08/30/16

The Devil in Ohio

© Olena Yakobchuk | 123rf.com

© Olena Yakobchuk | 123rf.com

Around the beginning of July 2016, there were a series of overdoses and deaths in Akron Ohio. The ABC News affiliate in Cleveland reported there had been 173 overdoses in Akron by July 22; 16 of which were fatal.  Some of the first people to overdose had not shot up—they were snorting what they thought was heroin. “As soon as I sniffed it, I knew something was up because it got me feeling super intense,” he said. When I woke up, I was on a stretcher. I was freaking out because I didn’t know what happened. I was tied down.”

The overdoses are being attributed to a street mixture of heroin and carfentanil, an opioid considered to be 4,000 times as potent as heroin. There were some misleading news reports at the time suggesting that heroin users themselves were mixing heroin and carfentanil (carfentanyl). Reporting for Cincinnati.com, Terry DeMio said that the Hamilton County Heroin Coalition warned carfentanil had been found in the local heroin of Cincinnati, Akron and Columbus. Dr. Marc Fishman said: “Carfentanil is one of the most potent opioids known, as an anesthetic agent by veterinarians for large animals, not used for humans.” Veterinarians who are licensed to use it cover up hands, arms and faces when they use it … and they keep naloxone handy.

Then the overdoses started happening again in the Cincinnati area. The Washington Post reported there were 78 overdoses and at least three deaths during a 48-hour period. By the end of the week, the overdose total has reached 174. Some of the overdose victims required multiple doses of naloxone to reverse the effects. Although they are still awaiting the lab results, the police believe this is another batch of heroin mixed with carfentanil. So far law enforcement has not been able to identify the source of the mixture. Newtown Police Chief Tom Synan said:

These people are intentionally putting in drugs they know can kill someone. . . . The benefit for them is if the user survives, it is such a powerful high for them, they tend to come back. … If one or two people die, they could care less. They know the supply is so big right now that if you lose some customers, in their eyes, there’s always more in line.

WKRC in Cincinnati reported thirty overdoses in the course of just one day—Tuesday August 23rd. One man overdosed while driving through an intersection. Another man overdosed at a gas station; with his child in the car. Three other people overdosed in the same house. “It was too early to tell if the spike in overdoses Tuesday night, August 23, had anything to do with carfentanil. But, it was found in several places throughout the city of Cincinnati in early August 2016.”

carfentanil molecule

carfentanil molecule

So what exactly is carfentanil? According to PubChem, carfentanil is an analog drug of fentanyl that was first synthesized in 1974 by a team of chemists working for Janssen Pharmaceuticals. It’s marketed under the trade name of Wildnil as a general anesthetic for large animals, like elephants and rhinoceros. Its extreme potency makes it an inappropriate agent for human use, unless you happen to be a Walter White-type of entrepreneur with heroin. It is classified as a Schedule II controlled substance.

A 2012 study found evidence that the Russian military used an aerosol form of carfentanil and remifentil in the 2002 Moscow theatre incident to subdue Chechen hostage takers. The Washington Post reported the death toll was 170 people; only 40 of the dead were attackers. Because of the lack of information provided to emergency workers, they didn’t bring enough naloxone or naltrexone to prevent the complications experienced by the gassed victims “from both respiratory failure and aerosol inhalation during the incident.” A 10 mg dose of carfentanil could sedate or kill a 15,000-pound elephant or take down a musk ox, bull moose or full grown buffalo. The same amount could kill 500 human beings.

Heroin cut with carfentanil offers a harder-hitting, longer-lasting high and allows dealers a shortcut to increase their supplies. But users often don’t know what they’re getting. In recent months, authorities have linked carfentanil to a spike in overdoses in several states, and have warned that it could spread to others.

On August 9, 2016 Canadian border officials reported they had intercepted a one-kilogram package of carfentanil heading to Calgary from China. The package was shipped to a 24 year-old man at his home address and labeled as “printer accessories.” A kilogram of carfentanil is equivalent to four metric tons of pure heroin. The package could have produced 50 million doses. Roslyn MacVicar of the Canadian Border Services Agency said: “It is hard to imagine what the impact could have been if even the smallest amounts of this drug were to have made its way to the street.”

In a DEA report Donald Cooper presciently thought that analogs of fentanyl would become a future drug of abuse He indicated that the already published synthesis schemes for fentanyl compounds allow for a variety of precursor chemicals to be used in synthesizing the drugs. The DEA became aware of this potentiality from the confiscated notes from an anonymous clandestine laboratory. Two formulas for synthesizing carfentanil have been extracted from separate volumes of the Journal of Organic Chemistry and made available for any enterprising chemist in “Synthesis of Carfentanil” on Erowid. The DEA indicated that over 12 different analogues of fentanyl have been clandestinely produced and identified in the U.S. drug traffic.

Interviewed by CBS News, Kevin McCutheon of Akron Ohio is a long-time addict. He believes when he overdosed he ingested carfentanil. He said he had used fentanyl and has been “doin’ dope,” but this wasn’t the same. The interviewer commented that he had tears in his eyes. He said it was because he was here and knew he shouldn’t be. “It’s the devil.”

08/26/16

Crumbling Pillars?

35367610 - ruin of temple e (temple of castor and pollux) in the archeological park of selinunte in southern sicily

© Andreas Metz | 123rf.com

On July 7, 2016, the Ark Encounter, a “life-sized Noah’s Ark experience” was opened to the public. The centerpiece of the Answers in Genesis “theme park” is a 510-foot long replica of Noah’s Ark, standing over 50 feet tall. The park has a petting zoo, daily animal shows, zip lines, live entertainment and a 1,500-seat restaurant. One of its exhibits shows children living alongside dinosaurs. Future phases seek to build the Tower of Babel and a building that will house “a walk through Biblical history.” Admission is $40 for adults and $28 for children. Parking costs an additional $10. Oh, and the total cost of the project was $100 million.

There is a ready-made market for the Ark Encounter. An ABC News poll in 2004 found that 60% of Americans believed that the biblical story of Noah was literally true. When sorted by faith groups, 44% of Catholics thought the biblical story of Noah was literally true; and 87% of evangelical Protestants thought it was literally true. Only 29% with no religious affiliation thought it was literally true. The problem is: “The scientific and historical evidence is now clear: there has never been a global flood that covered the entire earth, nor do all modern animals and humans descend from the passengers of a single vessel.”

The two main pillars of a young earth creationist understanding of the Bible are the creation of the earth 6,000 years ago and a global flood. They hang together to uphold young earth creationism (YEC). The “apparent” geological evidence for an age of the earth far beyond 6,000 years is explained by the cataclysmic destruction from a global flood. The layers of sedimentary rock from around the world; the extinction of multiple kinds of animals—including the dinosaurs and others—is explained by the Biblical account of Noah’s Flood.

In another article, I looked at how the argument for a young earth rests on the false assumption that a chronology for the age of the earth can be derived from the Biblical genealogies. See “The Fall of the Chronology of Ussher” for more on this issue. Here we discover there are cracks in the other pillar—the assertion of a global flood.

Two Christian geologists, Gregg Davidson and Ken Wolgemuth questioned whether Noah’s Flood could account for the earth’s complex geology in their essay: “Biblical and Scientific Shortcomings of Flood Geology.”

To explain the vast thicknesses and incredible complexity of the earth’s sedimentary deposits within a short history, it is argued that the Flood must have been both global and violent. Flood Geology is thus synonymous with belief in a young earth. It is our conviction that this position is unreasonable from both a biblical and scientific perspective.

One of the challenges raised by Davidson and Woglemuth has to do with salt deposits like those found in the Gulf of Mexico. Salt deposits form when water is evaporated. “During evaporation, the concentration of dissolved ions increases until the water cannot hold the salt in solution anymore and mineral salt begins to form.” The problem is these salt deposits are between layers of sediment that the global flood was supposed to have deposited. “ A single, flood cannot be called upon to explain both the salt and the overlying sediment.”

Another challenge is the Grand Canyon, with its alternating layers of limestone, sandstone and shale. The sequence defies any reasonable attempt to explain it by a single flood. However, if the deposits were formed at different times under varying stages of sea levels, it is very easy to explain them. “If explained with a single catastrophic flood that abided by God’s natural laws of physics and chemistry, logic must be stretched beyond the breaking point.” And the multiple layers of limestone found in the Grand Canyon are never found in flood deposits.

Then there is the fossil record. If a massive flood were responsible for the fossil record, we should expect to see life forms from every living “kind” mixed together. Mammoths should be mixed in with triceratops; pterodactyls with sparrows. Ferns and meadow flowers should be found along with trilobites and whales. But what we see is quite different.

There is an orderly sequence where trilobites only occur in very old rocks, dinosaurs in later beds, and mammoths in still later layers. Organisms like flowers and ferns are present together in more recent deposits, but only ferns with no flowers are found in older deposits.

There is a new book, The Grand Canyon, Monument to an Ancient Earth, which looks specifically at the geology of canyon rocks and landforms in the light of the claims of flood geologists. Two of the eleven contributors are Davidson and Woglemuth. In “Flood Geology and the Grand Canyon” four contributors from the book use explanations and illustrations from their book to challenge five kinds of evidence in the Grand Canyon that flood geologists say support a global flood.

They used a graphic from Answers in Genesis (here) that summarizes these five different “evidences,” and then gave a synopsis of where they specifically refuted these flood geology claims in The Grand Canyon, Monument to an Ancient Earth. In the conclusion to their article, the authors said the geology of the Grand Canyon is known fairly well after nearly 150 years of study. The geological evidence “is overwhelmingly inconsistent with flood geology.” The rocks reveal multiple episodes of deposition and intervening periods of erosion. The fossil evidence does not reflect the rapid burial of sea animals and small land animals out of the deep, turbulent water hypothesized as occurring with a global flood. “Flood geologists have failed to conceive a physical model for catastrophic formation that is consistent with the real geology of the Grand Canyon.”

Another book by two Christian geologists, The Bible, Rocks and Time, was written with the intent to convince readers on biblical and geological grounds “of the vast antiquity of this amazing planet that is our God-given home.” Along the way they point out the flaws of young earth creationism.

Although the issue of Earth’s antiquity may seem to be little more than an interesting intellectual exercise that has little immediate bearing on one’s life, we point out that this issue can have profound spiritual consequences for the church of Jesus Christ, the individual Christian and the nonbeliever as well.

An article by Ted Davis on BioLogos, “The Bible, Rocks and Time: Christians and an Old Earth,” quoted two excerpts from the book. One “snip” noted where a growing number of orthodox evangelical Christian writers have accepted and accommodated their thinking “to the mounting evidence for terrestrial antiquity.” Linked there was an article originally written by Davis Young, one of the authors of The Bible, Rocks and Time. The article, “Scripture in the Hands of Geologists (Part Two),” was originally published in the Westminster Theological Journal. Part Two of Young’s article surveyed the concordist tradition when interpreting the early chapters of Genesis by Christian geologists. Young and Stearley were quoted as saying in The Bible, Rocks and Time:

A growing number of orthodox evangelical Christian writers, including geologists, preachers, biblical scholars and theologians, accepted and accommodated their thinking to the mounting evidence for terrestrial antiquity. In response, they began to develop a variety of strategies purporting to show how the biblical data were consistent with the findings of geology. . . . Having been encouraged to look afresh at the biblical creation accounts, experts in the original languages became persuaded that there is no conflict between the data of nature and the teaching of Scripture. These individuals continued to insist on the inspiration of the Bible and refused to call Genesis a myth in order to explain difficulties. It was, however, accepted that the traditional exegesis of Genesis 1 was not the only one that adequately satisfied the biblical data.

The two pillars of a YEC view of Genesis pit the two books of God’s revelation, Scripture and Nature, God’s Word and God’s Works against one another. As a consequence, they have weakened and not strengthened His revelation in both books. This “two books theology” was an essential foundation for the rise of modern science. As Mark Mann said, “Christians need to ‘read’ Scripture and Creation together in order to understand the fullness of God’s Word and truth for us today.” In Redeeming Science, Vern Poythress pointed out that scientific laws are what can be known about God in the things that have been made. “Since the creation of the world, his invisible attributes, such as his eternal power and divine nature have been clearly perceived (Romans 1:20).”

In reality, what people call “scientific law” is divine. We are speaking of God himself and his revelation of himself through his governance of the world. Scientists must believe in scientific law in order to carry out their work. When we analyze what this scientific law really is, we find that scientists are constantly confronted with God himself, the Trinitarian God, and are constantly depending on who he is and what he does in conformity with his divine nature. In thinking about law, scientists are thinking God’s thoughts after him. (Redeeming Science, pp. 26-27)

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

08/23/16

Clinical Trial Sleight-of-Hand

7501727 - a rabbit in a hat and a magic wand against white background

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In 2005 a researcher named John Ioannidis published a seminal paper on publication bias in medical research, “Why Most Published Research Findings are False.” When Julia Belluz interviewed Ioannidis for Vox ten years later, she reported that as much as 30% of the most influential medical research papers turn out to be wrong or exaggerated. She said an estimated $200 billion, the equivalent of 85% of the global spending on research, is wasted on poorly designed and redundant studies. Ioannidis indicated that preclinical research on drug targets received a lot of attention since then. “There are papers showing that, if you look at a large number of these studies, only about 10 to 25 percent of them could be reproduced by other investigators.”

Ioannidis noted even with randomized control trials, there is empirical evidence indicating only a modest percentage can be replicated. Among those trails that are published, about half of the initial outcomes of the study are actually reported. In the published trials, 50% or more of the results are inappropriately interpreted, or given a spin that favors the sponsor of the research. “If you multiply these levels of loss or distortion, even for randomized trials, it’s only a modest fraction of the evidence that is going to be credible.”

One of the changes that Ioannidis’s 2005 paper seemed to produce was the introduction of mandatory clinical trial registration guidelines by the International Committee of Medical Journal Editors (ICMJE). Member journals were supposed to require prospective registration of trials before patient enrollment as a condition of publication. The purpose is that registering clinical trial ahead of time publically describes the methodology that should be followed during the trial. If the published report of the trial afterwards differed from its clinical trial registration, you have evidence that the researchers massaged or spun their research data when it didn’t meet the originally proposed outcome measures. In other words, they didn’t play by the rules they said ahead of time they were going to do in their research if they didn’t “win.”

Julia Rucklidge and two others looked at whether five psychiatric journals (American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and the Journal of Clinical Psychiatry) were indeed actually following the guidelines that said they would follow. They found that less than 15% of psychiatry trials were prospectively registered with no changes in their primary outcome measures (POMs). Most trials were either not prospectively registered, had either their POMs or timeframes changed sometime after registration, or they had their participant numbers changed.

In an article for Mad in America, Rucklidge said they submitted their research for review and publication in various journals, including two of the five they investigated. Six medical or psychiatric journals rejected it—they refused to publish Rucklidge et al.’s findings. PLoS One, a peer-reviewed open access journal did accept and publish their findings. She said while the researchers in their study could have changed their outcome measures or failed to preregister their trials for benign reasons, “History suggests that when left unchecked, researchers have been known to change their data.”

For example, an initial clinical trial for an antidepressant could be projected to last for 24 weeks. The 24-week time frame would be one of the initial primary outcome measures—will the antidepressant be more effective than a placebo after 24 weeks. After gathering all the data, the researchers find that the antidepressant was not more effective than placebo at 24 weeks. But let’s say it was more effective than placebo at 18 weeks. What gets reported is the results after 18 weeks; the 24 week original timeframe may disappear altogether when the research results are published.

People glorify their positive results and minimize or neglect reporting on negative results. . . . At worst, our findings mean that the trials published over the last decade cannot be fully trusted. And given that health decisions and funding are based on these published findings, we should be very concerned.

Looking ahead, Rucklidge had several suggestions for improving the situation with clinical trials.

1) Member journals of the ICMJE should have a dedicated person checking trial registries, trials should simply not be published if they haven’t been prospectively registered as determined by the ICMJE or the journals should state clearly and transparently reasons why studies might be published without adhering to ICMJE guidelines.2) If authors do change POMs or participant numbers or retrospectively register their trials, the reasons should be clearly outlined in the methods section of the publication.3) To further improve transparency, authors could upload the full clinical trial protocol, including all amendments, to the registry website and provide the raw data from a clinical trial in a format accessible to the research community.4) Greater effort needs to be made to ensure authors are aware of the importance of prospectively registering trials, by improving guidelines for submission (3) and when applying for ethical approval.5) Finally, reviewers should not make decisions about the acceptability of a study for publication based on whether the findings are positive or negative as this may be implicitly encouraging authors to be selective in reporting results.

Rucklidge also mentioned another study by Mathieu, Chan and Ravaud that looked at whether clinical trial registrations were actually looked at by peer-reviewers. The Mathieu et al. survey found that only one-third of the peer reviewers looked at registered trial information and then reported any discrepancies to journal editors. “When discrepancies were identified, most respondents (88.8%) mentioned them in their review comments, and 19.8% advised editors not to accept the manuscript.” The respondents who did not look at the trial registry information said that main reasons they failed to do so was because of the difficult or inconvenience in accessing the registry record.

One suggested improvement by Mathieu, Chan and Ravaud was for journals to provide peer reviewers with the clinical trial registration number and a direct Web link to the registry record; or provide the registered information with the manuscript to be reviewed.

The actions of researchers who fail to accurately and completely register their clinical trials, alter POMs, change participant numbers, or make other adjustments to their research methodology and analysis without clearly noting the changes is akin to the sleight-of-hand practiced by illusionists. And sometimes the effect is radical enough to make an ineffective drug trial seem to a new miracle cure.

08/19/16

Head-in-the-Sand

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© andreykuzim | 123rf.com

Within the U.S. the legalization of medical and recreational marijuana has rapidly increased over the past few years, but not without some disturbing trends. One of these is the rise in THC potency within cannabis. The 2016 World Drug Report (2016 WDR) indicated that cannabis THC potency in the U.S. has been increasing over the past thirty years. It went from less than 3.4% in 1993 to 8.8% in 2008. Bloomberg reported that more recent data suggests that THC potency in cannabis increased to 12.6% in marijuana seized by authorities in 2013. In states where recreational marijuana is legal, such as Colorado and Washington, some samples have reached as high as 30%, with the average around 17%, according to the 2016 WDR.

Mehmedic et al. published an article in the September 2010 edition of the Journal of Forensic Sciences that also concluded the increasing potency of THC in cannabis. While there was the above noted increase of THC in cannabis seized by authorities, the CBD concentration increased only slightly, from .3% to .4%. The cannabinoid with the greatest known medical potential in marijuana is CBD, not THC. The researchers concluded not only was cannabis more potent, the market share for higher-potency products was increasing. “The question now becomes: What are the effects of the availability of high-potency products on cannabis users?”

A partial explanation for the increased potency in legal commercial markets like Colorado is the popularity of edible cannabis products made with cannabis extract-based concentrates such as oil, “wax,” or “shatter.” The THC potency of these extracts can be up to 80-90 percent. In 2014, edible products accounted for an estimated 35% of retail sales of recreational marijuana in Colorado. This makes it difficult to determine the dose or amount of THC ingested in an edible, leading to potential over-intoxication. “With edible products, the slower onset and longer duration of intoxication could increase the risk of over-intoxication, especially for new or inexperienced users.”

One way of regulating this concern has been to implement stringent labeling and packaging requirements. Washington and Colorado require edibles to have a 10mg serving size of THC. Alaska and Oregon have drafted legislation to set the serving size at a maximum of 5 mg of THC. The increasing potency has not been the only concern within states where marijuana is now legal.

Since the legalization of recreational marijuana in Colorado and Washington, incidents of accidental ingestion of cannabis among young children have been increasing. The Washington Poison Control center reported the number of cannabis exposure calls for people under 20 doubled from 2010 to 2014. In Colorado, within one year of legalization there was a 29% increase in the number of marijuana-related ER visits and a 38% increase in the number of cannabis-related hospitalizations.

More people using marijuana recreationally means an increase in the number of individuals driving under the influence of marijuana. The 2016 WDR said studies suggested that although cannabis seemed to be less hazardous than alcohol with regard to driving impairment, it is much more dangerous when used in combination with alcohol. In both Colorado and Washington there have been increases in the percentages of crashes and fatal crashes of drivers who tested positive for marijuana from 2012 to 2015.

Not surprisingly, the number of arrests and court cases with cannabis-related offences dropped substantially in state that have legalized marijuana. But data on other marijuana-related offences such as citations or warnings for public consumption were not readily available. See the following chart taken from the 2016 WDR.

chartHowever, there has been a ripple effect of drug concerns in the states adjacent to states where recreational marijuana is legal. In December of 2014, Nebraska and Oklahoma sued Colorado, requesting that the U.S. Supreme Court reverse Colorado’s decision to legalize marijuana, as it had led to an increase in trafficking marijuana in these neighboring jurisdictions. Attorneys for Colorado and the Obama administration asked the Supreme Court not take up the lawsuit. But as it turned out, the Court was also reluctant to take on the dispute as well.

The Supreme Court justices spent more than a year pondering whether to take the case. The proposed lawsuit was scheduled and re-scheduled five times for a closed-door conference, where the justices would debate the merits of taking the case.

In March of 2016 the Supreme Court declined by a vote of 6-2 to hear their complaint against Colorado. But the vote did not rule out future challenges. The Colorado Attorney General said that while the state has had several legal victories in federal lawsuits surrounding Amendment 64 legalizing recreational marijuana, Nebraska and Oklahoma’s concerns will not disappear. Doug Peterson, the Nebraska Attorney General was quoted by the Denver Post as saying: “The Court’s decision does not bar additional challenges to Colorado’s scheme in federal district court.” The Oklahoma Attorney General, Scott Pruitt said:

The fact remains — Colorado marijuana continues to flow into Oklahoma, in direct violation of federal and state law. Colorado should do the right thing and stop refusing to take reasonable steps to prevent the flow of marijuana outside of its border. And the Obama administration should do its job under the Constitution and enforce the Controlled Substances Act. Until they do, Oklahoma will continue to utilize every law enforcement tool available to it to ensure that the flow of illegal drugs into our state is stopped.

The federal government cannot continue to sit on the sidelines while recreational marijuana laws take hold state-by-state. The medical potential needs to be scientifically delineated and a step towards that is rescheduling marijuana as a Schedule II controlled Substance. The adverse effects of increased THC potency should be investigated, monitored and ultimately regulated. The collateral harm in neighboring states where marijuana is not legal should be dealt with cooperatively between states or result in federally mediated changes. Continuing a head-in-the-sand approach at the federal level is no longer a viable option.

The United Nations Office on Drugs and Crime (UNODC) publishes a yearly report giving a global overview of the supply and demand of various drugs and their impact on health.  This is one of a series of articles discussing information from the 2016 World Drug Report.

08/16/16

Gaining in Humility

© unkreatives | stockfresh.com

© unkreatives | stockfresh.com

Matthew 5:38-40 in the Sermon on the Mount addresses the very human impulse to get even when someone does harm to you. Jesus succinctly says here, “Don’t do it!” The initial phrase, “an eye for an eye”, has become a justification in our time for getting even with the person who has done something against us. There is an Old Testament principle of reciprocity behind the phrase. When judging injury done to another, if there is harm, pay life for life, eye for eye, tooth for tooth, hand for hand (Exodus 21:23-25). There is a similar call in Leviticus 24:20 when someone injures their neighbor: whatever injury he has given a person shall be given to him.”

Sometimes called the “law of retribution” or lex talionis, this was a legal principle stating that punishment for wrongdoing should not exceed the crime. What’s more, as Exodus 21:22 indicated, judges and not the aggrieved person decided how to apply the principle in any specific case. Jesus clearly says: “Do not resist the one who is evil” (Matthew 5:39). It seems the message here is: “Don’t take the law into your own hands!”

In his commentary on Matthew, Leon Morris readily acknowledged how easily a desire for revenge rises up within us. “We have a natural tendency to retaliate when anyone harms us (or even when the harm is in our imagination!).” But Jesus challenges us to not seek to settle scores; to not hit back when someone hits us. This is again the message in 5:39: “To be the victim of some form of evil does not give us the right to hit back.” Even if someone were to legally deprive you of your tunic, don’t resist. Rather, give him your cloak as well.

Again there is an allusion to an Old Testament regulation in Exodus 22: 26-27 and Deuteronomy 24:12-13. If a neighbor’s cloak was taken in pledge for a loan, you should return it to him before evening, so he has something to sleep in. “A person had an inalienable right to his cloak; it could not be taken away from him permanently. Its voluntary surrender is thus significant.” Craig Blomberg said that in modern context, “coat” and “shirt” are parallels to “cloak” and “tunic” respectively. So the message is to go further than just giving up the shirt off your back.

As if this wasn’t enough, Jesus then said if you were forced to go one mile, go two. Here the reference is to the practice of “impressment,” which allowed a Roman soldier to conscript someone to carry his equipment or some other burden for one Roman mile. This was a legal and customary practice dating back to the time of the Persian government postal service. Both people and animals could be called upon without notice for temporary service. Again there is an echo of a modern saying, that of going the second or extra mile.

John Nolland noted in his commentary on Matthew how this practice could easily be abused by the Romans and resented by the Jews. “Hostility to Roman rule would make such impressment yet more distasteful.” Jesus said the proper response is generous and ungrudging compliance. It seems Jesus intensifies his point by giving a series of admonitions that could be rendered today as: Don’t take the law into your own hands! Don’t just give up the shirt off your back; give up your coat as well. Go beyond what is required of you; go that second mile.

One of the early daily meditation books used in Alcoholics Anonymous was the classic Christian devotional by Oswald Chambers, My Utmost for Your Highest. On July 14th, Chambers reflected on this passage, saying the teaching of the Sermon on the Mount is not to do your duty. Rather it is do what is not your duty. Don’t insist on your rights. Be humble. “Never look for right in the other man, but never cease to be right yourself. We are always looking for justice; the teaching of the Sermon on the Mount is—Never look for justice, but never cease to give it.”

Here we touch on what Bill W. said was the number one offender, destroying more alcoholics than anything else—resentment. In each and every situation Jesus gave in Matthew 5:38-41, resentment for the injury, insult and injustice that occurred would be expected. Jesus is saying, “Don’t go there.” Oswald Chambers says: Don’t look for justice, but never stop giving it to others. In his essay on Step Four, Bill W. said we need to learn that something has to be done about our vengeful resentments, self-pity, and unwarranted pride.

We had to see that when we harbored grudges and planned revenge for such defeats, we were really beating ourselves with the club of anger we had intended to use on others. We learned that if we were seriously disturbed, our FIRST need was to quiet that disturbance, regardless of who or what we thought caused it. . . . Where other people were concerned, we had to drop the word “blame” from our speech and thought.

After the first two or three attempts, the way ahead begins to look easier. “For we had started to get perspective on ourselves, which is another way of saying that we were gaining in humility.”

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

08/12/16

When Pain Feels Good

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© sapegina |stockfresh.com

Counter-intuitively, self-harm or self-injury is best seen as an attempt to relieve pain than to cause pain. An NPR program, “The History and Mentality of Self-Mutilation” noted that in the late 19th century, two American doctors described a strange phenomenon. Women were puncturing themselves with sewing needles. The practice was so common, that doctors began to refer to the so-called “hysterical” women who did this as “needle girls.” Hysteria was the “it” psychiatric condition of the time. Sigmund Freud’s first published book was one he co-authored with Josef Breur, Studies on Hysteria. But self-harm has a longer history, dating back even to the time of the Greeks.

Self-harm is found in situations as wide ranging as monasteries, nunneries and modern-day prisons. Within a religious context, the practice is called flagellation. The practice of mortifying the flesh for religious purposes within the Roman Catholic Church dates to 1054. Within Roman Catholic ritual, the fourth of the modern Stations of the Cross is the Flagellation of Christ. This station is based upon the scourging of Christ, just before he was delivered up to be crucified (Mark 15:15). Typically occurring before a crucifixion, scourging was with a cattail whip that had pieces of bone or metal tied into it.

In the 14th century, the Flagellants were condemned by the Roman Catholic Church as a cult. But a mild form is still practiced within a few strict monastic orders. And some members of the Catholic lay organization, Opus Dei, use a “discipline” during prayer. This is a cattail whip of knotted cords, which is repeatedly flung over the shoulders during private prayer. Reportedly, Pope John Paul II practiced this discipline regularly.

Armando Favazza, who has studied self-injury for several years, said its practitioners use it as a way to silence a swirl of pain and anxiety. “They describe it as popping a balloon. All the anxiety just seems to go away.” A 19 year-old woman interviewed in the NPR story said she has her own “kit”, consisting of a new pack of razors, a pair of scissors and a pink towel. Whenever she was stressed, she turned to her kit. Before cutting her mind is exploding. But when she feels pain, there’s a kind of peace. “I’ll just be really calm and my thoughts will finally kind of be making sense, instead of them like racing through my head and nothing quite clicking. Just kind of centralizes my thought on one thing.”

A 2010 article, “Self-Injurious Behavior in Adolescents” by Janis Whitlock defined self-injury or non-suicidal self-injury (NSSI) as “the deliberate, self-inflicted destruction of body tissue without suicidal intent and for purposes not socially sanctioned.” Most often, it is not a suicidal gesture, while it can result in severe harm or death. Studies tend to find what is referred to as common NSSI in 12% to 37.2% of American high school-aged individuals and 12% to 20% of late adolescent and young adult populations. “Overall, about a quarter of all adolescents and young adults with NSSI history report practicing NSSI only once in their lives.” The available evidence suggests that 40% of repeat NSSI report stopping within the first year, and 79.8% report stopping within 5 years of starting.

Unpublished data indicates females are slightly more likely to practice self-harm than males. In my counseling experience, I’ve talked with both males and females who attempted NSSI. This is also not an isolated American phenomenon. NSSI is present in a variety of countries and cultures globally. “Although most widely investigated in industrialized regions such as Europe, North America, Australia, and New Zealand, NSSI also occurs with some regularity in other industrialized and non-industrialized countries as well.”

Self-injury is strongly linked to childhood abuse, especially childhood sexual abuse; eating disorders, substance abuse, PTSD, depression and anxiety. While it is common among adolescents, NSSI often goes undetected. Some signs can include wearing long sleeves or pants during hot weather; constant use of wristbands/coverings, unwillingness to participate in activities with less body coverage, like swimming or gym class; and frequent bandages. Whitlock also highlighted what she saw as five key studies of NSSI. See her linked article for the details.

Moran et al. published a natural history study of self-harm in the British journal The Lancet in 2012. More girls (10%) than boys (6%) reported self-harm in adolescence. There was a substantial reduction of self-harm during late adolescence. During adolescence, self-harm was associated with depression and anxiety, antisocial behavior, high-risk alcohol use, cannabis use and cigarette smoking. While most adolescent self-harm resolved spontaneously, when mental health issues are associated, treatment mat be needed.

Most self-harming behaviour in adolescents resolves spontaneously. The early detection and treatment of common mental disorders during adolescence might constitute an important and hitherto unrecognised component of suicide prevention in young adults.

A Cochrane study by Hawton et al. in 2015 looked at pharmacological treatment for self-harm. The conclusion was: “There is currently no clear evidence for the effectiveness of antidepressants, antipsychotics, mood stabilisers, or natural products in preventing repetition of SH [self-harm].” They found no significant treatment effect for newer antidepressants, fluphenazine (an antipsychotic), mood stabilizers or natural products. While a significant reduction in self-harm behavior was found with flupenthixol (an antidepressant), the quality of the evidence for the study was very low. No data on adverse effects, other than the planned outcomes related to suicidal behavior, were reported.

We have reviewed the international literature regarding pharmacological (drug) and natural product (dietary supplementation) treatment trials in this field. A total of seven trials meeting our inclusion criteria were identified. There is little evidence of beneficial effects of either pharmacological or natural product treatments. However, few trials have been conducted and those that have are small, meaning that possible beneficial effects of some therapies cannot be ruled out.

In a 2004 article in The Journal of Biblical Counseling, “Self-Injury: When Pain Feels Good,” Ed Welch said anything that arouses unwanted emotions can trigger the self-harm cycle. Trouble in relationships or anything that can provoke shame could be triggers. Beliefs that you have violated a personal, cultural or religious taboo can initiate it. “Perhaps you just don’t tolerate your own humanness with its imperfections, weaknesses, dependencies and sins.” Welch described the cycle of self-harm as following the pattern in this graphic: self harm

These beliefs, personal experiences, and external circumstances mix into a stew of raw emotions that can include anger and frustration, anxiety, or a jumping-out-of-your-skin agitation. Without alternatives, self–injury gradually becomes the preferred response to these feelings because it works. You regain control. Your emotions are back in check. The screams within have been temporarily silenced.

Welch is approaching the issue of self-harm from a biblical, religious perspective. So his advice and action steps will include addressing the spiritual side of self-harm: “Self-injury is, at its root, about God. Avoid Him, and we miss true hope.” In order to address self-injury: 1) Allow other people in; ask for help. 2) Grow in honesty; don’t hide your behavior. 3) Feed yourself with Scripture; the Psalms are a good place to start. 4) Write out the meaning and purpose of your self-injury. 5) When you fail, don’t give in to hopelessness. “All human beings sin and fail. It is what we do!” 6) If you keep moving back into self-injury, notice the intentionality of your behavior. Are you putting barriers between yourself and your self-abuse strategies?

If you are interested in the complete article by Ed Welch, you can purchase it in booklet form on Amazon or at the Christian Counseling and Education Foundation (CCEF). The booklet is $3.99, but if you purchase it in its original form in The Journal of Biblical Counseling, you can purchase the full digital issue it appeared in (JBC Volume 22:2) for $4.99.

08/9/16

The Wrong Doorway

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© captainvector | 123rf.com

Laughing gas or nitrous oxide (N20) has a surprising variety of uses or effects. The World Health Organization lists it as an essential medicine because of its anesthetic and analgesic effects. It’s used as an oxidizer in rockets and motor racing to increase the power output of engines. N20 is also a major greenhouse gas, with a per unit mass impact that is between 265 and 310 times that of carbon dioxide. And it is in the top ten most popular recreational drugs globally.

The English chemist Joseph Priestley discovered nitrous oxide gas in 1772. Priestley is also known for his discovery of oxygen. Humphrey Davy experimented with N20 on himself and others in 1799. He coined the term ‘laughing gas’ after observing its effects on people who inhaled it. Although he reported its analgesic effects in 1800, this property was not tested or used for another 45 years. During that time, it was primarily a ‘party’ or entertainment drug.

A British dentist in 1845 was the first person to demonstrate the anesthetic properties of nitrous oxide. However, it was not widely used in dentistry until 1863. Gardner Quincy Colton and his partners opened a series of dental institutes using laughing gas. Within five years, they had performed a reported 75,000 extractions. A history of reported nitrous oxide users includes: Allen Ginsberg, Samuel Taylor Coleridge, Ken Kesey, Winston Churchill and William James.

In 1882 James published an article titled: “The Subjective Effects of Nitrous Oxide,” in the journal Mind.  He said his use of N20 helped him develop a greater understanding of Hegel’s philosophy and he strongly urged his readers to repeat the experiment. “With me, as with every other person of whom I have heard, the keynote of the experience is the tremendously exciting sense of an intense metaphysical illumination.” Truth was almost blindingly obvious. “The mind sees all logical relations of being with an apparant subtlety and instantaniety to which its normal consciousness offers no parallel.”

But as he “sobered up,” the feeling faded. James was left with a few disjointed words and phrases—like staring at a black cinder left after the fire has gone out. James said he had sheet after sheet of phrases written during intoxication with N20 that to his sober mind seemed to be “meaningless drivel.” The most coherent and articulate sentence that came to him was the following: “There are no differences but differences of degree between different degrees of difference and no difference.”

In his later, seminal work, The Varieties of Religious Experience, James again reflected on the significance of intoxication by alcohol and anesthetics. He said the influence of alcohol over humanity was due to its power to stimulate the mystical faculties of human nature. Sobriety diminishes; drunkenness expands. “The drunken consciousness is one bit of the mystic consciousness and our total opinion of it must find its place in our opinion of that larger whole.”

Nitrous oxide, according to James, stimulated the mystical consciousness to an extraordinary degree. “Depth beyond depth of truth seems revealed to the inhaler.” But that truth fades as the individual sobered up. Nevertheless, a profound sense of meaning persisted. “I know more than one person who is persuaded that in the nitrous oxide trance we have a genuine metaphysical revelation.” He then went on to describe his own previous experiments with N20 described in his 1882 article.

In an article for The Atlantic, “The Nitrous Oxide Philosopher,” Dmitri Tymoczko noted how the experience James had with nitrous oxide remained with him throughout his life. He wrote a second article about it in 1898, “Consciousness Under Nitrous Oxide.” Then in his last essay, completed in 1910, he implied N20 had had an abiding influence on his thinking. Tymoczko thought N20 was a ‘passport’ for James to see religion from the believer’s perspective. “Drugs helped James to understand what religious belief was like from the inside.”

 James’s experiences with nitrous oxide helped to crystallize some of the major tenets of his philosophy. His writings emphasize, for instance, the notion of pluralism, according to which “to the very last, there are various ‘points of view’ which the philosopher must distinguish in discussing the world.” Nitrous oxide had revealed in the most dramatic way possible the existence of alternate points of view.

Tymoczko used William James’s experience with nitrous oxide to argue how drugs can contribute to human well being; sometimes fulfilling an authentic religious need. He reasoned that drugs could allow even the most skeptical people to experience temporary periods of “pleasing falsehood,” dividing their life into periods of sober rationality and “ecstatic religious intoxication”, like William James. “Indeed, this is the real religious significance of drug use, from the Jamesian point of view–that it lets us choose, if only vaguely and temporarily, what to believe.”

He even referenced R. Gordon Wassson, who proposed that religion itself originated with drugs. According to Wasson, religion was a confused reaction to intense experiences provoked by the accidental ingestion of psychoactive plants. There have been examples where religious ritual has been entwined with the use of drugs. Some Native American cultures used psychedelic mushrooms in their rituals; and the Greek cult of Dionysus used wine to provoke visions. But Tymoczko went too far onto the magical mystery tour when he suggested that the use of wine by Christians could be a remnant of similar practices.

The Bible clearly puts the use of bread and wine within the context of a meal; not a mystical psychedelic religious rite. Tymoczko also failed to make a distinction made by James in The Varieties of Religious Experience that separated what James called institutional religion, like Christianity, from personal religion. James defined personal religion as “the feelings, acts, and experiences of [the] individual . . . in their solitude, so far as they apprehend themselves to stand in relation to whatever they may consider the divine.” James was looking at examples of personal religion, not institutional religion in The Varieties of Religious Experience. See “Spiritual, Not Religious Experience” for more on this distinction by James.

So now back to nitrous oxide. The significance of nitrous oxide to William James personally or to his philosophical and other writings has little to tell us about religious experience today. It may resonate with the increased interest in psychedelic drug rituals for therapeutic healing (See “Back to the Future with Psychedelics”). But before walking the path of Timothy Leary and Aldous Huxley, let’s take a look at what modern science tells us about N20—information that wasn’t available to James when he was doing his inhaling.

The Global Drug Survey, annually conducted by Adam Winstock and others, found that nitrous oxide was the seventh most popular drug in the world. More than 7% of the global survey respondents said they had used nitrous oxide in the past year. In the UK, it was used by 23.7% of respondents sometime over the past year. A recent article in the Journal of Psychopharmacology by Kaar et al., Winstock was a coauthor, indicated that the reported lifetime use of nitrous oxide for the UK and US was 38.6% and 29.4% respectively.

Most people using nitrous oxide recreationally do so infrequently without any serious side effects. But there is a subpopulation of heavy users. Quoted in an article for The Fix, Winstock said: “The majority of people who use it don’t use it very often, and only around 3% of heavy users say they have experienced negative health effects.” The Global Drug Survey found nitrous oxide use was associated with hallucinations (27.8%), confusion (23.9%), persistent numbness (4.3%) and accidental injury (1.2%). Accidental injury seems to be dose-dependent—injury is associated with higher numbers of ‘hits’ per session.

The pro-drug website, Erowid, has a ‘vault’ of information on nitrous oxide. Chronic exposure can effect reproduction in women. Immunological problems such as recurrent infections, decreased white blood cell counts and weakness have also been reported. There were also neurological issues with chronic N20 use.

A 1978 article in the British journal Lancet reported that a neurological disorder called myleneuropathy developed in 15 individuals with prolonged exposure to nitrous oxide. R.B. Layzer reported that: “The neurological picture is similar to that of subacute combined degeneration of the spinal cord, and it is possible that nitrous oxide interferes with the action of vitamin B12 in the nervous system.” A 1993 article by Flippo et al. in JAMA Surgery also described the dangers of neurologic degeneration from nitrous oxide. The abstract said:

Five cases (four from the literature and one new case) are presented in which patients unsuspected of having vitamin B12 deficiency developed subacute combined degeneration of the spinal cord following nitrous oxide anesthesia. Patients with vitamin B12 deficiency are exceedingly sensitive to neurologic deterioration following nitrous oxide anesthesia. If unrecognized, the neurologic deterioration becomes irreversible and may result in death.

Happily, some of these issues can be reversed. A 2003 article in the Wisconsin Medical Journal by Waclawik et al. described a case study of an individual who was a chronic nitrous oxide user whose neurological deficit was reversed after administering vitamin B12.

Sporadic use of N20 does not appear to be associated with serious health risks. But chronic exposure is another story. William James may have been influenced by experiences he had with nitrous oxide, just as Sigmund Freud’s use of cocaine shaped his psychoanalytic theories. N20 also fits with the current trend of looking for therapeutic healing or personal insight with psychedelics like LSD, ecstasy and even ayahuasca or ibogaine. But it is better suited as an anesthetic or analgesic in medical procedures; or an oxidizer in rocket engines than it is a doorway to religious experience.

08/5/16

The Fall of the Chronology of Ussher

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© Oleksandr Solonenko | 123rf.com

According to Bishop James Ussher, the world was created at nightfall on Saturday, October 22, 4,004 BCE. This amazingly precise declaration was just one of the important dates, both biblical and historical, that appeared in his seminal work, The Annals of the World. The “cosmological age” for creation occurring around 4,000 BCE was a widely accepted date in the 17th century. Its acceptance was partly based on 2 Peter 3:8, which says: “with the Lord one day is as a thousand years, and a thousand years as one day.” The application of the passage for the date of creation is that the six days of creation meant the earth would exist for 6,000 years—4,000 years until the time of Christ, and 2,000 years afterwards. If Ussher was correct, we are now living on borrowed time.

Ussher’s chronology was not the first to calculate that the creation of the world was around 4,000 BCE, but today it is the most well known. Others who had proposed similar biblically based estimates include: Bede (3952 BCE), the astronomer Johannes Kepler (3992 BCE), Sir Isaac Newton (4000 BCE), and Rabbi Jose ben Halafta (3761 BCE). Ussher’s very specific date was based on a desire “to get it right.” He used astronomical and religious sources to estimate the season of the year, day of the week and time of day he thought creation had to be. He believed the time was in the autumn, since that was the beginning of the Jewish calendar year, and on a Saturday evening, because of the Sabbath.

The Annals full title in English is a mouthful: “Annals of the Old Testament, deduced from the first origins of the world, the chronicle of Asiatic and Egyptian matters together produced from the beginning of historical time up to the beginnings of Maccabees.” It was 1300 pages, with 14,000 footnotes. Ussher worked on it for 20 years before it was published. The original printing sold well. What gave Ussher’s chronology staying power was its use in the margins of an edition of the Bible published by London bookseller Thomas Guy in 1675. Beginning in 1701 several editions of the King James translation included Ussher’s dates in its marginal notes and cross-references. The widely circulated Scofield Reference Bible, published in 1909 and revised in 1917, used Ussher’s dates and would become the main conduit of the chronology into modern times.

Ussher (1581-1656) was a careful and thoughtful man, well schooled in his faith and history. He was ordained in 1601 and was a professor at Trinity College in Dublin from 1607-1621. As early as 1624, he was invited to preach before King James I. He was made archbishop of Armagh in 1621 and primate of Ireland in 1634. When civil war broke out in 1642, he was in England. He never returned to Ireland. Ussher declined an invitation to join the Westminster Assembly of Divines (1643-49), who incidentally produced the Westminster Confession of Faith. He later preached against the legality of the Assembly.

He wrote on a wide variety of topics, mostly theological and historical, and was an expert in Semitic languages. “He was widely acknowledged for his thorough and impartial scholarship.” Stephen Jay Gould, the evolutionary biologist and paleontologist, said Ussher’s chronology was “an honorable effort for its time.” You can find more information about Ussher and his chronology here on Wikipedia, or in “James Ussher” in the Encyclopedia Britannica online. You can also listen to a 10-minute podcast on Ussher and his book, “Annals of the World, 1650,” for Documents that Changed the World.

Ussher’s chronology is the cornerstone for determining the age of the earth by young earth creationist organizations like Creation Magazine, the Institute for Creation Research, which was founded by Henry Morris, and Answers in Genesis, founded by Ken Ham. Here is a link to a timeline that appeared in Creation Magazine. It was based upon the details provided by Archbishop Ussher in his Annals of the World. Both the Institute for Creation Research (here) and Answers in Genesis (here) explicitly draw their declarations for the age of the earth from Ussher’s calculations. If you want, you can verify this claim by comparing their discussion of dates for creation to the timeline of Ussher’s chronology found in Creation Magazine. The organization Answers in Genesis also has a table listing 32 different individuals who calculated the date of the creation of the earth to be between 5501 and 3836 BCE.

But what if the assumptions made by Ussher and others about the biblical genealogies used to calculate the age of the earth were wrong?  William Henry Green, an Old Testament professor at Princeton Theological Seminary in the late 1800s, addressed this question in his 1890 article in the journal Bibliotheca Sacra, “Primeval Chronology.” Green said the accepted chronology of his time (Ussher’s chronology) was based upon an assumption that there were no gaps in the biblical genealogies, most notably those of Genesis 5 and 11. However, he examined the biblical genealogies and found: “There is an element of uncertainty in a computation of time which rests upon genealogies, as the sacred chronology so largely does.”

I here repeat, the discussion of the biblical genealogies above referred to, and add some further considerations which seem to me to justify the belief that the genealogies in Genesis 5 and 11 were not intended to be used, and cannot properly be used, for the construction of a chronology.

Green then went through an extensive examination of several different genealogies in the Bible to support his point that they regularly had gaps. He commented they are frequently abbreviated by omitting unimportant names. “In fact, abridgement is the general rule.” He thought the occurrence of an abridgement should not create surprise “and we are at liberty to suppose it whenever anything in the circumstances of the case favors that belief.” The analogy of Scriptural genealogies opposes the supposition that “the genealogies of Genesis 5 and 11 are necessarily to be considered as complete, and embracing all the links in the line of descent from Adam to Noah and from Shem to Abraham.”

On these various grounds we conclude that the Scriptures furnish no data for a chronological computation prior to the life of Abraham; and that the Mosaic records do not fix and were not intended to fix the precise date either of the Flood or of the creation of the world.

Biblical evidence is then available to indicate Ussher’s chronology was based on faulty assumptions regarding the genealogies of Genesis 5 and 11. They were not intended to construct a chronology and are improperly utilized by individuals and organizations that do so.

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

08/2/16

Not Everything Is As It Appears

16717908 - conceptual illusion portrait of a male model.

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On the Food and Drugs Administration (FDA) website is an article on: “The Impact of Direct-to-Consumer Advertising.” It stated that doctors, for the most part, believe that direct-to-consumer advertising for drugs has both positive and negative effects.  This conclusion was based on a survey of physicians released by the FDA in 2004. Most physicians thought direct-to-consumer (DTC) advertising stimulated their patients to ask thoughtful questions and become more aware of possible treatments. “Many physicians thought that DTC ads made their patients more involved in their treatment.” As I was reading this article, I had the distinct feeling that Rod Serling was giving his commentary over the opening music for his show and then he said: “Your next stop, the Twilight Zone.”

Although the above FDA page was last updated on 10/23/2015, the American Medical Association (AMA) publically called for a ban on direct-to-consumer advertising for prescription drugs and medical devices on November 17, 2015. The AMA news release said: “Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices.” Writing for STAT, Ed Silverman said he thought the chances of an advertising ban happening were negligible. Lawmakers have attempted to ban drug ads before without success; and court rulings recognizing the free speech rights of pharmaceutical companies could thwart any new attempts.

A public opinion poll done by the Kaiser Family Foundation was cited by Silverman as finding that about half of its respondents thought prescription drug advertising did a good job describing the potential benefits and side effects; and was mostly a good thing. Based on the Kaiser poll, Silverman concluded that most Americans believe drug ads allow patients to have greater involvement in their health care decisions. A spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed: ““It’s not a bad thing for patients to bring questions to the doctor’s office.”

This Kaiser poll echoed a 2011 article in Pharmacy and Therapeutics, by C. Lee Ventola, “Direct-to-Consumer Pharmaceutical Advertising.”  Ventola concluded the available evidence indicated there were both positive and negative effects on consumers from DTC advertising. He thought a ban or severe curtailment was unlikely. But remedies that maximized the benefits and minimized the risks of DTC advertising with prescription drugs were possible. “It is hoped that these measures will allow this controversial, but powerful, medium to be better utilized for the improvement of public health.”

However, STAT seems to have developed doubts about the validity of those findings. In conjunction with The Harvard T.H. Chan School of Public Health, they recently published the results of a poll on American’s attitudes towards changing regulations about prescription drugs.

The STAT-Harvard poll found that 57% of adults in the U.S. supported removing prescription drug advertising from television. Almost the same percentage (58%) opposed changing government standards to speed up the process of developing new prescription drugs and medical devices. Only 7% said they considered taking a drug they saw advertised on TV and 14% said they had experienced a serious side effect from taking prescription drugs in the past five years. Robert Blendon, a professor of health policy at Harvard who oversaw the poll, said: “There is a cautiousness about safety and efficacy here that people hadn’t realized before.”

The World Health Organization (WHO) noted that attempts to establish DTC advertising for drugs in Europe were “doomed to failure.” Back in 2009, 22 of the 27 European Union member states opposed the “information to patients” strand of a proposal for new pharmaceutical legislation. “This despite the fact that the legislation would have limited pharmaceutical companies to using the internet and specialist health publications to disseminate information.” According to Dr. Dee Mangin, an associate professor at the Christchurch School of Medicine and Health Sciences in New Zealand: “The truth is direct-to-consumer advertising is used to drive choice rather than inform it.”

However, the situation is different in the U.S. The STAT-Harvard poll comes just as lawmakers begin to grapple with whether to approve legislation to change government regulations, ones that are blamed by Pharma for slowing the approval process for new drugs and medical devices. The House passed H.R.6-the 21st Century Cures Act, in July of 2015. Among other things, H.R.6 seeks to revise government safety and effectiveness standards to speed up the approval process for new prescription drugs. It also includes more than $8 billion of additional funding for the NIH. However, disagreement between Democrats and Republicans in the Senate over how to pay for H.R.6 led to an impasse. So the House bill was broken up into several smaller ones.

Dr. Robert Califf, the newly appointed FDA commissioner, expressed concern that if the pending legislation was not carefully crafted, it could pose significant risks for the FDA and American patients. “Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm.” But there is a concurrent series of judicial actions that could make the regulatory situation even more chaotic.

On March 8, 2016, the FDA agreed that Amarin could promote its drug Vascepa for off-label use. This was the end result of an August 2015 ruling by a judge that Amarin could market its product to a broader patient population than the FDA had originally approved. The heart of the company’s argument was that it had a first Amendment right of  “commercial free speech” to market Vascepa off-label to a broader patient group. See “Opening the Off-Label Floodgates” for more on this issue. Given the recent court rulings in favor of the commercial free speech of pharmaceutical companies, the FDA needs to revise its regulations regarding off-label marketing. But it seems that some members of Congress are getting impatient with the time the agency is taking.

STAT indicated that two members of Congress have accused the Department of Health and Human Services (HHS) of delaying guidelines for off-label marketing of drugs and medical devices. They wrote they were “perplexed” the FDA had not yet issued new guidelines and thought a disagreement between HHS and FDA leadership was the reason for the delay. “They also attached a draft bill that would allow companies to market products for unapproved uses.” Michael Carone of the Public Citizen Health Research Group said: “The threat to patient health posed by the draft bill attached to their letter is tremendous.” According to STAT, one source said:

HHS leadership doesn’t trust industry to do the right thing … HHS leadership believes off-label speech will lead to more aggressive marketing of new products that will raise costs to [Medicare and Medicaid]. They are allowing both their prejudices [industry as the bad guy] and priorities [keeping spending down] to get in the way … The White House shares these fears, and as a result the FDA’s desire to issue guidance is stymied.

Not surprisingly, three of the interest groups contributing heavily to the reelection campaigns of these Congressmen were related to healthcare, according to MapLight. From April 1, 2013 to March 31, 2015 Joe Pitt’s reelection campaign received $256,150 from Health Professionals, $178,500 from Pharmaceuticals/Health Products, and $69,600 from Health Services/HMOs, for a total of $504,250. Fred Upton, who is chair of the House Committee on Energy and Commerce, received $304,700 from Pharmaceuticals/Health Products, $301,051 from Health Professionals, and $94,350 from Health Services/HMOs—for a total of $701,101.

The 21st Century Cures Act has a carrot-and-stick approach for health care reform embedded into it. The ‘carrot’ is a $9 billion increase of funding to the National Institutes of Health budget over the next five years. But the funding is attached to the ‘stick’ of faster approval of prescription drugs and medical devices. Ed Silverman said the House bill would allow the FDA to approve added uses for a drug WITHOUT relying on a randomized clinical trial. Daniel Carpenter, a Harvard political scientist who studies the FDA called the 21st Century Cures Act “the 19th Century Fraud Act” because of this provision. “This is a part of the bill that threatens to take us back more than a century.”

Instead of requiring a randomized clinical trial, the agency could base their decision on “clinical experience,” which essentially means anecdotal observations from physicians and patients.  The unreliability of basing judgments of drug effectiveness on anecdotal observations was why randomized double blind placebo-controlled method became the “gold standard” for clinical drug trials in the first place. Removing this requirement would be like returning to the time of patent medicines or stepping into the Twilight Zone of drug approvals. As he did when narrating the original show, Rod Serling has some words of wisdom we need to remember: “It may be said with a degree of assurance that not everything that meets the eye is as it appears.”