01/29/16

High on Overdoses

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© diego_cervo | stockfresh.com

A recent CDC Morbidity and Mortality Weekly Report indicated that in 2014 more people in the U.S. died from drug overdoses than any other year on record. There were approximately one and a half times more deaths from drug overdoses than from motor vehicle accidents. Sixty-one percent (28,647) of all drug overdose deaths were from opioids; the rate has tripled since 2000. Drug overdose deaths from heroin have more than tripled in 4 years. The overdose death rate involving synthetic opioids almost doubled between 2013 and 2014.

Drug overdose deaths are up for both men and women; in adults of nearly all age groups. The following table presents data for all overdose deaths in 2013 and 2014; by sex; and by age group. The death rates per 100,000 are given, as is the percentage increase from 2013 to 2014.

2013

2014

% change 2013-2014

#

Rate

#

Rate

All

43,982

13.8

47,055

14.7

6.5%

Male

26,799

17.0

28,812

18.3

7.6%

Female

17,183

10.6

18,243

11.1

4.7%

Age Group (yrs)

0-14

105

0.2

109

0.2

0.0%

15-24

3,664

8.3

3,798

8.6

3.6%

25-34

8,947

20.9

10,055

23.1

10.5%

35-44

9,320

23.0

10,134

25.0

8.7%

45-54

12,045

27.5

12,263

28.2

2.5%

55-64

7,551

19.2

8,122

20.3

5.7%

≥65

2,344

5.2

2,568

5.6

7.7%

The authors of the Report said these figures indicate the opioid overdose epidemic is worsening. That almost seems to be an understatement. In a CDC Press Release Tom Frieden, the Director of the CDC, said the increased number of overdose deaths was alarming. “The opioid epidemic is devastating American families and communities. To curb these trends and save lives, we must help prevent addiction and provide support and treatment to those who suffer from opioid use disorders.” He added how important it was for law enforcement to intensify its efforts to reduce the availability of heroin, illegal fentanyl and other illegal opioids.

The 2014 data on overdose deaths showed there were two interrelated trends driving the increase: “a 15-year increase in overdose deaths involving prescription opioid pain relievers and a recent surge in illicit opioid overdose deaths, driven largely by heroin.” Natural and semisynthetic opioids, which include oxycodone and hydrocodone, continued to be the most common type of opioid involved in overdose deaths.

Drug overdose deaths involving heroin continued to climb sharply, with heroin overdoses more than tripling in 4 years. This increase mirrors large increases in heroin use across the country and has been shown to be closely tied to opioid pain reliever misuse and dependence. Past misuse of prescription opioids is the strongest risk factor for heroin initiation and use, specifically among persons who report past-year dependence or abuse. The increased availability of heroin, combined with its relatively low price (compared with diverted prescription opioids) and high purity appear to be major drivers of the upward trend in heroin use and overdose.

The 2014 rates were highest in these five states: West Virginia, New Mexico, New Hampshire, Kentucky and Ohio.  There were statistically significant increases in overdose deaths for fourteen states: Alabama, Georgia, Illinois, Indiana, Maine, Maryland, Massachusetts, Michigan, New Hampshire, New Mexico, North Dakota, Ohio, Pennsylvania and Virginia. Here is an interactive CDC map with this data.

Supporting these findings by the CDC, the National Institute on Drug Abuse (NIDA) reported in “Overdose Death Rates” that there was a 3.4-fold increase in the total number of overdose deaths from opioid pain relievers and a six-fold increase in the total number of overdose deaths from heroin from 2001 to 2014. The following charts are from the NIDA report.

prescription overdoses

heroin overdosesThe CDC pointed to four ways to prevent overdose deaths:

  • Limit initiation into opioid misuse and addiction. Opioid pain reliever prescribing has quadrupled since 1999. Providing health care professionals with additional tools and information—including safer guidelines for prescribing these drugs—can help them make more informed prescribing decisions.
  • Expand access to evidence-based substance use disorder treatment—including Medication-Assisted Treatment—for people who suffer from opioid use disorder.
  • Protect people with opioid use disorder by expanding access and use of naloxone—a critical drug that can reverse the symptoms of an opioid overdose and save lives.
  • State and local public health agencies, medical examiners and coroners, and law enforcement agencies must work together to improve detection of and response to illicit opioid overdose outbreaks to address this emerging threat to public health and safety.

Overdoses are not just a U.S. problem. The World Health Organization (WHO) estimated that globally 69,000 people die from opioid overdose each year. The World Drug Report 2014 estimated thee were 183,000 drug-related deaths worldwide in 2012. The main type of drug implicated in those deaths is opioids.

International Overdose Awareness Day reported that like the U.S. both the UK and Australia have had more deaths due to overdose than road fatalities. Nearly four Australians die each day from overdoses. Ontario, Canada had a 242% increase in fatal opioid overdoses between 1991 and 2010. European Union nations reported 6,100 overdose deaths in 2012. “It is estimated that more than 70,000 lives were lost to drug overdoses in European union countries in the first decade of the 21st Century.”

The CDC recommendations, for the most part, are ones I’d endorse. But like riders attached to big spending bills that have to be passed by Congress, the little phrase in the second recommendation “including Medication-Assisted Treatment” isn’t necessary. Medications like naloxone and naltrexone have a place in the expansion of substance use disorder treatment. But the phrase “medication-assisted treatment” refers to these medications as well as two opioids—methadone and buprenorphine—used in opioid substitution therapy. There is proposed legislation to expand the availability of buprenorphine, the Recovery for Addiction Treatment Act, in committee.

My objection is simple. You don’t “treat” an opioid use disorder with another opioid. You simply substitute dependence on one opioid for another.

I’ve regularly voiced concern over the treatment of opioid dependency with methadone and buprenorphine. Stop and think for a minute. Isn’t it reasonable to find that an individual who was physically addicted to heroin or prescription opioids would improve when they substitute ingesting enough methadone (a Schedule II controlled substance) or buprenorphine (a Schedule III controlled substance) to neutralize their physical withdrawal symptoms? The positive evidence base for opioid substitution treatment is based upon medically assisting an addict to begin using another opioid.

The “evidence-based” effectiveness of opioid “maintenance” treatment involves using these acknowledged addictive substances (methadone and burprenorphine) for weeks and even years to manage or stabilize an addiction to other opioids. There is more information on this issue in other articles I’ve written: “The Seduction of Opioid Substitution,” “Another Head for the Hydra,” and “A Double-Edged Drug.”

Another one of the drug types showing an increase in overdose deaths since 2001 in NIDA’s “Overdose Death Rates” was benzodiazepines. There has been a five-fold increase in the total number of deaths related to benzodiazepines. “Benzos” combined with opioids like methadone and buprenorphine have a synergistic effect and will give the person a heroin-like euphoria with the right drug cocktail. They also contribute to the higher rates of accidental overdose deaths. Expect the opioid overdose death rates to continue to rise even if the expansion of opioid substitution curtails overdose deaths from heroin.

01/26/16

God Circuits in the Brain

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© adamfaheydesigns | stockfresh.com

Michael Persinger said he reproduced every aspect of the “God” experience in a laboratory. He modified a snowmobile helmet that had solenoids placed over the temporal lobes. The device produced magnetic fields patterned after physiological sources in an attempt to enhance the probability of activating the brain structure from which the signal was derived. “What we have found is that individuals who show a temporal lobe sensitivity or creativity and who are very religious—in that setting—they will have a religious experience. We can generate the presence, which is defined as “God.”

The device is known as the “God helmet,” as many subjects have reported having some sort of a mystical experience or altered state while wearing it. Persinger claims that 80% of his subjects reported feeling something when the magnetic fields were applied. He calls one of the most common sensations the “sense of presence.” This is feeling like there is someone else in the room with you when there is none. The results of his experiments have been mixed, as several effects reported by Persinger have not been replicated.

He disputes the failed replication attempts, saying that the experimenters did not actually replicate his process as claimed. You can watch a shorter video and a longer video on Persinger’s God helmet. The longer one includes commentary on a session with Richard Dawkins, the famed atheist. Dawkins said: “Unfortunately, I didn’t get the sensation of a presence.” He said he was disappointed, as he would have liked to experience something like what religious people experience.

The above research with the so-called God helmet is within a controversial field called neurotheology, which is “the scientific study of the neural correlates of religious or spiritual beliefs and practices.” Aldous Huxley was the first to use the term in his novel, Island. Other researchers object to the term, preferring expressions such as the neuroscience of religion. Following the thought of Laurence McKinney, many researchers into neurotheology hold that religious thought is a recent development tied to the evolution of the pre-frontal cortex in humans.

Andrew Newberg and others posit that neurological processes driven by the repetitive, rhythmic stimulation of human ritual contributes to transcendental feelings of connection. He said that ritual turns a meaningful idea into a visceral experience. “Rituals add substance to our beliefs, and the more intense the ritual, the more likely we are to have a religious or spiritual epiphany.” But rituals are hard to study because there are so many variables to consider. But, he said they are beginning to discover that thinking about God changes our brain. “The moment we encounter God, or the idea of God, our brain begins to change” (Newberg, How God Changes Our Brain).

Different religious activities have different effects on specific parts of the brain, but this does not make the results any easier to interpret. For example, praying silently affects one part of the brain, while praying out loud affects another part. And if you repeat the same prayer over and over, one part of the brain may be activated in the first few minutes, another part might quiet down ten minutes later, while other brain functions will change after forty or fifty minutes of intense prayer.

Newberg theorizes that different areas of the brain influence our perception of God. The frontal lobe creates and integrates all your ideas about God—positive or negative, including the logic used to evaluate religious and spiritual beliefs. The thalamus gives emotional meaning to your concept of God. The occipital-parietal circuit identifies God as an object that exists in the world. The parietal-frontal circuit establishes a relationship between YOU and GOD. “It places God in space and allows you to experience God’s presence. If the amygdala is overly stimulated, it suppresses the frontal lobe’s ability to think logically about God and elicits an emotional impression of an authoritative, punitive God.

Brain_headBorder

Newberg noted how his past research focused on individuals who were deeply committed to their religious and spiritual beliefs, but he discovered that even if you could take God out of the ritual, you could still influence the brain. “Spiritual practices are designed to stimulate dramatic experiences, but you can also transfer nearly any religious ideology from one spiritual practice to another and still receive the same neurological benefits from the experience.” He cited the research of Herbert Benson in the early 1970s, when he extracted key elements from Buddhist meditation to develop the relaxation response. Read “The Brain and God,” for a further discussion of How God Changes Your Brain.

In Religion and the Sciences of Origins, Kelly James Clark said that while neurotheology has the potential of reducing God to nothing more than electromagnetic brain stimulations, there is precious little evidence to support the claim. “According to the creators of the God helmet, God-spasms (religious beliefs) are the products of perfectly natural electromagnetic processes.” If there is a natural explanation for religious belief, you eliminate the need for a supernatural one. “But so far, they have failed to come up with a natural explanation.”

Above, Andrew Newberg commented on the difficulty in scientifically studying religious rituals because of the multiplicity of variables to consider. This also impedes the scientific proof or disproof of God. First, many people see God as an infinite, all-powerful, and all-knowing being. “In contrast, we are finite, fairly weak, and limited.” So how can we know if our beliefs about God and the universe are accurate or true?  Wouldn’t we have to experience and evaluate every possible variable, every potential perspective?

Even if we could test every religious belief and spiritual practice, each of us has a brain that will interpret the data and experiences in very different ways. There may be a universal or ultimate truth, but I doubt whether the limitations of the human mind will ever allow us to accurately perceive it or find any common ground, especially when it comes to the reality of God.

Newberg noted those who believe they have received the word of God, either directly or through scriptures. “But even the Bible cannot fully capture the reality of God. Our understanding will always fall short, no matter how perfect the words may be.” I think this is true for all religious and spiritual beliefs. And I also believe it is consistent with the teachings of the Bible, which for me, is the perfect, special revelation from God to humanity. IT is revelation from God and thus true. WE are limited and could never perceive the full reality of God or his revelation in the Bible.

There is a plain revelation of the invisible attributes of God, his eternal power and divine nature, in the created order (Romans 1:20). And yet God’s thoughts are not our thoughts; his ways are not our ways. “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).

Humans have both a physical (soma) and a psychological (psyche) nature. They are then psycho-somatic unities of body and soul, so finding evidence for physiological brain activity as a believer experiences God is to be expected. The shared human nature of believers and nonbelievers indicates that similar physiological brain activity should be expected as they experience what they understand to be God. The difference is in where the individual’s faith is grounded. For Christians, that faith is in Jesus Christ. Ephesians 2:8-9 says: “For by grace you have been saved through faith. And this is not your own doing; it is the gift of God.”

If Christianity is true, there will be a final, indisputable experience of God where science, religion and spiritual experience will coincide.  I wonder what brain scans would show then.

01/22/16

Discovering Adverse Drug Events

© Sherry Yates Young | 123f.com

© Sherry Yates Young | 123f.com

Okay, you probably don’t wonder about things like how many people to visit the emergency department (ED) of a hospital when they experience serious side effects or have an adverse drug reaction (ADE) from psychiatric medications. But when 26.8 million US adults, approximately 11.5% of the adult population, are using psychiatric medications, it’s a good thing that some people do wonder—and then set out to find an answer to their question. A study published in 2014 estimated that there were over 89,000 ED visits due to ADEs from the use of psychiatric medications from 2009 through 2011. That accounted for 9.6% of all adult ADE ED visits during the same time period. Almost half (49.4%) of the visits involved adult patients aged 19 to 44 years old; 33.3% were between 45 and 64; 17.3% of the ED visits were with adults 65 and older.

Hampton et al. used nationally representative public health data to estimate the numbers and rates of ED visits and hospitalizations for ADEs from psychiatric medications among adults between January 1, 2009 and December 31, 2011. To estimate the use of specific medications, they used publically available data from the National Ambulatory Medical Care Survey. To determine the number of US adults, men and women, between 2009 and 2011, they used National Center for Health statistics estimates, which are based on US census data. They excluded all ED visits resulting from intentional self-harm, documents drug abuse, therapeutic failures, nonadherence or drug withdrawal. They looked at the following classes of drugs: antidepressants, antipsychotics, lithium salts, anxiolytics (anti-anxiety drugs) and stimulants.

The researchers found that 52.8% of the adverse events were negative reactions to the drug. Unintentional therapeutic overdoses accounted for 33.8% of the adverse events and 12.9% were due to allergic reactions. Most of the cases were treated and released or left against medical advice (80.7%). But 19.3% were admitted, observed or transferred to another facility. Around 73 percent of the ADEs involved one implicated medication.

But the percentage of individuals seeking treatment for ADEs who were using multiple concurrent medications was high. Only 34.4% were only using one medication. 34.5% were using 1 to 3 medications. 17.7% were using 4 to 5 medications and 13.4% were using six or more concurrent medications. Polypharmacy of four or more concurrent medications involved 31.1% of the ED visits.

Ten specific medications, either alone or in combination with other medications were involved in 57.5% of the adverse drug—related ED visits. The brand names of the medication are in parenthesis. Surprisingly, Ambien or its generic version, was the number one medication implicated in adverse drug—related ED visits. Among adults 65 and over, Ambien alone was responsible for 21% of ED visits.  See the table below.

Data from the Drug Abuse Warning Network have shown that ED visits for zolpidem ADEs increased 220% from 2005 to 2010, and previous studieshave indicated that zolpidem use is associated with a substantial risk of falls. While the FDA’s recent efforts to modify recommended dosing regimens hold promise for reducing zolpidem ADEs, clinicians can also reduce zolpidem ADEs by prescribing zolpidem for insomnia, its sole FDA-approved indication, only after considering other treatments such as sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive behavior therapy.

Medications

No of Cases

Estimated # of visits

% of visits 

Zolpidem (Ambien)

445

10,212

11.5

Quetiapine (Seroquel)

320

6900

7.7

Alprazolam (Xanax)

241

5616

6.3

Lorazepam (Ativan)

233

5517

6.2

Haloperidol (Haldol)

250

4879

5.5

Clonazepam (Klonopin)

215

4571

5.1

Trazodone (Oleptro)

182

4249

4.8

Citalopram (Celexa)

175

4143

4.6

Lithium

217

4034

4.5

Risperidone (Risperdal)

166

3662

4.1

Antipsychotic medications, such as Seroquel, and lithium salts were implicated in significantly more ED visits relative to the number of outpatient visits at which they were prescribed than other psychiatric medications.” Since over 60% of antipsychotic prescribing has been found to be for off-label uses, it is probable that many of these ED visits were from off-label use. Disturbingly, “well over half of the off-label use of antipsychotics may be based on inadequate evidence.

Concerns about antipsychotics’ risks and their possible overuse have prompted the leaders of the American Psychiatric Association to urge providers to prescribe antipsychotics cautiously and only after exploring the feasibility of using alternate treatments.Avoiding antipsychotics in favor of other options less likely to cause ADEs could be particularly appropriate when considering treatment of major depressive disorder, insomnia, or anxiety disorders because the FDA has not approved the use of any antipsychotic for the first-line treatment of major depressive disorder, the use of any antipsychotic for the treatment of insomnia, or the use of any atypical antipsychotic for the treatment of anxiety disorders.

So adverse drug events with psychiatric medications contribute to a significant amount of the ED traffic in US hospitals. And the majority of them were from the misuse of ten specific medications. But it also seems that these adverse events are under reported—perhaps intentionally.

The FDA has an Adverse Event Reporting System (FAERS) that is the government’s primary safety surveillance system for harm resulting from therapeutic drugs. The Institute for Safe Medicine Practices published a Quarter Watch Report that concluded FAERS suffered from “a flood of low quality reports from drug manufacturers and it has not yet been updated for the changing environment in which drugs are marketed to health professionals and consumers.”

The FAERS system is critically important for two reasons. First, a majority of new FDA safety warnings on FDA approved drugs are generated from these ADE reports. “Despite its limitations, FAERS is the most reliable system for discovering new drug risks that had not been identified in pre-market drug testing.” Second, no other system has comparable international scope. It is sensitive enough to detect rare but catastrophic adverse side effects and the capacity to identify unexpected potential injuries.

The total number of adverse events reported to the FDA over a calendar year ending at the first quarter of 2014 (847,039) was more than double that of 2009 (336,753). Additionally, 96.6% of the case reports were collected and written by drug manufacturers. “Thus, the performance of the drug manufacturers, combined with FDA regulations and compliance activity, determines the quality, coverage and completeness of this safety surveillance system.” While the increased numbers of submitted reports indicate the drug manufacturers are now reporting radically more ADEs than in the past, the overall completeness of the reports was poor.

While drug manufacturers are now reporting adverse drug events in unprecedented numbers from around the world, we judged that the overall completeness of adverse event report was poor. For example, in 36% of cases the age of the patient was not determined; in 44% of cases no event date was indicated. A report was classified as reasonably complete if it contained age, gender, and an event date. While 85% of serious reports sent directly to the FDA were reasonably complete, only 49.4% of the manufacturer serious reports met this basic standard. We also identified thousands of case reports where the adverse event was classified as non-serious and indicated only common health problem such as a cold (n = 1,889), the sniffles (n = 906), or an injection that had been painful (n = 4,331). Manufacturer report quality for serious adverse events varied widely. The weakest performance was seen in four companies that submitted reasonably complete reports in only 15% or fewer cases; not one manufacturer equaled the FDA’s 85% record for complete reports; and only 5/74 (7%) manufacturers reported at least age and gender in 90% or more serious reports.

Some of the problems in the reporting system are that it does a poor job with ADEs from older generic drugs and for events involving newborns and children. For birth defects, the reporting is even more limited. Given the drastic increase in the use of psychiatric medications with children over the past twenty years, this seems to be a serious and dangerous flaw. “Even though 86% of outpatient prescriptions are for generic drugs, according to IMS Health Inc., the major brand name manufacturers provide the overwhelming majority of adverse event reports, even when sales of the brand name drug are extremely small.” And despite major global changes with medications and technology in the past fifteen years, the legally binding FDA guidance document specifying how drug manufacturers are to collect and report ADEs since 2001.

The Institute for Safe Medicine Practices concluded that improving FAERS should be a top priority of the FDA. Modernizing the ADE reporting requirements would provide a low-cost opportunity to improve safety surveillance as well as reduce some of the burden on drug manufacturers and focus resources in a more productive direction.  Some changes are straightforward: “We can’t think of a good reason why the quality and completeness of serious adverse event reports collected by drug manufacturers is so much worse than those collected online at the FDA.” The failure to get basic information like the patient’s age in 36% of the cases of adverse events suggests poor quality control and weak collection systems. “And does the system really need thousands of non-serious reports of the sniffles or that an injection was painful?”

Other changes may require substantial discussion and debate. Developing clear and usable protocols for manufacturer-initiated contacts with patients or health professionals may require new report data elements, and specific lists of questions to ask. Improving the quality of patient death reports is non-trivial because patient deaths typically involve multiple contributing factors, and assigning cause may be a subjective medical judgment. But there is no point in manufacturers submitting thousands of reports of deaths in which a possible drug role was never alleged, ascertained, or investigated. In all of these situations, much could be gained from requiring a simple critical question in company-initiated contacts that asked: “Was the drug suspected of contributing to the event?”

But can these simple and reasonable changes ever make it past the vast lobbying efforts of the pharmaceutical industry? Links to other reporting on this FDA study can be found here on Mad in America: “FDA System for Recording Adverse Drug Effects Perilously Deficient.”

01/19/16

Stress Sensitivity in Addiction and Relapse

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© felix Pergande |123rf.com

For addicts and alcoholics their drug of choice is often THE method of stress management. Having a difficult time with a rebellious teenager? Drink. Got in a car accident in the midst of a stressful week? Get high. Fired after telling off a demanding boss? Drink. Sometimes the stressor can be as minor as working long hours. Situations like these are commonly heard in recovery. All of the stressors leading to active drinking or drug use described here have happened in real life. Could it be that addicts and alcoholics are more sensitive to stress?

Researchers Mary Jeanne Kreek and George Koob have been systematically collecting evidence on the role of stress in drug abuse and relapse for a number of years. In a research paper published in 1998, Drs. Kreek and Koob noted that a variety of imaging techniques have demonstrated that chronic drug abuse causes alterations in specific aspects of brain function that are persistent over time, and in some cases, may be permanent. These abnormalities could contribute to adverse symptoms that are ultimately relieved by further drug use. In behavioral modification terms, this is known as the process of negative reinforcement—a behavior (drug use) is strengthened by removing or stopping an aversive stimulus (stress).

Initially drug use is motivated by the user’s high, but continued use leads to tolerance—adaptation to the presence of the drug. So another source of reinforcement, “the negative reinforcement associated with relieving negative affective and physical consequences of drug termination” becomes part of the cycle of drug use and addiction. The stress of living life on life’s terms could be magnified by brain abnormalities that result from a person’s increased difficulty coping with stressful situations.

Kreek and Koob have demonstrated in their research that the nervous system of an addict is hypersensitive to chemically induced stress. Steven Stocker, writing for NIDA, the National Institute on Drug Abuse, said Kreek’s research has suggested this hypersensitivity could exist before any initial drug use; or it could result from the effects of chronic drug use of the brain; or it could be due to a combination of both factors.

Stocker described how the stress hormone cycle of the body works. Initially, the body reacts to stress by secreting hormones into the blood and neurotransmitters in the brain. Some of the neurotransmitters seem to be either similar to the hormones, but acting in a different capacity in the brain. As the hormones travel through the body, they alter the metabolism of food so that the brain and muscles have enough metabolic fuel for potential activities such as fight of flight in response to the perceived source of stress. Within the brain, “the neurotransmitters trigger emotions, such as aggression or anxiety, that prompt the person to undertake those activities.”

Normally, stress hormones are released in small amounts throughout the day. But when the body is under stress, the level of these hormones increases dramatically. This process begins with the release of a hormone called corticotropin-releasing factor (CRF) by a part of the brain called the hypothalamus into the blood. CRF travels to the pituitary gland and stimulates the release of another hormone called adrenocorticotropin (ACTH). Then ACTH in turn triggers the release of cortisol and other hormones from the adrenal glands.

Cortisol travels throughout the body, helping it to cope with stress. If the stressor is mild, when the cortisol reaches the brain and pituitary gland it inhibits the further release of CRF and ACTH, which return to their normal levels. But if the stressor is intense, signals in the brain for more CRF release outweigh the inhibitory signal from cortisol, and the stress hormone cycle continues.

You can see a graphic depiction of this stress hormone cycle in the NIDA note written by Stocker. The stress hormone cycle is controlled by a number of other chemicals in addition to CRF and ACTH, among which are neurotransmitters called opioid peptides. These opioid peptides are chemically similar to drugs like heroin and morphine. “Dr. Kreek has found evidence that opioid peptides also may inhibit the release of CRF and other stress-related neurotransmitters in the brain, thereby inhibiting stressful emotions.”

It appears that heroin and morphine will inhibit the stress hormone cycle and thus the release of stress-related neurotransmitters just as the natural opioid peptides do. So when someone uses heroin or morphine (I’d think this could be applied to all or most natural or synthetic opioids), the drugs increase the inhibition of the stress cycle already being provided by the opioid peptides and help with the regulation of an emotional response to stress. Dr. Kreek suggested that individual addicts and alcoholics having difficulty coping with stressful emotions could find that using their drug of choice helps to blunt those emotions, which “could be a major factor in their continued use of these drugs.”

As the effects of opioid drugs wear off, the addict goes into withdrawal. During withdrawal, the level of stress hormones rises in the blood, and stress-related neurotransmitters are released into the brain. Unpleasant emotions are triggered by these chemicals, driving the addict to take more opiates. The short half-life for most opioids (like heroin) lasts only 4 to 6 hours. So opiate addicts can cycle through withdrawal three or four times a day. The constant switching of the stress systems of the body off and on heightens the stress sensitivity of the person. “The result is that these stress chemicals are on a sort of hair-trigger release. They surge at the slightest provocation.”

It seems a similar process could explain what happens to addicts who resume active drug use after a period of extended abstinence. If chronic drug abuse leads to long term or permanent dysregulation of the stress hormone cycle, then stressful periods of life have the potential to trigger dysregulation of the cycle and possibly lead to a resumption of drug use as a way to manage the stress.

I know someone who has said they feel the most “normal” in life when they are high. Chronic dysfunction and stress in their life seems to have repeatedly led them back to active drug use even after periods of extended abstinence. They’ve noticed that when they are happy (times of low stress), they feels the closest to “normal” without the influence of drugs.

In a 2007 review article, Koob and Kreek said relapse to drug addiction days, months, or years after the last use of a drug may be due in part to subtle factors that result from long-term changes or abnormalities in the brain after long-term exposure to a drug of abuse. “These changes may contribute to a general, ill-defined feeling of dysphoria, anxiety, or abnormality and also could be considered a form of protracted abstinence.” Genetic factors and early environmental factors could also contribute to some individuals being more vulnerable to acquiring drug addiction and relapse to drug use after achieving abstinence.

This increased vulnerability to stress, whether it is temporary or permanent, does not make a person “constitutionally incapable” of establishing and maintaining abstinence. But it does point to a serious relapse trigger and relapse warning sign that many addicts and alcoholics will have to actively monitor and manage—their stress levels. An excellent place to get help in managing stress if you are a recovering addict or alcoholic is a blog by Terence Gorski: “Using Stress Management in Relapse Prevention.”  “Managing Stress in Recovery” will describe my musings on Gorski’s model of stress management when I post the article here sometime in the next couple of weeks.

01/15/16

Sure Signs of Revival

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© petervick167 | 123rf.com

Beginning in December of 1734, the first wave of revival in Northampton Massachusetts reached its zenith around March and April of 1735. In his account of that time, A Faithful Narrative of the Surprising Work of God, Jonathan Edwards observed there were two effects. First there was a change in former sinful practices. People forsook their former vices.  They stopped their old quarrels and backbitings. “The tavern was soon left empty.”

The other effect was that people earnestly applied themselves to the “means of salvation.” That is, they actively prayed, read Scripture, meditated, sought out private conference (counseling) with their minister and actively participated in worship. “It was no longer the tavern, but the minister’s house that was thronged far more than ever the tavern had wont to be.” Some who had been exceedingly entangled with one temptation or another “were soon helped over former stumbling blocks.

According to Ian Murray, Edwards’ Faithful Narrative was possibly the most important book to precede “the great evangelical awakening on both sides of the Atlantic.” It went through three editions and twenty printings between 1737 and 1739. It also caught the attention of men like John Wesley, who wrote in his journal of “the truly surprising narrative of conversions lately wrought in and about the town of Northampton, in New England.” But the fire of revival burned down to the point that one minister wrote in the spring of 1740, “Religion lay as it were a-dying and ready to expire its last visible breath of life in this part of the visible church.”

But then George Whitefield reached Philadelphia at the beginning of November in 1739. On November 16th, he wrote to Edwards at Northampton. In a letter from Edwards to Whitefield dated February 12, 1740, he invited Whitefield to stop at Northampton. Within his letter, Edwards said: “I have a great desire, if it be the will of God, that such blessing as attends your person and labours may descend on this town.” Whitefield was not able to come to Northampton for another eight months. But as Ian Murray commented in his biography of Jonathan Edwards, by then “a general revival in the country had already begun.”

On October 17, 1740, George Whitefield wrote in his journal that he crossed the ferry to Northampton Massachusetts, where 300 souls had been “savingly brought home to the dear Lord Jesus” 5 or 6 years ago. That evening in the church where Jonathan Edwards was the pastor, he reminded the congregation of their former experiences; how zealous and lively they were at that time: “Both minister and people wept much.” Whitefield preached again on Saturday and twice on Sunday. Edwards was again noted by Whitefield to be weeping at the Sunday morning sermon and the people in attendance were equally, if not more, affected. Of the Sunday afternoon sermon, Whitefield said the Lord kept the good wine for last. He had not seen four such gracious meetings together since his arrival. Whitefield wrote in his Journals:

My soul was much knit to these dear people of God, and tho’ I had not time to converse with them about their experiences, yet one might see, that for the most part, they were a gracious tender people; and tho’ their former fire might be greatly abated, yet it immediately appeared, when stirred up.

Edwards wrote in a letter that a “visible alteration” had begun in Northampton in the spring before Whitefield’s visit. “There was more serious and religious conversation, especially among the young people.” Individuals were frequently consulting with their minister about salvation. And these changes continued until the time of Whitefield’s visit. Edwards described the effect Whitefield had as follows:

The congregation was extraordinarily melted by every sermon; almost the whole assembly being in tears for a great part of sermon time. Mr. Whitefield’s sermons were suitable to the circumstances of the town; containing a just reproof of our backslidings, and in a most moving and affecting manner, making use of our great professions, and great mercies, as arguments with us to return to God, from whom we had departed.

Edwards said that immediately afterwards people seemed more engaged in religion. They met together and talked with one another about religious things. They embraced every opportunity to hear the word preached. This continued throughout the following year. Ian Murray said: “No one could well keep track of the number of places which were also witnessing the revival.” The Great Awakening had begun.

In May of 1741, two people were “so greatly affected with a sense of the greatness and glory of divine things,” that it had a visible effect on their bodies. These scenes became common and reached their peak, according to Edwards, in August and September.

The months of August and September were the most remarkable of any this year, for apprearances of the conviction and conversion of sinners, and great revivings, quickenings, and comforts of professors, and for extraordinary external effects of these things. It was a very frequent thing, to see a house full of outcries, faintings, convulsions, and such like, both with distress, and also with admiration and joy.

Edwards and other preachers of the Awakening were constantly in demand to travel and preach in other towns. One of the places to which Edwards received and accepted an invitation was to the town of Enfield Connecticut, about thirty miles south of Northampton. He had been invited to preach there by the Enfield minister because he saw the town as “particularly stubborn to the message of the gospel.”

He repeated a sermon he had previously given to his own congregation, using Deuteronomy 32:35 as his text, on the subject of “Sinners in the Hands of an Angry God.” According to John Currid in his Foreword to the P&R Publishing edition of Edwards’ famous sermon preached at Enfield, the response of the congregation was amazing. Before Edwards had finished the sermon, people were moaning, groaning and crying out, wanting to know what they needed to do to be saved. An eyewitness said that Edwards was obliged to speak to the people and ask them to be quiet so that he might be heard. His preaching style was not flamboyant, like Whitefield. He “set his eyes on the bellrope at the rear, and spoke the words in a level tone, and with no high pomp of rhetoric or oratory.”

Incredibly, Edwards never mentioned this sermon in any of his other writings. Currid speculated this was because what happened in Enfield was a common occurrence in the revival of the summer of 1741.

Some of Edwards’ published works on revival, namely A Faithful Narrative of the Surprising Work of God, and The Distinguishing Marks of a Work of the Spirit of God were published and extensively circulated in England and Scotland at the time. Among those who were greatly encouraged to seek a time of revival from reading these works of Edwards was William McCulloch, the minister at Cambuslang. Providentially, George Whitefield had a crucial role in igniting the revival fires at Cambuslang as well as Northampton. See more on this in “Swift as Lightning.”

It’s been over 250 years since the Great Awakening and the times of revival at Northampton and Cambuslang. In both places, the physical effects were seen as incidental to the work of the Holy Spirit in the revival by many of its leaders. In Distinguishing Marks, Edwards said he did not expect a future restoration of the miraculous gifts described in First Corinthians 13, not did he desire it. It appeared to him it would add nothing to that time and would even diminish it.

I would therefore entreat the people of God to be very cautious how they give heed to such things. I have seen them fail in very many instances, and know by experience that impressions being made with great power, and upon the minds of true, yea eminent, saints—even in the midst of extraordinary exercises of grace, and sweet communion with God, and attended with texts of Scripture strongly impressed upon the mind—are no sure signs of their being revelations from heaven.

The sure signs of revival are not the “extraordinary external effects,” the moanings, the fallings, the crying out. There is a visible alteration—you renounce your former vices and sins and you earnestly apply yourself to the means of salvation. These signs of revival proceed from a new heart; a heart of flesh to replace your heart of stone.  And God will put his Spirit within you and cause you to walk in his statutes and obey His rules (Ezekiel 36:26-27).

01/12/16

Benign Coercion

© Colour | stockfresh.com

© Colour | stockfresh.com

Recently, two psychiatrists, Sally Satel and E. Fuller Torrey, wrote their second article, “Stop ignoring the needs of the seriously mentally ill,” for the American Enterprise Institute in support of the Helping Families in Mental Health Crisis Act of 2015 (H.R. 2646).  In their November 3, 2015 article, they bemoaned the opposition of what they referred to as a small but vocal faction of “advocacy groups opposed to all involuntary mental-health care” who have the ear of some committee Democrats.  According to Satel and Torrey, the problem is that these critics and the lawmakers receptive to their claims don’t seem to grasp the difference between serious mental illnesses and less disabling psychiatric conditions.

They highlighted three areas that in their opinion are particularly important aspects of H.R. 2646 that need to be passed. They want to see the creation of a new position, an assistant secretary for mental health and substance abuse, who would: “focus on coordinating the federal government’s programs and elevating the importance of caring for the most debilitated patients.” All the current funding and authority of the existing federal agency, SAMHSA, (Substance Abuse and Mental Health Services Administration) would be placed under this new assistant secretary. Allegedly, these radical advocacy groups oppose the creation of the position because of a threat to their current funding from SAMHSA.

The second major area of concern is the so-called assisted outpatient treatment (AOT) provision. AOT is said to be “a cost-saving and effective form of civil-court-ordered community treatment,” that targets individuals who habitually fall into a pattern of “self-neglect, self-harm, or dangerousness” when they are not taking medication. A judge could order these individuals into mandated and monitored “treatment” while they continue to live in the community. A violation of the court-ordered treatment conditions could results in “an evaluation of a patient’s need for further treatment.”

The third perceived concern is the expansion of psychiatric beds. The main culprit they point to seems to be the “outdated” law called the IMD exclusion, which prohibits Medicaid from paying for care delivered by “institutions for the treatment of mental diseases” (IMDs) for individuals between the ages of 22 and 64. This is supposed to have contributed to a shortage of psychiatric hospital beds. The authors claim there is a need for twice number of existing inpatient beds. Citing data from H-CUP, they said schizophrenia and bipolar illness represented two of the top three causes of 30-day Medicaid inpatient re-admissions. “Along with diabetes, these conditions resulted in about $839 million in hospital costs.”

In truth, these provisions are vital to the reversing the marginalization of the sickest patients by SAMHSA and the inadvertent problems caused by Medicaid’s disincentives. Misconceptions about the needs of these patients must not be allowed to interfere with the bill’s mark-up, so it will emerge from the Health Subcommittee with its bold and much-needed provisions intact.

David Shern, a Senior Associate in the Department of Mental Health at the Bloomberg School of Public Health, John Hopkins University, responded to the article by Satel and Torrey in “We Need REAL Change in Mental Health Policy, Not the Illusion of Reform.” Shern described the above three changes as simplistic approaches that ignore core parts of the problem. “They are ‘quick fix’ solutions that have little promise of doing much to address our contemporary crisis.” He agreed with the key features of the problem: incarcerating too many people with severe mental illness and a lack of effective engagement strategies with the mentally ill population. He agreed that a comprehensive approach to the problems was necessary. But “Drs. Satel and Torrey propose more of the same – strategies that have characterized the last 50 years.”

He said there was no reason to believe that adding an Assistant Secretary title to the existing bureaucracy would make any difference within HHS. Additionally, the new position would have no effect on other governmental departments critical for the community life of mentally ill individuals. “We’ve repeatedly learned that reorganizations are appealing but rarely accomplish the magic that the reorganizers hope to achieve.”

He then observed how “Involuntary Outpatient Commitment” has been renamed as “Assisted Outpatient Treatment” in H.R. 2646. The current legislation does nothing to improve the existing community service capacity. Provisions in the original version of the Helping Families in Mental Health Crisis Act actually called for cut backs in funding for existing community services. I’m not sure if those same cuts are still there. So according to Shern, “Creating a legal mechanism to compel individuals into a non-existent system is a cruel fiction that creates the illusion of fixing a problem.”

Ostensibly, for people who are not compliant with the system’s idea of care, having a judge order an individual to comply with the treatment plan will fix the problems of an inadequate system. (An inpatient stay is the ‘punishment’ for noncompliance.)

The third leg of the proposed reform involved “opening a spigot” of funding for inpatient services that was initially closed to keep states from shifting inpatient costs onto the federal government (the IMD exclusion). “That danger still exists.” Any expansion of residential alternatives should involve a systematic appraisal of the system of care available in each community and a plan for allocation of resources to ensure the range of needed services. “Preferentially funding one component of the system while neglecting others isn’t a smart approach.”

I found an additional problem with the call made by Satel and Torrey for expanding the number of psychiatric beds. They curiously lumped schizophrenia and bipolar in with diabetes to then give a cost figure of $839 million in hospital costs for causes of 30-day Medicaid inpatient re-admissions for adults between the ages of 18 and 64. I thought it was strange to have schizophrenia and bipolar disorder lumped in with diabetes in assessing hospital re-admission costs. Following the above link they provided to the H-CUP data they referenced, it seemed they took their cost figure from Table 3, which contained ten conditions with the most all-cause, 30-day re-admissions for Medicaid patients (aged 18-64).

The first thing I saw was that diabetes costs could have been easily left out of their figure, meaning that $839 million should have been $588 million for schizophrenia and bipolar re-admissions alone. The second thing I noticed was Satal and Torrey referred to the H-CUP category of “Mood disorders” as “bipolar.” Bipolar disorders are mood disorders, but so are the depressive disorders.  The NIH estimate of the prevalence of severe bipolar disorder among U.S. adults was 2.2%. The estimated prevalence for major depression among U.S. adults was 6.7%. If the combined re-admission costs for all mood disorders was $588 million, what was the cost for just bipolar disorders? If the ratio was evenly distributed, it would be roughly one-third of the $588 million figure—$196 million. Or do Satel and Torrey support “assisted outpatient treatment” for individuals refusing to remain on medication for major depression as well as bipolar disorder? What about the less serious mood disorders, like anxiety?

Was the reference of the H-CUP category of “mood disorders” as “bipolar disorder” intentional or not? Traditionally, bipolar disorder is seen as the most serious mood disorder. I don’t believe they were confusing the difference between serious mental illnesses and less disabling psychiatric conditions, as they suggested of the critics of H.R. 2646 and lawmakers above. So unless it was an unintentional slip, they were intentionally referring to the general category of mood disorders by its most serious condition: bipolar disorder.

The underlying assumption for the need of an assisted outpatient treatment (AOT) provision is that the targeted individuals fall into this pattern of self-neglect, self-harm, or dangerousness” because they are not taking medication. But the treatment efficacy for psychiatric medications has been increasingly questioned. Antidepressants have been shown to be of minimal value (See “Dirty Little Secret” and “Do No Harm with Antidepressants” and The Emperor’s New Drugs, by Irving Kirsch for more information). And the adverse consequences from neuroleptics and mood stabilizers have raised serious questions about the long-term use of such medications for schizophrenia and bipolar disorder (See “Creating Chemical Imbalances,” “Antipsychotic Big Bang,”  “Abilify in Denial” and Anatomy of an Epidemic, by Robert Whitaker for more information).

There is nothing benign about the assisted outpatient treatment provision within the Helping Families in Mental Health Crisis Act of 2015 (H.R. 2646). But it certainly is coercion. See “Murphy’s Law” for more on H.R. 3717, the original bill. See “Regarding Representative Tim Murphy’s Helping Families in Mental Health Crisis Act” for more information on H.R. 2646.

01/8/16

Academic Steroids

© ninto | stockfresh.com

© ninto | stockfresh.com

In response to the growing problem of the abuse of ADHD medications by college students, colleges and universities are instituting a variety of new campus rules. Some college clinicians are forbidden from diagnosing ADHD. Several now require students who bring ADHD medication from home to sign a contract that they will not divert their medications. Others require students to sign a release to have school officials confirm the truth of reported symptoms with parents. Duke University declared the nonmedical use of ADHD drugs to be a form of academic dishonesty. And Harvard is being sued for malpractice by the parents of a student who received an ADHD diagnosis and medication after one meeting with a clinical nurse specialist.

Mad in America pointed to an article by Watson et al., “The ADHD Drug Abuse Crisis on American College Campuses” and noted that ADHD drugs like Ritalin and Adderall have become so common on college campuses that there have been “exponential increases in emergency room visits, overdoses, and suicides by students taking these drugs.”

While ADHD meds are popularly known as “academic steroids,” there is no clear evidence that they facilitate cognitive functioning or scholarship. In fact, “compelling new evidence indicates that ADHD drug treatment is associated with deterioration in academic and social-emotional functioning.” Lower GPAs have been found to be associated with HIGHER rates of ADHD drug abuse in a couple of studies (Arria et al., 2008; McCabe et al., 2005). But this effect is not just limited to students with lower GPAs. ADHD drug abuse is a more common problem at competitive colleges and universities with high admission standards. “There is an emerging trend for medical students to abuse these drugs.”

There was a story in The New York Times about a student who died from prescribed ADHD medications. He never had ADHD, but used a classmate’s ADHD medications to cram for exams. Then he decided to get his own prescription to help him study for medical school entrance exams. He had been a presidential scholar with a high GPA. His academic performance plummeted AFTER he began to use ADHD drugs. This raises the possibility “that low GPAs may often follow—not always precede—use of the medication.” Eventually he became violently delusional and spent a week in a psychiatric hospital. Upon his release, his doctor gave him another prescription for 90 days of Adderall. He hung himself in his bedroom two weeks after he was out of Adderall.

The substantial risk associated with stimulant drug treatment might be best evaluated against associated academic and/or social emotional gains—namely, the reason that the drugs get prescribed in the first place. After 30 years of research on the topic, not a single study has linked ADHD drug treatment with improved academic outcomes. Hundreds of studies have documented that it is associated with short-term improvements in focus and performance on boring, repetitive tasks; nevertheless, these gains have not been shown to translate to improvements in higher order learning or scholarship.

ADHD drugs have a high addictive potential and as early as 1995, the DEA was warning about the potential for abuse with methylphenidate, the generic name for Ritalin, Concerta, and Daytrana. Although it is regularly described as benign, it has the same abuse potential as other Schedule II stimulants, like cocaine and methamphetamine.

It’s been long established that neither drug addicts nor lab rats can distinguish between cocaine and methylphenidate [Ritalin, Concerta, Daytrana]. Now, a growing body of evidence has actually linked methylphenidate treatment to an increase proclivity toward cocaine abuse in rats. These preclinical findings add to the cautionary note about lax attitudes toward ADHD diagnosis, which has the potential to become the gateway to more serious substance use and abuse.

The lead author of the article, “The ADHD Drug Abuse Crisis on American College Campuses,” Gretchen LeFever Watson, is no stranger to the ADHD wars. In the mid 1990s, she began a program of ADHD research. When LeFever et al. published their findings in the American Journal of Public Health, they concluded that the high prevalence rates found by their study suggested that “ADHD was overdiagnosed and overtreated in some groups of children.” They called for additional prevalence studies:

Further research is needed to clarify the long-term social, psychological, and biological consequences of ADHD drug therapy; to determine the prevalence of multimodal ADHD treatment; and to provide a framework for design and implementation of educational programs that ensure appropriate use of stimulant medications and nonpharmacologic interventions.

But in the course of her ongoing efforts to improve ADHD treatment in southeastern Virginia, the area where she did her research, “LeFever was repeatedly attacked for reporting high rates of ADHD diagnosis and treatment.” One of the attacks was an anonymous allegation of scientific misconduct. Although she was ultimately cleared of all allegations, the net effect of the attacks against her was that her research into psychosocial interventions that “raised questions about the effectiveness of ADHD drug treatment was terminated and study findings were suppressed.” You can read a detailed description of LeFever’ s research and the attacks on her here: “Shooting the Messenger: The Case of ADHD.”

The reason her work was targeted is simple—it conflicted with drug industry interests. So ADHD experts with ties to the pharmaceutical industry repeatedly launched ad hominem attacks upon LeFever Watson and her work. “These attacks ultimately led to a decade of significant ADHD research and community-based interventions being mischaracterized in professional venues and media outlets.” The eventual suppression of her work contributed to the escalation and expansion of ADHD diagnosis and drug treatment among Americans of all ages.

The rate of ADHD diagnosis now exceeds all reasonable estimates of the true prevalence of the disorder. As a consequence, ADHD drugs are readily available on American high school and college campuses where they are increasingly abused with serious and sometimes lethal consequences.

01/5/16

They Shall Become One Flesh

Before Eve

© Wiley Miller | wileytoons.com

In the satirical comic strip, Non Sequitur by Wiley Miller, there is a series he’s done over the years with the title B.E. (Before Eve), “When men were men because there weren’t any women yet.” In one cartoon panel, Adam is hanging out with his all male animal buddies, drinking beer, eating pizza and watching sports on TV. When he began to get a feeling that something was missing in his life, that his glass was half full, Rolph, his dog friend, took Adam’s beer glass and filled it from the beer tap. Adam attempted to say he was speaking metaphorically, and Rolph interrupted him, saying that was as deep as they should get on Super Bowl Sunday.

Another time when Adam felt he needed something more substantial in his life, Rolf and went to “the Big Guy,” so God invented stout beer. . . . and it was good. Not meant to portray biblical truth, nevertheless the B.E. comics illustrate the duality of fulfillment and the sense of something missing that would have been the experience of a single male “Man” alone within the created order.

“But for Adam there was not found a helper fit for him” (Genesis 2:20).  Intriguingly, the first step in God’s making a suitable helper for the man was to have Adam exercise his stewardship responsibilities (Genesis 1:26) in naming the animals. But this naming process had an additional purpose besides being the first taxonomy of the animal kingdom. God was preparing Adam to see his need for a mate and helper.

While he was like the other creatures because he was made from the ground, Adam was also unique among these creatures because he was created in the image of God and commissioned by God to rule over the order (Genesis 1:26-30). Kenneth Mathews noted in his commentary on Genesis that a systematic search among all creatures would have demonstrated to Adam that he was alone among all created beings in the sense that he was one of a kind. He could not fill the earth and subdue it; he could not be fruitful and multiply, if he continued on in the condition of being “alone” without a suitable helper.

So God caused a deep sleep to fall over Adam. And while he slept, God took a rib (sēlāʿ) from the man and made from it a woman (Genesis 2:21-22). In The Theological Wordbook of the Old Testament, John Hartley suggested the Hebrew word for rib here is better translated as “side.” This passage is the only time in the Old Testament where sēlāʿ is used in reference to man. With the exception of Second Samuel 16:13, it has an architectural sense, referring to the sides of objects like the ark of the covenant (Exodus 25:12, 14); or a location within a building (Exodus 26:35).

It can also mean a side chamber (I Kings 6:5; Ezekiel 41:6). “This picture describes the intimacy between man and woman as they stand equal before God.” As Matthew Henry famously said: “That the woman was made of a rib out of the side of Adam; not made out of his head to rule over him, nor out of his feet to be trampled upon by him, but out of his side to be equal with him, under his arm to be protected, and near his heart to be beloved.” Kenneth Mathews commented that the symbolism of the “rib” is that the man and the woman are fit, suitable companions for one another—socially and sexually. So when God presented the woman to the man, Adam spoke for the first time:

Then the man (ʾādām) said,

“This at last is bone of my bones

and flesh of my flesh;

she shall be called Woman (ʾiššâ),

because she was taken out of Man (ʾîš).” (Genesis 2:23)

The poetic form of the verse underscores the importance of this creative event: God made a distinct helper and companion for Adam that was his metaphysical equal, for she was taken out of him. A suitable companion could not be found among the animals, so God made a fit helper out of the flesh and bone of Adam himself. God fashioned the man’s rib into a woman (Genesis 2:22); so the man (ʾādām) named his companion woman (ʾiššâ), because she was made from man (ʾîš). In Beyond Sex Roles, Gilbert Bilezikian commented that since woman was taken from man, there could be no confusion about her full participation in humanity. “She was made from the same material as his own body.  From one being, God made two persons.”

The woman is not a mere extension of the man. She is created with a unique individuality in her own right without a suggestion of inferiority. Yet being formed from the man’s body, she has a continuity with him not found in any other creature.  Hartley again made a helpful observation: “Therefore woman’s origin makes it possible for a man and a woman to establish a dynamic relationship in which they become ‘one flesh’ (cf. Gen 2:24).”

There seems to be a unique relationship being acknowledged here. Bruce Waltke pointed out that while the Genesis narrator named Adam by his relationship to the ground (ʾădāmâ) in Genesis 2:7, Adam named himself in 2:23 in relation to his wife. The word for “woman” here (ʾiššâ) is the most commonly used Hebrew word for woman and wife in the Old Testament. The Hebrew word for man (ʾîš) is typically used for an individual male in contrast to ʾādām for mankind. Frequently it is also rendered as husband (Ge 3:6). While the use here of ʾîš andʾiššâ may be nothing more than a playful literary device, the surrounding context announced the beginning of a close and intimate relationship between the man and the woman.

It reflects God’s desire to provide man with a companion who would be his intellectual and physical counterpart. The permanency intended in the relationship is expressed in the assertion that man should leave his parents and cleave to his wife.

A close relationship between the man and the woman is also suggested in Adam saying: “This is at last bone of my bones and flesh of my flesh.” The phrase ‘flesh and bone’ is used figuratively to denote kinship (e.g., Genesis 29:14; Judges 9:2; 2 Samuel 19:12-13). It can also have a covenantal meaning, as in 2 Samuel 5:1-3. Genesis 2:24 reinforced a covenantal meaning, when the narrator commented: “Therefore a man shall leave his father and his mother and hold fast to his wife, and they shall become one flesh.” Leaving father and mother and clinging to one’s wife signifies the ending of one allegiance and the beginning of another. “Already Scripture has sounded the note that marriage is a covenant, rather than an ad-hoc, makeshift arrangement.” (Victor Hamilton, The Book of Genesis Chapters 1-17) Paul clearly had this covenantal understanding in mind with his quotation of Genesis 2:24 in Ephesians 5, where he discussed marriage and how it represented the relationship between Christ and the church.

The ‘one-fleshness’ emphasizes that in a biblical marriage, the man’s primary loyalty is to his wife. Despite the bond of kinship with his parents, he is to leave them and cling to his wife; creating a new kinship bond with her.  Theirs is to be a fully shared life. “Marriage is the most profound bond that exists between two human beings; within it nothing can be withheld. . . . All other relational claims are subordinate to those of marriage.” Marriage was designed as a life-long exclusive relationship. It simultaneously puts a barricade around the husband and wife, while demolishing all barriers between them. This one-flesh union of husband and wife is actually a reunion, where the flesh and bone that God took from the man to form the woman is returned to him within the marriage covenant as his wife.

But their marital union was a union of mortal flesh: like “a wind that passes and comes not again” (Psalm 78:39). Any merely human manifestation of the redemptive purposes of God would fall short, ultimately pointing us to its needed future fulfillment in Christ. This was as true of pre-Fall marriage as it was of post-Fall marriage. The profound significance of marriage as it was instituted in Genesis chapter two would only become fully revealed with the completed work of Christ  (Ephesians 5:31-32).