07/31/15

A Common Spiritual Path

© Weldon Schloneger | 123RF.com

© Weldon Schloneger | 123RF.com

A self-identification as having no religious affiliation was the big news in a study by the Pew Research Center, the 2014 U.S. Religious Landscape Survey. “The number of religiously unaffiliated adults has increased by roughly 19 million since 2007.” Those individuals who are religiously unaffiliated generally are less religiously active, but many believe in God and even pray on occasion. According to the Religious Landscape Survey, “Many people who are unaffiliated with a religion believe in God, pray at least occasionally and think of themselves as spiritual people.”

This spiritual, but not religious group of individuals—those indicating that they have no particular religious affiliation, reported as “nothing in particular” in the survey—are the third largest “religious” group in the U.S. behind Evangelical Protestants (25.4%) and Catholics (20.8%); Nothing in particulars (15.8%). So there is a large group of Americans who are not atheists or agnostics; nor are they religious. I wouldn’t be surprised if a significant percentage of this group were active within 12 Step groups like Alcoholics Anonymous.

For a number of years I have been struck by the fact that there are both religious and nonreligious individuals who are critical of the presumed religiosity of Alcoholics Anonymous (A.A.). Nonreligious critics see it as too religious; religious ones believe it isn’t religious enough. Ironically, A.A. and other Twelve Step recovery programs modeled after it consistently claim they not religious at all.

Historical, religious influences upon A.A. are readily acknowledged by the organization, as are its nonreligious influences. Somewhere in the mix is the claim that it is a spiritual, but not religious program—a claim that is too often dismissed by its critics without an understanding of its origins and meaning. At the center of this debate are the Twelve Steps themselves, whose treatment of God is the flashpoint for both sides.

A.A. was founded in 1935, in the midst of a full social and cultural retreat away from the influence of Christian religious belief on American life. Doctrine, dogma and creeds were found to be increasingly irrelevant after the so-called Scopes Monkey Trial of 1925. In the Scopes Trial, a high school biology teacher named John Scopes was found guilty of violating Tennessee’s Butler Act, which made it unlawful to teach evolution. The trial pitted modernists, who saw Christian religion as consistent with evolution, against fundamentalists who believed that evolution was contrary to Scripture and Christian belief and therefore should not be taught in public schools.

In many ways, the issues debated in the Scopes trial now haunt the dispute over A.A. and the Twelve Steps. And it seems these concerns can be articulated within three basic questions. First, is there a place for God in the practice of addiction recovery? Second, is Twelve Step recovery consistent with the Christian religion? Third, should Christians holding to the importance of the Bible as the rule for faith and life participate in Twelve Step recovery programs?

Many individuals have answered the first question with a resounding “No!” and organized intentionally nonreligious support groups such as: Rational Recovery, SMART Recovery, Secular Organizations for Sobriety, and Women for Sobriety. On the other hand, many Christians believe there is a place for God in recovery. But they question if Twelve Step recovery is consistent with Scripture and feel that Christians should be cautious about participating in groups that do not explicitly affirm that Jesus is Lord. So they organized faith-based support groups that reach out to the still-suffering addict and alcoholic from a self consciously Christian perspective. Some of these include: Alcoholics for Christ, Alcoholics Victorious, Celebrate Recovery, Christians in Recovery, and Overcomers Outreach. Then there are the Twelve Step-based groups that answer “yes” to all three questions: Alcoholics Anonymous, Narcotics Anonymous, Cocaine Anonymous, Marijuana Anonymous, Gamblers Anonymous, Emotions Anonymous, Sex Addicts Anonymous, Overeaters Anonymous, Clutterers Anonymous, and many more.

My own answers to these three questions would be nuanced. With regards to the first question, is there a place for God in addiction recovery, I would answer with a resounding “Yes”! I’d also reject the charge that such an affirmation makes Twelve Step addiction recovery inherently religious. The supposed religiosity of the Twelve Steps rests upon the premise that any belief in a Supreme, Transcendent Being is inherently religious. A.A., which originated the Twelve Steps, held that belief in some sort of God was normal. The A.A. Big Book said: “Deep down in every man, woman, and child, is the fundamental idea of God.” Twelve Step recovery believes that a religion takes this fundamental belief in God and the rituals that accompany it, and then institutionalizes them. See “What Does Religious Mean?,” “Spiritual, Not Religious Experience,”  and “The God of the Preachers” for more on these distinctions.

With regard to the second question, is Christianity consistent with the Twelve Steps, I would say it is and it isn’t. There are many parallels between Christianity and Twelve Step recovery. Yet Biblical Christianity makes an explicit claim that Jesus Christ alone is the way to God: “I am the way, the truth, and the life. No one comes to the Father except through me” (John 14:7). When Christians hold that these words are infallible, that along with all the remaining words of the Bible they are the very breath of God, then compromising them as A.A. does is considered to be a serious break with orthodox Christian belief.

Lastly, I would say that Bible believing Christians can and should participate in non-Christian Twelve Step groups. But I would add that this participation is not a substitute for their fellowship with other members of the body of Christ. Christian faith matures within the context of fellowship with other Christians. Members of A.A. know this is true for alcoholics as well. Recovery matures within the context of fellowship with other recovering alcoholics. Sadly, Christian fellowship alone is often not vibrant enough for addicts and alcoholics to establish and then maintain their abstinence and sobriety. Their recovery can be strengthened within the fellowship of Twelve Step-based groups.

I plan to use the book of Romans as the anchor point for a series of articles that will illustrate how there is a common spiritual path upon which Christians and individuals can travel together—at least for part of their journeys. So there are two primary audiences to whom this series of articles is written: bible-believing Christians who find participation in Twelve Step groups helpful and even necessary for their recovery, and members of Twelve Step groups who desire to grow spiritually within the context of Christian fellowship.

I hope to demonstrate to both groups that they can do so without fear of compromising either their Christian faith or their recovery. Religious critics of A.A. can also gain an understanding of what is meant by its claim to be a spiritual, but not religious program. And perhaps soften their opposition to Christians participating in Twelve Step recovery. There is a richness and depth to the compatibility of Twelve Step recovery and Scripture that proceeds from the deep structure of Scripture.

But the concerns that will be addressed here are not just those encountered by Christians involved in self-help groups based upon the Twelve Steps. Increasingly, Western culture itself has become “spiritual, but not religious” in a way that builds upon the view of religion and spirituality found in the Twelve Steps. I think the 2014 U.S. Religious Landscape Survey illustrates this. Americans in particular have historically had diverse opinions on what it means to be “one nation under God” that fits with the idea being spiritual but not religious. Self-defined higher powers and the subjective experience of transcendence articulated in the writings of William James have become a basis for the spirituality of millions of individuals.

The same religious and theological challenges encountered as we journey along the path of recovery through the book of Romans occur repeatedly when discussing the relevance of Christianity to the lives of the millions of spiritual, not religious individuals who sit beside us on planes and in coffee shops; who live in our neighborhoods; who commute to work with us; and who even sit in the church pews beside us on Sunday.

If you’re interested, more articles from this series can be found under the link for “The Romans Road of Recovery.” “A Common Spiritual Path” (01) and “The Romans Road of Recovery” (02) will introduce this series of articles. If you began by reading one that came from the middle or the end of the series, try reading them before reading others. Follow the numerical listing of the articles (i.e., 01, 02, etc.), if you want to read them in the order they were originally written. This article is “01,” the first one Enjoy.

07/29/15

Pharma Goes to Court

© Satori | 123RF.com

© Satori | 123RF.com

Okay, stay with me on this one. I want to talk about some jousting going on in the court system between Pharma and regulatory agencies, like the FDA. Amarin Corporation is suing the FDA, saying that the FDA violated its first amendment rights to free speech. The company argued that it has “a constitutional right to share certain information about its products with doctors.” Lawyers for the company believed this was the first time a manufacturer has sued the agency before the FDA ruled against them. The future “blockbuster” at the center of this fight is an omega-3 fatty acid product derived from fish called Vascepa. That’s right prescription strength fish oil.

As a matter of fact, according to Katie Thomas of The New York Times, Vascepa is the only existing product for Amarin. The FDA approved Vascepa for patients with extremely high levels of triglycerides, which are linked to heart disease. When the company sought to expand the drug’s approved reach to individuals with severe levels of triglycerides, the FDA denied its request. Lawyers for the company claim the company is not trying to market Vascepa to a wider population of patients than it was approved for, which is illegal. Amarin merely wants to make statements about its product that manufacturers of fish-oil supplements make—namely that there is “supportive but not conclusive research” that shows fish oil products like Vascepa may reduce the risk of coronary hear disease.

A lawyer for Amarin pointed out where doctors are already prescribing Vascepa off-label, which is legal for doctors to do once the FDA approves a drug for any purpose. “Those doctors who are already prescribing off-label need more information, not less, about what their treatment options are.” John Sullivan said on Drug and Device Law, that the content of Amarin’s supporting brief was convincing. In addition to the “truthful, non-misleading statements it wants to provide to healthcare workers, it wants to provide the results of its ANCHOR clinical trial and other peer-reviewed articles on the connection between the active ingredient in Vascepa and coronary risk.

But is all this legal dancing around just about the right of a relatively small biopharmaceutical company to make the same claims about its prescription drug that dietary supplement companies can make about their fish oil products?

Toni Clarke, writing for Reuters, noted where drug companies have been increasing their efforts to pressure the FDA to relax its guidelines since a 2012 decision  (2-1) from the Second Court of Appeals overturned the conviction of a sales representative for Orphan Medical, who was caught talking to physicians about off-label uses for the narcolepsy drug, Xyrem. The court said truthful and non-misleading off-label “speech” was protected by the First Amendment. “Pharmaceutical companies are citing the Caronia and similar rulings to pressure the FDA to let them talk more freely about off-label use.”

A coalition of pharmaceutical companies known as the Medical Information Working Group has petitioned the FDA to “’adequately justify and appropriately tailor its regulatory regime in light of Caronia and similar rulings.” This coalition includes Pfizer, Sanofi, Novartis AG, Johnson & Johnson, Eli Lily and Co., GlaxoSmithKline, Purdue Pharma, and Bayer Healthcare Pharaceuticals. What’s at stake is the right of manufacturers to attempt to persuade physicians to use their products for unapproved uses. This would be a potentially serious weakening of the FDA’s regulatory authority. Oh, and it could mean billions of dollars in potential sales for Pharma.

The FDA sent a letter to Amarin, essentially saying that it did not have concerns with most of the information Amarin proposed to communicate to doctors. The FDA pointed to existing guidance documents that indicated Amarin could distribute the results of its ANCHOR clinical trial results through peer-reviewed articles. Further, it said Amarin could communicate summaries of those trail results, but not in marketing materials or through sales reps.

Then on June 23, 2015, the FDA filed its brief in response to Amarin’s Motion for Preliminary Injunction. The brief called the lawsuit a frontal assault on the framework for new drug approval, rather than a narrower as-applied constitutional challenge. Lisa Baird, writing for ReedSmith, further noted where the FDA felt that if successful, the Amarin litigation “has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

At the heart of the matter is the distinction made by the FDA between drugs and dietary supplements. The FDA brief noted that Amarin ignored “the critical reality that drugs present markedly different considerations from dietary supplements.” After citing several legal rulings in support of this claim, the FDA said that Amarin wanted to market Vascepa as a drug intended to treat patients who are already being treated with statins, but continue to be at risk for cardiovascular disease. “Yet, FDA has found on multiple occasions that the heart disease claim did not meet the statutory standard of significant scientific agreement as the claim is based on ‘less persuasive studies.’” The potential harm posed by drugs is presumably much greater than that posed by dietary supplements.

These considerations amply justify a more cautious approach to drug approval and promotion, and the applicable statutory scheme recognizes this necessity. Unlike drugs, there is no statutory requirement of premarket approval for dietary supplements to be distributed. See 21 U.S.C. § 301 et seq. In addition, as a result of Pearson, claims about dietary supplements are held to a much lower standard (credible evidence) than the robust evidentiary requirement for drugs (substantial evidence) or the intermediate standard that FDA applies to reprints. See 21 U.S.C. § 355(d) & (e); Woodcock Decl. ¶¶ 31-32. Unlike for drug claims, qualified health claims “can be made [for dietary supplements and foods] under some circumstances even when the weight of the scientific evidence is against the claim, provided there is some credible evidence supporting it.” Woodcock D ecl. ¶ 33. Indeed, the June 5 Letter advised Amarin that if it “were to repackage and re-label [its] product as a dietary supplement” and ensure that other relevant conditions were met, “FDA would not object to your inclusion on that dietary supplement of the” heart disease claim. June 5 Letter at 10. Plaintiffs thus conflate two separate regulatory regimes and seek to make Amarin subject only to the aspects of each regime that it finds convenient—an approach that is unsupported by law and contrary to logic and sound public health policy.

This is an important and potentially a serious game changer in FDA attempts to protect the public from the growing evidence of the harmful marketing tactics of Pharma. This jousting between Amarin and the FDA is taking place in the context of the recent approval of “The 21st Century Cures Act,” which was unanimously approved by the House Energy and Commerce Committee on May 21, 2015. Toni Clarke reported that language in the bill adds pressure on the FDA to relax its guidelines.

Allen Frances, in his book Saving Normal, published a chart that he called the drug company “hall of shame.” Prepared by Melissa Raven, PhD, it listed the fines and settlements by Pharma companies for off-label promotion, marketing and fraudulent misbranding of 20 well know pharmaceuticals. Most of the companies noted above who are part of the Medical information Working Group were listed there. Here are the companies and their total fines and settlements between 2004 and 2012 recorded in the table in Saving Normal. The fines and settlements combine both civil and criminal cases. Johnson & Johnson ($1.44 billion); GlaxoSmithKline ($3 billion); Abbott ($1.5 billion); Novartis ($422.5 million); Forrest ($313 million); AstraZeneca ($520 million); Pfizer ($2.3 billion); Eli Lily ($1.415 billion); Bristol-Myers Squibb ($515 million); Purdue (almost $635 million). I think it’s clear why Pharma is going after the FDA. The sum total in fines and settlements from the chart was $12.06 billion between 2004 and 2012.

The FDA announced that it plans to hold a public meeting this summer to address drug company concerns with restrictions on what they can say about off-label use of drugs. But as of the beginning of July, I could find no indication of a set date and time for the public meeting. Perhaps the FDA decided to delay scheduling the meeting until there was an indication what would happen with the 21st Century Cures Act. They may also want to see further reaction to its June 23, 2015 brief filed in response to Amarin’s Motion for Preliminary Injunction.

If I wanted to build case law precedents to justify my constitutional right to share certain information about my pharmaceutical products with doctors, I think I’d first try to have the courts rule in favor of a product like pharmaceutical grade fish oil. It’s already sold as a dietary supplement and there are hardly any known side effects. If successful, I’d build on it and the Caronia case by filing additional litigation in an attempt to cut off the FDA regulations against off-label promotion and marketing of pharmaceuticals at the knees.

07/27/15

Clearing Away the Medical Marijuana Smoke

© lunamarina | stockfresh.com

© lunamarina | stockfresh.com

There have been some studies that demonstrate potential medicinal benefits of marijuana use, but they often don’t meet the clinical trial standards used by the FDA to approve medications for human consumption. With the state-by-state movement to legalize marijuana progressing, there is a need for quality scientific research into the potential medical benefits of marijuana. Although marijuana has been used recreationally and medicinally for centuries, the mechanics of how it works are not clearly understood. This is partly because there are over 400 different chemicals in cannabis. THC, the psychoactive ingredient in cannabis, was just isolated in the 1960s. What follows are reviews of some articles that look at the benefits and the concerns with medical marijuana.

Marijuana has been used as a folk medicine as far back in time as five thousand years ago. The first medical use likely occurred in Central Asia and spread from there to China and India. The Chinese emperor Shen-Nung is known to have prescribed it in 2800 BC.  Between 2000 and 1400 BC it came to India, and from there to Egypt, Syria and Persia. The Greeks and Romans valued marijuana as hemp for ropes. Europeans ate its seeds and used its fibers to make paper. An urban legend falsely held that the U.S. Constitution, Declaration of Independence, and Bill of Rights were written on hemp paper. All three were actually written on parchment.

An Irish doctor, W. B. O’Shaughnessy, working in Calcutta in the 1830s, wrote a paper on the medical uses of cannabis, which were strikingly similar to those known today—vomiting, convulsions and spasticity. By 1854, the medical use of cannabis was listed in the US Dispensatory. Nineteenth-century physicians had cannabis tinctures and extracts for ailments from insomnia and headaches to anorexia and sexual dysfunction. “Cannabis-containing remedies were also used for pain, whooping cough, asthma, and insomnia and were compounded into extracts, tinctures, cigarettes, and plasters.”

The above short history on the history of medical marijuana was taken from an article by J. Michael Bostwick, “Blurred Boundaries: The Therapeutics and Politics of Medical Marijuana.” He noted how the term medical marijuana refers to botanical cannabis, which contains hundreds of compounds—including the two most often used medicinally, THC and cannabidiol (CBD). Synthetic cannabinoids are produced in a laboratory. Botanical cannabis attracts the notoriety and controversy—because it is the same substance used recreationally by “stoners” to get high.

Bostwick noted how the recreational and medical marijuana use of marijuana is not always distinct, which has medical implications for both seasoned and naïve users. For example, naïve users may decide to stop using medical marijuana because of the psychoactive effects of the THC. Although most users will experience a mild euphoria, a few experience dysphoria, anxiety and even paranoia.

As cannabis strains are bred that amplify THC content and diminish counteracting cannabidiol, highs become more intense but so do degrees of anxiety that can rise to the level of panic and psychosis, particularly in naive users and unfamiliar stressful situations.

The Bostwick article reviewed the often-blurred relationship between medical and recreational users. He discussed a Canadian study that found medical cannabis use often followed recreational use; and that most medical users continued using marijuana recreationally.  Another study of 4100 Californians found that medical users preferred inhaling their medication. Smoked cannabis has a more rapid response and is easier to titrate so that users get the analgesic effects without the higher levels favored by recreational users seeking the high. Given some of the medical problems from smoking marijuana, using vaporizers or nasal sprays may be an effective alternative delivery system.

Doctor Robert DuPont, in his book The Selfish Brain: Learning from Addiction, referred to marijuana as “a crude drug, a complex chemical slush.” Marijuana and hashish contain over 420 different chemicals, falling into 18 different chemical families. THC and cannabidiol (CBD), are only two of sixty-one cannabinoids, chemicals found only in the marijuana plant. THC is highly soluble in fats, and this quickly passes the blood-brain barrier. The factor, plus the fact that it is insoluble in water, means that it is trapped in bodily organs like the brain and reproductive glands, remaining there of days or even weeks afterwards.

Grant et al. reviewed evidence on the medicinal usefulness of marijuana in “Medical Marijuana: Clearing Away the Smoke.” They noted that most of the studies on the efficacy and safety of cannabinoids for pain and spasticity have occurred since the year 2000. A series of randomized studies at the University of California Center for Medicinal Cannabis Research (CMCR) found that cannabis significantly reduced pain intensity. A significantly greater proportion of individuals reported at least 30% reduction in pain on cannabis; the threshold of decreased pain intensity generally associated with improved quality of life. Medium doses of 3.5% THC cannabis cigarettes were as effective as higher dose (7% THC).

Oral preparations of synthetic THC (dronabinol, Marinol) and a synthetic THC analogue (nabilone, Cesamet) are legally available. Studies suggest that dronabinol significantly reduces pain. The effects on spasticity are mixed: “there may be no observable change in examiner-rated muscle tone, but patients report significant relief.” There has been less research done with nabilone, but there have been reports of modest analgesia. Dronabinol and nabilone are FDA-approved for control of acute and delayed nausea and vomiting from cancer chemotherapy.

Alternative delivery systems for cannabis include vape-pens, sublingual devices, and others that use a metered spray device. The advantages to such systems seem to be the use of known cannabinoid concentrations, predetermined dosing portions, and time-out systems that may help prevent overuse.

There are side effects, which are dose-related in terms of severity. Grant et al. reported that they seem to decline over time and are of mild to moderate severity. “Reviews suggest the most frequent side effects are dizziness or lightheadedness (30%-60%), dry mouth (10%-25%), fatigue (5%-40%), muscle weakness (10%-25%), myalgia [muscle pain] (25%), and palpitations (20%).” There is little data on a timeline of adverse or therapeutic effects. There have been concerns that rapid tolerance to adverse effects may indicate a corresponding tolerance to beneficial effects. But studies of oral sprays in multiple sclerosis report that you can reduce the incidence and severity of adverse effects by downward self-titration without loss of analgesia.

There are additional adverse effects, including some psychiatric side effects, especially with cannabis having high concentration of THC. See the original article for more specifics. The longer-term health risks of medicinal cannabis are unclear; most of the current evidence is based upon non-medical use. Some medical professionals indicate that effective medicinal use of cannabis requires significantly less marijuana than is typically consumed by recreational users.

In “The Current Status of Medical Marijuana in the United States,” Doctor Gerald McKenna noted how the majority of medical marijuana users in Hawaii claim they have chronic pain. He said a main problem in getting the medical profession to support the use of medical marijuana is that it is not widely used medicinally in a non-smoking form. “Authorizing use by inhalation of a drug with an unknown number of co-drugs contained in the same raw form is not supportable.” He said that supporting the use of medical marijuana by inhalation because users prefer it is akin to supporting the inhalation of any other drug taken orally. His impression is that medical marijuana laws have been passed “to bypass the illegality of marijuana.”

He did recommend removing marijuana from Schedule I controlled substance so research could be done more easily. “Until that research is done, stating that marijuana is useful for treating chronic pain, anxiety, post-traumatic stress disorder, depression, and other health conditions remains anecdotal and conjectural.”

It has become clear that the federal government needs to modify its resistance to reclassifying marijuana’s Schedule I Controlled Substance status to allow more quality research into its use and to fund that research. Otherwise, the current circus of inconsistent regulations from state to state, and unverified claims about the medicinal benefits of marijuana will have us back in the days of patent medicines, as far as marijuana is concerned. Further reflections on medical marijuana can be found in: “Let’s not Get Ahead of Ourselves,” “Is the Cart Before the Horse?” and “Marijuana Peek-a-Boo.”

07/24/15

Sincere Love to God

© elvinstar | stockfresh.com

© elvinstar | stockfresh.com

Sincere Love to God is a constant growing love, and an everlasting love, it holds out in all times and seasons, and variety of conditions, prosperity and adversity, praise and persecution, health and sickness, plenty and poverty, liberty and bonds, yea, in death it self, and after death through all eternity; death doth not terminate this grace, but perfect it. (Anonymous)

One of the graces that demonstrate the sure, indwelling presence of the Holy Spirit in us is Love. Where God dwells by his Spirit, there is sincere love to God and sincere love to others, for God’s sake.  As the apostle John said: “Little children, let us not love in word or talk but in deed and in truth” (1 John 3:18). Because this love is a special work of the Holy Spirit, it works for good in all things—regardless of how bad these things may be in themselves. All things work together for good in those who love God (Romans 8:28). There is always a redemptive purpose to be found in what happens to God’s people.

The person who sincerely loves God has a sure argument that they are greatly loved by God: “We love because he first loved us” (1 John 4:19). But someone might ask, isn’t that love in us a special work of the Spirit of God? Surely it is. “But sincere Love to God, strongly argues special Love in God towards him that hath it, therefore sincere Love to God must needs be a special work of the Spirit of God in whomsoever it is.” The following Scriptures clearly support the claim that sincere love for others, for God’s sake, is a real testimony of the person’s union with Christ.

And this is his commandment, that we believe in the name of his Son Jesus Christ and love one another, just as he has commanded us. Whoever keeps his commandments abides in God, and God in him. And by this we know that he abides in us, by the Spirit whom he has given us. (1 John 3:23-24)

Whoever loves has been born of God and knows God. (1 John 4:7)

If we love one another, God abides in us and his love is perfected in us. (1 John 4:12)

Without sincere love, all profession of faith in religion is but a gilded hypocrisy. Where love is, God dwells. But where it is not, the devil dwells. More love means a greater likeness to God; less of it means a greater likeness to the devil. Experience shows that those individuals who have great gifts and responsibilities and little or no love, will show more of the devil’s nature than God’s—and will act more like the devil than god when they have power.

Love is the sweetest flower in all the garden of God, but it is a flower which the Devil cannot endure the smell of, because he is not capable of it, and knows that where Love dwells, he must vanish; and therefore it is his main design to destroy Love, if possible, in all sorts and sects, and to root it up and banish it from the hearts of all men; The Devil is well content, that men should pray, preach, read, hear Sermons, and make a faire shew outwardly, provided this spring not from Love, nor tendeth not to the increase of Love, to God nor man; but if he see Love be the root and fruit of mens services, then he goes cunningly, and Serpent-like to work, to make breaches in this wall, that he may get in and destroy this flower, he deviseth wayes to divide men’s judgments, to the end he may destroy this affection of Love out of their hearts; if he prevaile not this way then he will raise up jealousies to destroy Love and Charity, yea sometimes render the best of graces, the worst of vices; and as in tempting a Carnal man, he sometimes stiles lust, Love, so in tempting a spiritual man, he sometimes stiles sincere Love, lust; and by these wiles makes a breach on Charity, to the end he may get into the garden of God, and root up this sweet grace of Love.

Someone might ask how he or she can know, one way or the other, whether his or her love of God is sound and sincere.  The author said they must examine themselves to see if they find a true testimony of the Holy Spirit’s indwelling in them. The properties of this sincere love to God are these:

Sincere love to God is seated in the heart. It carries the whole heart and soul to God—both the inner and the outer person. What God requires and commands is in His Word, namely that we should love God with our whole heart and soul. By the whole heart is meant every faculty of the soul; the whole inner person. So there cannot be a division between God and the world, between God and sin—as the hearts of all hypocrites are.

Sincere love is carried to God and fastened upon Him. There we cleave to Him in affection; more than anything else. From a due consideration of his perfection, we account Him to be our chief happiness. We rejoice in him above all things. We fear his displeasure more than all others. We depend upon him for all things, and aim for his glory in all things.

Sincere love to God is guided by faith, not by sight. As Peter said: “Though you have not seen him, you love him. Though you do not now see him, you believe in him” (1 Peter 1:8).  We also see this in Job, who continued to love God and obey him, as we see in Job 23:8-11. This plainly shows that his love was guided by faith and not by sight.

Sincere love to God is a strong love. It will compel a person to obey even to the death. It will constrain the person to do or suffer anything that God sees fit to impose upon them without replying “in tongue or in heart” against God. “It will make a man serve God with all his might.” It bears all things, believes all things, hopes all things, and endures all things (1 Corinthians 13:7).

Sincere love to God is an endearing affection. It endears Christ to the person above all things; so that they will part willingly with all others things rather than Christ, even to laying down their lives. This is illustrated for us in the parables of the Hidden Treasure and Pearl of Great Price (Matthew 13:44-46) and in all the trials of the saints in Hebrews 11.

This is now the third reflection I’ve done on excerpts from Evidence for Heaven, written by an anonymous Puritan female author. Edmund Calamy was credited as the author, but he himself acknowledged it was actually written by a female member of his church. After writing the first two reflections (Evidence for Heaven and More Evidence for Heaven), I planned to stop. But then in another meditation from Day by Day with the English Puritans, I read the above quoted passage on Love as the sweetest flower in the Garden of God and again believed her thoughts needed to reach a wider audience.  I’m thinking there will be more reflections to come.

 

07/22/15

No Laughing Matter

© Ievgen Soloviov | Dreamstime.com

© Ievgen Soloviov | Dreamstime.com

In his famous work, The Varieties of Religious Experience, William James discussed what he said was the ability of nitrous oxide (laughing gas) to produce “mystical consciousness” to an extraordinary degree. “Depth beyond depth of truth seems to be reveled to the inhaler.” But the revelation fades as the gas wears off. What is left seems like nonsense to the awakened mind. But the sense of “a profound meaning” persists. James said he knew more than one person who was persuaded that a genuine metaphysical revelation could come in a nitrous oxide trance. Now, laughing gas is being researched as a treat for depression.

James said he had personally tried nitrous oxide, and even wrote of his experience in print. He said one impression from these experiments stayed with him—that our waking consciousness was but one of several other potential form of consciousness. “No account of the universe in its totality can be final which leave these other forms of consciousness quite disregarded.”  Looking back on his own experiences, he saw them converge towards a kind of insight that he felt had metaphysical significance.

His essay was “Subjective Effects of Nitrous Oxide,” and it appeared in the 1882 volume 7 issue of Mind. It can be found in a few places online. I’ve linked it on the website Erowid, which will also have other references we’ll examine. In his essay, James said that the keynote of nitrous-oxide intoxication was an intense sense of metaphysical illumination that occurred as the altered state of consciousness was wearing off.

The mind sees all logical relations of being with an apparant subtlety and instantaniety to which its normal consciousness offers no parallel; only as sobriety returns, the feeling of insight fades, and one is left staring vacantly at a few disjointed words and phrases, as one stares at a cadaverous-looking snow peak from which sunset glow has just fled, or at a black cinder left by an extinguished brand.

What James saw as the most coherent and articulate of his bursts of insight was this: “There are no differences but differences of degree between different degrees of difference and no difference.” James said there was an initial rapture of emotion in “beholding a process that was infinite” that turned to horror as the individual realized they were caught in an inevitable fate, “with whose magnitude every finite effort is incommensurable and in the light of which whatever happens is indifferent.”

As James himself said in the essay, just as every person’s encounter will vary, the individual’s personal experience with nitrous oxide will vary from time to time. However, he still thought that there still was a common thread running through all those who were intoxicated with nitrous oxide, namely an “intense metaphysical experience.”

A group of researchers, Nagel et al., reported on a pilot study done to assess the potential of nitrous oxide as a rapidly acting treatment for treatment resistant depression (TRD). The theory was based upon the influence of nitrous oxide on the NMDA receptor, which has been “implicated” in the neurobiology of depression. Other NMDA receptor antagonists, such as ketamine, have been shown “to provide a rapid and sustained antidepressant effect” when used at low doses. Given the similar mechanisms of action, the researchers hypothesized that nitrous oxide may also have rapid antidepressant effects on treatment resistant depression. So they designed a study to assess the immediate (2 hours) and sustained (24 hours) antidepressant effects of nitrous oxide in TRD patients.

Patients received either an admixture of up to a maximum of 50% nitrous oxide and 50% oxygen (as the active ingredient) or 50% nitrogen/50% oxygen (as the placebo) for one hour. Outcomes were assessed for each participant at baseline, 2 hours after treatment and 24 hours after treatment. The results indicated a significant improvement in depressive symptoms at 2 and 24 hours. There was also a sustained improvement with some participants for 1 week. Yet there were several limitations noted by the researchers of this study.

The full 60-minute nitrous oxide treatment was only completed by 15 of the 20 patients. The placebo treatment was completed by 20 individuals. The side effects for the treatment group were noted to be mild or moderate (nausea, anxiety, vomiting) and immediately reversible. This suggested an acceptable risk/benefit ratio of nitrous oxide for TRD to the researchers.

Their discussion suggested several limitations of the study. The small sample size meant that the results should be interpreted with caution until the results were replicated in larger populations. They also noted that the euphoric effects of nitrous oxide are hard to mask, so the blinding attempted in the study may not have been adequate. Despite knowing this, the researchers did not try to assess whether or not the participants were aware of their group assignment, “and this limits our conclusions.”

They also pointed out that there could have been a masking effect of depressive symptoms, meaning that: “the depressive symptoms were not really altered, but rather ‘covered up’ by other effects.” They noted where symptom masking has been evident with rapidly acting psychostimulants like cocaine and methylphenidate, “which promote a transient alteration in mood but not a true antidepressant effect.” Their preliminary study concluded there was evidence that nitrous oxide may have rapid and marked antidepressant effects in patients with TRD. They called for further studies that would attempt to determine optimal antidepressant dosing strategies and the risk/benefit of nitrous oxide in a larger and more diverse population of individuals with TRD.

Psychiatrist Sandra Steingard expressed reservations with the promotion of nitrous oxide as a rapid acting treatment for depression. She commented that while she never personally tried nitrous oxide herself, she knew others who did and expected that her mood would undoubtedly have been elevated as theirs was. Her suggestion was the observed “treatment’ effects of nitrous oxide were actually drug effects that would occur with any individual who used it. She proceeded to voice several questions on the use of nitrous oxide, ketamine or stimulants to treat depression. She thought there was a huge potential for harm; possibly greater than the drugs psychiatrist currently prescribed for depression.

What are the long term side effects? How hard is it to stop them?  How do we deal with the corrupting influence of the profit driven forces so powerful in medicine?  Most of these drugs are still studied over weeks and then prescribed for years. With drugs like stimulants, ketamine and nitrous oxide, I have a particular worry because these drugs are known to cause psychosis. Colleagues of mine have told me that they do not see people who become psychotic on stimulants. If they don’t, they are not looking. I am not comfortable assuming when an 18 year old develops psychotic symptoms after several years of treatment with an antidepressant that these two things are not related or that the psychosis was inevitable because the person had a diathesis to Bipolar Disorder. Stimulants are used to create animal models of psychosis because we have known for decades that stimulants can cause a person to become psychotic.

Erowid is the website for an organization that seeks to “provide accurate, specific, and responsible information about how psychoactives are used in the United States and around the world.” So you will find pro and con information on the use and effects of psychoactive substances there. Here are a few of the catalogued articles on problems from nitrous oxide use and abuse: “Asphyxia deaths from the recreational use of nitrous oxide;” “Suicide by nitrous oxide poisoning;” B 12-related medical problems from nitrous oxide: “Nitrous oxide myleopathy in an abuser of whipped cream bulbs [whippets] (nitrous oxide is used in whipped cream cans), “Myleneuropathy after prolonged exposure to nitrous oxide,” and this case report from outside of Erowid of a woman who developed myleopathy.

Below is a quote from a 1991 article on “Health hazards and nitrous oxide” in medical settings. Here is a link to a case report of an individual who suffered paranoid delusions after abusing whippets.

Although N2O was for many years believed to have no toxicity other than that associated with its anesthetic action, bone marrow depression in patients administered N2O for extended periods of time and neurological abnormalities in health care workers who inhaled N2O recreationally have disproved this notion.

Simply put, regardless of the short-term reversals of a depressed mood state, it does not seem that there will be any long-term benefits from the therapeutic use of nitrous oxide (N2O). And there seems to be plenty of concerns with its use. Treating depression with laughing gas is no laughing matter.

07/20/15

Dangerous Drug Cocktails

© Claudio Ventrella | 123RF.com

© Claudio Ventrella | 123RF.com

When the largest pharmacy benefit company in the U.S. with revenues of $104 billion publishes a study of patients’ use pain medications, it gets some attention. That was exactly what happened when Express Scripts published “A Nation in Pain.” FiercePharma and The New York Times, among others, highlighted some disturbing trends with the prescribing habits of painkillers. Around 60% of the patients taking opiates were also prescribed other sedative drugs, like muscle relaxants and benzodiazepines—a great way to overdose and die.

The CDC has said that the U.S. is in the midst of a prescription painkiller overdose epidemic. Since 1999, the amount of prescribed painkillers has almost quadrupled. But there hasn’t been an overall change in the amount of pain being reported. “Every day, 44 people in the U.S. die from overdose of prescription painkillers, and many more become addicted.” In 2013, that meant more than 16,000 deaths from painkillers. These overdoses often involved benzodiazepines. Almost 7,000 people are treated in ERs each day for their misuse of prescription painkillers. The most commonly identified drugs in overdose deaths include:

  • Hydrocodone (e.g., Vicodin)
  • Oxycodone (e.g., OxyContin)
  • Oxymorphone (e.g., Opana)
  • Methadone (especially when prescribed for pain)

“A Nation in Pain” looked at 6.8 million insured Americans of all ages who filled at least one prescription for an opioid to treat either short-term or long-term pain from 2009 through 2013. Short-term users were defined as patients who were prescribed an opiate pain medication for a total supply of 30 days or less within a one-year period. Long-term users were those prescribed an opiate pain medication for more than a 30-day supply in a one-year period. Some of the key findings of their study included a decline of 9.2% in the number of Americans filling a script for opioids between 2009 and 2013 (See the graphic below).

rx-painkillers-sales-and-deaths-700wBut this decline was offset by an increase of 8.4% in the number of prescriptions filled and the number of medication days per prescription. The number of short-term users declined 11.1%, while the number of long-term users remained constant.  Nearly half (46.9%) of long-term patients continued to use painkillers for three years or longer. “Almost 50% of those patients were taking only short-acting opioids, putting them at higher risk of addiction.” Of the nearly 60% of patients noted to be using potentially dangerous and fatal drugs in combination with their painkillers, 33% were using benzodiazepines. The most common cause of overdose deaths with multiple drugs involves opioids and benzodiazepines.

A majority of patients (58.5%) were using opiate pain medications with other prescription drugs that carry safety risks when used concurrently. Among long-term opioid patients, 29.2% had prescriptions for benzodiazepines in the same month. Opioids, muscle relaxants and benzodiazepines all suppress the respiratory system. Taking them concurrently can increase these reactions exponentially.

While there could be rare instances when opioids and benzodiazepines or muscle relaxants may be appropriate to prescribe together, seeing these potentially dangerous mixtures used so commonly by such a high percentage of patients is of great concern.

Many patients were taking two or more short-acting opioids at the same time; 27.5% of the long-term opioid users were doing so. This combination of longer-term usage and concurrent usage of two or more short-acting opioids was a recipe for developing drug dependence and addiction. Of the patients taking these potentially dangerous combinations of medications, two-thirds (66.6%) were prescribed the drugs by two or more physicians. Almost 40% filled them at two or more pharmacies. Glen Stettin M.D., a Senior Vice President at Express Scripts said better coordination of care is needed to correct this problem.

People looking to abuse controlled substances will often attempt to obtain prescriptions from multiple prescribers; and fill prescriptions at multiple pharmacies. So Express Scripts has developed programs to counter the abuse by restricting certain patients to one pharmacy, and in some cases, to one prescriber. But drug addicts are nothing if not determined and ingenious. The following story may seem extreme, but with my experience working with addiction, I could see it happening.

Lynne Nowak, M.D., the Medical Director of Personal Health Solutions at Express Scripts told of a patient admitted to her hospice practice with a terminal illness. The patient was taking high doses of both short-acting and long-acting opioids, along with benzodiazepines and other medications. After gathering information and additional medical records, Doctor Nowak and her team discovered that the patient had fabricated a terminal illness and admitted himself to hospice care to get the medications.

In an appendix, Express Scripts indicated the top opioids in the U.S. according to their market share in 2013 were:

  • •Vicodin®/hydrocodone with acetaminophen (46.1%);
  • •Ultram®/Tramadol (14.7%);
  • •Percocet®/oxycodone with acetaminophen (13.6%);
  • •OxyContin®/oxycodone (8.3%);
  • •Tylenol® with Codeine/codeine with acetaminophen (3.8%).

The huge preference for Vicodin® will likely fade by 2015, as it was reclassified upwards as a Schedule II controlled substance in October of 2014. This means that there will be greater restrictions on refills. Schedule II prescriptions require a physical prescription (no pharmacy call-ins) and a face-to-face visit with the prescriber. Ultram®/Tramadol is a Schedule IV controlled substance, and I expect that we will see an increase in how often it is prescribed with the increased restrictions on Vicodin®.

07/15/15

Pathologizing Grief

© Kzenon | stockfresh.com

© Kzenon | stockfresh.com

In January of 2015, an article on “Complicated Grief” was posted in The New England Medical Journal blog. The author described complicated grief as “intense grief after the death of a loved one that lasts longer than expected according to social norms and causes functional impairment.” While it was said that psychotherapy is a first-line treatment, the author reported that antidepressant medication is commonly used. This is just the latest stage in a rather complicated refashioning of grief from a normal human experience into a mental disorder.

The symptoms of complicated grief were said to be: “persistent, intense yearning, longing, and sadness.” Along with these “symptoms” can be a sense of disbelief or failure to accept the reality of the person’s death. Persistent thoughts or images of the deceased can occur. Ruminating on the circumstances of the death, with feelings of anger or guilt was said to be common. Avoiding situations that remind the person of the loss is common. Holding on to the deceased by repeated reminiscing, viewing, touching or smelling the deceased person’s belongings can occur as well.

People with complicated grief often feel shocked, stunned, or emotionally numb, and they may become estranged from others because of the belief that happiness is inextricably tied to the person who died. They may have a diminished sense of self or discomfort with a changed social role and are often confused by their seemingly endless grief.

Complicated grief is not a psychiatric diagnosis, although you wouldn’t know that from reading the above description. It explicitly uses diagnostic-like language in its discussion in an attempt to gain legitimacy for “Prolonged Grief Disorder” to be included in the International Classification of Diseases, 11th edition, due for release in 2017. The boat has passed on inclusion in the DSM, which went through its own controversy over grief when the DSM-5 removed the bereavement exclusion (BE) from the existing Major Depression Disorder (MDD) in 2013.

Within the DSM, the bereavement exclusion meant that a diagnosis of MDD could not be made if the loss of a loved one was a better explanation for the observed symptoms of depression. However, the time frame to avoid the grieving process from qualifying as MDD has been progressively shrinking. Within the DSM-III, the BE was one year; within the 4th edition, it was two months. Now in the DSM-5, bereavement is no longer an excuse. If you meet the diagnostic criteria for MDD over a two-week time period, you are just as depressed as anyone else, according to the DSM.

Joanne Cacciatore, who has specialized in the psychotherapeutic treatment of grief and bereavement for almost twenty years, has been an outspoken critic of these changing guidelines and pseudo-diagnoses. In March of 2012 she wrote an essay opposing the proposed elimination of the BE from the DSM-5. Her eloquent essay reached 100,000 readers in two weeks. She stated her opposition to both of the above ‘time limits’ for grief, and pointed to the historical movement of the DSM to medicalize normal human emotion. She said:

We should not, ethically or morally, medicalize grief.  To do so is to medicalize love.  We rarely mourn for that which we do not love. I can only begin to imagine what the sages, and mystics, and shamans of the past might think of a society which does so.

Allen Frances was also openly critical of the DSM-5 and its changes with regard to bereavement. In his own blog on the Huffington Post in March of 2012, he published Dr. Cacciatore’s open letter to the Board of Trustees of the American Psychiatric Association. She pointed to the arbitrariness of the two-week time frame, stating that it not only contradicts common sense, but rests on weak scientific evidence. To her knowledge there was no empirical evidence to support it.

One thing in which the literature is clear: long-term psychological distress is common in this population and other populations suffering traumatic deaths. In my experience both as a researcher and clinician in the field and also as a bereaved parent, the DSM-5 proposal is radical, unnecessary, challenges what it means to be human, and for some may be dangerous.

But the APA was not moved. Frances tried again in January of 2013, as the DSM-5 was preparing to go to press at the end of the month. He said: “The American Psychiatric Association has just four more weeks to reverse this dreadful mistake that flies in the face of clinical common sense and is unsupported by the limited available science.” He put together his own top ten list of harmful changes in the DSM-5, and medicalizing grief was number two. In case you aren’t aware, Dr. Frances’ credibility in voicing these concerns come from his long career as a psychiatrist and as the person selected by the APA to chair the DSM-IV. He said:

After 40 years and lots of clinical experience, I can’t distinguish at two weeks between the symptoms of normal grief and the symptoms of mild depression — and I challenge anyone else to do so. This is an inherently unreliable distinction. And I know damn well that primary care doctors can’t do it in a 7-minute visit. This should have been the most crucial point in DSM-5 decision-making because primary care docs prescribe 80 percent of all antidepressants and will be most likely to misuse the DSM-5 in mislabeling grievers.

Returning now to the essay “Complicated Grief,” let’s look at Dr. Cacciatore’s response. She commented how the bereaved were again at risk of being diagnosed and “treated” for “absolutely normal feelings and experiences” after a painful and traumatic loss. Responding to the above description of complicated grief, she said:

Ha! Social norms? Around grief? Talk about pathology! Western culture’s “social norms” and expectations around grief, especially when traumatic, are as abnormal and avoidant as any society could get. The average bereavement leave is three days, many bereaved parents are medicated within days or weeks after a traumatic loss (even in the presence of data to suggest these medications can be harmful and iatrogenic), and mourners are expected, and then pressured, to get back to ‘life-as-usual’ often within weeks or mere months, even after traumatic death. And our social networks often fail as others’ tolerance wanes in the months and years that follow.

Perhaps there is better guidance for conceiving a time frame for grief and bereavement in the book of Ecclesiastes (3:1-8) than in the DSM. There the Preacher said there is a season and a time for everything under heaven. Notice that he doesn’t try and quantify “season” or “time.” A time to be born and a time to die; a time to weep and a time to laugh; a time to mourn and a time to dance; a time to keep silent and a time to speak. When weeping turns to laughing, when mourning is replaced by dancing, then the season of grief has run its course. However, when individuals attempt to pathologize human emotion by blurring the line between grief and psychiatric disorder, it is a good thing that people like Joanne Cacciatore and Allen Frances choose to speak up and not remain silent.

07/13/15

Getting High is an Global Problem

Package with a drug against the passports and U.S. dollars

© blinow61 | stockfresh.com

Looking at information gleaned from the 2014 World Drug Report suggests two drug trends to expect over the next few years. A bumper crop of opium poppies globally (particularly in Afghanistan), points to an increased worldwide problem with heroin. Afghanistan grew about 80% of the world’s opium poppies in 2013. Second, the development of new psychoactive substances (NPS) has accelerated and doesn’t appear to be slowing down anytime soon. By December of 2013, there were 348 known NPS, an increase of 200% since 2009. There are now more NPS than the number of substances under international control (234).

Globally, an estimated 243 million people aged 15-64 used an illicit drug in 2012. The three primary groups of illicit drugs were: cannabis, opioids, and cocaine or amphetamine-type stimulants (ATS). Generally, men are two to three times more likely than women to have used an illicit substance. While there are regional trends to consider, overall global drug use seems to be stable. The extent of problem drug use, determined by the number of regular drug users and those with drug use disorders, was also stable globally, at around 27 million people. The estimated number of global drug users by drug type is in the table below.

Global Drug Use by Drug Type

Cannabis

Amphetamine-like stimulants

Cocaine

Opiates

(heroin, opium)

Opioids (opiates and synthetics)

Amphetamines

Ecstasy

Users in millions

177.6

34.4

19.36

17.20

16.40

33.00

% of global population 15-64

3.80%

0.70%

0.40%

0.40%

0.40%

0.70%

There has been an increase in global opioid and cannabis use since 2009, while the use of opiates, cocaine and ATS has either remained stable or decreased. Reports on the types of drugs individuals seek treatment for can provide information on which drugs have the highest impact on health in the various geographic regions. Cannabis treatment is prevalent in Africa, the Americas and Oceania. It should be noted that between 2003 and 2012 that those seeking treatment for cannabis increased in Western and Central Europe (19% to 25%), Eastern and South Eastern Europe (8% to 15%), Latin America and the Caribbean (24% to 40%) and Oceania (30% to 46%).

Opioids dominate treatment requests in Eastern and Southern Europe and Asia. Cocaine is major treatment factor in the Americas, especially in Latin America and the Caribbean.  ATS use disorders are responsible for a significant proportion of the treatment demand in Asia and Oceania.

Global estimates are that one in six problem drug users got treatment in the past year. However, there are large regional differences. One in 18 problem drug users receive treatment in Africa (mostly for cannabis use), while one in five problem users in Europe, one in four in Oceania and one in three in North America receive treatment.

Drug-related deaths were estimated to be around 183,000 in 2012. Overdose deaths from opioids (heroin and non-medical use of prescription opioids) are the main drug type implicated in those deaths. Most overdoses occur when opioids are mixed with other sedating substances, like alcohol and benzodiazepines. See the global data in the table below from the 2014 World Drug Report.

Table 2

North America continues to be a major market for illicit drug use. It has the largest percentage of opioid users, cocaine users and cannabis users. It was second in percentage of ATS users. Cocaine use has been declining since 2006, partly because of a sustained shortage. Yet there has been a slight increase in prevalence recently. Columbia’s recent decision to stop spraying coca crops could stimulate a greater resurgence in cocaine use.

In the United States, opioid-dependent drug users are increasingly turning to heroin because of its greater availability and lowered cost to regular users. The greater availability of heroin in the United States is likely due to higher levels of heroin production in Mexico and Mexican traffickers expanding into “white heroin” markets. Anecdotal evidence is that Mexican drug cartels are switching from growing marijuana to opium poppies due to the lower demands for marijuana in the United States. See “The Economics of Heroin.”

The rapid growth of NPS has led to a key supply control strategy of restricting the availability of the precursor chemicals necessary to manufacture them. Most drugs, whether they plant-based or synthetic, require chemicals to change them into the final product. While chemical are only one of the components required for the illicit manufacture of plant-based drugs like heroin and cocaine, ‘they constitute the essential components of illicitly manufactured synthetic drugs.”

NPS are found throughout the globe. Of the 103 countries that gave information for the World Drug Report, 94 countries reported the emergence of some kind of NPS in their markets. The increase from August 2012 to December 2013 of newly identified NPS was mostly due to new synthetic cannabinoids (50% of newly identified new psychoactive substances) followed by new phenethylamines (17%), other substances (14%) and new synthetic cathinones (8%). See the following chart from the 2014 World Drug Report.

figure 60Reviewing this report on worldwide drug use reminds me that getting high is an everywhere problem. This year the transition from pharmaceutical painkillers to heroin and the higher cultivation levels of opium poppies suggests a pending increase in heroin addicts and overdose deaths. The rapid explosion of new psychoactive substances onto the drug scene in the past few years feels like a “back to the future” move to the days of patent medicines, when heroin was a cough suppressant and cocaine was a toothache cure. Teething medications contained morphine. Coca-Cola (with cocaine) was a temperance drink and tonic, “a cure for all nervous affections.”

Cannabis is becoming more potent and toxic just as legalization movements gain steam and increase its use and availability. Coca eradication efforts that seemed to have had an effect on the cocaine market are to be suspended—perhaps leading to a resurgence in cocaine use. Getting high is an everywhere problem and it seems like it’s not going away anytime soon.

07/10/15

American Christianity is Evolving

© ribah | stockfresh.com

© ribah | stockfresh.com

The Pew Research Center recently released its new Religious Landscape study and it seems to have stimulated differing opinions on the status of Christianity in America. CNN reported that Millennials are leaving the church in droves. Ryan Bell, the former Seventh Day Adventist minister who took a year off (and counting) from belief in God, titled his article: “American Christians Scramble for Silver Lining in Pew Religion Poll.” But evangelicals like Joe Carter of the Gospel Coalition and Ed Stetzer, a contributing editor for Christianity Today had a different take on the Pew Religious Landscape study.

Daniel Burke, the CNN Religion Editor highlighted the finding that the percentage of the Americans saying they were Christian dropped from 78.4% in 2007 to 70.4% in 2014. This was attributed by the Pew Research Center to the fact that more millennials are saying they are not affiliated with any faith. Thirty-six percent of younger millennials (18-24) identified as unaffiliated as 34% of older millennials (25-33). Twenty-three percent of Gen Xers (34-49), 17% of Baby Boomers (50-68) and 11% of the Silent Generation (69-86) were reportedly unaffiliated.

Burke pointed to how almost every major branch of Christianity lost a significant number of members. Greg Smith, from Pew Research, was quoted as saying: “We’ve known that the religiously unaffiliated has been growing for decades . . . But the pace at which they’ve continued to grow is really astounding.” The declines were deepest among Catholics and mainline Protestants. Burke’s conclusion was that the older generations were not as effective in passing along their faith as their forebears were.

Ryan Bell simply concluded: “Americans are losing their religion.” He noted the surprising increase among nones (religiously unaffiliated) to 22.8% of the population. He cautioned that atheists who celebrated these results as a victory were being too enthusiastic. Of the 22.8%, 4.0% said they were agnostic (a 1.6% increase since 2007), 3.1% said they were atheist  (a 1.5% increase since 2007) and 15.8% said they were “nothing in particulars” (a 3.7% increase since 2007).

Several analyses of the Pew study have focused on the dramatic increase in the “unaffiliated” or “religious nones.” But look at what Pew Research means by “nones.” They are generally less religiously observant, but all nones are not nonbelievers. “In fact, many people who are unaffiliated with a religion believe in God, pray at least occasionally and think of themselves as spiritual people.” A better statement would seem to be that “Americans are losing their religious affiliation.” But this doesn’t appear to be happening with evangelicals. The Pew Research Center said:

The new survey indicates that churches in the evangelical Protestant tradition—including the Southern Baptist Convention, the Assemblies of God, Churches of Christ, the Lutheran Church Missouri Synod, the Presbyterian Church in America, other evangelical denominations and many nondenominational congregations—now have a total of about 62 million adult adherents. That is an increase of roughly 2 million since 2007, though once the margins of error are taken into account, it is possible that the number of evangelicals may have risen by as many as 5 million or remained essentially unchanged.

Bell didn’t seem to think much of the fact that there was only a minor decrease (-.9%) in the percentage of individuals saying they were evangelical, from 26.3% in 2007 to 25.4% in 2014.  He pointed to how 35% of childhood evangelicals left their faith as adults. But Bell neglected to say that 41% of evangelicals were converts from other faith groups. This meant evangelicals were the only Christian faith group that gained, rather than lost members as their children grew to adulthood. However, he was correct to say that most of the Catholics or mainline Protestants leaving their faith group are becoming unaffiliated and not evangelicals. Among adults with no religious affiliation, 28% are former Catholics and 21% are former mainline Protestants.

The unaffiliated religious group was the most fluid over time, with only 21% of individuals currently identifying as such being raised within that tradition, while 90% of Catholics were raised as Catholics. Mainline Protestants and evangelicals were in-between with 42% and 39% respectively having been raised in religious groups other than their current identification.

Joe Carter concentrated his response on what he saw as the important “takeaways” related to evangelicalism. He said claims that conservative forms of evangelicalism are rapidly declining because of pernicious sexism, religious intolerance and conservative politics don’t seem to be true. He wondered whether this new information would be enough to lead critics of evangelicalism to alter their conclusions. Among the important takeaways he pointed to were a few we’ve already touched on, namely: evangelical Protestants have increased slightly or remained essentially unchanged while mainline Protestants declined significantly. He also noted that 65% of adults raised as evangelicals still identify as evangelicals. But there were a couple of additional interesting facts about evangelicals to look at as well.

One of these was how racial and ethnic minorities now make up 24% of evangelicals. This was an increase of 5% since 2007, with most of that increase (4%) coming from Hispanics. Another finding is that more Americans who self-identify as gay, lesbian or bisexual say they are evangelical (13%) than mainline (11%), atheist (8%), or agnostic (9%). Only Catholics had more individuals (17%) who self-indentified as gay, lesbian or bisexual. Among non-Christians, the four primary faith groups had very few individuals who self-identified as gay, lesbian or bisexual: Jewish (2%), Muslim (1%), Buddhist (2%), Hindu (1%).

As a quick aside, among individuals who self-identified as gay, lesbian or bisexual, 41% said they were religiously unaffiliated—8% said they were atheist; 9% were agnostic; and 24% were nothing in particular.

Ed Stezer has written several articles about the Pew Research Center data, for Christianity Today and other media outlets, including USA Today, CNN and The Washington Post.  The link here for “Nominals to Nones” gives you access his other articles. Stezer made a distinction between three categories of Christians: cultural, congregational and convictional. He said the first two were nominal Christians who said they were Christian, but did not attend church services regularly or shape their lives around their faith convictions, as convictional Christians did. Cultural Christians were the least connected, calling themselves “Christian” because of heritage or culture. Congregational Christians had a connection to a local church, but rarely attended.

He said we see cultural and some congregational Christians now identifying themselves as “unaffiliated” or “nones.” Stezer supported this conclusion with a quote by Conrad Hackett, from Pew Research, “People with low levels of religious commitment are now more likely to indentify as religiously unaffiliated, whereas in earlier decades such people would have indentified as Christian, Jewish or as part of some other religious group.” In his CNN article, he looked at data from the General Social Survey (GSS) that suggested what we are seeing the death of is cultural and congregational Christians.

So, the big story is this: convictional Christians are remaining relatively steady with a slight decline. The nominals (cultural and congregational Christians) are often becoming the nones; and the sky is just not falling (unless you are a mainline Protestant).

His 3 key takeaways from the Pew Religious Landscape Survey were: convictional Christianity is rather steady; there have been significant shifts in American Christianity; and mainline Protestantism continues to hemorrhage. He said Christianity isn’t dying, but it is evolving. It’s becoming less nominal, more defined and more outside mainstream American culture. So we don’t need to run around saying, “The sky is falling!”

Christianity is losing, and will continue to lose, its home field advantage; no one can (or should) deny this. However, the numerical decline of self-identified American Christianity is more of a purifying bloodletting than it is an arrow to the heart of the church.

07/8/15

Family Likeness in Depression Drugs?

© Brijith Vijayan  |123RF.com

© Brijith Vijayan |123RF.com

Ketamine is the new antidepressant darling, reportedly with relief in as little as 2 hours. In a previous article, “Falling Down the K-Hole,” I wrote about the use and potential problems of ketamine to treat depression. But as described below, there continues to be more to the ketamine family antidepressant story. There has also been an interest in developing ketamine-like substances, supposedly without the negative side effects. There are even ketamine treatment centers available, although insurance companies won’t pay for the treatment.

Ketamine Treatment Centers of Princeton promote ketamine to treat major depression, bipolar disorder, anxiety, PTSD and OCD. NY Ketamine Infusions offers ketamine infusion therapy to treat depression and chronic pain. One center said the potential for addiction is supposed to be minimized by administering ketamine in low doses in a medical setting, with infrequent dosing and no access of ketamine at home. Pause here for a minute and read between the lines of that last sentence before reading further.

Karl Jansen, a British psychiatrist and one of the world’s leading experts on ketamine, wrote Ketamine: Dreams and Realities. His work is a balanced pros-and-cons look at ketamine. He described multiple cases of ketamine addiction, stating: “Some users wish to return again and again, attempting to go further out and further in.” He indicated that tolerance is rapid and marked; and the ability to remember the experience fades. Yet there is little evidence of physical dependence on the drug. A few users will continue to take the drug for its cocaine-like effects, its calming effects, or its potential relief from anxiety, depression and craving. The fading of the psychedelic effects can lead to using higher doses of ketamine in order to resume its dissociation experience.

But there have been reports of ketamine psychosis. A 1994 study in the Archives of General Psychiatry (now JAMA Psychiatry) reported that ketamine produced behaviors similar to the symptoms of schizophrenia; and induced alterations in perception and symptoms similar to dissociative states. Jansen said:

Sometimes, ketamine can produce certain effects resembling psychosis. These effects can take a variety of forms. For example, the user may appear to be in a trance. Their eyes may move from side to side without seeing the external world. Limbs can move in strange ways and into bizarre postures. Despite an outward appearance of being “switched off” in some way, interviewing the person afterwards may show that the mind was staging an intense inner drama. While these people do not usually spring into action as may be seen in catatonic schizophrenia, they can suddenly sit up on the bed, speak a short phrase, and then lie down again without actually having “come ‘round.” Some people regard the odd movements and postures as a form of yoga and therapeutic bodywork. The “traveler’s tales” on their return, are often very different from the accounts typically linked with schizophrenia. Many users are absolutely convinced that their ketamine experiences were real.

Ketamine was first synthesized in 1962 by a Parke Davis pharmacist; patented in 1963; and found to be a useful anesthetic in 1965, the year it also became known as a potent psychedelic. Parke Davis patented it as an anesthetic in 1966. In the late 1960s, it was first used as a field anesthetic during the Vietnam War. It is also on the WHO list of essential medicines for a health system. It was classified as a Schedule III controlled substance in 1999.

There are reports of ketamine-related fatalities, but ketamine as the sole cause of death is rare. There have been a few reports, like this 2004 article in the Journal of Analytical Toxicology, where two men apparently died from ketamine intoxication. In 2002, an article in the International Journal of Legal Medicine reported that an EMT was found dead by his girlfriend as a result of a fatal combination of ketamine and suffocation during autoeroticism.

D.M. Turner, in The Essential Psychedelic Guide, wrote that a major concern with the safe use of ketamine was its very high potential for psychological addiction. He said that he knew several regular psychedelic drug users who never had problems controlling their use. But they would consume ketamine non-stop until their supply was exhausted. “I’ve seen very few who can use it in a balanced manner if they have access to it.” Turner’s death by drowning in 1996 was ketamine-related.

In a 2014 animal study, Gideons et al. compared the effectiveness of ketamine to another NMDA receptor antagonist, memtamine. Despite their similar potency as NMDAR antagonists, memtamine does not exert rapid antidepressant effects. Their study confirmed previous research showing this difference between ketamine and memtamine. They also discovered some differential functional effects between the two drugs that provided insight into why ketamine and not memtamine has a rapid antidepressant action.

Sanacora and Schatzberg said in their 2015 article in Neuropsychopharmacology that there was now incontrovertible evidence that single dose intravenous ketamine was associated with an improvement in depressive symptoms that could last several days. However, the actual mechanisms at work to produce the effect remained unclear. Conventional wisdom suggested that the effects of ketamine on the NMDA receptor produced the antidepressant effect. Other studies have shown several drugs that act as NMDAR antagonists with antidepressant-like effects. They also acknowledged that ketamine can produce dissociation and psychosis.

Overall, the combined data from preclinical and clinical studies using a variety of different NMDAR modulating drugs provide generally consistent evidence that antidepressant effects are associated with NMDAR antagonism, and that this is probably the primary mechanism through which ketamine is generating its antidepressant effects.

A molecular cousin to ketamine, GLYX-13 (Rapastinel), has been shown to induce antidepressant results similar to ketamine without the side effects of hallucinations, excessive sleepiness and substance abuse behavior. A study by Joseph Moskal, a molecular neurobiologist at Northwestern University, showed that GLYX-13 and ketamine produce rapid acting antidepressant-like effects in rats that lasted for 24 hours. Moskal is the Founder and Chief Scientific Officer for Naurex, the pharmaceutical company developing Rapastinel.

In February of 2014, the FDA granted fast track status to Rapastinel. Naurex, reported that Phase 2 clinical studies showed patients with major depression had a significant reduction of depressive symptoms within two hours that lasted seven days with a single dose. Repeated dosing achieved a clinically meaningful reduction in depressive symptoms that lasted ten weeks after the last drug dose. Naurex expects to begin Phase 3 clinical trials in 2015. Clinical trails are now recruiting participants to assess the effects of GLYX-13 on individuals with OCD and learning and memory in both healthy individuals and those diagnosed with Schizophrenia of Schizoaffective Disorder.

Johnson & Johnson is developing esketamine, another ketamine knock-off, and hopes to seek FDA approval in 2018. But Clinical Trails.gov, accessed in June of 2015, indicated the study for estketamine was not recruiting participants yet. Doctor Sanacara was quoted in an NPR story as saying: “I think it’s highly probable that we’ll see some version of one of these treatment being approved in the relatively near future . . . In my mind it is the most exciting development in mood disorder treatment in the last 50 years.” Sanacora has done consulting work for both Naurex and Johnson & Johnson.

The rhetoric on the clinical trials through Phase 2 for Rapastinel and esketamine sounds promising, but let’s take a wait-and-see attitude. Their molecular cousin, ketamine, has some seriously bad side effects. One question to be asked is whether or not these medications will be classified as controlled substances, as ketamine is. I think we’ll need to see whether, despite all the assurances, Rapastinel and esketamine act out just like their cousin. Like human families, bad behavior runs in pharmaceutical families.