09/30/16

Chantix Tug-of-War

© AndreyPopov | stockfresh.com

© AndreyPopov | stockfresh.com

On May 18, 2008, George MacDonald was at Fort Benning Georgia. George and his identical twin brother James had successfully completed Infantry Training and the Airborne Course at Fort Benning. They had also been selected for the U.S. Military Academy Preparatory School. George was a one-time Eagle Scout. He got up from his bunk to do some laundry and slipped a knife into his pocket. He approached the bunk where Rick Bulmer, who he did not know, was sleeping. Then he stabbed and slashed Rick more than 50 times. A month before, MacDonald had been prescribed Chantix by an Army doctor to help him stop smoking.

Nine hours after the killing, Macdonald wrote: “I snapped and didn’t like it … I was stretched and it made me crazy.” The military judge refused to allow an involuntary intoxication defense and quashed a subpoena issued to Pfizer by MacDonald’s lawyer. Within a month of the judge’s decision, the FDA imposed a black box warning on Chantix. “Within weeks of the military trial judge’s decision in 2009 to quash the subpoena, Pfizer began getting hit with civil lawsuits claiming Chantix had caused suicides, suicide attempts or other neuropsychiatric problems.” MacDonald was convicted of premeditated murder in 2009 and sentenced to life without parole.

The U.S. Court of appeals for the Armed Forces overturned MacDonald’s conviction saying the trial judge had erred in not allowing the involuntary intoxication defense. MacDonald agreed to plead guilty to the unpremeditated murder of Rick Bulmer and his sentence was reduced to 45 years. Bulmer’s family was outraged, according to Tom Jackman writing for The Washington Post. “’It’s a mindblower, and we don’t understand it,’ said Bulmer’s mother, Wendy Smith. ‘He cold-bloodedly killed my son. He knew what he was doing and … he should take his punishment.’”

In a 2010 clemency request for his brother, James wrote that he remarked to his brother that life had started to feel like a video game, where he was disconnected from his body. James had also been prescribed Chantix. George agreed he felt the same way. James said, “I remember the two of us waking up at night having really weird dreams, scary dreams.” In 2013, James killed himself by jumping off of a 19-story building. His sister said he never got over his grief over his brother’s ordeal. You can read more about the MacDonald case here, here  and here on McClatchyDC.

George MacDonald is not alone is claiming that his use of Chantix led to violent acts. In the beginning of August 2016, a Maryland man was found not criminally responsible for shooting his wife in the neck because he was “involuntarily intoxicated” from Chantix. A woman who was taking medication for other reasons used Chantix briefly in 2007. She got her daughter off to school and the next thing she remembered was standing in her kitchen in a puddle of blood. Six hours has passed during which she had used a kitchen knife to cut her left arm. Federal prosecutors dropped charges against a man who “who extremely psychotic and disorganized” aboard a United Airlines flight because of a “Chantix-induced psychotic disorder.”

Al Jazeera reported that Chantix has been linked to 544 suicides and 1,869 attempted suicides.  As a result of a report issued by the Institute for Safe Medication Practices that said the organization had “immediate safety concerns” about individuals operating aircraft, trains buses and other vehicles who were using Chantix, the FAA and Defense Department banned Chantix use among pilots and air traffic controllers.

Eventually some 2,700 former Chantix users sued Pfizer in 2011. Pfizer began to settle with the lawyers representing the mass of civil lawsuits at a cost of $299 million through the first quarter of 2013. Pfizer said the settlement would allow the company to focus on the benefits of the drug. This strategy has been the typical way pharmaceutical companies try to settle lawsuits they aren’t sure they can win. It keeps subpoenaed records out of the hands of the public and other individuals who may want to sue them as well. And it prevents the articulation of a coherent argument about the association between a specific drug and an adverse event from being made in the public square. It enables the pharmaceutical continue to assert as Pfizer did in a statement to McClatchy: “There is no reliable scientific evidence that Chantix causes serious neuropsychiatric events.”

Chantix is approved for use in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 10 million in the United States.

Then in April of 2016 the results of a study on more than 8,100 people were published in Lancet. The study had been ordered by the FDA because of the ongoing reports of neuropsychiatric adverse events with Pfizer’s Chantix and GlaxoSmithKline’s Zyban. “The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo.” However, the funding for the study was from Pfizer and GlaxoSmithKline.

Writing for STAT News, Ed Silverman quoted the study authors as saying: “The findings show that it is highly unlikely that (the medicines) contribute to neuropsychiatric adverse events.” The results of the EAGLES study, which the Lancet article was reporting, were processed by Clinical Trials.gov on September 1, 2016, and are available here: Clinical Trials.gov Identifier: NCT01456936.

The results may be a boon for Pfizer, which has struggled for a decade to transform Chantix into a blockbuster product, but instead has encountered negative publicity, expensive litigation, and stalled sales.

Pfizer plans to ask the FDA to remove the black box warning from Chantix. A company spokesperson said: “Available scientific evidence concerning neuropsychiatric events in patients attempting to quit smoking does not support a boxed warning in the Chantix label.” The FDA will review the findings along with additional scientific evidence as they continue to evaluate the issue.

Thomas Moore, a senior scientist with the Institute for Safe Medical Practices, said it would be a mistake to claim the study proves that severe psychiatric side effects don’t occur with Chantix. Because it was a manufacturer-sponsored study done in 140 different centers in 16 countries, Moore suggested it be independently reviewed. Early onset cases of psychosis, aggression and suicidal behaviors have been observed with Chantix by regulators in many countries, “far outnumbering those reported for other smoking treatments.”

With eight different treatment arms, the number of patients in each may not be enough to capture the severe psychiatric side effects for which the drug is known.  The study’s severity assessments were subjective judgments, and the combined endpoint included many psychiatric side effects that Chantix is not suspected of causing.

The criticism by Moore has some legitimacy. Here is a study that found Chantix (varenicline) was no better than NRT (nicotine patch) and C-NRT (nicotine patch and lozenge) with regard to abstinence. “However it is notable that there were significant adverse events of varenicline compared to NRT (e.g. nausea, insomnia, sleepiness) and C-NRT compared to NRT (indigestion, nausea, mouth problems and hiccups).” The website RxISK described several examples of “Chantix and Violence” that were originally reported in the FDA database for adverse drug events.

MacDonald’s case was one of the ones reported on RxISK. There it was reported that George and his twin brother (James) enlisted in the Army were selected for an appointment to the United States Military Academy Preparatory School.  The reported adverse effects experienced by MacDonald included: nightmares, psychosis, homicidal ideation, senseless act, and homicide. The Case report said:

Appellant had been experiencing “new and strange thoughts” including a “person [was] telling me . . . dangerous things that arent [sic] me.” These included violent thoughts of killing someone. On May 18, 2008, one month after the Army doctor prescribed Chantix, Appellant fatally attacked Private (PVT) Bulmer while he was sleeping, stabbing him to death. Prior to this attack, Appellant did not know nor had he ever interacted with PVT Bulmer.

The other cases reported suicidal and homicidal ideation, a suicide attempt, uncontrolled aggression/anger, and senseless violence. What follows are two more of the case reports on RxISK. Thomas Moore sent this information to RxISK.

By the third day of taking Chantix I was completely out of control. I woke my boyfriend up in the middle of the night and started physically beating him. I contemplated suicide about 5 times a day and contemplated homicide about 3 times a day. On Saturday while at home she got into a verbal argument with her mom over a minor issue and reports now that she was ‘totally out of hand’ and she was unable to control her impulses and was yelling and screaming and crying. She acutely became suicidal and also became homicidal threatening her mother with a shotgun. Her mother fled the house and called police. She locked herself in the bathroom and eventually calmed down.

In October of 2014, five nonprofit consumer organizations (Consumer Reports, Institute for Safe Medication Practices, National Center for Health Research, National Physicians Alliance, and Public Citizen) petitioned the FDA to require that the Chantix have boxed warnings clearly describing adverse psychiatric adverse events: suicidal behaviors, aggression/violence, psychosis, and depression. Additional risks with Chantix the petition noted were: sudden blackouts, seizures and impaired vision. I hope and expect they will again protest when Pfizer formally requests that the FDA drop its black box warning for Chantix.

For a previous article about the tug-of-war over problems with Chantix, see “Smoke and Mirrors.”

09/27/16

The Secret of Kratom

36473493 - tablet with the chemical formula of kratom (mitragyna speciosa) mitragynine. drugs and narcotics

© Vitally Vodolazskyy | 123rf.com

So you’ve never heard of kratom? A CDC study of kratom exposures reported to poison centers showed a tenfold increase from 26 in 2010 to 263 in 2015. If kratom becomes more widely known and used, those figures will be increasing. The CDC published a report on kratom on June 29, 2016, citing its potential as an “emerging drug of abuse.” The cited NIDA document, “Drug Facts: Kratom,” does not refer to it as an emerging drug of abuse as claimed, but it does say, “Like other opioid drugs, kratom may cause dependence.” The CDC report itself suggested it was an emerging public health threat.

Kratom use appears to be increasing in the United States, and the reported medical outcomes and health effects suggest an emerging public health threat. Members of the public and health care providers should be aware that the use of kratom can lead to severe adverse effects, especially when consumed in combination with alcohol or other drugs.

Kratom is a tropical tree-like plant native to Thailand, Malaysia, Myanmar and other countries in Southeast Asia. It has a long history of use as a stimulant in low doses. Kratom is often brewed as a tea, but it can also be smoked or swallowed in capsules. Southeast Asian laborers and farmers chew the leaves for energy to work harder and to relieve muscle strains. It has been used as a substitute for opium when opium is not available. And it’s used to manage opioid withdrawal symptoms. Long-term kratom use has produced anorexia, weight loss, insomnia, skin darkening, dry mouth, frequent urination and constipation.

The DEA included kratom on its Drugs of Concern list and recently announced its intention classify kratom and two of its psychoactive chemicals temporarily as a Schedule I controlled substances. “The two chemicals are called mitragynine and 7-hydroxymitragynine. By banning the active chemicals, the DEA is making sure that both the plant and any synthetic versions of it are included in the new regulation.” STAT reported the DEA is authorized to temporarily place substances in Schedule I for up to two years when it believes they are a potential public health threat. If their studies demonstrate there is a threat, the ban will remain. If not, it will revert to being legal.

Like marijuana, it contains multiple alkaloids, but mitragynine and 7-hydroxymitragynine are the primary active one in the plant. At lower doses, it produces stimulant effects. Users report increased alertness, physical energy, talkativeness and sociable behavior. At higher doses, opiate effects, including sedation and euphoria occur. “Effects occur within 5 to 10 minutes of ingestion and last 2 to 5 hours.” The DEA announcement described the following health risks from kratom in some detail.

Several deaths associated with kratom have been reported, often when it is mixed with other substances. There are also reports of drug-induced liver damage, psychosis, seizures, weight loss, insomnia, tachycardia, vomiting, poor concentration and hallucinations. Fifteen of the reported deaths occurred between 2014 and 2016. There was a cluster of nine deaths reported in Sweden from a kratom product called “krypton.” See “Krypton Can Kill You.”

The CDC kratom study said 24.5% of the reports on adverse events were for minor complications; 41.7% required some treatment and were considered to be moderate complications. There were major complications—meaning life-threatening signs or symptoms, with some residual disability—for 7.4% of the kratom exposures. The adverse effects included: tachycardia [abnormally rapid heart beat] in 25% of the reported cases, agitation or irritability in 23.8%, drowsiness in 19.4%, nausea in 14.7% and hypertension in 11.7%.

A recent article in the International Journal of Legal Medicine by Warner, Kaufman and Grundmann reported the death of a young adult who had mixed kratom with prescribed medications—Prozac and Lamictal. Another article, “A Drug Fatality Involving Kratom,” noted a 17-year-old male with a history of heroin abuse and chronic back pain who died from a “possible Kratom toxicity.” He had mixed kratom, benzodiazepines and over-the-counter cold medications (containing DXM?).

In “Pharmacology of Kratom,” Prozialeck et al. found there was an increasing level of kratom use, especially among college students. They also noted a large number of online vendors and general information websites for kratom. An Internet search they did with Google had more than 2 million hits in February of 2012. When I repeated the search in August of 2016, I had over 6.36 million hits. Prozialeck et al. said their search of websites indicated kratom was being used for pain management as well as a recreational drug.

Kratom is regulated as an herbal product in the U.S. and is currently considered a legal substance, despite the CDC concern for its abuse potential. Along with the DEA declaration that there isn’t a legitimate medical use for kratom, this meant: “it cannot legally be advertised as a remedy for any medical reason.”

Pharmacologically, the mitragynine in kratom activates the μ, δ, and κ opioid receptors. Its main activity is on the μ receptor, the one that produces the analgesic and euphoric effects with opioids; and of course results in physical dependency. Despite kratom’s reputation as a “legal opioid,” there have been few scientific studies that addressed its psychoactive properties. Most of the available information is in anecdotal reports, like those on the website, Erowid.

Erowid has a plethora of Kratom reports categorized in groups such as: First Times, Combinations, Preparation/Recipes, Difficult Experiences, Health Problems, Addiction & Habituation, Mystical Experiences and Medical Use. A nondrinking male reported it caused liver toxicity in “Killing My Liver.” A more serious reaction resulted in a hospital stay for a drug–induced hepatic injury in “”Almost Destroyed My Liver.” Then there was a disturbing report under Addiction & Habituation called “This Thing Is a Secret.”

A man with a history of drug and alcohol addiction hadn’t used any “hard stuff” like heroin, alcohol, amphetamines or cocaine in five years. He was active in Alcoholic Anonymous. Then in January of 2005, he decided to order some kratom on a whim from an online vendor. When it kicked in, it had a “Definite opiate effect.” Nine months later, when he wrote his report for Erowid, he said he was using it daily. If he forgets to place his order in time, he’ll have to go a day without it. It was just like the withdrawals from his hydrocodone/Ambien habit.

His wife doesn’t know. No one knows, except the people he orders kratom from. He said he felt guilty spending family money of the stuff, but not guilty enough to stop. “Maybe I’ll quit some time, but for now, things are maintaining. It’s better than shooting heroin or oxycontin or any stuff like that…”

 Naturally, I don’t go around blabbing to my AA associates about how I am using this plant every day. They are some of the best people I have ever met and cherish their friendship. We have a saying in AA, ‘your secrets keep you sick.’ This Kratom thing is a secret.

Prozialeck et al. reported that as kratom use has expanded to Europe and the U.S., there have been increasing reports of individuals becoming physically dependent or addicted to kratom. Most of the published studies, like this one by McWhirter and Morris were case reports. They described a case of kratom dependence in a 44-year-old man with a history of alcohol dependence and anxiety disorder. His withdrawal symptoms were consistent with mild opioid withdrawal: anxiety, restlessness, tremors, sweating and cravings.

Evidence suggests that kratom is being used extensively for both medical and nonmedical purposes. Recent studies have shown that kratom contains a variety of active compounds that produce major pharmacologic effects at opioid and other receptors. Kratom and kratom-derived drugs may potentially be used for the management of pain, opioid withdrawal symptoms, and other clinical problems. At the same time, serious questions remain regarding the potential toxic effects and the abuse and addiction potential of kratom. This issue is further confounded by the lack of quality control and standardization in the production and sale of kratom products. The possibilities of kratom products being adulterated or interacting with other drugs are also serious concerns. Until these issues are resolved, it would not be appropriate for physicians to recommend kratom for the treatment of patients. Nevertheless, physicians need to be aware that patients may use kratom or kratom-based products on their own. Further studies to clarify the efficacy, safety, and addiction potential of kratom are needed.

Regulating kratom presents issues similar to what we are now facing with marijuana. Both plants contain dozens of compounds with some potential medical use. Both are currently not viewed by the U.S. government as having any medical use.  Where marijuana’s classification as a Scheduled I controlled substance makes scientific research into its potential medical uses difficult, the limited use and knowledge of kratom contributes to it being understudied. Each also has one or two dominant psychoactive ingredients.

There is also a lack of quality control with both. The strength of THC or CBD in marijuana and mitragynine or 7-hydroxymitragynine in kratom can vary widely. Products containing these herbal substances cannot be guaranteed to carry similar doses of the active ingredients. And they are likely to have contaminants, such as pesticides, if grown commercially. The limited, scientifically reliable knowledge of their medical usefulness, and the lack of regulation with regard to that knowledge, results in a wide variety of anecdotal claims similar to past the age of patent medicines.

What is to be done? Federal funding of research into kratom’s potential medical uses needs to occur. The two-year temporary classification as Schedule I can be extended another year if more time is needed while the studies of it medical uses are completed. A permanent classification of kratom as a Schedule I Controlled substance seems inadvisable. Remember that hasn’t worked very well with marijuana. Future classification as a controlled substance seems reasonable, given its activation of the μ, δ, and κ opioid receptors. But let’s base it upon reliable scientific information.

09/23/16

The Zenith of Rest

© grace21 |stockfresh.com

© grace21 |stockfresh.com

According to John Walton, the seventh day of the Genesis creation account can be something of a theological afterthought. “It appears to be nothing more than an afterthought with theological concerns about Israelites observing the sabbath—an appendix, a postscript, a tack on.”  There is a literary structure to the first six days in Genesis 1 that C. John Collins called “exalted prose,” but the pattern ends there. Then we hear that God rested from his work of creation on the seventh day. But what does God resting have to do with creation? And why would God rest? It’s not as if He was actually tired from all his creative activity. Then what does it mean for God to rest?

Walton believes that rest is the objective of creation. In fact, without the seventh day of rest, the other six days of Genesis 1 don’t achieve their full meaning. “Even though people are the climax of the six days, day seven is the climax of this origins account.” To make his point, he turned to Scripture. The Hebrew word for “rested” in Genesis 2:2 is šābat, which means to sever, put an end to, cease. The English term “Sabbath” is derived from it.

In Deuteronomy 12:10, God told the Israelites that when they crossed over the Jordan and lived in the land He was giving them, they would have rest from their enemies and live in safety. After Moses died and Joshua was preparing the Israelites to cross the Jordan, he told them to remember what Moses had told them about the Lord providing them a place of rest. As Joshua was about to release the Reubenites, the Gadites and the half-tribe of Manasseh to return across the Jordan to their lands, the narrator said the Lord had given them rest on every side, just as He said He would (Josh 21:44). When David saw that the Lord had given him rest from all his enemies, he thought he would build a house for the Lord to dwell in (2 Samuel 7:1-2).

The rest that God offers his people is freedom from invasion and conflict. Now they can live at peace and conduct their daily lives without interruption. “It refers to achieving a state of order in society.” When Jesus invited those who were weary and burdened to come to him, he offered them rest (Matthew 11:28). He invited people to participate in the ordered kingdom of God, where their yoke would be easy and their burden light. The author of Hebrews looked to a future rest, where anyone who entered it would rest from their works as God did from his (Hebrews 4:10-11).

In light of this usage, we can discern that resting pertains to the security and stability found in equilibrium of an ordered system. When God rests on the seventh day, he is taking up his residence in the ordered system that he has brought about in the previous six days. It is not something that he does only on the seventh day; it is what he does every day thereafter. Furthermore, his rest is not just a matter of having a place of residence—he is exercising his control over this ordered system where he intends to relate to people whom he has placed there and for whom he has made the system to function.

God was not only making a home for the people He created in His image when He created the cosmos, he was making a home for himself. But in the ancient world, the temple was not only the residence of a god, it was the throne room from which the god ruled and maintained order. So an ancient reader, according to Walton, would have recognized Genesis 1 (referring to Genesis 1:1-2:3) as a temple story or text. Temple-building accounts often accompanied cosmologies. After he established order, which was the focus of ancient cosmologies, the deity “took control of that ordered system.” When the deity rests in the temple, he is assuming his rightful place and his proper role—he is assuming the throne.

This is the element that we are sadly missing when we read the Genesis account. God has ordered the cosmos with the purpose of taking up his residence in it and ruling over it. Day seven is the reason for days one through six. It is the fulfillment of God’s purpose.

God built the cosmos to be sacred space, and the account in Genesis 1 is an account of the origins of sacred space rather than an account of the origins of the material cosmos. Rather than an ancient temple where people could relate to their god by ritually meeting his needs, “God built the cosmos to be sacred space and then put people in that sacred space as a place where he could be in relationship with them.”

What I’ve presented above are ideas and quotes from John Walton in The Lost World of Genesis and The Lost World of Adam and Eve. His views of Genesis 1 and 2 have their critics, but I’ve found his argument stimulating in a number of different ways. You can introduce yourself to his thought here, in a series of articles and even a video series on the evolutionary creation website, BioLogos. His interpretation of Genesis is certainly consistent with evolutionary creation, but exists independent of it. You can accept his understanding of Genesis without becoming an evolutionary creationist.

I think his sense of Genesis 1 as a temple text fits nicely with a redemptive historical understanding of Scripture as a whole. And I think it could fit there as follows.

Walton sees Genesis 1 as God building a sacred space, a temple, in which He would also place people so He could be in relationship with them. In Genesis 2 and even into Genesis 3, we see the reality of this fellowship with God. Then as a consequence of their sin, God drove Adam and Eve from the sacred space of the Garden (Genesis 3:23-24). However, this was not the end of his plan to be in relationship with people. Even before their sin, God had already begun to point them to the work of redemption He would accomplish in His Son.

In Genesis 2, He made a helper for the man because He saw that it was not good for the man to be alone (Genesis 2:18). Presented with the woman, the man said: “This at last is bone of my bones and flesh of my flesh; she shall be called Woman, because she was taken out of Man.” Here God instituted biblical marriage. The following comment on this action by God—“Therefore a man shall leave his father and his mother and hold fast to his wife, and they shall become one flesh” (Genesis 2:24)—will later be quoted by Paul in Ephesians 5:31. Paul saw this action by God in Genesis 2 as a mystery referring to Christ and the church. The coming of Christ revealed that God’s establishment of biblical marriage was a protoevangelium, if you will.

In Genesis 3, is the judgment statement against the serpent has been understood by many since Justin and Irenaeus in the 2nd century as the protoevangelium: “I will put enmity between you and the woman, and between your offspring and her offspring; he shall bruise your head, and you shall bruise his heel.” The protoevangelium is the first (proto) gospel (evangelion); the first reference in Scripture of the idea of a Messiah. So before God put the man and the woman out of the Garden, He gave them two hints of his future plans in Christ.

After Moses completed the tabernacle (Exodus 40:34) and when Solomon had finished his prayer dedicating the temple ((2 Chronicles 7:1-2), these structures were filled with the presence of the Lord and became sacred space. In Ezekiel’s vision of the temple, the glory of the Lord filled the temple and the Lord said the place of his throne and the place where he will dwell will be in the midst of the people forever (Ezekiel 43:4-7).

Then in Christ, “the Word became flesh and dwelt among us” (John 1:14). Jesus called people to Him that they might have rest (Matthew 11:28), for he is the Lord of the Sabbath (Matthew 12:8). When he ascended into heaven, he sat at the right hand of the Father (Mark 16:19). When he returns, he will return the same way as he left (Acts 1:11). His return will be to fulfill the mystery of Genesis 2:24, revealed in Christ (Ephesians 5:32)—the marriage supper of the Lamb, and his bride, the church (Revelations 19:7).

In the new heaven and new earth, in this new sacred space, God will fulfill His intent to dwell with his people: “Behold, the dwelling place of God is with man. He will dwell with them, and they will be his people, and God himself will be with them as their God” (Revelations 21:3). There will not be a temple in this New Jerusalem, the Bride of the Lamb, because its temple is the Lord God and the Lamb (Revelations 21:22). The Sabbath rest of Exodus 20:11 will be made manifest. The seventh day of the Genesis creation account will have reached its zenith.

For more articles on creation in the Bible, see the link “Genesis & Creation.”

09/20/16

Appalling Silence on ECT

© rangizzz | 123rf.com

© rangizzz | 123rf.com

Kenny was put on antidepressants at the age of 14 because he was struggling in a difficult family situation. His symptoms became worse. The psychiatrist added another drug with again worsening symptoms. At one point, he was taking six different psychiatric drugs. Kenny was eventually told his depression was “treatment resistant” and needed electroshock therapy.  “The risks were downplayed.” He was given 30 rounds of ECT and went from a high school honor student to having to be retaught how to tie his shoes. Wait, there’s more!

Kenny lost all memories of childhood and all memories of high school. He says it’s an identity crisis. He suffered severe headaches for a year and a half after the shocks and had to see a cardiologist because ECT left him with heart arrhythmia. Testing by a neurologist, done six months after the shocks, showed a loss of 50 IQ points compared to his high school IQ. Kenny still suffers from night terrors about the shocks.

Dr. Langemann’s article on “Shock Therapy” for the Huffington Post also referred to a biomedical engineer who said the “brief pulse” of ECT is actually a series of several hundred pulses, and not a single pulse. These pulses overstimulate brain cells, causing rapid random firing, intentionally causing a Grand Mal seizure. “The current causes overheating inside the brain and the electric field can tear holes in the cells (which causes the cells to die).” She noted that a conservative estimate is that 100,000 patients per year receive ECT.

Incredibly, ECT has never been through the standard clinical trial process to prove its safety or efficacy. Although the FDA has had the authority to regulate medical devices since 1976, it disregarded ECT machines because they’ve been in widespread use since the 1950s, according to STAT News in “Psychiatric Shock Therapy.” The FDA placed ECT machines in the class III (high risk) category where they have remained since that time. But in December of 2015, the FDA made public a draft document proposing to reclassify ECT machines as a class II (low risk) device. Before the public comment period ended in late March of 2016, the FDA had received 2,040 comments on its draft rule. The agency has not set a timetable for issuing its final ruling.

While the proposed regulations would indicate that ECT was “safe and effective” and only moderately risky for adults, it would only be approved for adults with severe depression who haven’t responded to medication or other therapies. It would remain classified as a high risk  (class III) for psychiatric conditions other than major depression and for children and adolescents. There would be new requirements as well. Doctors would have to warn patients of the side effects of ECT, which include confusion and memory loss; and that long-term safety for ECT is not proven.

Psychiatrists warn that that these new regulations could lead to insurers not covering ECT and doctors not recommending it for younger patients and those with conditions like schizophrenia, bipolar disorder and catatonia. (They say it like that’s a bad thing) Charles Kellner, a professor of psychiatry at the Icahn School of Medicine said, “Its use for these indications is widespread, even ubiquitous, and to deny the extensive evidence in support of that is indefensible.” Supporters say ECT has come a long way since it was portrayed in “One Flew Over the Cuckoo’s Nest.” Patients get anesthesia and sedatives to minimize pain and muscle spasms, so they are less likely to hurt themselves during the ECT seizure. “Ultra-brief pulse therapy delivers a fraction of the electricity used in the past.” However, as noted above, this claim is disputed. See “The Frankenstein Monster of ECT” and “Is ECT Brain Disabling?” on this website.

Writing for GlobalResearch, Dr. Gary Kohls described ECT “therapy” sessions as: “sub-lethal electrocutions of the brain that reliably produces seizures and coma.” He noted that the perceived improvement with ECT is often because of the frequent short-term and long-term memory loss that occurs with shock treatment. “The patient may no longer remember the traumatizing interpersonal/sexual/social/ psychological/spiritual conflicts that previously made them feel sad, nervous, depressed, anxious or hopeless.” He lamented that studies show physicians reach for their prescription pad within minutes of most clinic encounters. “Time is money.”

Dr. Kohls then quoted excerpts from the testimony of Leonard Roy Frank before the Mental Health Committee of the New York State Assembly in 2001. Mr. Frank was a psychiatric survivor and activist who personally experienced 35 ECT procedures and 50 insulin coma treatments. The transcript of his testimony can be read here in its entirety. He said:

This was the most painful and humiliating experience of my life. My memory for the three preceding years was gone. The wipeout in my mind was like a path cut across a heavily chalked blackboard with a wet eraser. Afterwards I didn’t know that John F. Kennedy was president although he had been elected three years earlier. There were also big chunks of memory loss for events and periods spanning my entire life; my high school and college education was effectively destroyed. I felt that every part of me was less than what it had been.

Frank then elaborated on some of the adverse effects from ECT. With regard to memory loss, he indicated that the APA downplays memory loss, saying most patients actually report improved memory; and only a minority of patients report problems with memory loss. He said the vast majority of individuals he has talked to reported moderate-to-severe amnesia going back two years and more from the time they received ECT.  His own experience was noted above.

Quoting the 2001 APA Task Report on ECT, Frank noted where a reasonable ECT-related mortality rate was suggested to be 1 per 10,000 patients. However, some studies show the ECT death rate is about one in 200. This rate may not still be accurate, as an increasing number of the elderly are being electro shocked. “Statistics based on California’s mandated ECT reporting system indicate that upwards of 50 percent of all ECT patients are 60 years of age and older.”

Frank described what he referred to as “the myth of informed consent.” While outright force is seldom used, “genuine informed consent is never obtained” because ECT specialists minimize the procedure’s nature and effects to candidates and their families; and because of the implicit coercion that can be brought to play. There is a lack of accountability with psychiatry. It was a “Teflon” profession, meaning what little criticism there is doesn’t stick. “Psychiatrists routinely carry out brutal acts of inhumanity and no one calls them on it — not the courts, not the government, not the people.”

Electroshock could never have become a major psychiatric procedure without the active collusion and silent acquiescence of tens of thousands of psychiatrists. Many of them know better; all of them should know better. The active and passive cooperation of the media has also played an essential role in expanding the use of electroshock. Amidst a barrage of propaganda from the psychiatric profession, the media passes on the claims of ECT proponents almost without challenge. The occasional critical articles are one-shot affairs, with no follow-up, which the public quickly forgets. With so much controversy surrounding this procedure, one would think that some investigative reporters would key on to the story. But it’s happened only rarely up to now. And the silence continues to drown out the voices of those who need to be heard. I’m reminded of Martin Luther King’s 1963 “Letter from Birmingham City Jail,” in which he wrote: “We shall have to repent in this generation not merely for the vitriolic words and actions of the bad people, but for the appalling silence of the good people.”

Psychiatrist Peter Breggin has advocated against ECT for decades. You can watch an 11-minute video he did called, “Electroshock is Brain Trauma.” He indicated the 100,000 per year estimate for ECT was based on data he gathered in 1979 for his book critical of shock treatment. He said today every large city has several places that do shock treatment. “It’s extremely remunerative.”

Dr. Lagemann indicated that standard treatment is 9 to 12 shocks, at a cost of $2,000 to $2,500 each. When you do the math, you come up with a minimum income of $1.8 billion (9 x 100,000 x $2,000 = $1.8 billion). About half the cost is covered by Medicare. Mr. Frank indicated that in 2001, psychiatrists specializing in shock treatment earned $300,000-$500,000 a year compared to other psychiatrists whose mean annual income was $150,000.

What’s wrong with shock treatment? How does it work? It’s not as mysterious as the advocates make out. Shock works by passing an electric current through one or both frontal lobes of the brain, producing an electrical lobotomy.  The electricity also passes through the memory centers of the temporal lobe, causing additional devastation. Finally, the current passes throughout the brain and that, along with the severe seizures that result, causes widespread brain dysfunction and damage. Some patients initially become euphoric from the damage, whereupon the shock doctor notes approvingly, “mood elevated.” All patients eventually become apathetic and indifferent, and unable to resist, whereupon the doctor notes with finality about the outcome, “no longer complaining.”

Dr. Breggin said the only reason that modern shock doctors don’t talk about ECT as damaging the brain is because he publicized and documented how it was in his book, Electroshock: Its Brain-Disabling Effects. He noted that when ECT treatment is done, it results in a period of coma. “How could a blow to the brain with electricity so severe it causes a coma, and you’re not harmed by it?” Very often the EEG brain waves flat line—that’s temporary brain death. The person wakes up completely disoriented. The longer the treatment continues, the more past memory the person loses.

The STAT News article noted where a woman who had 66 ECT treatments between 1996 and 2010 to treat depression left such holes in her memory that she couldn’t recall her wedding day or the birth of her children. Her 28-year marriage ended, ““because I couldn’t remember that relationship, and without those memories, I had no emotional connection.”

Dr. Breggin created a free website about shock treatment: ECT Resources Center.  Among its documents is a simple introductory statement and brochure for widespread distribution. There are also PDFs of more than 100 scientific articles on issues with ECT. He urged people to do everything they can to stop someone they know getting ECT, because they will never be the same afterward.

As of September 1st, there has not been an announcement of what the FDA plans to do with ECT. But when the FDA announced it was soliciting comments of the proposed regulatory changes, the American Psychiatric Association created a form letter for psychiatrists to “take the lead in expressing their views” regarding the role of ECT in clinical practice and treating major depressive disorder. See “Time is Now to Support the ECT Reclassification Effort.” The letter asserted that ECT was an important treatment option for some people with severe mental health conditions. “Your proposed reclassification will greatly improve access to safe, effective treatment for individuals with serious and persistent psychiatric disorders.” You can download and read a copy of the form letter in the above link. I wonder how many of the 2,040 comments were APA form letters from psychiatrists?

09/15/16

What’s in a Day?

© AnnaOmelchenko | stockfresh.com

© AnnaOmelchenko | stockfresh.com

Christianity sees the seventh day of creation tied to the fourth commandment in Exodus 20:8-11. Exodus 20:11 said God made the heaven and earth in six days and rested the seventh day. “Therefore the Lord blessed the Sabbath day and made it holy.” C. John Collins observed that for many people, this implies that not only was the creation week “the first ‘week’ of the creation, but in fact it was of identical length to the week we are familiar with.” A day in Genesis 1 is twenty-four hours and a week is seven twenty-four hour days. Any other interpretation is a violation of the authority of Scripture and is forbidden. But what if that’s not what Genesis 1 means when it refers to days and a week?

In Redeeming Science Vern Poythress pointed out that although some people think that the length of a 24-hour day in Genesis 1 is obvious, “the text does not directly state how long the days were in terms of ordinary human measurement.” The use of the Hebrew word for day (yom) and the evening and morning refrain points to a correspondence between God’s work and the human sabbatical pattern, but it does not prove the correspondence is an identity.

The next thread to pull in the seven twenty-four-hour day understanding is that the seventh day doesn’t have the formulaic beginning and ending: “And God said . . . And there was evening and there was morning, the ______ day.” The usual reply is that seventh day in the creation week was the day God rested from all his creative work (Genesis 2:1-3). Since he completed his work in the sixth day, the seventh day would not have a formulaic ending because the creative work was completed. Nevertheless, this is a distinct break in the pattern of the workweek with the first six days.

But how long is the seventh day? Poythress said the seventh day has a special blessing and holiness because God rested on it from all his work (Genesis 2:3). God’s rest is the pattern for human rest, as we see in the fourth commandment. Since God rested on the seventh day of creation, He blessed the Sabbath and made it holy (Exodus 20:8-11). The holiness belongs to God’s rest, not the day itself. “The holiness extends to the day precisely because it is the day of God’s rest.” In order to deserve the holiness it receives, the seventh day must be linked closely to God’s rest. So he concludes that since God’s rest goes on forever, “God’s day of rest also goes on forever.”

While God’s work of creation was finished and his rest from it lasts forever, our rest on the seventh day isn’t absolutely finished yet. We begin again on the first day of the next workweek. But our work is heading towards the coming time of absolute, final rest (Hebrews 4:9-11). “Our human rest on one day of 24 hours looks not only backward to God’s rest from creating but also forward to our final ‘day’ of rest.” Human 24-hour Sabbath rest both foreshadows our final rest, and imitates the final rest of God, into which He has already entered. “This foreshadowing involves analogy to the reality to which it points, rather than pure identity of length.” So again, God’s seventh day in Genesis 2:2-3 is unending.

“And if this is so, then it is analogous rather than identical to a human day of 24 hours.” If the seventh day of the creation week is analogical, then the pattern of God’s entire workweek forms an analogical pattern to our work and rest. God’s workweek is not the same as a human workweek, but they correspond to one another. They are analogical. Now look at this conclusion another way.

An original reader of Genesis 1 would recognize and relate to the rhythm of God working with a rhythm like that of a human work week rather than a description of His activity segmented into 24-hour days. “The pattern that strikes him is the rhythm of work, not the question of the ticking clock.” The Israelites did not have mechanical clocks, so measurement by clock time (i.e., 24-hour days) makes no sense to them. The time pattern of workdays, followed by night—evening and morning—would make the most sense to them.

Poythress said in Christian Interpretations of Genesis 1 the analogy in Genesis 1 extends to the entire week, including the evenings and mornings, and isn’t just focused on the word day. “God pauses between his works from one day to the next.” This reflects the human work pattern noted in Psalm 104:23: “Man goes out to his work and to his labor until the evening.”

Now look at the pattern of evening and morning, repeated in the six days of creative work in Genesis 1. God is working during the day and “resting” during the evening, just as man does in his work. The lack of “evening and morning” for the seventh day in Genesis 2:3-4 indicates the continuation of his day of rest from the work of creation. “God’s rest from the work of creation is everlasting.” He no longer “creates” animals or plants or humans —the conception and birth of Christ being the only exception. So by inference, the day of God’s rest is everlasting; and not 24-hours long. So when Exodus 20:8-11 establishes a 24-hour Sabbath day of rest imitating the day of God’s rest from his creative works, it is analogical to God’s rest. “So again the salient factor is not the length of time, as measured by a clock of some kind, but rather the kinds of activities that take place during the day.”

We see God having the same pattern of work and rest, moving towards His Sabbath. The first day is God’s workday, followed by rest; and another workday and rest; continuing until the Sabbath day of rest. God cannot be literally said to “rest,” since he cannot get tired, so the language of his workweek and Sabbath is once again analogical and not literal. The narrator of Genesis “wanted primarily to tell us about the making and shaping of the earth as a place for humans to live in fellowship with their Maker.” See this link for free ebook copies of the two works referenced above by Vern Poythress, Redeeming Science and Christian Interpretations of Genesis 1.

C. John Collins said the best term for the formulaic language used in Genesis 1 was “exalted prose.” By this he meant the language is “higher” than ordinary language, as is the language in a very traditional high-church liturgy. “The language here is stylized, very broad-stroke, and majestic in its simplicity.” It makes the same truth claims as traditional prose narrative. But “we must not impose a ‘literalistic’ hermeneutic on the text.”

The alternative understanding proposed by Collins and Poythress for a literalistic sense of the days in Genesis 1 is called the analogical days view. There is an analogical, but not an identical correspondence between God’s workweek in Genesis and the human workweek of six 24-hours days and a day of rest. The days in Genesis are structured to set a pattern for our own rhythm of rest and work. The length of time for the creation week, either before or after it, is irrelevant to the purpose of the account. Poythress closed his discussion of the analogical day view in Redeeming Science with the following:

Thus, when some advocates of the 24-hour-day view claim to have specific information about the length of the days, they fall short in hearing what Genesis does and does not say. They sincerely desire to honor God’s word, and to follow God wherever he leads, but they have not done full justice to the passage. In harmony with the analogical day view, the passage simply teaches that God made the world in six days but does not provide details about how to measure the exact length of the days by some objective, nonhuman standard.

For more articles on creation in the Bible, see the link “Genesis & Creation.”

 

 

09/13/16

E-Cigarettes Are Just Unhealthy

© diego_cervo | stockfresh.com

© diego_cervo | stockfresh.com

The pros and cons of e-cigarettes have been trading studies and expert opinions back-and-forth for a number of years. In “Nicotine without smoke: tobacco harm reduction,” The Royal College of Physicians sees e-cigarettes as “an ideal tobacco harm reduction product.” While acknowledging that e-cigarettes are not currently made to medical standards and are probably more hazardous than nicotine replacement therapy (NRT), the report said it was unlikely that the health risks from long-term vapor inhalation would exceed 5% of the harm from smoking tobacco. The report also downplayed concerns that e-cigarettes will increase tobacco smoking and act as a gateway to smoking in younger people. But this strong endorsement is not the last word on the saga of e-cigarettes.

Writing for AfterParty Magazine, Tracy Chabala pointed to a study published in the New England Medical Journal raising the danger of inhaling formaldehyde at concentration levels higher than that of nicotine. If that doesn’t good healthy, you’re correct. Formaldehyde is a known cancer-causing agent, and “How formaldehyde-releasing agents behave in the respiratory tract is unknown.” The study authors calculated the risk from e-cigarettes to be 5 to 15 times as high as the risk of long-term smoking. What’s more, “formaldehyde-releasing agents may deposit more efficiently in the respiratory tract than gaseous formaldehyde, and so they could carry a higher slope factor for cancer.”

In her article,“Can Your E-Cigarette Give You Cancer?,” Tracy Chabala noted there were several strong opinions on the study. A lawyer for the American Vaping Association said the study used the vaping device “in a manner that no one does.” He likened it to leaving a steak on the grill all day—“many cancer-causing substances might be formed but no one would eat such charred works.”  I’m not sure I buy his analogy, that vaping with an e-cigarette is like having a good steak on the grill. But his point seems to be that one limit of the study was that the researchers based their findings on a method of using their devise that no one actually does when vaping.

What the study actually reported was that they used an e-cigarette with a “tank system” and a variable-voltage battery. The aerosolized liquid was collected in an NMR spectroscopy tube over five minutes with each puff of their device taking 3 to 4 seconds. They did not find any formaldehyde-releasing agents at the low voltage setting. However, they did detect agents at the high voltage setting. The lawyer for the American Vaping Association seems to have overplayed his analogy. A biologist from the American Cancer Society said he was reasonably convinced that all the formaldehyde released during the test tube studies would likely break down into formaldehyde in the e-smoker’s lungs. I think I’m going with the opinion of the biologist on this one.

The President of The Cancer Action Network, an advocacy group of the American Cancer Society, urged the federal government to consider the new findings and finalize its proposal to regulate all tobacco products, including e-cigarettes. The findings were just another example of how little is known about these products or the varying levels of exposure to toxic chemicals that can result from using any of the hundreds of different types of e-cigarette devices. He said federal regulation was imperative to help address the health risks of e-cigarettes and others who are exposed to e-cigarette vapor. “Furthermore, until the FDA finalizes its proposal to regulate e-cigarettes and other tobacco products, the industry’s unfettered ability to market these products to kids remains a threat to public health.”

In May of 2016, David Nather reported for STAT News that the FDA issued a set of rules regulating e-cigarettes for the first time, despite strong resistance from the industry. All states would now be required to ban the sale of e-cigarettes to anyone under the age of 18. All devices that went on sale after February 15, 2007 would be subject to FDA review unless the manufacturers can prove their products are ”substantially equivalent” to products being sold or that there is another reason they should be exempt. Dr. Robert Cardiff, the FDA commissioner said: “Today’s rule is a milestone in consumer protection. It marks a new chapter in our efforts to do everything we can under the law to protect Americans from the dangers of tobacco products.”

Manufacturers would have between a year and two years to prepare their applications, depending on whether they are submitting to the reviews or arguing they should be exempt. Then they would have another year to win approval from the FDA. The rule would not ban flavored tobacco products, including e-cigarettes. But the FDA is working on a rule that would restrict cigar companies from using flavors in their marketing just as cigarette makers can’t include flavors in their sales pitches.

The president of the American Vaping Association said it was a big win for American cigarette companies and a giant loss for small businesses.  He predicted that in two or three years, “nearly every vape shop in the country will be closed.” I’m not sure that would be such a bad thing. It seems that the rhetoric pitting Big Tobacco against little vape shops has ignored the real concern over the potential health hazards of vaping instead of smoking tobacco products.

While acknowledging there are anecdotal reports that some people have used e-cigarettes to stop smoking, Mitch Zeller of the FDA said the agency needed more data on how e-cigarettes are being used, including how many people who use e-cigarettes never used tobacco products before. “I hope everyone can agree that kids should not initiate on e-cigarettes simply because of the harm that can come from nicotine.”

Lobbyists for the cigar and e-cigarette industries pushed Congress to create bills that would either exempt them from the new rules or grandfather in products already on the market. Representative Tom Cole of Oklahoma, the chairman of the House subcommittee funding health programs, added a measure to the FDA’s funding bill for next year that would get rid of the February 2007 effective date. Cole said his legislation “provides the same framework for new tobacco products without needlessly subjecting small businesses to unnecessary regulations and without treating law abiding adults like naïve children.”

Mitch Zeller noted that Cole’s measure would eliminate all reviews of e-cigarette products that came on the market after 2007 (the vast majority of them) and clear the way for future products that are similar in design. The proposal “would have an enormously adverse impact on public health and the ability of FDA to do its job.” Beginning on August 8, 2016, the FDA will start regulating e-cigarettes, all cigars, waterpipes (hookahs), tobacco, pipe tobacco, and nicotine gels.

So this leads us to the newest published study of e-cigarettes in the journal Environmental Science & Technology by Sieiman et al., “Emissions from Electronic Cigarettes.” Their study found that all electronic cigarettes emit harmful chemicals. Levels of those toxic compounds are affected by factors in the use of e-cigarettes such as temperature, and the type and age of the device.

A news release from Berkley Lab said the study found that the thermal decomposition of propylene glycol and glycerin leads to the emissions of toxic chemicals such as acrolien and formaldehyde. Propylene glycol and glycerin are found in most e-liquids, the substance vaporized in e-cigarettes. There were 31 different toxic chemicals found at significant levels in e-cigarette vapor. Hugo Destailats, one of the researchers said that while it may be true emissions are much lower from e-cigarettes than conventional ones, that’s only true for certain users, for example, long time smokers who cannot quit. “Regular cigarettes are super unhealthy. E-cigarettes are just unhealthy.”

One of their findings indicated there was a big difference in emissions between the first and last puffs. They found that vapor temperature rose quickly in the first 5 to 10 minutes until it reached a steady state temperature around the twentieth puff.  Emission levels between the first few puffs and the steady state increased by a factor of ten of more. Factors affecting the levels included the device used, the battery voltage and the emitted compound.

In order to test effects due to the device aging, the researchers used a single device over nine consecutive 5-puff cycles without cleaning it. Emissions for formaldehyde, acetaldehyde, and acrolein, which are all irritants or carcinogens, increased. “In some cases we saw formaldehyde levels increase 60 percent between cycles 1 and 9.”

This effect is consistent with the buildup of polymerization byproducts on or near the coil leading to accumulation of the sort of residues that are often referred to in the blogosphere as ‘coil gunk’ or ‘caramelization.’ Heating these residues would provide a secondary source of volatile aldehydes.

Looking at the effect of voltage on emissions, the researchers found that as the voltage increased, both the amount of e-liquid consumed per puff and the vapor temperature were higher. Destailats pointed out this did not mean e-cigarettes were safer to use at lower temperatures. “We found there are emissions of toxic chemicals at any temperature at which you use the device. . . . And the higher the temperature, the more emissions.”

This won’t be the last word in the e-cigarette saga. The back-and-forth conflict is just getting started. You should also keep in mind there is another aspect to the e-cigarette conflict. E-cigarettes are modified or “hacked” to smoke marijuana—dry herb, hash oil or THC liquids. They’re called, ironically, e-joints. See “E-Cigarettes and E-Joints” or do your own Google search.

09/9/16

The Dragon Threat

© Linda Bucklin | 123rf.com

© Linda Bucklin | 123rf.com

The DEA released its updated “National Heroin Threat Assessment Summary” on June 27, 2016 and the news is not good. Chuck Rosenberg of the DEA called the death and destruction from heroin and opioids “unprecedented and horrific.” The number of users, treatment admissions, overdose deaths, seizures from heroin traffickers all increased since the 2015 Summary. The increased demand and use of heroin is being driven by greater availability of heroin in the U.S. and prescription opioid users switching to heroin because it’s cheaper. “The problem is enormous and growing, and all of our citizens need to wake up to these facts.”

There were three big takeaways in the 2016 Summary: 1) the number of people currently using heroin almost tripled between 2007 and 2014. 2) Deaths due to heroin more than tripled between 2010 and 2014. 3) Deaths due to synthetic opioids, like fentanyl, increased 79% between 2013 and 2014. You can access a pdf of the full report here.

In 2014, 10,574 American died from heroin-related overdoses. Geographic areas of the country particularly hard hit are in the Northeast and the Midwest. See Map 2 in the 2016 DEA Summary. Not surprisingly, availability levels are the highest in these areas as well. Possible reasons for the increase in overdoses and deaths include: more heroin users, especially those who are new to heroin, who are young and inexperienced; the higher purity of heroin found in certain areas and the use of adulterants like fentanyl.

Twenty to thirty years ago, the average retail-level purity of heroin available in the U.S. was about 10%. By 1999, the average purity was 40%. While the purity increased, the price decreased. The average price per gram in 1981 was $3,260 in 2012 US dollars. By 1999, the price for a gram of heroin had dropped to $622. Heroin prices have remained low since then. With an increase in purity, heroin can be snorted or smoked, which broadens its appeal. “Many people who would never consider injecting a drug were introduced to heroin by inhalation.”

Beginning in late 2013, several states started reporting overdose death due to fentanyl and acetyl-fentanyl. There were 5,544 reported synthetic-opioid-related deaths in 2014. But the DEA speculated it was much higher because of a lack of standardization in reporting; and because coroners and state crime labs don’t initially test for fentanyl or its analogs unless they have a reason to do so. The eastern U.S. is the area most effected by this, because white powder heroin from South America predominates. Fentanyl, also a white powder, is mixed with heroin or sold disguised as white powder heroin. The following chart is from the 2016 DEA Summary.

Heroin deathsThe Mississippi River has historically been a geographic dividing line with Mexican, “black tar” and brown powder heroin more common west of the Mississippi and white powder heroin, now supplied from South America, common east of the Mississippi. But that is changing. Mexican traffickers are making inroads into major eastern cities. Mexican organizations are now the most prominent wholesale-level traffickers of heroin in Chicago, New Jersey, Philadelphia, and Washington DC. Increased trafficking of Mexican heroin means more heroin is entering the U.S. across the Southwest border from Mexico. Black tar heroin is popping up more frequently in the Northeast, although it still comprises a small percentage of the heroin seized.

Mexican traffickers have taken a larger role in the U.S. heroin market, increasing their heroin production and pushing into eastern U.S. markets that for the past two decades were supplied by Colombian traffickers. This is notable because Mexican traffickers control established transportation and distribution infrastructures that allow them to reliably supply markets throughout the United States

The DEA also noted the increase in counterfeit prescription pills, many which contain deadly amounts of fentanyl. Small-scale local drug entrepreneurs can buy the materials and equipment to produce the counterfeit drugs online and set up their own operation, ala Breaking Bad. “Fentanyl pill press operations have been identified in the United States, Canada, and Mexico, indicating a vast expansion of the traditional illicit fentanyl market.” Oxycodone and other opioid painkillers are the main counterfeited medications, but traffickers are also packaging fentanyl as Xanax and other benzodiazepines. See “Buyer Beware Drugs” for more information.

When comparing heroin use to other drugs in the U.S., we find that the population of heroin users is slightly smaller than the estimated population of methamphetamine users and significantly smaller than individuals reporting current cocaine use. However, the number of individuals reporting current use of prescription pain relievers non-medically was about TEN TIMES the size of heroin users. So although a rather small percentage of prescription drug abusers (4%) will try heroin, this represents a significant increase in the number of heroin users because the size of the prescription drug abuse population is so much larger. See the following chart taken from the 2016 DEA Summary.

chart 7Behind all these statistics are real people, some living and some now dead. And despite all the law enforcement efforts over the past several decades, the problem seems to be getting worse. So two federal law enforcement agencies decided to combine their efforts and try a different tactic. They thought they’d try to address the problem from the demand side instead of the supply side.

Back in February the FBI and DEA released a documentary film addressing the growing epidemic of prescription drug and heroin abuse. “Chasing the Dragon: The Life of an Opiate Addict” is intended as an educational film for high school and above. Educational materials have had mixed effectiveness with decreasing drug usage. But the value of this film is in its portrayal of the real people who chased the dragon and became part of the above statistics. You can watch the film here.

09/6/16

The Wrong Birthright

© Wieslaw Jarek | 123rf.com

© Wieslaw Jarek | 123rf.com

In Sunday School we reviewed the life of Jacob and I was again struck by the strange encounter of Jacob and Esau, where Esau “despised his birthright” by trading it to Jacob for some red stew (Genesis 25:29-34). Surely there was more going on just that. And even if we grant that Jacob was more cunning and devious than Esau, surely he would have known the significance of selling his birthright. He couldn’t have been THAT stupid, could he? And even though Jacob was an opportunist, there wasn’t any trickery here, as there would be later when he stole Esau’s blessing. So what’s going on?

Let’s open with a look at the term “birthright,” since it seems to have had value to Jacob, but was of little significance to Esau. According to the Dictionary of Biblical Imagery, the birthright traditionally went to the firstborn son, meaning he would receive a double portion of the inheritance, the right to bear the family’s name and other privileges. This practice was also consistent with Deuteronomy 21:15-17, which expressly forbade favoritism to a younger, more beloved son when distributing an inheritance. What happened between Jacob and Esau would be a violation of the Mosaic Law—if they had lived under it.

However, this practice was not universal in the ancient Near East, and it does not seem to be how Jacob, Esau, Isaac and Rebekah understood the birthright tradition. At the time of the patriarchs, the inheritance of the “firstborn,” the birthright, seems to have been independent from the blessing and something the firstborn could sell to someone else, as Esau did. In his commentary, Kenneth Mathews pointed out that both Jacob and Esau assumed that Esau had the right to sell his birthright. Jacob demonstrated this when he required Esau to trade his birthright for some red stew. Esau showed the same understanding when he complained that Jacob had cheated him twice—first for the birthright and then by tricking him out of a blessing by their father (Genesis 27:36).

Esau’s willingness to give up his birthright is less puzzling if the birthright and blessing are seen as separate actions. Consider this. Esau comes home hungry and exhausted from hunting and asks Jacob for some of the “red” stew he has just prepared. Jacob then said for the first time, “Sell me your birthright now.” I think Esau initially thought Jacob was not serious, so he reached for some stew and said: “I am about to die; of what use is a birthright to me?”

Jacob then repeated his demand: “Swear to me now,” and Esau now saw Jacob was serious. The right move would have been to go elsewhere to satisfy his hunger. But what if he thought the future blessing, as the eldest son, would overrule selling his birthright? Esau knew he was his father’s favorite. Surely their father would not recognize Jacob’s lame attempt to “buy” his birthright. So Esau took an oath, ate his stew and bread, and then left.

And it seems that initially, Esau was right. When Isaac was old, and he could not see, he called Esau and told him to hunt game and prepare a delicious meal so that he may eat it and “bless you before I die” (Genesis 27:2-4). Rebekah overheard the two of them, and plotted with Jacob to trick her husband, so that Jacob instead of Esau would receive the blessing from Isaac. Even though Jacob had “bought” Esau’s birthright, it hadn’t been enough to position himself as the son who had the right to receive his father’s blessing. Isaac still intended to bless Esau, who would retain the rights and privileges that came with it. As an aside, while Isaac was a bit of a foodie, loving the game Esau would catch (Genesis 25:28), I wonder if the meal also had some role in the pending ritual where Isaac was to bless Esau.

It seems that Isaac and his family members all placed greater importance on the blessing than the birthright. We see this in three ways. First, in Esau’s easy agreement to trade his birthright to Jacob for some red stew. Second, in the cunning way that Rebekeh and Jacob tricked Isaac to have him think he was blessing Esau, when in fact he was blessing Jacob. They both went to a good bit of trouble and risk to trick Isaac. And third, Isaac felt he could not undo the blessing he gave to Jacob, even though he obtained it through trickery (Genesis 27:1-40).

The plots and counter plots in the story of Jacob and Esau highlight competitive and dysfunctional behavior worthy of a modern soap opera or reality TV show. Jacob surely had a take-no-prisoners attitude towards obtaining Esau’s position as head of the family and Rebekah supported him. Esau rested on the assurance of his rights as the eldest and the knowledge that he was his father’s favorite. Surely this was enough to overcome Jacob’s transparent attempt to rob him of his birthright. Why did this rivalry start?

Look at the prophecy given to Rebekah when she had a difficult time during her pregnancy in Genesis 25:22-23. It seemed as if the children she carried were fighting one another in her womb. She was told: “Two nations are in your womb, and two peoples from within you shall be divided; the one shall be stronger than the other, the older shall serve the younger.” What follows in Genesis suggests that Rebekah took this prophecy to heart. Both her actions and those of Jacob are consistent with attempts to fulfill the final the final clause of the prophecy: “the older shall serve the younger.”

But Isaac apparently dismissed the significance of the prophecy as an explanation for his wife’s problematic pregnancy. When Rebekah gave birth, she had twins. There was a reasonable explanation for his wife’s difficult time—she had been carrying twins. And Isaac seems to have seen the birth of twins as all about him.

Gordon Wenham in his Genesis commentary noted where the first son was held in particular esteem as the first fruits of his father’s strength. But God had granted Isaac a double portion of TWO sons! Jacob had a similar view of the significance of his firstborn son when giving his deathbed blessings: “Reuben, you are my firstborn, my might, and the firstfruits of my strength, preeminent in dignity and preeminent in power” (Genesis 49:3). Isaac saw Esau as having the birthright and attendant privileges of the firstborn from the beginning. Jacob was simply a sign of God’s favor upon Isaac and his willingness to fulfill what He said to Isaac in Genesis 26:4-5:

I will multiply your offspring as the stars of heaven and will give to your offspring all these lands. And in your offspring all the nations of the earth shall be blessed, because Abraham obeyed my voice and kept my charge, my commandments, my statutes, and my laws.

So when Jacob made him swear to sell his birthright for a meal, Esau knew it was a pathetic attempt on Jacob’s part that their father would never go along with. So he made a bargain that he knew would never be honored. Nevertheless, he showed contempt for his right as the firstborn in trading his birthright. As Gordon Wenham observed, “Esau has treated with flippancy something of great worth.”

Jacob was trying to grasp what wasn’t his to take—Esau’s birthright—because of how he and Rebekah interpreted the prophecy about him and Esau before their birth. Esau was flippant with something he should have treated with the respect and honor it deserved. He trusted in custom and tradition instead of God. Isaac was blind to the truth of the prophecy, at least until he realized that the person he had blessed was Jacob and not Esau (Genesis 27:28-40). Yet Jacob’s successful usurping of Esau’s blessing didn’t work.

Because of the animosity it caused between them, Jacob had to leave all he had schemed to obtain behind because Esau intended to kill him after their father died. In the end, Esau not only received the double portion of the firstborn, he also seems to have been given Jacob’s share because Jacob went to Rebekah’s brother Laban. What seems to have been intended as a shorter time period to let Esau cool down, turned into twenty years. It was on this journey that Jacob heard personally from the Lord, as had his father Isaac and his grandfather, Abraham (Genesis 28:13-15). He had been trying to grasp the wrong birthright.

09/2/16

Antidepressant Scapegoat

5169097 - goat. photo based illustation. the scapegoat was a goat that was driven off into the wilderness as part of the ceremonies of yom kippur, the day of atonement, in judaism during the times of the temple in jerusalem. the rite is described in leviticus 16.

© Elena Ray | 123rf

The Hamilton Depression Rating Scale (Ham-D) is the most widely used clinician-administered assessment scale. In use since the 1960s, it is seen as the “gold standard” for assessing depression. As such, it was the assessment tool of choice when antidepressant clinical trials were being done. The only problem was many, if not most, of the antidepressants that came to market had a statistically significant effect on the Ham-D that was not observable clinically. Irving Kirsch called this a “dirty little secret.” Both the pharmaceutical companies bringing the drugs to market and the FDA knew there was essentially no difference between the effects of the drug and the placebo used in the clinical trial.

Kirsch’s research into the placebo effect with antidepressants has been established and repeatedly replicated; it wasn’t a fluke, one-and-done study. Search his name in Google or start here with “Dirty Little Secret,” “Modern Alchemy with Antidepressants,” or “Do No Harm with Antidepressants.” Kirsch showed clearly that study participants were able to regularly break the double blind methodology of the clinical trials because the researchers continually used inert placebos. The real drugs given to study participants produced side effects; the inert placebo pills didn’t. All you had to do was pay attention to any side effects you may or may not exhibit to have about a 75% chance of accurately predicting whether you were in the experimental group of the control group.

But Swedish researchers suggested that the reason SSRI antidepressants haven’t performed better than placebo was because they were measured incorrectly. Heironymus et al. said that if 16 of the 17 items in the Ham-D were ignored and only the single item assessing depressed mood was utilized, “scientifically valid support for the tested drug being antidepressant” could be shown. They said their decision to focus on depressed mood was because it was one of the two key symptoms required by the DSM-IV definition of depression; and it is given particular importance by the FDA when the agency evaluates the efficacy of an antidepressant.

While not claiming that assessing depressed mood only is the optimal way of recording symptom severity, or that other symptoms are irrelevant, we do suggest that a treatment faithfully outperforming placebo in reducing depressed mood can hardly be regarded as ineffective.

Perceived flaws with the Ham-D have been pointed out by previous researchers. In 2004, Bagby et al. looked at the psychometric properties of the Ham-D and found the internal, interrater, and retest reliability estimates overall were mostly good. However, many of the individual scale items were poor contributors when measuring the severity of depression. Some had poor interrater and retest reliability. “For many items, the format for response options is not optimal.” They concluded that:

Evidence suggests that the Hamilton depression scale is psychometrically and conceptually flawed. The breadth and severity of the problems militate against efforts to revise the current instrument. After more than 40 years, it is time to embrace a new gold standard for assessment of depression.

They said many of the individual items were poorly designed and add up to a total score whose meaning was unclear. At the very least, they thought the Ham-D needed a complete overhaul of its items. The researchers thought it was time to retire the Ham-D, as it is measuring a conception of depression that is several decades old. “The field needs to move forward and embrace a new gold standard that incorporates modern psychometric methods and contemporary definitions of depression.” In other words, the new gold standard needs to include current DSM symptoms.

I wonder if the Bagby et al. study may be suggesting we set aside the Ham-D prematurely. A cursory comparison of the Ham-D and the current edition of the DSM, the DSM-5, suggested there is a good bit of overlap. An article by Michael Schreiner, “Major Depressive Disorder DSM 5 Criteria,” gives the DSM-5 diagnostic criteria; the Ham-D is described here in a NIH document.

The DSM-5 lists nine potential symptoms of depression, five of which are required to exist within a two-week period of time for a diagnosis of major depression. The symptoms have to cause clinically significant distress or impairment in social, occupational or other important areas of functioning. Every one of the nine symptoms is mentioned one way or another within the Ham-D.

The nine DSM-5 symptoms are:

1. Depressed mood most of the day, almost every day, indicated by your own subjective report or by the report of others. This mood might be characterized by sadness, emptiness, or hopelessness.
2. Markedly diminished interest or pleasure in all or almost all activities most of the day nearly every day.
3. Significant weight loss when not dieting or weight gain.
4. Inability to sleep or oversleeping nearly every day.
5. Psychomotor agitation or retardation nearly every day.
6. Fatigue or loss of energy nearly every day.
7. Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day.
8. Diminished ability to think or concentrate, or indecisiveness, nearly every day.
9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a   specific plan for committing suicide.

There are clear differences between them as well. The Ham-D scale devoted three items to sleep disturbance; the DSM-5, only one. Some items in the Ham-D, like agitation and retardation (slowness of thought and speech) were mixed into two different symptoms in the DSM-5. Hypocondriasis was in the Ham-D, but not the DSM-5. The Ham-D item on “work and activities” was broken into a symptom of fatigue and also appeared in a separate category B: “Symptoms cause clinically significant distress or impairment in social, occupational or other important areas of functioning.”

The case for a more psychometrically sensitive depression scale, one that has a greater correspondence to how depression is currently diagnosed, makes some sense. But is the problem really that a more effective diagnostic scale needs to be developed? Perhaps the issue is that the Ham-D hasn’t had a very good track record in demonstrating the effectiveness of antidepressant drugs. So researchers and pharmaceutical companies would like a scale that more clearly demonstrates efficacy with medications than the Ham-D. Or maybe the Ham-D is being scapegoated for the failures of antidepressant drugs. Then again, maybe the problem is trying to “treat” a complex human condition like depression by manipulating one or two neurotransmitters with antidepressants.