09/19/17

Aversion to Holiness

© Jorge Casais | 123rf.com

In chapter four of Indwelling Sin in Believers, John Owen began to unpack how indwelling sin is enmity against God. Here in chapter five, he described how this enmity manifests itself as aversation—turning from God and all things associated with God in disgust. Aversation is an older term, with a more intense sense of disgust than the similar modern term aversion. A Biblical example of aversation would be the enmity between the Jews and Samaritans.

The Samaritans believed they were the true descendents of Israel and the keepers of the Torah. During New Testament times, their main religious site was Mount Gerizim. They believed that the Jewish temple and priesthood were illegitimate. They took their name from the Hebrew phrase “keeper of the law.” They believed Mount Gerizim was where both the patriarchs and the Israelites (when they first arrived in Canaan) made sacrifices. The Samaritan version of the Pentateuch also said God’s people should worship him in Shechem, making worship in Jerusalem illegitimate. They also believed that their messiah would be a prophet like Moses.

Needless to say, this made the Jews and Samaritans religious, ethnic and cultural enemies with a strong aversation for one another. This context lays the foundation for the encounter between Jesus and the Samaritan woman in chapter four of the gospel of John. John Owen said there is an aversation in the law of sin against everything of God. All reluctance towards religious practices designed to attain communion with God, all carnality and religious formality springs from this root. “It will allow an outward, bodily presence unto the worship of God, wherein it is not concerned, but it keeps the heart quite away.”

Some people pretend they have no aversation towards the things of God. Rather, they believe they have liberty or freedom from these duties. Owen thought this pretended liberty came from “ignorance of the true state and condition of their own souls.” or through a lack of faith and interest in Christ. “It may be, whatever duties of worship or obedience such persons perform, they may, through want of faith and an interest in Christ, have no communion with them; and if so, sin will make but little opposition unto them therein.” It can often be found in the emotions, where there is a secret loathing about any “close or cordial dealing with God.”

Even when convictions, sense of duty, dear and real esteem of God and communion with him, have carried the soul into its closet, yet if there be not the vigour and power of a spiritual life constantly at work, there will be a secret loathness in them unto duty; yea, sometimes there will be a violent inclination to the contrary, so that the soul had rather do any thing, embrace any diversion, though it wound itself thereby, than vigorously apply itself unto that which in the inward man it breathes after. It is weary before it begins, and says, “When will the work be over?”

Aversation is also found in the mind. When we pray we should be able to  “fill our mouths with arguments” to God (Job 23:4). Our minds should be ready to plead for the considerations that prevail with God. What if it starts, but then wanders or fades—“all from this secret aversation unto communion with God, which proceeds from the law of indwelling sin.” Others are so occupied with family or public duties that they have little time for private prayer. This is the source of many foolish opinions and the beginning of many who fall away from God.

Finding this aversation in their minds and affections from closeness and constancy in private spiritual duties, not knowing how to conquer and prevail against these difficulties through Him who enables us, they have at first been subdued to a neglect of them, first partial, then total, until, having lost all conscience of them, they have had a door opened unto all sin and licentiousness, and so to a full and utter apostasy.

Owen said he was convinced that among believers, there were two common ways of backsliding. The first was from a great or notorious sin that bloodied their consciences, tainted their affections or and intercepted all delight of having anything more to do with God. The second was from weariness in contending against “the powerful aversation, which they found in themselves.” The reason for all of this is, that giving way to the law of sin in the least is giving strength to it. Leaving it alone lets it grow. Failure to conquer it, is to be conquered by it.

The best way to prevent the fruits and effects of this aversation is to stay in a universally holy frame of mind. It is impossible to keep the heart in a holy frame of mind for one duty, unless it is done for all of them. “A constant, even frame and temper in all duties, in all ways, is the only preservative for any one way.” Strive to prevent the beginnings of this aversation. Guard against temptations; oppose them. Strive to possess your mind with the beauty and excellency of spiritual things, and so this cursed aversation of sin will be weakened.

As an aside, Owen suggested his readers develop a humble awareness of the presence of this aversation to spiritualness present in our nature. If someone were to recognize its efficacy, what consideration can, be more powerful, to bring them unto humbly walking with God?” Since God delights to dwell with individuals who are “of an humble and contrite spirit,” so it can be effective in weakening the remaining sin within us.

In closing the chapter, Owen urged that we labor to occupy our minds with the beauty and excellency of spiritual things, so that “this cursed aversation of sin” can be weakened. “Let, then, the soul labour to acquaint itself with the spiritual beauty of obedience, of communion with God, and of all duties of immediate approach to him, that it may be filled with delight in them.”

09/15/17

Dysfunctional fMRIs

© abidal | 123rf.com

Neuroscientists at Dartmouth placed a subject into an fMRI machine to do an open-ended mentalizing task. The subject was shown a series of photographs depicting human social situations with a specific emotional reaction. The test subject was to determine what emotion the individual in the photo must have been experiencing. When the researchers analyzed their fMRI data, it seemed like the subject was actually thinking about the pictures. What was unusual about this particular fMRI study was that the subject was a dead Atlantic salmon.

Craig Bennett and other researchers wrote up the study to warn about the dangers of false positives in fMRI data. They wanted to call attention to the need to improve statistical methods in the field of fMRI research. But Bennett’s paper was turned down by several publications. However, a poster on their work found an appreciative audience at the Human Brain Mapping conference and neuroscience researchers began forwarding it to each other. The whimsical choice of a test subject seems to have prevented publication of the study, but it effectively illustrated and important point regarding the potential for false positives in fMRI research. The discussion section of their poster said:

Can we conclude from this data that the salmon is engaging in the perspective-taking task? Certainly not. What we can determine is that random noise in the EPI time series may yield spurious results if multiple comparisons are not controlled for. Adaptive methods for controlling the FDR and FWER are excellent options and are widely available in all major fMRI analysis packages.  We argue that relying on standard statistical thresholds (p < 0.001) and low minimum cluster sizes (k > 8) is an ineffective control for multiple comparisons. We further argue that the vast majority of fMRI studies should be utilizing multiple comparisons correction as standard practice in the computation of their statistics.

According to Alexis Madrigal of Wired, Bennett’s point was not to prove that fMRI research is worthless. Rather, researchers should use a set of statistical methods known as multiple comparisons correction “to maintain most of their statistical power while keeping the danger of false positives at bay.” Bennett likened the fMRI data problems to a kind of darts game and said: “In fMRI, you have 160,000 darts, and so just by random chance, by the noise that’s inherent in the fMRI data, you’re going to have some of those darts hit a bull’s-eye by accident.” So what, exactly, does fMRI measure and why is understanding this important?

The fundamental basis for neural communication in the brain is electricity. “At any moment, there are millions of tiny electrical impulses (action potentials) whizzing around your brain.” When most people talk about ‘brain activity,’ they are thinking about the activity maps generated by functional magnetic resonance imaging (fMRI). Mark Stokes, an associate professor in cognitive neuroscience at Oxford University said fMRI does not directly measure brain activity. Rather, fMRI measures the indirect consequences of neural activity, the haemodynamic response, which permits the rapid delivery of blood to active neuronal tissues. This indirect measurement is not necessarily a bad thing, if the two parameters (neural activity and blood flow) are tightly coupled together. The following figure from “What does fMRI Measure?” illustrates the pathway from neural activity to the fMRI.

A standard fMRI experiment generates thousands of measures in one scan (the 160,000 darts in Bennett’s analogy), leading to the possibility of false positives. This wealth of data in an fMRI dataset means that it is crucial to know how to interpret it properly. There are many ways to analyze an fMRI dataset, and the wealth of options may lead a researcher to choose one that seems will give him or her the best result.  The danger here is that then the researcher may then only see what they want to see.

Anders Ecklund, Thomas Nichols and Hans Knutson said that while fMRI was 25 years old in 2016, its most common statistical methods have not been validated using real data. They found that the most commonly used software packages for fMRI analysis (SPM, FSL, AFNI) could result in false positive rates up to 70%, where 5% was expected. The illusion of brain activity in a dead salmon discussed above was a whimsical example of a false positive with fMRI imaging.

A neuroscientist blogging under the pen name of Neuroskeptic pointed out that a root problem uncovered by Ecklund’s research is spatial autocorrelation—“the fact that the fMRI signal tends to be similar (correlated) across nearby regions.” The difficulty is well known and has software tools to deal with it, but “these fixes don’t work properly.”  The issue is the software assumes the spatial autocorrelation function has a Gaussian shape, when it fact, it has long tails, with more long-range correlations than expected. “Ultimately this leads to false positives.” See Neuroskeptic’s article for a graph illustrating this phenomena.

There is an easy fix to this problem. Ecklund and colleagues suggested using non-parametric analysis of fMRI data. “Software to implement this kind of analysis has been available for a while, but to date it has not been widely adopted.” So there is still value in doing fMRI research, but a proper analysis of the dataset is crucial if the results are to be trusted.

Neuroskeptic also discussed an analysis of 537 fMRI studies done by Sprooten et al. that compared task-related brain activation in people with a mental illness and healthy controls. The five diagnoses examined were schizophrenia, bipolar disorder, major depression, anxiety disorders and obsessive-compulsive disorder (OCD). The analysis showed very few differences between the disorders in terms of the distribution of the group differences across the regions of the brain. “In other words, there was little or no diagnostic specificity in the fMRI results. Differences between patients and controls were seen in the same brain regions, regardless of the patients’ diagnosis.”

Sprooten et al. speculated that the disorders examined in their study arose from largely overlapping neural network dysfunction. They cited another recent meat-analysis by Goodkind et al. that also found “shared neural substrates across psychopathology.” Sprooten et al. said: “Our findings suggest that the relationship between abnormalities in task-related networks to symptoms is both complex and unclear.”

Neuroskeptic didn’t think there was a need to assume this transdiagnostic trait was an underlying neurbiological cause of the various disorders. He wondered if something like anxiety or stress during the fMRI scan could have been captured by the scan.

It’s plausible that patients with mental illness would be more anxious, on average, than healthy controls, especially during an MRI scan which can be a claustrophobic, noisy and stressful experience. This anxiety could well manifest as an altered pattern of task-related brain activity, but this wouldn’t mean that anxiety or anxiety-related neural activity was the cause of any of the disorders. Even increased head movement in the patients could be driving some of these results, although I doubt it can account for all of them.

A paper in NeuroImage by Nord et al. commented how numerous researchers have proposed using fMRI biomarkers to predict therapeutic responses in psychiatric treatment. They had 29 volunteers do three tasks using pictures of emotional faces. Each volunteer did the tasks twice one day and twice about two weeks later. While the grouped activations were robust in the scanned brain areas, within-subject reliability was low. Neuroskeptic’s discussion of the study, “Unreliability of fMRI Emotional Biomarkers,” said these results could be a problem for researchers who want “to use these responses as biomarkers to help diagnose and treat disorders such as depression.”

Neuroskeptic asked one of the researchers if it was a “real” biological fact that activity in the brain areas studied actually varied within subject, or was the variability a product of the fMRI measurement? He didn’t know, but thought it wasn’t simply a measurement issue. He also thought it was perfectly possible “that the underlying neuronal responses are quite variable over time.”

Grace Jackson, a board certified psychiatrist, wrote an unpublished paper critiquing how fMRIs and other functional brain scans are being presented to the public as confirming that psychiatric disorders are real brain diseases. She pointed out the failure of media discussions to point out that functional imaging technologies, like fMRI, “are incapable of measuring brain activity.” They assess transient changes in blood flow. She also commented on the existing controversy of using this technology for diagnosis. “Due to theoretical and practical limitations, their application in the field of psychiatry is restricted to research settings at this time.”

She said even if abnormal mental activity could be objectively defined and reliably determined, “it remains unclear how any functional imaging technology could differentiate the brain processes which reflect the cause, rather than the consequence, of an allegedly impairing trait or state. She concluded with a quote from a position paper drafted by the American Psychiatric Association that said imaging research cannot yet be used to diagnose psychiatric illness and may not be useful in clinical practice for a number of years. “We conclude that, at the present time, the available evidence does not support the use of brain imaging for clinical diagnosis or treatment of psychiatric disorders…”

No current brain imaging technology, including fMRI, can be used to diagnose or treat psychiatric disorders. fMRI technology does not directly measure neural activity and has a demonstrated tendency to generate false positives, especially if the statistical analysis of the fMRI dataset is done incorrectly. Given the limitations of functional imaging technology, it is unclear how fMRI—or any other functional imaging technology—will be able to clearly distinguish between brain activity that causes an impaired neural trait or state, and brain activity that is a consequence of an impaired neural trait or state. And yet fMRI scans are presented to the public, by some individuals, as measuring brain activity and proving the existence of some psychiatric disorders. In their hands fMRI technology has become dysfMRI: dysfunctional MRI technology.

09/12/17

Trouble in Plumas County

© Natallia Yeumenenka | 123rf.com; “Plumas” is Spanish for feathers.

Situated in the Sierra Nevada region of California, Plumas County is an attractive recreational destination for a wide variety of activities, including boating, camping, fishing, hiking, skiing, hunting and others. The Explore Plumas County webpage says it is “a Wilderness of Wonders,” where the wilderness is untouched. “Natural beauty is etched in the snow-capped peaks and towering pines.” It is said to be a four-season travel destination with fresh mountain air and pristine, blue waters. You are encouraged to explore the mountain ranges and wilderness, where there is “something new to discover with each experience”—including illegal marijuana growers.

I’m not a resident of Plumas County. But as I was completing another article (“Pot Market Getting a ‘Black’ Eye”) on the problems with how the expanding recreational marijuana has helped the black market for marijuana to flourish instead of weakening it, I ran across the current debate over marijuana in Plumas County. Looking closer at the issues in this small, rural county helps to illustrate some of the problems that come with the political and cultural pressures to legalize marijuana.

The photos on the Explore Plumas County webpage are seductively beautiful. I want to go visit; maybe for a very long time. The county is in the northern end of the Sierra Nevada range. The entire county population is only 20,007, as of the 2010 census. But Plumas County is in the midst of a political and culture war over whether or not there should be a greater presence of marijuana in the county. Cannabusiness Law noted currently there is a ban on the retail sales of marijuana as well as manufacturing. Current zoning codes do not permit commercial marijuana growing, but the codes are under review. The webpage also provides you with information to contact local officials and let them know you oppose the bans … or approve them, I’d add.

On November 8, 2016, California voters approved Proposition 64, the Adult Use of Marijuana Act (AUMA). Beginning in 2018, it allows “the sale of marijuana for adult use in licensed stores under regulations to be established by the state Dept. of Marijuana Control (DMC) in conjunction with local governments.” The possession and use of up to one ounce of marijuana (or 8 grams of concentrates) and personal use cultivation of up to six plants is also legal. It also reduces fines for most illegal cultivation, sale, transport and possession for sale offenses from felonies to misdemeanors—with possible exceptions for violent or repeat offenders. See the California NORML website for the following quote and more information on Proposition 64 and other California marijuana laws.

Commercial sale, cultivation, and production of marijuana are allowed only by licensed providers. Illegal sale, transport, manufacture, cultivation, or possession with intent to sell are generally punishable as misdemeanors, with felony enhancement allowed for special circumstances and three-time offenders. Minors under 18 are in no case subject to imprisonment, but may be punished by drug education and community service.

Medical marijuana has been legal in California since 1996 with Proposition 215, the Compassionate Use Act. And it is because of the fallout from that change that many of the current problems in Plumas County have occurred. The Los Angeles Times reported that four weeks before the 1996 general election where Proposition 215 was approved, Senator Diane Feinstein said “you’ll be able to drive a truckload of marijuana through the holes in it.” The devil is in the details, and she said this particular bill lacked details. Nevertheless, the assessment of the author of the LA Times article was it had been an incredible success, despite its vague wording and instances of abuse. Read on before you accept that statement.

After the approval of Proposition 215, the cultivation of marijuana took off in the so-called Emerald Triangle, consisting of the counties of Mendocino, Humboldt and Trinity, along the northern coast of California. Plumas County is on the opposite, eastern side of the state, at the same latitude as the Emerald Triangle counties. The Emerald Triangle has been estimated to produce 60% of America’s marijuana. As was noted above, Plumas County previously banned the retail sales and manufacturing of marijuana, and had zoning restrictions for the cultivation of marijuana. Nevertheless there have been serious problems with illegal activities involving marijuana within the county.

In July of 2015, Plumas County authorities reported that along with Forest Service law enforcement, they recovered about 23,000 marijuana plants at two separate locations. The estimated value of the plants was in excess of $10 million. Officers from Plumas County SWAT, the Forest Service and California Fish and Wildlife took part in the eradication raids. Two suspects were encountered near one site, but they avoided capture in the brushy steep terrain. Residents were encouraged to contact authorities if they saw any signs of marijuana gardens, such as drip lines, gardening tools, bags of fertilizer or pesticides, trash piles or remote campsites.

In August of 2016, John Bartell reported for KXTV how the Plumas National Forest was plagued with illegal grows. Reportedly, teams were finding illegal grows on a weekly basis. One local cattle rancher said he lived next to an illegal marijuana grow. “They had pit bulls running free and they attacked 2 cows and bit their ears off.” A Plumas County detective said they regularly encounter a number of individuals who are not residents of the United States cultivating the gardens. Often they turn out to be Mexican nationals. “Some are out here for 3 or 4 months and are promised $10,000 or $20,000 to grow.” There have been instances of hunters wandering into fields where they were killed. Safety in the Plumas National Forest is now a serious concern.

This is not simply an isolated problem for Plumas County. In Yosemite National Park, park rangers are regularly discovering and destroying large marijuana growing operations, attributed to the same Mexican cartels. Here is a video report on this problem from the Travel Channel. A park ranger is quoted as saying the park has had several marijuana growing plantations located within its borders. Some of these growing plantations have been worth as much as $14 million. “These are not simply a few people that want to have a garden and grow something for their use.”

There is a “Plumas People Opposed to Commercial Cannabis” Facebook page with multiple articles describing issues from the illegal marijuana grows. Banned pesticides are showing up in California water. A Reuters article, appearing on US News & World Report, noted toxic chemicals from illegal marijuana farms are found in California’s rivers and streams feeding the state’s water supply. The chemicals have turned thousands of acres into toxic waste dumps. Law enforcement officers who have inadvertently touched plants and equipment have been hospitalized. ”Scores of animals have died.”

A New York Times article noted that despite the promise of a legal market, many growers are not signing up. Hezekiah Allen, the executive director of the California Growers Association, estimated only about 11% of growers in the Emerald Triangle have applied for grow permits. The paperwork to obtain a permit, the fees and the taxes are given as reasons for not doing so. Lori Ajax, the chief of California’s Bureau of Cannabis Control said there are folks who have been operating for a long time with minimal local oversight or no oversight at all. She thought it was going to take some strong enforcement to bring people into the regulated market.

California, which by one estimate produces seven times more marijuana than it consumes, will probably continue to be a major exporter — illegally — to other states. In part, that is because of the huge incentive to stay in the black market: marijuana on the East Coast sells for several times more than in California.

The drastically reduced legal consequences in Proposition 64 for most of the illegal offenses related to the cultivation, sale, transport and possession of illegal marijuana from felonies to misdemeanors, at least for the first couple of offenses, means there is very little motivation for illegal growers to enter the legal market. The Mendocino County district attorney said people living in the urban centers of California, like San Francisco, Los Angeles, and San Diego don’t realize the crime rate in the rural areas where marijuana is being grown.

Among the cases he is handling are a robbery and slashing death of a grower; the murder of a man at a marijuana farm by a co-worker wielding a baseball bat; an armed heist in a remote area by men who posed as law enforcement officers; and a robbery by two men and a juvenile who were invited to a barbecue and then drew guns on their hosts and fled with nine pounds of marijuana.

There was a meeting of the Plumas County Cannabis Working Group on the afternoon of Thursday, September 7th, 2017. The Facebook page for the Plumas People Opposed to Commercial Cannabis Facebook page related some of the concerns expressed by residents. One concerned resident noted how the drafted ordinance document was written by a pro commercial growing committee, “whose members stand to make large amount of money.” She also raised the issue of the potential environmental impact of water, pesticides and drainage into their creeks and rivers. Another person during the meeting raised a concern that approving commercial grow operations would lead to less county and/or state support to address the anticipated increase in local crime. A pro grower responded by saying high fences, guard dogs and private security forces would keep criminals in check. The concerned individual responded: “Yes, that’s JUST what we want here.”

In an open letter to the Plumas County Supervisors, another Plumas county resident noted how some individuals said the best way to improve Plumas County was to bring in the anticipated influx of cash from approving commercial growing. “They urge us to look for the money, trust them for a higher standard of character and compliance than has been reported elsewhere, and trust the free market.” But that isn’t happening in other areas. See “Pot Market Getting a ‘Black’ Eye.”

Another resident also voiced her concerns that every member of the Cannabis Work Group was someone in favor of commercial cultivation. The Work Group was “not a balanced representation.” She noted where the issue of odor was minimized. See the above linked New York Times article for a report that a police reconnaissance helicopter could smell pungent marijuana plants from 800 feet above an illegal grow. Concerns over an increase in crime, homelessness and changes in the community culture have been largely unanswered, she said.

credit: Sierra REC Magazine

People move to or visit Plumas County for the natural beauty, rural lifestyle, recreational opportunities, the mountain air, the open vistas, to raise families, to escape the culture and crime of the city. All of these would be changed in some degree by widespread cannabis cultivation. High fences would predominate, along with heavily secured tall hoophouses. The oft-referenced Mexican Cartels are unlikely to simply pack their suitcases and go home; what will they do here instead? Who will buy up properties and small farms and lease acreage for this lucrative crop? What large commercial interests may impact land use, local politics, ecological concerns, the small town culture? How does greed divorced from responsible citizenship change a community?

The decision on commercial marijuana growing in Plumas County isn’t finalized yet. The next scheduled meeting of the Cannabis Working Group is Thursday September 14th, starting at 10 AM PDT. There are a number of issues it seems; these are only a few. Will the façade of an unbalanced work group be addressed? What about the impact on local crime and the environment? If this is supposed to bring money into the county, how will that work when already California produces multiple times the amount of cannabis that can be consumed in the state? And it will be illegal to send any cannabis grown in Plumas County out-of-state. Doesn’t that set the county residents up for an explosive increase in illegal grows if commercial marijuana growth is approved? That is what happened in Colorado, which was better prepared enforcement-wise for recreational marijuana than California seems to be.

I live in Allegheny County, Pennsylvania, in a township whose population in the 2010 census was over 8,000 more than the entire population of Plumas County. My home state approved the Pennsylvania Marijuana Act (for medical marijuana) on April of 2016. There aren’t any dispensaries open yet; the state has just begun to register practitioners. In June of 2017 twelve companies were awarded growing licenses, including one in western PA fronted by Jack Ham, a former linebacker for the Pittsburgh Steelers. Growing will only be done in warehouses.

The only types of medical cannabis allowed initially are pills, oils, gels, creams, ointments, tinctures, liquid, and non-whole plant forms for administration through vaporization. Given the issues noted above in Plumas County and other counties in California, I hope residents of my home state will work together, as the residents of Plumas County are currently doing, to prevent similar concerns from developing in Pennsylvania. Residents of other states that have started down the road to legalization, be forewarned and learn from the current trouble in Plumas County.

If you sympathize with those Plumas County residents opposed to commercial marijuana growth in their county, give them some encouragement on the “Plumas People Opposed to Commercial Cannabis” Facebook page.

09/8/17

Pot Market Getting a “Black” Eye

© tlorna | 123rf.com

On April 3, 2017 the governors of four states with legalized recreational marijuana—Alaska, Colorado, Oregon and Washington—sent a letter to Attorney General Jeff Sessions. They asked that the Trump administration “engage” with them before making any changes to the existing federal regulatory and enforcement systems. Their particular concern was potential revision to the “Cole Memo,” an Obama-era policy that attempted to strike a balance between federal interests and state sovereignty in the growing legalization of marijuana. The governors said the Cole Memo provided guidance to the foundation of state regulatory systems and was “vital to maintaining control over marijuana in our states.” They warned that overhauling it could produce unintended consequences such as diverting “existing marijuana product into the black market and increase dangerous activity in both our states and our neighboring states.”

On July 24, 2017, Attorney General Sessions replied individually to the governors who signed the April 3rd letter. You can review copies of the letters sent to Governor Brown of Oregon and Governor Inslee of Washington. Each letter pointed to documents from the respective states that raised serious questions about the efficacy of marijuana “regulatory structures” in that state. He then directed their attention to the concluding paragraph of the memo that said it “does not alter in any way the Department’s authority to enforce federal law, including federal laws relating to marijuana, regardless of stat law.”

Among the specific concerns for Oregon Sessions highlighted was that only 30% of the marijuana market in Oregon was compliant with state marijuana laws. There was a “pervasive illicit cannabis cultivation in the state,” which was trafficked out-of-state. Law enforcement was said to be unable to keep pace with out-of-state diversion. “The reality of legalization is that it has provided an effective means to launder cannabis products and proceeds.” Individuals were said to be exploiting legal mechanisms to obscure their products’ origin and their true profits.

Among the concerns he highlighted for Washington was the lack of regulation and oversight of the medical marijuana market has “unintentionally” led to a growth of the black market. “Since legalization in 2012, Washington State marijuana has been found to have been destined for 43 different states.” The recreational marijuana market is incompletely regulated. One of the leading regulatory violations has been the failure to use and/or maintain the traceability of marijuana products.

Writing for The Washington Post, Christopher Ingraham said the Sessions’ letter indicated he remained deeply skeptical of efforts to legalize recreational marijuana. But for now, Justice Department actions will be dictated by the Cole Memo. Federal non-interference seems to hinge on whether there is evidence of a public health or safety threat. John Hudak, a drug policy expert with the Brookings Institution, said the Sessions letter is an important indicator that Sessions is serious about enforcing marijuana law under the Cole Memo. He also expressed concerns with the accuracy of the data Sessions cited. He said reports compiled by law enforcement authorities were “notorious for cherry-picking data and failing to put data into context.” He suggested the Attorney General was drawing conclusions on incomplete data or data taken out of context.

Reporting for the Associated Press, Andrew Selsky said Governor Brown responded to Attorney General Sessions, noting the document he cited to her on Oregon marijuana problems was invalid and had incorrect data and conclusions. She went on to say new laws, including the tracking of all marijuana grown for legal sale, will help cut down on diversion into the black market. She added that she had recently signed legislation making it easier to prosecute the unlawful import and export of marijuana products. A Washington state official similarly said Sessions made claims about the situation in the state of Washington that were “outdated, incorrect, or based on incomplete information.”

Pause for a moment here. There isn’t denial that diversion occurs, just that the data the reports were based on was incorrect, outdated, incomplete. The thinking seems to be that more legalization will lessen the black market problem. Oregon Congressman Earl Blumenauer said: “”The more that we go down the path of legalization, regulation and taxation, diversion becomes less and less of a problem.” But is this just wishful thinking, rhetoric expressed to encourage the ongoing march towards nationwide legalization?

In a different article, Selsky noted the movement in several states, including Oregon, Colorado and California to implement tracking systems for marijuana and marijuana products. “The tracking system is the most important tool a state has,” according to Michael Crabtree. But as the systems rely on user honesty, they aren’t fool-proof. ““We have seen numerous examples of people ‘forgetting’ to tag plants.”

In California, recreational pot sales become legal in January of 2018. The Emerald Triangle area of northern California is the largest cannabis-producing region in the U.S. It is estimated to produce 60% of America’s marijuana. Although growers have been cultivating marijuana in the area since the 1960s during San Francisco’s Summer of Love, the industry really took off when Proposition 215 legalized medical marijuana in 1996.

Senator Mike McGuire, who represents the Emerald Triangle region, thought California’s tracking program would help limit the cannabis black market. But implementing a fully operational legal market in California could take years. “In the first 24 months, we’re going to have a good idea who is in the regulated market and who is in the black market.”

Anthony Taylor is a licensed marijuana processor and lobbyist. But as far back as the 1970s, he was growing cannabis illegally in an area east of Portland. He said it is easier to grow marijuana illegally these days because authorities don’t have the resources to uncover every operation. Growers who risk selling outside the state can earn thousands of dollars per pound, according to Taylor.

The Los Angeles Times reported that Hezekiah Allen, the executive director of the California Grower’s Association, warned that California growers are in for a “painful downsizing curve” when new laws go into effect in January of 2018. “We are producing too much.” He estimated the state cannabis growers produce eight times the amount of marijuana the citizen’s of the state can consume. He expects that some growers will stay in the black market and continue to illegally send marijuana to other states. Some growers may stop growing cannabis, but he expects others simply just won’t apply for state permits.

Lori Ajax, chief of California’s Bureau of Medical Cannabis Regulation said: “For right now, our goal is to get folks into the regulated market, as many as possible.” But, “There are some people who will never come into the regulated market.”

A Denver Grand Jury indicted 62 people and 12 businesses for operating the largest illegal marijuana uncovered in Colorado since Colorado legalized recreational marijuana in 2012. The drug bust, known as Operation Toker Poker, executed almost 150 search warrants at 33 homes and 18 warehouses and storage units in Denver. Seizures included 2,600 illegally cultivated marijuana plants and 4,000 pounds of marijuana. The ring operated from 2012 to 2016 and brought in an estimated $200,000 a month. The operation produced more than 100 pounds of cannabis monthly and shipped it to Kansas, Texas, Nebraska, Ohio, Oklahoma and other states.

Read original articles on Operation Toker Poker here at: The Denver Post, U.S. News, and the Daily Mail.

The DEA and State Patrols for Kansas and Nebraska participated in the investigation. Barbara Roach, special agent in charge of the DEA’s Denver field office, said since 2014 there has been an influx of organized criminal groups coming to Colorado in order to produce marijuana to sell in other states. “The marijuana black market has increased exponentially since state legalization.” Colorado Attorney General Cynthia Coffman said: “The black market for marijuana has not gone away since recreational marijuana was legalized in our state, and in fact continues to flourish.”

Andrew Freedman, a cannabis regulation consultant, said he is hopeful that state legislation passed in 2017 will make it more difficult for criminal to grow quantities of marijuana for the so-called “gray market,” while using a legal interest in the business as a cover. “

 I do think the experiment is under the microscope, . . . Anything negative that happens will be a national story. This was a weakness in our system, and I’m hopeful the legislation shores up that weakness, but it is something the story will be judged on.

So it seems the expectation that ongoing legalization of recreational marijuana will make diversion less of a problem is wishful thinking. It may even be rhetoric to calm the fears of individuals who are unsure about where they stand on the issue. What does seem clear from the information above is that legalizing recreational marijuana in Colorado hasn’t made diversion go away; and officials seem to think it has been “flourishing.” At least one California official expects state regulation will not be followed by all the instate cannabis growers when the new laws go into effect. Even cannabis supporters acknowledge there will be a time lag of perhaps years before the regulatory machinery can get a handle on illegal cannabis growers.

09/5/17

Darwin’s Conversion: Not

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Surrounded by family members and in the arms of his loving wife Emma, Charles Darwin died on Wednesday, April 19, 1882. Among his last spoken words was a statement that he was not “the least afraid to die.” Darwin’s hope, and the family’s original intention, was for him to be buried in the family vault in St. Mary’s church at Downe. History intervened, and Charles Darwin was instead interred in Westminster Abbey on the morning of April 26, 1882—not far from the resting place of Sir Isaac Newton. Ironically, although Darwin indentified himself as an agnostic, and said he had rejected Christianity at the age of forty, within two weeks of his burial, there was a sermon preached in Wales saying that Darwin had, “in his last utterances confessed his true faith.” The problem is, it wasn’t true.

Dearman Birchall, his wife and their four children had taken a holiday at the southern Wales resort town of Tenby. On May 7th they head a minister named Huntingdon preach a sermon in which: “He spoke of Darwin one of the greatest thinkers who had in his last utterances confessed his true faith.” The quote was from a diary entry, and can be found in The Darwin Legend, by James Moore. There were other scattered rumors of a deathbed conversion by Darwin over the next three decades, including an 1887 sermon in Toronto by the Reverend John Mutch. This led a reporter for the Toronto Mail to write to Darwin’s close friend and supporter, Thomas Huxley to confirm the truth of Mutch’s statement. Huxley’s reply, on February 12, 1887 follows:

I have the best authority for informing you that the statement which you attribute to the Revd Mr. Mutch of Toronto that “Mr Darwin, when on his death bed, abjectly whined for a minister and renouncing Evolution, sought safety in the blood of the Saviour” is totally false and without any kind of foundation.

Huxley consulted Darwin’s son Francis, who gave Huxley permission to reply to the reporter, denying any deathbed conversion of his father. Yet the question is how such a rumor could have arisen and been repeated by a minister so far away from Darwin’s home in Downe. James Moore convincingly demonstrated the likely source was a British evangelist active in the temperance movement, named Elizabeth Cotton, who became Lady Hope in 1887 when she married Sir James Hope. She reported meeting Darwin in the autumn of 1881, about six months before his death.

However the story of their meeting did not appear in print for thirty-four years. Moore speculated that if this encounter was the origin of all the post-1882 deathbed stories of Darwin’s conversion, it was spread initially by word of mouth among English evangelicals and their American connections. John Mutch could then have heard the story from someone in those circles and repeated it in his 1887 sermon. “Whatever the case, there is no doubt that Lady Hope was making discreet comments about Darwin to her religious friends long before the story was published.”

In August of 1915 Lady Hope was in East Northfield Massachusetts for the annual conference at Northfield Seminary, the girl’s preparatory school founded by D. L. Moody. She approached one of the speakers, A. T. Robertson, and told him her story of Darwin’s conversion. Robertson then repeated it when he next spoke. An editor from the Watchman-Examiner was there and insisted Lady Hope write the story out so he could publish it, giving it “the widest publicity.” Two weeks later, the Watchman-Examiner carried her story under the title, “Darwin and Christianity.”

In The Darwin Legend, Moore quoted the entire story, which can also be found in the Wikipedia entry for “Elizabeth Cotton, Lady Hope.” The story went “viral,” to use a modern idiom, with over fifty known texts identified by James Moore that repeated the Lady Hope legend through 1993, when he published his book. The story happened to take place in the midst of the anti-evolution crusade involving William Jennings Bryan and the “monkey trial” of 1925. See “Structure of an Evolutionary Revolution” for more on Bryan and the Scopes Trial. Bryan did not repeat the story even though he knew of it, saying that using it would only aid the other side in the fight against evolution. But that did not deter others.

Members of Darwin’s family repeatedly and vehemently denied Lady Hope’s story. Darwin’s son Francis, who edited The Life and Letters of Charles Darwin, including an Autobiographical Chapter, in 1887, wrote Huxley in 1887 about the Toronto Mail reporter. He said: “By all means answer as you propose. You have my authority that the statement is false and without any kind of merit.” Francis wrote at least three letters after the Lady Hope story was published denying its veracity. In a letter to the secretary of the Protestant Press Bureau, on May 28, 1918, Francis said:

Lady Hope’s account of my father’s views on religion is quite untrue. I have publically accused her of falsehood, but I have not see a reply. My father’s agnostic point of view is given in my “Life and Letters of Charles Darwin,” Vol. I., pp. 304-317. You are at liberty to publish the above statement. Indeed, I shall be glad if you will do so.

Henrietta Darwin Litchfield, Darwin’s third daughter and the eldest daughter to reach adulthood, responded to an enquiry from the editors of The Christian, an interdenominational evangelical weekly, who asked her to confirm or deny the truth of a “highly-colored story . . . going the round of the American papers” about her father’s death-bed. If it was true, then many people would have been glad to learn that “some higher and deeper devotion claimed his soul.” If it wasn’t true, then “the facts should be known.” On February 23, 1922 in The Christian, Henrietta said:

I was present at his deathbed. Lady Hope was not present during his last illness, or any other illness. I believe he never even saw her, but in any case, she had no influence over him in any department of thought or belief. He never recanted any of his scientific views, either then or earlier. We think the story of his conversion was fabricated in [the] U.S.A. In most of the versions hymn-singing comes in, and a summer-house where the servants and villagers sang to him. There is no such summer-house, and no servants or villagers ever sang hymns to him. The whole story has no foundation whatsoever.

Lady Hope died in Sydney Australia on March 9, 1922. She had traveled there for medical treatment for breast cancer. Eighteen years after her death, a professor of biology, S. James Bole, published an undated letter he had received from her in the early 1920s, having promised to keep it private during her lifetime. He had written to her, “asking for the story.” She said Darwin heard she was in his village, holding meetings to discuss the Gospel and Temperance and asked if she would call upon him. She said when she arrived, he had a large Bible open before him to the book of Hebrews, which he said was “the Royal Epistle.” The contents of the letter to Bole are quite similar to the account Lady Hope gave in the Watchman-Examiner.

Darwin is supposed to have commented on some of the great Gospel truths to her, and how Christ was the King, Savior and Intercessor. When Lady Hope asked him about certain doubts that were raised about Creation from what he wrote,

He seemed greatly distressed, his fingers twitched nervously, and a look of agony came over his face as he said: “I was a young man with unformed ideas. I threw out queries, suggestions, wondering all the time over everything, and to my astonishment, the ideas took like wildfire. People made a religion of them.”

So she continued to tell her story until the day she died. But as Francis Darwin said, if his father had had an evangelical conversion experience in the last years of his life, surely that would have become known to his family. They have spoken and were quoted above as saying it never happened.

However, there is an outside chance that some kind of an encounter happened between Darwin and Lady Hope, but it would not have unfolded as she related in her story. Lady Hope was in Downe Village, near the Darwin estate, in September and possibly early October of 1881. Moore said: “The story, though imaginative, cannot be dismissed as pure invention. It contains striking elements of authenticity, to which Lady Hope added convincing new detail.”

For proprieties sake, she would not have met with him alone; and a likely third party would have been Darwin’s wife, Emma, who was well known for her own Unitarian faith. Before they married, his father, Robert Darwin, warned Charles that a husband should conceal his religious doubts from his wife so that she didn’t fear for his salvation. The younger Darwin ignored his father’s advice, revealing his doubts to Emma while they courted. When she was first pregnant, she wrote him that she didn’t feel she could say exactly what she wanted to him. What if she died in childbirth? Would he join her in heaven? It would be a nightmare “if I thought we did not belong to each other forever.”

Emma’s silence on the possibility of a conversion experience by her husband in the final months of his life speaks loudly to the fact that it did not happen. After her husband’s death, the family debated over whether a section of his autobiography, a private narrative originally written only for family members, should be published. In a section on religious beliefs Darwin had wondered how anyone “ought to wish Christianity to be true,” given its doctrine of everlasting punishment for unbelievers. For in those numbers would be his father, his older brother Erasmus, and almost all his best friends. Emma wrote to Francis, who was editing the Life and Letters, wondering how Charles’s religious friends would react to the sometimes-raw honesty of his thoughts. If there had been any legitimate reversal in Darwin’s agnosticism at the end of his life I think Emma would have insisted on its inclusion.

The autobiography was dismembered, the section on religious belief was removed to a separate chapter in the Life and Letters, and only “extracts, somewhat abbreviated,” were printed.

The unedited version of Life and Letters with Darwin’s clear rejection of many basic Christian beliefs would not be published until 1958, almost 100 years after Origin of the Species. Darwin’s unvarnished religious convictions were apparently more of a concern than his scientific ones.

09/1/17

Circle the Pfizer Wagons

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The U.S. Preventive Services Task Force (USPSTF) recommended that all adults, including pregnant women and women who have recently given birth, be screened in primary care settings for depression. The screening would be done by: general practitioners, family physicians, nurse practitioners or physician assistants. USPSTF said screening adults for depression in primary care settings was accurate, it was effective in relieving depressive symptoms and the likelihood of harm from screening and treatment was small. The problem is that over 60% of individuals diagnosed with depression in primary care did not meet the DSM criteria for major depressive disorder. This rises to 80% with individuals over 65.

Albert Siu and the USPSTF published “Screening for Depression in Adults” in the January 2016 issue of JAMA. The authors said: “The USPSTF found convincing evidence that treatment of adults and older adults with depression identified through screening in primary care settings with antidepressants, psychotherapy, or both decreases clinical morbidity.” Commonly used screening instruments included the Patient Health Questionnaire (PHQ) in its various forms, as well as several others. But the USPSTF did not believe these instruments were getting as many false positives as noted above. “The accuracy of screening tests in the general adult population was established in the 2002 and 2009 USPSTF reviews and found to be convincing.”

Psychiatrist Vivek Datta pointed out the USPSTF guidelines did recommend that screening occurred when there were “adequate systems in place” for further evaluation and treatment. However, “55% of all US counties do not have a single mental health provider.” He noted that many of the symptoms screened for are nebulous and include “symptoms that are quite common in the general population and do not necessarily indicate a mental disorder requiring treatment.” They could represent the effects of a chronic medical problem. Moods are influenced by a variety of factors, such as our level of physical activity, what we eat, our financial security, alcohol and drug use, to name a few.

Symptoms of depression can occur as a result of lifestyle factors, substance use, medical illness, life events, interpersonal difficulties, and as a consequence of wider social policies. Comprehensive assessment frequently does not occur because of the lack of adequate services for those with mental health problems. The recommendation to screen all adults for depression ignores the social matrix in which depression occurs, will lead to further overdiagnosis and overtreatment of minor morbid mental states, and further overburden mental health services.

A Glut of Antidepressants” was published on August 12, 2013, in The New York Times. It mentioned an April 2013 study published in the journal Psychotherapy and Psychosomatics that found almost 62% of 5,639 individuals “who had been given a diagnosis of depression within the previous 12 months did not meet the criteria for major depressive episode.” Several other studies have reported that: “diagnostic accuracy is low in general practice offices.” The study’s lead author said: “The vast majority of individuals diagnosed with depression, rightly or wrongly, were given medication.” Doctors must resist the temptation “to take out the prescription pad and write down an antidepressant and hand it to the patient.”

The NYT article did indicate that not only are doctors prescribing more medication, their patients are demanding it more. I think this is a likely an outcome of the decision to permit direct-to-the-consumer advertising for pharmaceuticals in 1997. See “Pharma and Advertising” or “Not Everything is As It Appears” for more on this topic. If anything at all was done to “confirm” the patient’s or doctor’s impression that there was a depressed mood state, using a quick screening instrument seems likely given the short time period most patients spend with medical staff in a primary care setting.

James Davies, the co-founder of the Council for Evidence-Based Psychiatry, wrote “The Sedated Society,” where he commented on how a BBC radio program had failed to mention the problem with the PHQ-9 (mentioned above) and the GAD-7, which he said two of the most powerful questionnaires in the NHS (National Health Service). He said they have been used throughout the primary care system in the UK to assess whether or not a person has depression or anxiety. He said: “They set a very low bar for what constitutes having a form of depression or anxiety for which a drug should be prescribed.” He said the tens of millions of people who filled out these screening questionnaires don’t know that Pfizer Pharmaceuticals paid for their development and continues to hold the copyright for them. Their distribution throughout the NHS was paid for by Pfizer, which incidentally makes two of the most prescribed antidepressant and anti-anxiety drugs in the UK.

Although the BBC didn’t get Davies’s message out about the PHQ-9 and GAD-7, several news outlets did. At Vice, Hannah Ewens said “a few of us in the office” took the test, with everyone except one person got at least a score of mild depression. She personally scored within the “moderately severe depression” range, but doesn’t have depression at the moment. “If I have trouble sleeping ‘on several days’ or ‘nearly every day’ that bumps up my score significantly. And herein lies the problem: all of the indicators are symptoms of a modern lifestyle as well as signals of depression.” Ewens added that James Davies believes reliance on these questionnaires is becoming too commonplace because GPs don’t have the time to do proper interviews.

The Telegraph, another UK media outlet, echoed the Davies concern that the threshold for identifying possible depression was too low. Henry Bodkin noted that a PHQ chart was likely present in almost every GP consulting room over the last 20 years. He also said critics like Davies have said the GAD-7, also developed by Pfizer to screen for anxiety, sets the diagnosis bar too low. “These forms have a very low criteria for anxiety and depression. . . . Millions of people have filled them in and got medication, but did they know they were developed by Pfizer?”

Pfizer enlisted two “rock stars” in the field of psychiatric diagnosis to develop the PHQ-9 and GAD-7: Robert Spitzer and Janet Williams. Spitzer was the chairperson for the seminal changes incorporated into the DSM-III. Originally Williams was his text editor; later she became his wife and collaborator. Listen to an All Things Considered broadcast on Spitzer and the DSM, “The Man Behind Psychiatry’s Diagnostic Manual.”

In the September of 2001 issue of the Journal of General Internal Medicine, Kurt Kroenke, Robert Spitzer and Janet Williams published “The PHQ-9.” Their article examined “the validity of a brief, new measure of depression severity” called the PHQ-9. They concluded that data from their two studies provided “strong evidence for the validity of the PHQ-9 as a brief measure of depression severity.” Kroneke et al. also said brief measures were more likely to be used in the busy setting the typical medical practice. The brevity of the PHQ-9 was thought to make it “an attractive, dual-purpose instrument for making diagnoses and assessing severity of depressive disorders.” The Acknowledgements section said the development of the PHQ-9 was underwritten by an educational grant from Pfizer US Pharmaceuticals. Scrolling down further you’ll see:

From the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire (PRIME-MD PHQ). The PHQ was developed by Drs. Robert L. Spitzer, Janet BW Williams, Kurt Kroenke, and colleagues. . . . PRIME-MD is a trademark of Pfizer Inc. Copyright 1999 Pfizer Inc.

Then in the May 2006 issue of JAMA Internal Medicine, the same three authors introduced the GAD-7, a brief self-report scale to identify generalized anxiety disorder (GAD). Not surprisingly, they concluded: “The GAD-7 is a valid and effective tool for screening for GAD and assessing its severity in clinical practice and research.” They expected the GAD-7 to have “considerable utility in busy mental health settings and clinical research.” Once again is an acknowledgement that the development of the GAD-7 was underwritten by an unrestricted educational grant from Pfizer Inc.

If you want to see or use copies of these scales, Pfizer’s lawyers have been clearly involved in dialing back the company’s responsibilities if the scales don’t live up to their creator’s optimistic expectations. On the Pfizer website, on the “Terms of Use” page for the two scales, is the following. Pfizer said since the questionnaires relied on patient self-report, all responses should be verified by the clinician. A definitive diagnosis should be made on clinical grounds, “taking into account how well the patient understood the questionnaire, as well as other relevant information from the patient.” Diagnoses should rule out normal bereavement, Bipolar Disorder, and other potential causes of depressive symptoms. Then there is the following disclaimer. The “all caps” formatting is in the original.

PFIZER MAKES NO WARRANTIES OR REPRESENTATIONS OF ANY KIND AS TO THE ACCURACY, CURRENCY, OR COMPLETENESS OF THE INFORMATION ACCESSED AND USED THROUGH THIS WEB SITE.
YOU AGREE THAT ACCESS TO AND USE OF THE PHQ AND GAD-7 SCREENERS IS AT YOUR OWN RISK. PFIZER DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER PFIZER NOR ANY PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE PHQ/GAD-7 SHALL BE LIABLE FOR ANY DAMAGES, INCLUDING WITHOUT LIMITATION, DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT, OR PUNITIVE DAMAGES, ARISING OUT OF ACCESS TO, USE OF OR INABILITY TO USE THE PHQ/GAD-7, OR ANY ERRORS OR OMISSIONS IN THE CONTENT THEREOF.

The rhetoric about the GAD-7 and PHQ-9 and its variations related by their creators, Spitzer, Williamson and Kroneke seems to have been negated by Pfizer. Instead of the PHQ-9 being “an attractive, dual-purpose instrument for making diagnoses and assessing severity of depressive disorders” and the GAD-7 being “a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research,” Pfizer disclaimed all warranties expressed or implied for a particular purpose. Pfizer nor any party involved in creating the PHQ/GAD-7 will be liable for any damages from access or use of these questionnaires. Any users access and use the PHQ and GAD-7 does so “at your own risk.”

It seems that Pfizer circled their wagons to avoid any corporate liability coming from the use of these questionnaires despite the fact they paid for their development and continue to market them aggressively to general practitioners in the US and the UK. But the potential for the over diagnosis and over treatment of depression through the PHQ-9 has now reached a new height. Psychiatry Advisor reported in August of 2017 that Google announced whenever someone searches for ‘clinical depression,’ they have an option to take the PHQ-9. Google partnered with NAMI, the National Alliance on Mental Illness, to make depression screening with the PHQ-9 part of searching for ‘depression’ on the site. NAMI said: “We hope that by making this information available on Google, more people will become aware of depression and seek treatment to recover and improve their quality of life.”

So where did all that effort with the PHQ-9 and GAD-7 get Pfizer? Pfizer currently hold the rights to the brand rights for Xanax (alprazolam), an anti-anxiety drug, and Zoloft (sertraline), an antidepressant. Both have been available as generics for a number of years. And although The Telegraph article didn’t name Pfizer’s top selling antidepressant and anti-anxiety drugs in the UK, they must be the same two. Up-to-date yearly sales data for psychiatric drugs is hard to come by, unless you pay an organization like IMS for access to their sales data. But there is data available from 2013.

IMS Health listed the top 25 dispensed prescriptions in the US in 2013. Xanax and its generic, alprazolam, was the 13th most prescribed medication. Zoloft and its generic, sertraline, was the 18th most prescribed medication. Among the psychotropic medications listed they were number one and number three respectively. PsychCentral reported similar findings, with the added information that Xanax was the number one prescribed psychiatric drug in 2005, 2009, 2011 and 2013. Zoloft sank as low as the 4th most prescribed psychiatric drug in 2009 and the 3rd most in 2011.

08/29/17

Zombie Drug

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Flakka was big news 18 to 24 months ago, with Broward County in Florida as ground zero. People were stripping themselves naked and running through traffic; trying to break INTO police substations; impaling themselves on iron fences and other sorts of mayhem. Others were grunting and moaning incoherently; and still others were catatonic, earning flakka the nickname of “the zombie drug.” After China banned the manufacture and export of alpha-PVP (the chemical name for flakka) in early 2016, it seemed to quickly fade from the news. But like all good zombie stories, flakka seems to have risen from the dead.

The website Lovin Malta reported flakka has made its way to Malta, an island country in the Mediterranean Sea. A forensic chemist said: “Flakka has been circulating across Europe and it has definitely found its way southwards to Malta too, as is the trend for many drugs.” He couldn’t confirm if anyone had overdosed on it, or if police made any arrests, “but it is definitely here.” The Malta Police Force confirmed with Lovin Malta there was a suspected case of flakka in 2015, but they could not prosecute or arrest the person, because flakka is not an illegal substance in Maltese law. Read the Lovin Malta reports here and here.

On October 17, 2016, Carrie-Anne Greenbank reported for 9 News Queensland that flakka was thought to be responsible for a mass overdose on the Gold Coast. One person was in a two day induced coma after being given the suspected drug at the Sin City Nightclub on the Gold Coast of Australia. He had acute kidney failure, 2-3 seizures and wasn’t able to stomach even water. He was one of sixteen who overdosed and were taken to a hospital. Annastacia Palaszczuk, the Premier of Queensland, Australia, said: “Do not put your life at risk. It is not worth it.” See the video report on the 9 News Queensland Facebook page, here.

Another 9 News report on November 11, 2016 had a short video clip of a Queensland man suspected of suffering from a flakka overdose. He was screaming and resisting the restraint of eight ambulance workers. The report also mentioned Shelbi, a 24 year-old woman from Los Angeles who last used flakka nine months before, in February of 2016. Shelbi was on an episode of the TV series, Intervention, where she was filmed beginning a sentence and then completely losing her focus, unable to continue. She said: “The last time I used flakka was nine months ago, and still to this day… Huh?”

An April 3, 2017 story by The National, a Middle East English-language news service, reported that after advice from the Dubai Police, the Ministry of Health recommended that flakka and cathinone be added to the list of banned mind-altering illegal substances in the UAE, the United Arab Emirates. Flakka wasn’t found in Dubai or the UAE, so the action is a pre-emptive one. Dr. Amin Al Amiri, chairman of the narcotic review committee, said the law needed to be revised so it could keep up with new challenges, like flakka. “We are adding it after making sure it belongs in the law.”

Colonel Eid Hareb, director general of the anti-narcotics department, said: “We have not had any flakka cases or what they call ‘zombie cases’ here in Dubai or in the UAE, but we do not want it to come here. . . . We don’t want people to use this drug, that is why we put it on the list.” Anyone caught using flakka or cathinone in the UAE could face at least two years in prison. If someone is found guilty of trafficking the substances, they could get the death penalty.

The Indonesia Expat has a May 31, 2017 story about flakka that said flakka was suspected of coming into Indonesia. The Head of the National Narcotics Agency, Budi Waseso, told reporters in South Jakarta that the agency was investigating the report. There was a review on May 15-16, and the analysis was submitted to the Ministry of Health. It recommended that alpha-PVP be placed as a Group 1 substance in the annex of the Narcotics Act.

In case you didn’t check out any of the flakka YouTube videos or read any of the news stories on the drug in 2015 or 2106, here is a short flakka primer drawn from a psychiatric case report, “Flakka-Induced Prolonged Psychosis,” a Psychiatric Times article, Flakka: A Deadly High” and a World Health Report. Drug effects from flakka can last one hour, several hours, or several days. Users may seem to have “super human strength,” be very agitated or even comatose.

The primary ingredient is pyrrolidinopentiophenone (alpha-PVP), a synthetic cathinone. It is an analogue of prolintane, which inhibits norepinephrine-dopamine reuptake, meaning it acts like a stimulant. Flakka is 10 to 20 times more potent than cocaine and MDPV (methylenedioxypyrovalerone), an ingredient in bath salts. You can smoke, snort, vape, inject or use it sublingually (under the tongue). It enters the bloodstream very quickly and has a serious risk of overdose.

It is known to provoke a condition called agitated delirium, causing bizarre behaviors, anxiety, agitation, violent outbursts, confusion, myoclonus (muscles twitches and jerks), and rare cases of seizures. Individuals with agitated delirium from flakka use can hallucinate and be violent, aggressive and paranoid. Self-injury and suicidal tendencies have been reported as well. “Clinical symptoms of agitated delirium involve tachycardia [abnormally rapid hear rate], hypertension [abnormally high blood pressure], hyperthermia [abnormally high body temperature], diaphoresis [excessive, abnormal sweating], and mydriasis [pupil dilation].” Multiple fatalities have been reported with flakka.

The WHO Report recommended placing flakka under international control as a Schedule II controlled substance. The WHO Schedule II is for substances whose liability for abuse constitutes a substantial public health risk and which have very little if any therapeutic value. It also indicated multiple member states have taken measures to curb the misuse of alpha-PVP.

Fifteen member states of the EMCDDA (Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Poland, Romania, Slovenia, Sweden, and the United Kingdom) as well as Turkey and Norway reported that alpha-PVP is controlled under drug control legislation. Four member states (Austria, Cyprus, Portugal and Slovakia) reported alpha-PVP is controlled under drug control legislation prohibiting the unauthorized supply of defined or qualifying new psychoactive substances. Other two member states (Belgium and Czech Republic) started the process of controlling the substance using drug control legislation. In the United State of America, alpha-PVP has been temporarily scheduled into schedule I pursuant to the temporary scheduling provisions of the Controlled Substance Act (CSA). In Japan, alpha-PVP has been controlled under the Narcotics and Psychotropics Control Act.

The psychiatric case report described a 17 year-old girl with no prior history of psychiatric diagnosis and who was never previously seen by a mental health professional. She was involuntarily committed to a psychiatric hospital after being transferred from a local Emergency Department “for altered mental status with agitation and psychotic behaviors, including auditory hallucinations.” She was treated with olanzapine (Zyprexa) and lorazepam (Ativan) for agitation. At first, she was bizarre and illogical and needed staff assistance with activities of daily living.

During the initial evaluation, she was drowsy and incoherent; unable to give an accurate history of the events leading up to her altered state. According to her mother, she was alone in her bedroom yelling, “Go away!” The mother said she was not sleeping and has no history of nightmares or sleep terrors. Her bizarre, disorganized and psychotic behavior continued through the fifth day of her hospitalization. She had mentioned she might have taken flakka, but was vague about the circumstances.

Finally, on day six, the patient became coherent, alert and oriented to person, place, time, and situation, and capable of completing her activities of daily living. She remained somewhat constricted and at times required redirection and instructions to complete tasks. When asked about her symptoms for the past week, she described an incident that happened at school the day before being admitted to the hospital. She claims that a group of her “friends” were pressuring her to try Flakka with them. Although she refused, she believes that they put some on the food she was eating because she claimed it tasted funny and felt weird ever since. She also denies any recent major stressors or traumatic events that could have led to her behaviors. After one more day of observation, the patient did not display any more overt psychotic symptoms and was discharged home with the appropriate scheduled outpatient appointments.

The reported circumstances for how she ingested flakka seem suspect to me. I’d guess she tried flakka voluntarily, perhaps under pressure from her friends. The sweaty socks smell with flakka would be the signal not to eat the food. Left unsaid in the case report, but more than likely, the girl would have continued to take her medications after discharge; at least the antipsychotic olanzapine. Although she didn’t have any “overt” psychotic symptoms at the time of her discharge she continued: “to have residual symptoms including psychomotor agitation and slowing of cognition.”  (Hmmm… Could these symptoms be side effects from the medication?) A bad trip with flakka seems to have started her on a journey through the world of psychiatric treatment, with its own series of complications. Would she have gone there without the flakka? It’s hard to tell.

I’ve written previously about flakka on this website; and you can read those articles, which are linked here: “Fading Flakka Fad,” “High on Flakka,” and “Flack from Flakka.” You can also read about potential problems with psychiatric medications here: “Antipsychotic Big Bang,” Worse Results with Psych Meds,” and “Blind Spots with Antipsychotics,” Part 1 and Part 2.  There are several additional articles on the concerns with psychiatric medications.

08/25/17

Enslaved by Freedom

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In the early 1980s, a Christian friend waxed eloquent about the writings and thought of Francis Schaeffer to me. I was a young Christian then and respected this friend’s endorsement, but didn’t think I was up to tackling his five volume collected works which had just been published in 1982. So I bought the smallest book I could find by Schaeffer in the bookstore instead, Escape From Reason. It was so full of thoughtful theology, apologetics and philosophy that I have been reading, re-reading and referencing it since then.

In Escape from Reason, Schaeffer developed a helpful way of conceiving how the modern understanding of humanity came about. But unlike other modern thinkers, he went back to the thought of Thomas Aquinas, over three hundred years before Descartes. See “Not a Ghost in the Machine” for more on Descartes. Schaeffer thought the real birth of modern humanistic thought began with Aquinas’ distinction between nature and grace. According to Schaeffer, Aquinas thought grace was a higher level of existence that included God the Creator, heaven and heavenly things, the unseen and its influence on the earth and the human soul. The lower level of nature contained every thing created—all earthly things, all that is visible, and what nature and humans do on the earth, including the human body.

Similar to the Cartesian mind-body distinction, Aquinas did not see a complete separation between nature and grace—between the human body and soul. However, he had an incomplete view of the biblical Fall, according to Schaeffer. Aquinas thought human will was fallen, but human intellect was not. “From this incomplete view of the biblical Fall flowed all the subsequent difficulties.” In Aquinas, one realm of human existence could potentially be independent of God. Human intellect wasn’t entirely non posse non peccare— not able not to sin—to use Augustine’s description of human nature after the Fall. According to Schaeffer, this meant there was a potential for us to act as if human reason could be autonomous from God.

From the basis of this autonomous principle, philosophy also became free, and was separated from revelation. Therefore, philosophy began to take wings, as it were, and fly off wherever it wished, without relationship to Scriptures. This does not mean this tendency was never previously apparent, but it appears in a more total way from this time on.

When nature was made autonomous by Aristotelian thought in Aquinas, it began to annex grace. Schaeffer stressed that when nature is conceived as autonomous from God, it becomes destructive and it will ‘eat up’ grace. “Nature gradually became more totally autonomous. . . . By the time the Renaissance reached its climax, nature had eaten up grace.” But the Reformation was a counter balance to this autonomy of intellect.

In the Scriptures, God spoke truly about the upper level and the lower level. He spoke truly about Himself and heavenly things, and He spoke truly about nature—the created order of the cosmos and humanity. This is known as the two-books theory of God’s revelation—special revelation in Scripture and general revelation in nature. This was incidentally the starting point for many of the first modern scientists. Francis Bacon (1561-1626), an English philosopher and scientist, is generally seen as the father of empiricism. He said:

God has, in fact, written two books, not just one. Of course, we are all familiar with the first book he wrote, namely Scripture. But he has written a second book called creation.

Scripture also says we are made in the image of God, but fallen because “at a space-time point of history,” humanity sinned. Although the people of the Reformation knew they were morally guilty before God, they were not nothing. “These people knew they were the very opposite of nothing because they were made in the image of God.” And when the Word of God was listened to, the Reformation had tremendous results—in culture and in people becoming Christians.

The Bible tells us God is “both a personal God and an infinite God.” This personal-infinite God is the Creator of all things. Therefore, everything else is finite; everything else is created. This Creator-creature distinction places a chasm between God and all created things—humanity, animals, plants, and the machine. Yet when you come to the side of humanity’s personhood (Descartes’ mind-body composite), we were made in the image of God—created to have a personal relationship with Him. So humanity’s relationship is upward with God and not merely downward with the rest of the created order. Schaeffer pictured this relationship as follows:

On the side of God’s infinity, humanity is as separated from God as the Cartesian sense of machine and the other aspects of the created order. This is the Creator-creation distinction. However biblically, there is a different story on the side of human personality. Being made in the image of God, we were created to have a personal relationship with Him. Here our relationship is upward and not just downward; and there is a difference between humans and the rest of the created order.

If you are dealing with twentieth-century people, this becomes a very crucial difference. Modern man sees his relationship downward to the animal and to the machine. The Bible rejects this view of who man is. On the side of personality you are related to God. You are not infinite but finite; nevertheless, you are truly personal; you are created in the image of the personal God who exists.

Schaeffer said there is nothing truly autonomous from God; not the human mind or reason. There can be nothing apart from the lordship of Christ and the authority of the Scriptures. God made the whole person and He is interested in the whole person. While the modern humanist may have been conceived during the Renaissance, the Reformation provided the corrective to his dilemma. Although dualism in Renaissance thought has contributed significantly to the modern world’s sorrows, there is still hope in Christ. In another of his works, A Christian View of the Bible as Truth, Francis Schaeffer said:

The ancients were afraid that if they went to the end of the earth, they would fall off and be consumed by dragons. But once we understand that Christianity is true to what is there, including true to the ultimate environment—the infinite, personal God who is really there—then our minds are freed. We can pursue any question and can be sure that we will not fall off the end of the earth. Such an attitude will give our Christianity a strength that it often does not seem to have at the present time.

What happened is that rationalism evolved and became entrenched in science. The uniformity of natural causes in creation or nature was gradually closed to any intervention from outside, from God. Nature became a closed system devoid of any intervention from God. The distinction of nature and grace no longer made sense. “There was no idea of grace—the word did not fit any longer.” There was no room for revelation, so the problem was redefined in terms of freedom and nature. “Nature has totally devoured grace, and what is left in its place ‘upstairs’ is the word ‘freedom’.”

At this time we find that nature is now so totally autonomous that determinism begins to emerge. Previously determinism had almost always been confined to the area of physics; to the machine portion of the universe.

This autonomous freedom is one where the individual is at the center of the universe. It is a freedom without restraint; without limitations. Descartes’ conception of the mind as a thinking thing, the person as a fundamentally rational, mind-bound individual, fits well within this freedom. And here we can see the fulfillment of the promise of the serpent in the story of the Fall. Eating of the forbidden fruit opened human eyes and made us like God, with the freedom of knowing good and evil independent of Him. As Blaise Pascal observed: “Original sin is foolish to men” who seek to be autonomous beings.

If interested, you can watch Francis Schaeffer unfold more of his thinking in several YouTube videos. Here is a link to one on “The Flow of Materialism.”

08/22/17

It Takes Away Your Soul

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In case you missed it in July, there was an annual day of awareness … for the problems that result from the prescription and use of benzodiazepines. World Benzodiazepine Awareness Day (W-BAD) is on July 11th. The first W-BAD was in 2016, so it’s just getting started. The need for greater awareness of the adverse effects from benzos can be seen in the 2016 W-BAD promotional video, here. It’s over 24 minutes long, so be prepared to spend some time. If that’s too much time for you to take at the moment, here’s one take away quote from Wendy in Melbourne Australia about her experiences while on and then getting off of benzos: “It takes away your soul.”

I was pleasantly surprised to see an extended quote on the dangers of benzodiazepines from Dr. Neil Capretto was used in the 2016 W-BAD video. Dr. Capretto is the Medical Director for Gateway Rehabilitation Center, a drug and alcohol treatment program I’m familiar with in Western Pennsylvania, Dr. Capretto said:

People were innocently put on this medication [benzodiazepines] and in some instances it works out well. [But] there is a significant risk and we see it all of the time. Many people who have lost many years of their lives, who have lost jobs, been on the verge of suicide. I’m aware of cases where people have committed suicide. The drug can be dangerous, it can be fatal. During withdrawal the heart rate can go up, they may have a seizure, sometimes the body temperature can go up and in some cases it’s fatal.

The W-BAD video has individuals from around the world, telling about their experiences while using benzos, when tapering off them, and the ongoing protracted withdrawal experiences they suffered through. For some individuals, those adverse effects lasted months and in some cases were permanent. There were three W-BAD objective listed towards the end if the video, which are listed below.

To encourage the establishment of a mandatory maximum prescribing period of no more than 4 week, including taper period (based on the Committee on Safety of Medicines’ 2-4 week prescribing guidelines).

To encourage the establishment of ‘specialized’ withdrawal facilities for those who so desperately need them.

To encourage the provision of proper training for doctors and medical staff and to help them learn more about proper tapering practices to discontinue the drugs as well as about the serious implications of benzodiazepines.

The Committee on Safety of Medicines is an independent advisory committee that advises the UK Licensing Authority on the quality and safety of medicines. In 2005 it was replaced by the Commission on Human Medicines, combining the functions of the Committee on Safety of Medicines and the Medicines Commission. The Committee issued guidelines for UK physicians and medical professionals on the use of benzodiazepines in January of 1988. Pause for a minute. These concerns were evident almost thirty years ago.

The original document said there had been concerns regarding benzodiazepine dependence for several years, and cited a British Medical Journal article from 1980 to support the claim. It noted that withdrawal symptoms could include anxiety, confusion, insomnia, depression, and perceptual disorders. These symptoms could occur even when following therapeutic doses over SHORT periods of time (emphasis in the original). “These may sometimes be difficult to distinguish from the symptoms of the original illness.”

They discouraged the use of benzodiazepines to treat insomnia, unless it was severe and subjecting the person to extreme distress. If used, they should be used intermittently. “The use of benzodiazepines to treat short-term ‘mild’ anxiety is inappropriate and unsuitable.” When the anxiety is severe, disabling or subjecting the person to unacceptable distress they can be used for short-term relief—“two to four weeks only.”  The Committee then gave the following quote from the above noted article in the March 29, 1980 issue of the British Medical Journal. The point of all this is these concerns and recommendations with benzodiazepines have been know since the 1980s, but have been largely ignored on a global scale, as illustrated in the 2016 W-BAD video linked above.

The committee further noted that there was little convincing evidence that benzodiazepines were efficacious in the treatment of anxiety after four months’ continuous treatment. It considered that an appropriate warning regarding long-term efficacy be included in the recommendations, particularly in view of the high proportion of patients receiving repeated prescriptions for extended periods of time.It further suggested that patients receiving benzodiazepine therapy be carefully selected and monitored and that prescriptions be limited to short-term use.

Finding a “specialized” withdrawal facility can be difficult. Be careful of what the centers promise and their cost. Do your homework when searching for a “specialized benzodiazepine withdrawal facility.” A mere “benzodiazepine withdrawal facility” search will net multiple residential drug and alcohol treatment centers. Not every person who has been using benzodiazepines long enough to need medical inpatient detoxification support has been abusing benzos, and treatment at a drug and alcohol treatment center is often inappropriate. Plus the withdrawal protocol is often too rapid.

The New Beginnings Recovery Center in North Palm Beach Florida is an example of a treatment program that uses a protracted withdrawal method. I have no experience with their treatment program and can’t endorse it. But what I’ve seen of their methods fits with a patient or client-centered method of withdrawal, which I do think is best with benzodiazepines. Here is a link to the New Beginnings page on their Benzodiazepine Withdrawal Treatment Program. Here is a short YouTube video clip discussing the Heather Ashton Method for benzodiazepine withdrawal used at the New Beginnings Recovery Center.

Going slowly, at a pace controlled by the individual withdrawing from benzos, is the method most likely to produce positive results. It will take several weeks, months, and even in some cases, years. I’ve run across two medical professionals who advocate for this protracted withdrawal method, Dr. Peter Breggin and Dr. Heather Ashton.

I am personally familiar with Dr. Breggin’s work and have read many of his resources, including two that would be helpful for benzodiazepine withdrawal: Your Drug May Be Your Problem and Psychiatric Drug Withdrawal. Start with Your Drug May Be Your Problem for personal information on the process and try Psychiatric Drug Withdrawal for more technical discussions, if that’s needed. Both books discuss withdrawal from multiple classes of psychiatric drugs. There is a YouTube channel for Peter Breggin. He also has his own website with more information at: breggin.com.

The Ashton Protocol, or Ashton Method, is new to me, but from what I’ve reviewed it fits with the protracted withdrawal process I’m familiar with in Dr. Breggin’s material. Here is a YouTube clip, “Dr. Heather Ashton- Benzodiazepine Withdrawal.” You can see several other YouTube videos about her method with a “Dr. Heather Ashton” search on YouTube. Dr. Ashton also wrote “Benzodiazepeines: How They Work and How to Withdraw,” which has become known as “The Ashton Manual.”  A digital copy is available here on benzo.org.uk for free. A printed copy can be ordered.

From the brief review I’ve done so far, it seems likely to be a very helpful resource for individuals looking for assistance in getting off of benzodiazepines. Within a documentary by Shane Kenny, “The Benzodiazepine Medical Disaster,” which is linked below, Dr. Asthton said she wrote the manual for patients who weren’t getting help from the doctors. They seemed to know better what to do than the doctors. “It was for them. And the interesting thing is, although patients from all over the world have snapped it up, doctors still don’t read it.”

Protracted withdrawal will extend far beyond any acute medical withdrawal phase, and ongoing medical and therapeutic support on an outpatient basis is advisable. Getting medical support for protracted benzodiazepine withdrawal as an outpatient could be challenging. You may have to educate a willing physician on the necessity of an extended, rather than a shorter-term withdrawal. You can use the material recommended above from Peter Breggin and Heather Ashton to first educate yourself, and then any physician or psychiatrist willing to work with you on a protracted benzodiazepine withdrawal.

There are also many online information and support groups, such as: benzo.org.uk, which as been around since July of 2000. “Benzo.org.uk is dedicated to sufferers of iatrogenic benzodiazepine tranquilliser addiction.” In addition to the link to The Ashton Manual noted above, it has a wealth of information, including a FAQ document and links to online benzodiazepine withdrawal support groups on a support page. They also called out a specific support group called BenzoBuddies.

BenzoBookReview.com is a website with a list of books on benzodiazepine withdrawal. Information there includes memoirs and how-to guide books, with reviews and summaries of each book. The site is for anyone interested in information about benzodiazepine misuse and how to help benzodiazepine sufferers. That includes their families, doctors, psychologists, psychotherapists, drug counselors, and all professionals.

Other helpful resources include: Benzodiazepine Information Coalition, Beyond Meds, and Mad in America. Search the Mad in America site for “benzodiazepines.” Information on their “Withdrawal Resources” page will include a scientific literature review on withdrawal from benzodiazepines, as well as other classes of psychotropic drugs. Mad in America linked a short video by the group Benzodiazepine Recovery, “Benzodiazepine Withdrawal Symptoms” where individuals shared their top three most debilitating benzodiazepine withdrawal symptoms.

There are several helpful YouTube resources, such as Benzo Brains, by Jocelyn Pedersen. W-BAD also has a YouTube channel and a website: w-bad.org. Their YouTube channel has a short informational video (almost 3 minutes) on the risks of taking benzodiazepines. Start there to begin the education process with someone.

Look under Resources on w-bad.org for the Documentaries link. You will find information on “As Prescribed” by Holly Hardman, which is in production. Scrolling further down you will see a link to another documentary, “The Benzodiazepine Medical Disaster” by Shane Kenny. It features an in depth interview with Heather Ashton. Also remember what Melanie said about why this information on benzodiazepines is so important: “It takes away your soul.”

08/18/17

Public Health Time Bomb

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May came and went with the vast majority of people in the U.S.—including me—being totally unaware that it was Hepatitis Awareness month. May 19th was National Hepatitis Testing Day. Hepatitis-C (HCV) is the most common form of viral hepatitis in the U.S. The number of new HVC infections almost tripled between 2010 (850) and 2015 (2,436). We need to be more aware of this disease and its treatment because it kills more Americans than any other infectious disease, including HIV. Yes, more people than HIV. CDC data indicated nearly 20,000 Americans died from hepatitis-C-related causes in 2015; and the majority of those deaths were people 55 and older.

“Because hepatitis C has few symptoms, nearly half of people living with the virus don’t know they are infected and the vast majority of new infections go undiagnosed.” The highest rate of new infection occurs among 20- to 29-year-old injection drug users. But ¾ of the 3.5 million Americans living with hepatitis C are baby boomers born between 1945 and 1965. They are six times more likely to be infected with hepatitis C and are at much greater risk of dying from the virus. Around ½ of all the deaths from HCV in 2015 occurred within this age range. You can read the three CDC press releases this information was taken from here, here and here.

These press releases highlighted information in report, “A National Strategy for the Elimination of Hepatitis B and C” that suggested a strategy to eliminate both as public health problems by 2030. Immunization against hepatitis B (HBV) can prevent 95% of infections. There is no vaccine against HCV, but there are anti-viral drugs that can cure hepatitis C, but the costs are prohibitive. The introduction of the report said:

There is no longer any reason to disregard these diseases. There is an effective vaccine to prevent hepatitis B, advances in treatment can prevent most deaths in those chronically infected with HBV, and hepatitis C is now curable with a short course of easily tolerated treatment.

CDC data on HCV suggested that 75% to 85% of newly infected adults and adolescents develop chronic infections. From 2000 to 2002 incident rates for acute HCV decreased for all age groups except for persons aged 0-19. Then the rates remained fairly steady from 2002 through 2010. Between 2010 and 2015 rates increased for persons in all but the oldest (<60 years old) and youngest (0-19 years old) age categories. The largest increase was among persons between 20 and 29 years old. See the following graph of the reported CDC data.

The drug companies charge between $60,000 and $90,000 for a 12-week course of treatment. This is way out of proportion to the cost of treatment in third world countries. Eliminating HCV as a public health problem by 2030 would require mass treatment, but none of the direct-acting agents come off patent before 2029. In the long run, HCV treatment is cost-effective, but that doesn’t address the upfront costs charged by pharmaceutical companies for their drugs. So the cost of antivirals that cure HCV is a major obstacle. 

These drugs have strained the budgets of public and private payers alike. Faced with the unenviable task of allocating scarce treatment, payers gave first priority to the sickest patients, those at most immediate risk of death. Many also imposed sobriety restrictions, fearing the risk of re-infection in active drug users too great to justify the expense of treatment. Such restrictions have met with criticism. Overt drug rationing offends the American public, but it is difficult to know how else to act in the face of such high prices.

One of the recommendations of the report is for the federal government to purchase the rights to one of the direct-acting antiviral treatments for use with neglected populations such as individuals on Medicaid, in prisons and those treated through the Indian Health Services. This would be a voluntary transaction between the government and the pharmaceutical companies providing the antivirals. The company would be guaranteed reasonable compensation and the licensed drug would only be used in the limited markets (noted above) the companies aren’t now reaching.

Calculations show that the licensing rights should cost about $2 billion, after which states would pay about $140 million to treat 700,000 Medicaid beneficiaries and prisoners. By comparison, the status quo would cost about $10 billion over the next 12 years to treat only 240,000 similar patients.

Critics of the strategy suggest it sets a dangerous precedent by having the government negotiating a license for a costly medicine. Actually, it seems that the federal government’s reluctance to interfere with the pharmaceutical industry may have emboldened it to initially set the extremely high prices foe HCV drugs.

The Senate Finance Committee’s 2014 investigation into the pricing of sofosbuvir [Solvadi] concluded that Gilead had deliberately elevated the price in an effort to raise the market floor, ensuring continued high prices for all future hepatitis C treatments. Action now might discourage other companies from pursuing this strategy in the future.

A CNN article on the report by Susan Scutti noted the hardest hit areas of the U.S. in terms of new HCV infections are parts of Appalachia and rural areas of the Midwest and New England. Seven states, Indiana, Kentucky, Maine, Massachusetts, New Mexico, Tennessee and West Virginia, have infection rates that are two times or more than the national average. Ten other states have rates above the national average: Alabama, Montana, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Utah, Washington and Wisconsin.

There is a website, HepVu, presented by the Rollins School of Public Health at Emory University, which partnered with Gilead Sciences, the original price gauging pharmaceutical company with its antivirals, Solvadi and Harvoni. The original drug development research into Solvadi was done at Emory. Despite the Gilead partnership, HepVu has some helpful information, including an interactive map by state in the U.S. The home page stated there are an estimated 3.9 million people in the U.S. living with past or current hepatitis C infection. You can look up each state’s individual profile.

For example, within my home state of Pennsylvania, there are an estimated 142,100 people living with Hepatitis C. The HCV mortality rate is 4.952 per 100,000 persons, with 629 hepatitis C deaths in 2014. In West Virginia, there are an estimated 24,400 people living with Hepatitis C. The HCV mortality rate is 5.9 per 100,000 persons, with 110 hepatitis C deaths in 2014. In Ohio, there are an estimated 119,100 people living with Hepatitis C. The HCV mortality rate is 4.9 per 100,000 persons, with 567 hepatitis C deaths in 2014. Go to the site and check out your own state’s data.

The outrageous price of medications to treat hepatitis C illustrates how pharmaceutical companies are feeding off of the problems they had a hand in creating. The rise in hepatitis C infections comes as a result of increased IV drug use, which resulted from the prescription opioid epidemic leading individuals to switch from prescription opioids to heroin. And the public health problems with hepatitis C will only get worse since it often goes undiagnosed for years. It’s a public health time bomb.

The above recommendation to have the federal government negotiate a license for one of the existing Hepatitis C treatments is a good one. It just might deter other companies from trying the same pricing trick in the future with other medications. But the cozy lobbying relationship between Pharma and Congress could prevent it.

For more on this issue, see: “Is There No Balm in Gilead?,” “I Guess I’m a Little Bit Socialist,” “Riding the Hep C Gray Train,” “Impeccable Timing” and “Hepatitis Hostages.” Also see “Pharma Companies Hunt in Packs” for more information on the issues of the high cost of prescription drugs.