 and then declined.  In addition, the rate of accidental poisoning, such as drug overdoses, increased significantly in 2005 and 2006. Dr. Stone concluded:

These data should be sufficient to dispel any serious concerns, but nearly 10 years after the labeling changes, the idea that the boxed warning had adverse consequences persists in the minds of many health professionals, in the media, and among the general public.

Psychologist Philip Hickey also wrote a critique of the Lu et al. study. He quoted several statements from the National Institute of Health (NIH) press release about the study and then proceeded to devastatingly show how the statements were false. Both the link provided by Hickey and a search of the NIH site failed to find the noted press release. It seems to have been removed.  He concluded that the Lu et al. study was meant to be PR and spin, not science.

The fundamental message in the study, and in the NIH press release, is:  If you reporters print bad things about antidepressants, this will lead to reduced usage of these products, which in turn will lead to more suicides, and you will have blood on your hands!

But why is there a PR campaign for antidepressants occurring now? Julia Calderone’s article in Scientific American,The Rise of All-Purpose Antidepressants,” may have provided a clue. She noted that doctors commonly use antidepressants to treat conditions they are not approved for by the FDA—so-called off label use. “Studies show that between 25 and 60 percent of prescribed antidepressants are actually used to treat [off label] conditions.”  So the message is, if you reporters print bad things about antidepressants, doctors could lose one of the main drug options they have for altering brain chemistry.

Antidepressants are ineffective in treating all but the most serious cases of depression. There have also been reliable studies showing that the placebo effect accounts for virtually all of the drug effect of antidepressants. Could the placebo effect also be at work in the off-label use of antidepressants? They have been shown to have serious side effects warranting the inclusion of the black box warning. If anything, the warning should be extended to include adults, the age group most often using antidepressants.


It’s Just a Dream

Using dreams can be really powerful. There was someone who had such a realistic using dream that she asked to get a urine screen at her outpatient treatment program. No, really. She was pretty sure she just had a dream. But it was SO REAL, that she wasn’t 100% sure. There had been many times before where she woke up in her own bed with only vague memories of a night of partying. Her screen was negative and her relief was positive. She really wanted to get and remain abstinent, so a powerfully real using dream upset her terribly.

Another person had a series of using dreams while she was in treatment. Initially her dreams were of her actually getting high, but then she’d wake up before she actually used. Then she would say no in her dream when offered something. Then she started to answer that she wasn’t using drugs anymore because she was in recovery.

These people were in early recovery and their experiences with using dreams were within the first couple of months of abstinence. In “Drunk Dreaming,” Kristen McGuiness referenced a 1998 study that said 85% of the participants with six weeks or less of abstinence had 2.4 using dreams per month. Reportedly, those who had a higher number of using dreams were more likely to use again. An addiction specialist quoted in the article suggested that the person should tell a sponsor or friend what happened; what you were feeling. Maybe there was something that was a trigger to you. “Take responsibility for continued sober action. It’s a good hint that something might be off balance.”

She quoted another addictions counselor who said that drinking or using dreams were an essential part of early sobriety. “So many issues come up, and people have so many mood swings and emotional highs and lows.” People can have them for a long time after they are sober. They often occur around the anniversaries of their sobriety. They can happen when addicts or alcoholics are forced to focus on someone else’s addiction. “You can be sober for decades and after spending time with another alcoholic or addict, you might be triggered and have a using dream.”

I don’t know if I’d assume that using dreams are always either triggered by environmental experiences or unconscious desires to drink or use drugs. Charles Gillispie wrote a short essay reviewing some of the studies on using dreams. He said that using dreams could, in-and-of-itself, be a positive sign that the individual is more engaged in the recovery process. “In other words, [they] take their struggle with substance abuse seriously enough to dream about it at night.” The importance may not be within a particular dream, but how the person’s dream content shifts over time.

Another study he referred to suggested that the person’s response to the dream was more important than the content of the dream—whether or not they used in the dream. One response could be frustration that the dream wasn’t real—I’d add or disappointment that they didn’t get high in the dream. Alternatively, the person could be relieved that the dream wasn’t real. The frustrated first group had relapse-pending dreams; the second, recovery-affirming dreams.

Guinevere had a thoughtful discussion on a using dream she had after several years of abstinence, “Dreaming About Drugs or Drinking—What to Do About It.” She described a time period of typical life stressors, just life on life’s terms. Simply, she was going through a time of transition and disruption to her normal routine. One night she dreamed she had a bunch of fentanyl patches, her former drug of choice. When she first detoxed, she had drug dreams “pretty often.” They were the frantic, searching through the house for something kind.

She knows her early drug dreams were partly a chemical thing; partly a psychological thing. Withdrawal takes time and sleep deprivation is part of the withdrawal process. She also realized how she’d trained herself by using drugs.

I’d managed the way I felt with chemicals, instead of allowing the feelings to pass. I didn’t want the painful feelings to persist, so I used chemicals to get rid of them; I didn’t want the joyful feelings to leave me, so I used chemicals to try to prolong them—or else to get rid of the fear of the joy leaving me.

Her dream, she realized, wasn’t about actually using drugs, but about the temptation to do so—“the presence of drugs in my mind and consciousness.”  When she tried to touch the drugs in her dream, they’d disappear. When she pulled her hand away, they’d reappear. “It’s around. It’s not Gone.” But she’s learned to deal with feelings without chemicals. And her Common Sense told her, “It’s just a Dream.”

In “Drunk Dreams,” Sophie Saint Thomas noted how the purpose and cause of dreams is hotly debated topic, with “no solid interpretation of their meaning or cause.”  She commented that the cure for dreams surrounding old behaviors seems to be time. “As your recovery evolves, and your brain starts to change the association of the behavior from their manifestation of the reward of dopamine and serotonin released.” The important thing, she said, is to process the dreams and not get hung up on shame, which can lead to relapse.

Talk about them, think about them, write them down if you can, and remember that they don’t necessarily mean anything but are just a reflection of where you are in a process so just observe them. . . .  Don’t give them any more credit than they deserve.


The Limits of Human Reason

I know there is nothing in the word or in the works of God that is repugnant to sound reason, but there are some things in both that are opposite to carnal reason as well as above right reason; and therefore our reason never shows itself more unreasonable than in summoning those things to its bar that transcend its sphere and capacity. (John Flavel)

So what do you think? Can human reason be unreasonable? The question is not as “Alice in Wonderland-ish” as it may sound. Jonathan Evans wrote an essay in the Psychological Bulletin, where he said: “Few reasoning researchers still believe that logic is an appropriate normative system for most human reasoning.” In his essay on “Deductive Reasoning,” Joshua Schechter noted that the psychological study of deductive reasoning has shown that subjects are highly prone to errors in evaluating the validity of logical arguments. They are “more likely to mistakenly identify an invalid argument as valid if its conclusion is believable.”

The above quote by John Flavel can be found within his work, The Mystery of Providence. The link is to a Google ebook edition. Flavel warned his readers to not pry too curiously into the secrets of Providence; and to not “suffer your shallow reason arrogantly to judge and censure its designs.” He said there were “hard texts” within both the work of God (creation) and the word of God (Scripture). We should modestly and humbly reverence, but not “dogmatize too boldly and positively upon them.” The opening quote occurred at this point.

Flavel then said there is nothing opposed to sound reason in either creation or Scripture. However, there are some things in both that are opposed to carnal reason and beyond “right,” sound reason. “Carnal” in a modern sense refers to bodily appetites, especially sexual ones. But the Greek sense of the term translated as “carnal” has the meaning of “the mind of the flesh.” In other words, the mind that is dominated by our flesh is the starting point for all carnal thinking, all reasoning. It makes the human mind the “judge” of all reasoning.

So our reason is at its most unreasonable when it makes the human mind the arbiter of how we think about creation and Scripture. “Beware, therefore, you lean not too much to your own reason and understanding. Nothing is more plausible, nothing more dangerous.” Right, sound reasoning places God at the center. We are to “think God’s thoughts after Him.” But we can’t with a carnal mind.

While modern psychology and philosophy would not agree with what has just been said, they do seem to indicate that human perception is not always trustworthy. Watch this YouTube video titled, “Step Into an Optical Illusion” about an art exhibit called “Demon Hill.” … You really have to watch the video to get what is coming next, so I’ll wait until you’re done. . . . Incredible wasn’t it?

In an online Psychology Today article, David Ropeik discussed the implications of Demon Hill. It elegantly demonstrated that “reason and rationality” only carries us so far. The Demon Hill room is tilted 20 degrees on one axis and 9 degrees on another, which you can SEE as you walk into it. But this visual information will simply not let your brain accept the truth. “It’s not an experience you can logic your way out of.” Or as Michael Landy, the neuroscientist in the video, said: it shows that people are cognitively impenetrable.

“You can know that what you are perceiving is wrong but you’ll still perceive it that way.” The real world is the product of physical and psychological processes that blends facts and feelings, intellect and instinct. When the two conflict, human perception gives the upper hand to instinct and subconscious gut reaction, not evidence-based reason.

When reason and evidence clashes with emotion and instinct, no matter how clear and compelling the evidence, we are ‘cognitively impenetrable’ to just the facts, and our brain literally denies that evidence if it conflicts with how our instincts—the subconscious part of the risk perception system that is beyond our control—make that evidence feel.

Ropeik said that Demon Hill is a warning and a challenge “to those who have naïve faith in the supreme powers of reason.” Sometimes we are “cognitively impenetrable” to evidence that conflicts with our deeper instincts. “We can’t ‘logic’ our way through life.” Or as the narrator in the video said: “Our experience of the world depends not on what is true, but on what we perceive to be true.” This is eerily similar to one of my favorite quotes of Cornelius Van Til:

The idea of brute, that is utterly uninterpreted, “fact” is the presupposition to the finding of any fact of scientific standing. A “fact” does not become a fact, according to the modern scientist’s assumptions, till it has been made a fact by the ultimate definitory power of the mind of man. (Van Til, Common Grace)

It seems modern psychology may agree with Flavel that our reason is at its most unreasonableness when we use it to judge those things that transcend its sphere and capacity.

“For my thoughts are not your thoughts, neither are your ways my ways, declares the Lord.  For as the heavens are higher than the earth, so are my ways higher than your ways and my thoughts than your thoughts”  (Isaiah 55:8-9).

We need to start our thinking, as best we can, from God’s perspective. We must seek to think His thoughts after Him.


Where There’s Smoke …

As much as 4 ½ years before the publication of the DSM-5, there was growing public criticism of the American Psychiatric Association (APA) and the process they used to develop it. The amazing thing about this criticism is that it was from within the ranks of psychiatry itself … by psychiatrists who had been in charge of previous revisions of the DSM.

In a 2008 article, Benedict Carey of the New York Times pointed out the importance of the DSM as a “medical guidebook and a cultural institution.” It is used to help doctors make diagnoses and to provide diagnostic codes to insurance companies. The National Institute of Mental Health made the use of DSM criteria a requirement for funding research. But for the first time, the APA required its DSM contributors to sign a nondisclosure agreement.

Research psychiatrist Robert Spitzer said that when he first heard about the agreement, he went “bonkers.” Spitzer said: “Transparency is necessary if the document is to have credibility, and, in time, you’re going to have people complaining all over the place that they didn’t have the opportunity to challenge anything.”

Robert Spitzer, the chair of the “landmark” third edition of the DSM, has been hailed as the rescuer or savior of psychiatry. Allen Frances, the chair of the 4th edition of the DSM said in his book, Saving Normal, that Spitzer was a rare man. “Without Robert Spitzer, psychiatry might have become increasingly irrelevant.” Even critics of modern psychiatric diagnosis, such the authors of the book Mad Science, acknowledge Spitzer’s importance to psychiatry: “Robert Spitzer was a most unlikely rescuer of American psychiatry.”

On June 26, 2009, Frances published an article in the Psychiatric Times where he identified what he saw a grave problems with the DSM-5. He also was critical of the lack of transparency. Pointing to his own efforts with the DSM-IV, he said their goal had been to ensure that everyone would understand what they were doing and how they were going about it. “There was explicit accountability for decision making on all changes.” He cautioned against the stated ambition to effect a “paradigm shift” in psychiatric diagnosis with the DSM-5.

So long as psychiatric diagnosis is stuck at its current descriptive level, there is little to be gained and much to be lost in frequently and arbitrarily changing the system. Descriptive diagnosis should remain fairly stable until, disorder by disorder, we gradually attain a more fundamental and explanatory understanding of causality.

Frances specified his concerns with the DSM-5 process, which included the following: 1) there was no scientific basis to justify a paradigm shift in psychiatric diagnosis at this time; 2) there was a failure to provide clear methodological guidelines on the level of empirical support for the changes; 3) there was a failure to be open to wide scrutiny and useful criticism; 4) there was a failure to set and meet clear timelines; there was a likelihood that time pressure would lead to an unconsidered rush on last-minute decisions.

The members of the APA working on the DSM-5, including the DSM-5 Chair, David Kupfer, responded APA to Frances on July 1, 2009. They suggested that both Spitzer and Frances were repeating “factual errors and assumptions” about the development of the DSM-5. After their refutation of the concerns expressed by Frances, they stated:

Both Dr. Frances and Dr. Spitzer have more than a personal “pride of authorship” interest in preserving the DSM-IV and its related case book and study products. Both continue to receive royalties on DSM-IV associated products. The fact that Dr. Frances was informed at the APA Annual Meeting last month that subsequent editions of his DSM-IV associated products would cease when the new edition is finalized, should be considered when evaluating his critique and its timing.

Robert Spitzer responded to the criticisms raised about Allen Frances and himself on July 2, 2009. Spitzer noted how the DSM-5 debate had taken an ugly turn, by suggesting that he and Frances were critiquing the DSM for financial reasons. He limited his comments to what he saw as the core issue of transparency. After raising a series of questions with regard to the opaqueness and “empty rhetoric” on the DSM-5 as the most open and inclusive DSM ever, Spitzer saw two possible reasons for the lack of transparency. First, the answers to his questions were known, but for some reason, the DSM leadership was withholding it; perhaps to shield themselves from criticisms. A second possibility was that the DSM-5 leadership didn’t know the answers to his questions. “Given their plan to publish DSM-V in May 2012, if the second possibility is the case, it is inconceivable that this publication deadline could realistically be met. “

Both Spitzer and Frances continued their challenges to the process of review and approval of the DSM-5 by the APA and gained more support and even some victories. You can also read a more detailed description of the dispute here. The publication of the DSM-5 was delayed until May of 2013, but the controversy merely grew. Allen Frances became one of the most vocal critics of the DSM-5, with multiple blogs and articles looking at the problems and concerns. He’s even written two books, Saving Normal and Essentials of Psychiatric Diagnosis as a result of this controversy. You can scroll through some of his articles on the Huffington Post for starters.

Oh and with regard to the veiled accusation of Spitzer and Frances criticizing the DSM-5 for financial reasons, David Kupfer, Chair of the DSM-5 Task Force, has been outed for failing to report financial interests in Adaptive Testing Technologies, a company that designs tests and implements large scale adaptive testing systems for mental health assessment. After an investigation, the APA said (Letter-to-Assembly-20140114.pdf; now removed from the APA website): “Dr. Kupfer should have disclosed to APA his interest in PAI in 2012.” However, it did not find that his interest in PAI had any influence on DSM-5’s inclusion of dimensional measures for further study in Section 3. One blogger, 1 Boring Old Man said:

It seems like Dr. Kupfer et al. are pursuing a strategy of only acknowledging this particular Conflict of Interest when forced, as in the situation with JAMA Psychiatry, and avoiding talking about it otherwise – mirrored so far by the APA President and Board of Trustees.



Back to the Future with Psychedelics

© Zhuxi1984 | Dreamstime.com - Back To The Future Photo

© Zhuxi1984 | Dreamstime.com – Back To The Future Photo

“I am 100 percent in favor of the intelligent use of drugs, and 1,000 percent against the thoughtless use of them, whether caffeine or LSD.” (Timothy Leary, in Chaos and Cyber Culture)

We’re going “back to the future” with recent research into the therapeutic benefits of hallucinogens for treating alcoholism and mood disorders. (See additional stories here and here; and a previous blog, “As Harmless as Aspirin?”) Classical hallucinogens such as LSD, mescaline or psilocybin, and dissociative anesthetics such as ketamine and PCP might be “useful” in the treatment of major depression, anxiety disorders and OCD. A recent study concluded: “There was evidence for a beneficial effect of LSD on alcohol misuse.” A single dose of LSD was found to be associated with a decrease in alcohol misuse. Another longitudinal study suggested that: “hallucinogens may promote alcohol and drug abstinence and prosocial behavior in a population with high rates of recidivism [with individuals on probation or parole].”

An issue of Current Drug Abuse Reviews (volume 6, number 1, 2013) was devoted to the investigation of psychedelics and their potential as therapeutic agents in the treatment of addiction. Several different articles suggested the therapeutic benefits of a variety of psychoactive substances—some classics and some newer ones.

Rick Doblin, in “Psychedelic-Assisted Psychotherapy for the Treatment of Addiction,” said: “There are multiple frameworks for understanding how psychedelic therapy can alleviate substance abuse.” He noted that the idea that psychedelics can be helpful in combating drug abuse conflicts with “the notion that psychedelic drug use is inherently wrong.”

Michael Bogenschutz of the University of New Mexico Health Sciences Center suggested that sacramental use of classic hallucinogens, like the Native American Church’s use of peyote, “is strongly associated with decreased alcohol and drug use.”

Lisa Jerome and others lobbied for studies that tested MDMA-assisted psychotherapy in people with an active substance use disorder. “It appears that MDMA, like classic psychedelics, may have a place in addressing substance abuse or dependence, which could be linked to its pharmacology or its psychological effects.”

Ayahuasca, a psychotropic brew prepared from an Amazonian vine and bush, may be associated with reduced substance use and “improvements in several cognitive and behavioral states.”

Thomas Kingsley Brown reported that ibogaine, a psychoactive alkaloid found in a rainforest shrub of West Central Africa, helps with withdrawal symptoms and reduces drug cravings..

A study of ayahuasca-assisted treatment for substance use problems by Gerald Thomas and others suggested that it was associated with significant improvements in several factors related to problematic substance use. While this particular study occurred in Canada, ayahuasca has been used as a remedy to help overcome drug addictions in Peru and Brazil. “Although these programs claim improved health outcomes for patients who complete them, neither has been evaluated with sufficient scientific rigor to provide definitive evidence of the success of their approaches.”

Ibogaine is not used in the US to treat addiction because of its severe side effects, which include hallucinations, bradycardia (slow heart rate), whole-body tremors and ataxia (lack of muscle control during voluntary movements). It also had cerebellar toxicity with high doses in rats. Nevertheless, it is a growing form of treatment outside the US. A subculture of ibogaine clinics has sprung up in Mexico. Read about a trip to one here.

A synthetic derivative of ibogaine, 18-MC, has been developed and is said to show promise. It resulted in “a long-lasting decrease in ethanol, morphine, cocaine, methamphetamine and nicotine self-administration [in rats], and attenuation [decrease] of opioid withdrawal symptoms.” Significantly, it is not expected to have hallucinogenic effects and does not have the negative side effects noted above with ibogaine.

In 2012 Savant HWP, a privately-owned pharmaceutical company in California, received a three-year grant from the National Institute on Drug Abuse (NIDA) for the pre-clinical development of 18-MC. Stanley Glick, the scientific founder of Savant and a long time researcher with ibogaine, said: “18-MC is likely to be the first of a new generation of agents effective against a broad spectrum of addictions—from hard drugs such as heroin and cocaine, to alcohol, nicotine and even sugary, high-fat foods, possibly reducing obesity rates.” On September 23rd of 2014 Savant announced they had begun human safety clinical trials on 18-MC. “Savant HWP plans to develop 18-MC as a treatment for many forms of addiction and compulsive behavior, with an initial focus on cocaine and opiate dependencies.”

The so-called “psychedelic treatment” approach, based on the original work of Humpry Osmond, uses pre and post therapeutic sessions and one large dose of your hallucinogen-of-choice (LSD, ayahuasca, psilocybin, mescaline). The spiritual, therapeutic goal is captured here by Aldous Huxley’s description of his experience with mescaline in The Doors of Perception:

The man who comes back through the Door in the Wall will never be quite the same as the man who went out. He will be wiser but less cocksure, happier but less self-satisfied, humbler in acknowledging his ignorance yet better equipped to understand the relationship of words to things, of systematic reasoning to the unfathomable Mystery which it tries, forever vainly, to comprehend.

But we should remember the warnings of Albert Hofmann, the inventor of LSD, who cautioned not to underestimate the potential negative consequences of a deliberate provocation of mystical experiences with hallucinogens like LSD. “Wrong and inappropriate use has caused LSD to become my problem child.” In the “LSD state” the boundaries between the self and the outer world effectively disappear. “A portion of the self overflows into the outer world. . . . This can be perceived as a bless[ing], or as a demonic transformation imbued with terror.”


Lead Us Through Temptation

We shall never know what strength there is in grace if we know not what strength there is in temptation. We must be tried, that we may be made sensible of being preserved. (John Owen)

Although John Owen published Temptation in 1658, it continues to speak today with clarity into the nature of temptation, what it means to enter into temptation, and how to prevent it.  Each of these three facets of his work were built around the caution given by Jesus to his disciples in the Garden of Gethsemane: “Watch and pray that you may not enter into temptation”  (Matthew 26:41). Owen’s first task was to lay out the general nature of temptation and tempting, leaving the special nature of how it denotes evil for another chapter of his book.

Temptation, then, in general, is any thing, state, way, or condition that, upon any account whatever, hath a force or efficacy to seduce, to draw the mind and heart of a man from its obedience, which God requires of him, into any sin, in any degree of it whatever.

Whatever causes or provides an opportunity for us to sin is temptation. It is anything that distracts us from our duty or diverts us from communion with God. It will seek to thwart the obedience required of us by either bringing evil into our hearts, or drawing out the evil that indwells there.  Anything within or outside us that has the ability to hinder our duty or provoke the occasion to sin is temptation. An exquisite portrayal of this reality lies within the pages of C.S. Lewis’s classic, The Screwtape Letters.

Be it business, employment, course of life, company, affections, nature, or corrupt design, relations, delights, name, reputation, esteem, abilities, parts or excellencies of body or mind, place, dignity, art,—so far as they further or occasion the promotion of the ends before mentioned, they are all of them no less truly temptations than the most violent solicitations of Satan or allurements of the world, and that soul lies at the brink of ruin who discerns it not.

In this general sense, temptation is neutral. Owen likens it to a knife that can either cut meat of the throat of someone. “It may be his food or his poison, his exercise or his destruction.” And God uses it to try or prove us. First, He uses it to show us what lies within us. He tempted Abraham to show him his faith. Owen said Abraham did not know the power and vigor of his faith until God drew it out of him.

God also tempts us to show himself to us. We discover that God alone keeps us from sin. “Until we are tempted, we think we live on our own strength.” Although anyone else may sin in a particular manner, we will not. And when the trial comes, we quickly see what our defense is by whether we stand or fall. Remember how Paul said in Romans 7:18, “For I know that nothing good dwells in me, that is my flesh.” According to Owen, we must be tried so that we may realize how we are being preserved.

Many times I have talked with Christians who see the wreckage of their lives from active intentional patterns of sin in their lives. They often have great difficulty seeing past the broken relationships; the wasted years; the hurt they did to others. What I try to do is to get them to see, without excusing or diminishing the serious and consequences of their sin, is that despite all that they have done, God still chose them. For by grace they were save through faith. We cannot know the strength of grace without knowing the power of temptation.

I knew a man who came to Christ after his toddler son drowned in a swimming pool accident.  He was in early recovery and instead of picking up drugs he picked up salvation. He had a tattoo on his forearm that said “Li’l Devil” and from what I heard him say he really was when he was an active drug user. He used to talk about how he LOVEDD to get high. God eventually took him through the complication of liver failure due to Hepatitis C. He’d not used drugs since before coming to Christ.

I knew a man who’s surname was Grace—he was well-named. He kept the return of his cancer secret because he needed to care for his wife who had her own health problems. At her funeral it came out that his cancer had returned. He lost his arm and eventually his life to cancer. But he was one of the best examples of a husband and a man of God that I was privileged to know.

I know a couple whose faith and marriage has been tried by what Owen called “an active efficiency towards sinning.” God used sinful circumstances to turn their lives and family upside down. Yet they arose with a stronger, deeper marriage and relationship with Christ. And they wouldn’t trade what they’ve been through if it meant they couldn’t be guaranteed the same deepening of their marriage and their faith.

Owen would point to these people and say that God accomplished their trial or temptation by putting upon them great sufferings. “Our temptations arise from the ‘fiery trial;’ and yet the end is but a trial of faith.” Oh Lord, lead us through temptation. Help us to know you better and deeper. That we may clearly see the beauty of salvation and the strength that is in your grace.

A digital copy of Owen’s work, Of Temptation, is available here.


Is a Gram Better than a Damn?

Stockfresh Image by leedsn

Stockfresh Image by leedsn

I first became aware of dietary supplements such as DMAA a few years ago. I was meeting with an individual at an outpatient drug treatment center to work out how his urine test came up positive for stimulants when he insisted he hadn’t taken any. It turns out he had been encouraged by a friend to try a pre-workout dietary supplement, “Jack3d,” that was supposed to improve his workout. The market has exploded since then with various analog stimulants being sold as “smart drugs” or brain enhancers, as well as bodybuilding, athletic and weight-loss enhancers.

Andrew Seaman on Yahoo News reported on a joint announcement from Harvard Medical School and two public health organizations of a study they conducted that found the stimulant DMBA in multiple dietary supplements. DMBA is an analog of the synthetic stimulant DMMA. In April of 2013, the FDA issued a warning that DMMA was associated with serious illness and even death. The FDA even went as far as saying to companies known to use DMAA in dietary supplements that products containing DMAA were illegal.

Compared to its authority over drugs and other medical products, the FDA has limited authority over dietary supplements. It is required to undertake lengthy scientific studies and complex legal steps to force the removal of dietary supplements that may be unsafe or illegal—IF the company refuses to remove the products voluntarily. The issued warnings are typically complied with. After the FDA’s warning about DMAA, all but one of the 11 companies stopped making and selling products containing DMAA. The one company who didn’t was the company making Jack3D.

The new concern is for DMBA, allegedly a natural product “extracted from pouching tea.”  Look at the above link for “a joint announcement” to see how similar the chemical structures of DMAA and DBMA are. Following the release of the above noted study, two U.S. senators called on the FDA to inspect products containing DMBA:

Given FDA’s existing authority, your agency should immediately launch an investigation of products containing these untested stimulants and issue warning letters to manufacturers demanding that they provide the necessary safety information. If necessary, we urge you to exercise the full range of your authority to rein in adulterated and misbranded products, which includes warning letters to facility inspections, product seizures, injunctions, and criminal prosecutions.

The problems with synthetic, analog drugs and dietary supplements are now a global concern. See other articles on Faith Seeking Understanding that address the explosion of new psychoactive substances (NPS). The analog chemical market has expanded to include so-called “smart drugs” or nootropics such as: Alleradd, Modfanil, Nuvigil, New Mood or Alpha Brain. You can find information on several different smart drugs here on the website Erowid.

Alleradd is clearly meant as a substitute for the prescription ADHD medication Adderall. As Paul Gaita noted in his article, “Brain Boosting ‘Smart Drugs’ on the Rise,” like the makers of NPS, “many smart drug manufacturers sidestep government intervention by either labeling their substance’s compounds as ‘not for human consumption’ or listing the ingredients under different brand names.” By the way, Alleradd seems to have been rebranded as OptiMind. These substances are even available on Amazon. Prescription medications beyond ADHD medications are also being used off label for increased cognitive functioning and academic performance.

Modafinil (also known by the brand name of Provigil) was approved by the FDA as a treatment for narcolepsy and other sleep disorders. But it is reported to be used by 1 in 5 students to enhance their academic performance. An estimated 90 percent of Modafinil’s users take it to increase attention, wakefulness and cognitive functioning. Armodafinil (Nuvigil) is a close cousin to Modafinil that reportedly has some benefits over Modafinil in promoting wakefulness. Airline pilots, medical personnel and others are taking  them. More information on Modafinil and Armodafinil is available on Erowid.

A new study published in PLOS One suggests that the reported cognitive enhancement of Modafinil doesn’t work with everyone. And when it does, it only helps people who are not creative.

Our study backs up previous research that suggests psychostimulants improve people at the lower end of the spectrum in cognition, whereas they impair people who are at the optimum level of cognitive function — healthy people for example.

It seems that we are increasingly moving towards a society like that portrayed in Aldous Huxley’s novel, Brave New World. The phrase “a gramme is better than a damn” in the book stood for the belief that the greatest good for the greatest number of people was to minimize any negative emotions or feelings. The question we face as we continue to move inexorably closer to a “better living through chemicals” world is this: is a gram of the drug promising to make us smarter, skinnier, or more focused worth it?


Growing Out of Alcoholism

While driving home, I caught the end of an NPR program, “This American Life,” with Ira Glass. I later learned the feature I was listening to was the third segment of a program they titled “The Leap.” The interview was of a woman, Tina, who came into Alcoholics Anonymous (A.A.) at the age of 13. As an adult, she began to question whether or not she was truly an alcoholic, decided she wasn’t, and now drinks socially. Still not really intrigued? Her story of getting sober at 13 is in the A.A. pamphlet, “Young People and A.A.”

So what about Tina? How did she grow out of alcoholism; or are we waiting for the “yet”—the inevitable slide back into drinking alcoholically? The above link for “The Leap” will take you to a page to either listen to the broadcast or read a transcript of the program. Tina’s segment, “The Wisdom to Know the Difference,” is the third of three in the broadcast and transcript.

For twenty years of her life she didn’t question that she was an “alcoholic.” Then she began to wonder what would happen if she drank. “Asking herself, should I take a drink, was basically asking, should I turn my back on what I believed about myself for 20 years?”

As a child, Tina’s parents had been part of The Children of God, a cult or “new religious movement.” In what seems to have been normal for members at the time, they moved around a lot—four different countries before she was three years old. Her life with The Children of God would have been full of dysfunction, abuse and trauma. This is speculation on my part from easily obtained information on The Children of God, especially the stories of former cult members.  She would have been primed to become a preteen who turned to alcohol and drugs.

She was eventually sent to a girl’s group home, where she lived until she graduated from high school. It was while she was there that she began attending A.A. meetings. She became a popular A.A. speaker—“the girl who got sober when she was 13, and could tell the hell out of her story.” By the time she was 33, Tina had been married for several years. She was a columnist and political commentator, “a long way from the miserable, angry girl she’d been who dropped out of school and spent her time drinking and smoking pot with the older kids.”

So when she began to wonder if she could drink alcohol socially, she talked it over with her husband, who was supportive of whatever she decided. She discovered that she could drink socially, and now believes that: “I’m not an alcoholic. Not by any measure.”  No personality changes from drinking; no gradual increase in how much she drinks.

So how does a non-alcoholic child come to believe that she’s an alcoholic? Tina makes sense of what happened to her this way. She went to her first A.A. meeting for something to do. While she was there, she found she could relate to what other people at the meeting said. They had been rejected by family too. They had felt trapped and furious and desperate too. People told her they used to be exactly like her.

There was no other way of explaining at the time. And it wasn’t until, I mean, this is very recently, there was no way for me to figure out why I kept on getting locked up. Why I kept on being sent away. Why my mother was fuming at me.

If she was an alcoholic, she could make sense of her life—and she could fix the problem. A.A. gave her a new life, with goals, discipline, a belief system. And most importantly, people to relate to when things were bad or when they were good.

It’s really liberating to find your people. To find people who you relate to. To find people that ask you to come back. And that was what I experienced. I didn’t have people asking me to come back. . . . And being able to feel true happiness, just feeling like I was OK, and there was no crisis, that was what I learned in Alcoholics Anonymous. That is the irony, right? I’m not an alcoholic, but my life was saved by AA.

Tina’s story illustrates the elasticity of terms like “addict” and “alcoholic.” In one sense it also challenges the sense of the saying, “Once an alcoholic, always an alcoholic.” But it doesn’t negate the validity of 12-Step recovery organizations like A.A. Here’s why I think so. What Tina really grew out of was her addictive behavior.

The addiction researcher Carlton Erickson doesn’t like the terms “addiction” or “alcoholism.” He said in his book, The Science of Addiction, that they aren’t scientific. They are too broad, too vague and too easily misunderstood. He said he prefers the terms alcohol dependence or drug dependence, saying they are closer to what scientists mean when the terms alcoholism or addiction are used by nonscientists. Similarly, he prefers the term drug misuse to drug abuse, “because it more clearly places the responsibility for drug use on the person.”

Erickson’s distinctions become important when we turn to how drug users are diagnosed within the DSM, the Diagnostic and Statistical Manual of Mental Disorders. Well, that is how they were diagnosed within the fourth edition of the DSM, when there was substance (or drug) abuse and substance (or drug) dependence. The current edition of the DSM, the fifth, has a continuum of substance use disorders, which confusingly combines two distinct types of substance use problems into one continuum.

Drug abuse (or misuse) is the intentional overuse of drugs “in cases of poor judgment, self-medication, overcelebration, and other situations where drugs can be harmful or illegal.” Drug dependence is “compulsive, pathological, impaired control over drug use, leading to an inability to stop using drugs in spite of adverse consequences.” Erickson then said:

Anyone who has a drinking problem and who wants to stop is welcomed into their group [A.A.] and declares, “I’m an alcoholic.” There is no formal distinction between “abusers” and “dependents” in community A.A. meetings. . . . A proper diagnosis is not important when people are trying to find a way to stop drinking. If successful, they are much better off than before they worked the fellowship program” (p. 20).

An individual like Tina can use A.A. to stop abusing alcohol, as described by Erickson, and then turn her life around. She would identify as an “alcoholic” during the time she was an active member of A.A. But, applying A.A.’s Third Tradition (which says you are a member of A.A. if you say you are), if she no longer had the desire to stop drinking, if she does not see herself as a member of A.A., then in that sense, she’s no longer an alcoholic. Diagnostically, it would seem she was an alcohol abuser who grew out of the need to self-medicate because of the dysfunction of her early life.



Humility Through Anonymity

Stockfresh image by tashatuvango

Stockfresh image by tashatuvango

“We live in a world where anonymity is the key to keeping yourself.” (Quotes About Anonymity, Dominic Riccitello)

Matthew 6:16 -18 applies the principle of anonymity to fasting, the third and final aspect of personal piety discussed in this passage of the Sermon on the Mount. As with the first two (almsgiving and prayer), fasting was supposed to be done anonymously. But as D. A. Carson pointed out, what began as spiritual self-discipline, was eventually prostituted into pompous self-righteousness. “What was once a sign of humiliation became a sign of self-righteous self-display.” So Jesus is saying here that if you made a public show of your fasting, then you have all the reward you are going to get. It wasn’t a true act of piety.

And when you fast, do not look gloomy like the hypocrites, for they disfigure their faces that their fasting may be seen by others. Truly, I say to you, they have received their reward. But when you fast, anoint your head and wash your face, that your fasting may not be seen by others but by your Father who is in secret. And your Father who sees in secret will reward you. (Matthew 6:16-18)

A self-righteous day of fasting at that time meant you would intentionally neglect your appearance. But this was more than just a bad hair day. Your hair wasn’t to be brushed or combed; your face wasn’t to be washed—you get the picture. And by doing this, EVERYONE WOULD KNOW WHAT YOU WERE DOING—without having to say a word. The look on your face and the way you were dressed was enough to let everyone know how “spiritual” you were by fasting that day. This kind of false humility can be found in a wide variety of human activities.

D. A. Carson observed: “Almost anything that is supposed to serve as an outward sign of an inward attitude can be cheapened by this hypocritical piety.” The truth of Carson’s observation has been embodied within the Eleventh Tradition of Alcoholics Anonymous (A.A.): “Our public relations policy is based on attraction rather than promotion; we need always maintain personal anonymity at the level of press, radio, and films.” Personal anonymity meant that A.A. was saying, “It wished to publicize its principles and its work, but not its individual members.”

Bill W. observed that A.A.’s Eleventh Tradition was much more than a sound public relations policy or an institutional denial of self-seeking. It was “a constant and practical reminder that personal ambition has no place in A.A.” Anonymity is further embedded in A.A. within their Twelfth Tradition: “Anonymity is the spiritual foundation of our traditions, ever reminding us to place principles before personalities.”

Here again is the foundation of what Jesus was teaching in Matthew 6 on anonymity: Do not mix self-promotion with personal piety or spirituality. D. A. Carson voiced a helpful question for individuals who think they may be doing just that:

Who am I trying to please by my religious practices? Honest reflection on that question can produce most disquieting results. If it does, then a large part of the solution is to start practicing piety in the secret intimacy of the Lord’s presence.

Again, Bill W. captured this truth in the opening statement to his essay on the Twelfth Step: “The spiritual substance of anonymity is sacrifice.” Bill went on to describe how A.A. learned that “anonymity is real humility at work.” Moved by the spirit of anonymity, its members try to give up their natural desire for distinction both within A.A. and before the general public. “We are sure that humility, expressed by anonymity, is the greatest safeguard that Alcoholics Anonymous can ever have.”

Humility is a safeguard for the church as well as A.A. Jonathan Edwards said that humility prepares the mind for divine light, clears the eye to look at things as they truly are, and keeps believers out of the devil’s reach. Another Puritan, Thomas Brooks said: “God delights most to dwell with the humble, for they do most prize and best improve his precious presence.” Remember that your Father who sees in secret will reward you.

And finally, we of Alcoholics Anonymous [and the church of Christ] believe that the principle of anonymity has an immense spiritual significance. It reminds us that we are to place principles before personalities; that we are actually to practice a genuine humility. This to the end that our great blessings may never spoil us; that we shall forever live in thankful contemplation of Him who presides over us all (the long form of Tradition Twelve).

This series is dedicated to the memory of Audrey Conn, whose questions reminded me of my intention in seminary to look at the various ways the Sermon on the Mount applies to Alcoholics Anonymous and recovery. If you’re interested in more, look under the category link “Sermon on the Mount.”



Hepatitis Hostages

Stockfresh image by stokkete

Stockfresh image by stokkete

In September of 2014, Gilead Sciences announced a deal with seven Indian drug companies to produce less expensive generics for their blockbuster Hepatitis C drug, Sovaldi. Gregg Alton, an executive vice-president for Gilead said: “This announcement is a game-changer. . . . The great thing is we are making this medication available to millions of people around the world.” Alton also said: “Gilead is working to make its chronic Hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible.” The medication could be on the market in India by the third quarter of 2015. The licensing deal will cover 91 countries, which have an estimated 100 million people living with Hepatitis C. But the cost to Americans and the profits to Gilead for Sovaldi are through the roof.

Through the third quarter of 2014, Gilead has made $8.6 billion in profit from Sovaldi (see info here, here, and here.)—most of it from American sources. It is on schedule to exceed $10 billion in sales for 2014. This is largely because of the extreme cost differential of Sovaldi to Americans. The charge to US patients is $1,000 per pill; $84,000 for a full 12-week course of treatment with the drug. In June of 2014, Forbes contributor Robert Glatter reported that Gilead was offering Sovaldi at a 99% discount to countries like Egypt and India. The production cost for Sovaldi is somewhere between $130 and $150 per pill. Gardiner Harris of the New York Times reported that Gilead will introduce the drug in India for around $10 per pill.

Rohit Malpani, of Doctors Without Borders, observed that: “Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 percent of people with hepatitis C live today.” Gregg Alton said that Gilead would provide middle-income countries with discounted prices for Sovaldi. “Pricing for Thailand, Mexico or Brazil will be very different than the U.S. price.”

As early as the spring of 2014, concern was that the cost of Sovaldi in the U.S. would lead to a huge rise in healthcare costs. There are over 3 million potential customers with Hepatitis C in the U.S. PharmExec.com reported in April that a large insurer, United Health Group, reported a decline in its first-quarter earnings, in part because it spent more than $100 million on hepatitis C treatments. In July, the Senate Finance Committee informed Gilead it was launching an investigation into the pricing of Sovaldi.

Given the impact Sovaldi’s cost will have on Medicare, Medicaid and other federal spending, we need a better understanding of how your company arrived at the price for this drug.

Gilead defends the price, citing the eventual cost savings over time. “The value of a cure … is underestimated in terms of the overall advantage that the health care system receives from it.” Yet some organizations are suggesting that treatment be withheld until the condition is more serious. The problem with that is determining how far Hepatitis C has progressed can be difficult. And there is evidence that early treatment means there is a better chance of curing Hepatitis C. Also, early treatment can avoid damage to the liver from the virus.

Withholding treatment is already a reality in the California prison system. The chief pharmacy officer of San Francisco’s Public Health Department said that if they used their entire drug budget for the year, they could only treat 24 or 26 of the 108 inmates estimated to be infected with Hepatitis C.  “It’s crazy. It’s just insane. And that’s where this whole conversation about price becomes important, because at what cost?” Nationwide, at least 500,000 inmates have chronic Hepatitis C. The net costs of their treatment alone could exceed $30 billion.

Now Gilead Science has had a new treatment for Hepatitis C approved—Harvoni. It is a combination of Solvadi and the NS5A inhibitor ledispasvir. Harvoni is “the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.” The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation because of its potential to offer a major advance in treatment over available therapies. Nezam Afdhal, a principle investigator in the Harvoni trials said: “For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks.”

The cost of Harvoni will be $94,500 for a full 12-week course of treatment. But that is roughly in line with the previous cost of Sovaldi and the drugs used with it. “Many patients should be able to take Harvoni for only eight weeks, at a cost of about $63,000.” The shorter time period can be considered for treatment-naïve patients without cirrhosis.

But the cost is still too high for many insurance companies and Medicaid programs, who are restricting the use of Sovaldi to the most seriously ill patients. Some are requiring patients to demonstrate they have not abused alcohol or illicit drugs for a number of months or limiting the treatment to “once-in-a lifetime.” Dr. Steven Miller, the chief medical officer of Express Scripts, which manages pharmacy benefits for employers and insurance companies, said: “Their budgets just are not going to be able to tolerate it.”

The small population argument justifying a high cost of drug treatment (to motivate the drug’s development) like that used for drugs like Acthar and Soliris doesn’t apply to Sovaldi and Harvoni. If every American with Hepatitis C was treated with Sovaldi, the cost would be $250 BILLION! Treating everyone on the planet would cost $14.28 TRILLION. “To put those numbers in perspective, the U.S. spent about $381 billion on prescribed medicine last year.” Gilead defended the cost of the medicine, saying: We believe the price of Harvoni reflects the value of the medicine.” The Motley Fool suggested that Harvoni could generate as much as $12 billion in its first full year on the market.

Even when factoring in the negative impacts of competition, shortened treatment durations, and the need for additional approvals, Harvoni should still double the marijuana industry’s 2018 revenue forecast by this time next year.

Gilead Sciences announced its third quarter financial results for 2014. Gilead’s total revenues for nine months ending on September 30th was $17.25 billion. This compared to $7.76 billion for the same period in 2013. $7.33 billion of the $8.6 billion in sales of Sovaldi for 2014 was made in the U.S. market.

Plain and simply, the American health care system and Americans with Hepatitis C are being held hostage by Gilead Sciences. In their pursuit of record-breaking profits from Sovaldi and Harvoni, Gilead is creating a health care crisis by refusing to negotiate a more reasonable cost to Americans. See my previous articles, “Is There No Balm in Gilead?” and I Guess I’m a Little Bit Socialist,” for more on Gilead Sciences and Sovaldi.