10/13/17

Feuding Ideologies, Part 2

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In the first paragraph of “Dying To Be Free,” you are introduced to Patrick, a smiling 25 year-old who had just completed a 30-day drug treatment center. Among his possessions was “a talisman he’d been given by the treatment facility: a hardcover fourth edition of the Alcoholics Anonymous bible known as ‘The Big Book.” It pages were full of highlights and Post-It notes. He was said to be a “natural” 12-step convert. Four days later, his father found him dead of an overdose.

As you read about Patrick’s struggles with addiction, you get a picture of how he and his parents tried to help him establish sobriety. There is a reference to his residential treatment stay as a “30-day wonder,” where he received a crash course on the tenets of the 12-steps. “Staff at the center expected addicts to reach a sort of divine moment but gave them few days and few tools to get there.” In Part 1 of this article, I addressed concerns that an underlying ideology of addiction as a strictly biomedical disease contributed to a biased, distorted picture of addiction treatment in the U.S. by the author of “Dying To Be Free.” Here we will look at how he also misrepresents the recovery philosophy and history of A.A.

There is a preponderance of religious or magical rhetoric when describing 12 Step, abstinent-based change in “Dying To Be Free.” Already we’ve noted the main text of Alcoholics Anonymous, also called Alcoholics Anonymous, was referred to as a talisman and a “bible.” Patrick was a “natural 12-step convert.” Another reference described the AA Big Book as being the size of a hymnal, with an appeal to faith made in “the rat-a-tat cadence of a door-to-door salesman.” Addicts at a certain treatment center were supposed to “reach a sort of divine moment” in treatment or recovery. Entering the drug treatment system, which is dominated by the principles of abstinence embedded in the 12-Steps, was said to require a “leap of faith.”

In a description of the Grateful Life Treatment Center in northern Kentucky, it was noted that the wall above the desk of the center’s intake supervisor had a “Jesus bumper sticker.” Why add that detail unless you are trying to capture the scene in a particularly religious way? When describing treatment facilities modeling themselves on the 12 Steps, not only were recovering addicts said to be cheap labor, they were said to provide the “evangelism” to shape the curricula of the facilities. A resident of Grateful Life was noted to be “as close to a true believer as the program produces.”

At one point, the author of “Dying To Be Free,” Jason Cherkis, said AA came out “evangelical Christian movements.” More accurately, there is a clear historical connection between a nondenominational Christian movement popular during the 1920s and 1930s called the Oxford Group and Alcoholics Anonymous. The two cofounders of A.A., Bill W. and Dr. Bob met as a result of their personal association with the Oxford Group. A.A. approved books, such as Pass It On, Doctor Bob and the Good Oldtimers and AA Comes of Age freely acknowledge the connection and give further details about it. However, a crucial distinction made by A.A. within its 12 Steps is glossed over by Cherkis and others, namely the spiritual, not religious understanding of God and recovery embodied in the Twelve Steps.

Drawn from the thought of the American psychologist, William James, this distinction between religious and spiritual experience seems to underlie the widespread sense of generic spirituality in American culture today. The Varieties of Religious Experience  (VRE) by James had a fundamental influence on Bill W., the formulation of the Twelve Steps and the spirituality based upon them. In VRE James made a distinction between institutional and personal religion. Worship, sacrifice, ritual, theology, ceremony, and ecclesiastical organization were the essentials of what he referred to as institutional religion.

Personal religion/spirituality for his [James’] purposes was defined as “the feelings, acts, and experiences of [the] individual . . . in their solitude, so far as they apprehend themselves to stand in relation to whatever they may consider the divine.” In the broadest sense possible, this spirituality consisted of the belief that there was an unseen order to existence, and supreme good lay in harmoniously adjusting to that order.

Whether their disregard of the spiritual, not religious distinction is intentional or not, Cherkis and others give an incomplete and biased picture of Twelve Step recovery when they fail to note it. The very heart of Twelve Step spirituality is the permissibility of the individual to formulate a personal understanding of their “god.” So what unites members of Twelve Step groups like A.A. is the diversity of religious and spiritual belief permitted—even to accepting a lack of belief. I’ve written several other articles on the similarities and differences between the spirituality of the Twelve Steps and religious spirituality on this website. There are three particular articles that discuss the influences on the spiritual, not religious distinction of Twelve Step recovery: “What Does Religious Mean?”, “Spiritual Not Religious Experience” and “The God of the Preachers.”

Another example of how “Dying To Be Free” misrepresents the recovery philosophy of A.A. is the following. While introducing a discussion of Charles Dederich and the origins of Synanon, Cherkis said Dederich and others took a “hardline” message” from some of Bill W.’s written philosophy. Cherkis wrote: “Those who can’t stick with the program are ‘constitutionally incapable of being honest with themselves,’ reads the Big Book. ‘They seem to have been born that way.’” The two selective quotes were from the first paragraph of chapter five, “How It Works,” in Alcoholics Anonymous. Notice how the context of the complete paragraph changes your understanding of what Bill W. said in his “philosophy”:

Rarely have we seen a person fail who has thoroughly followed our path. Those who do not recover are people who cannot or will not completely give themselves to this simple program, usually men and women who are constitutionally incapable of being honest with themselves. There are such unfortunates. They are not at fault; they seem to have been born that way. They are naturally incapable of grasping and developing a manner of living which demands rigorous honesty. Their chances are less than average.

As Cherkis began to discuss the history of the expansion of drug treatment facilities in the 1960s, he quoted Nancy Campbell, a professor at Rensselaer Polytechnic Institute, as saying: “The history of 12-step came out of white, middle-class, Protestant people who want to be respectable.” She added that it offered community and belonging that was predicated on being normal, respectable and having a stake in mainstream society.  Campbell may be a historian, but she seems to have a distorted view of the early history of 12 Step recovery in A.A.

From the sociological perspective of labeling theory A.A. and other organizations based on their 12 Steps, like N.A. (Narcotics Anonymous), can at least partially be seen as social movements that seek to combat negative images associated with socially deviant drinking or drugging behavior, “in effect denying that their actions make them deviants.” This applies the idea of tertiary deviance, first described by John Kituse in: “Coming Out All Over: Deviants and the Politics of Social Problems.” Kituse noted that some people stigmatized as deviant (here as alcoholics) “rebel against their labels and attempt to reaffirm their self-worth and lost social status.” The above quote and reference to Kituse is found in a standard social science textbook by Clinard and Meier, Sociology of Deviant Behavior.  So part of Campbell’s assessment of 12 Step groups as social movements seeking to offer community and belonging, with a “stake in mainstream society” is accurate. However, the quote attributed to her glosses over the early history of A.A., which was the beginning of the 12 Step movement.

A.A. celebrates the anniversary of its founding on June 10, 1935. That was in the midst of the Depression. Bill W. and his wife Lois were living then in a house owned by her father on Clinton Street in New York City. In September of 1936, Lois’s father died and the house was taken over by the mortgage company, which allowed them to stay on for a small rental. In the midst of the Depression, they didn’t want the house to be empty. While struggling with “their acute poverty,” Bill was almost persuaded to accept a position as a paid alcoholism therapist at Towns Hospital, where he himself had been treated several times. He eventually declined the offer.

Almost two and a half years after the founding of A.A., Bill W. was jobless and Dr. Bob was in danger of losing his house. In 1938, through the charity of John D. Rockefeller Jr., $5,000 was approved for a fund that would pay off Dr. Bob’s mortgage and allow a weekly draw of $30 for each of them. Rockefeller told one of his associates afterwards: “But please don’t ever ask me for any more.” In 1939, as the Depression eased, the mortgage company was able to sell the Clinton Street house and Bill and Lois became homeless. They lived “as vagabonds,” as various places for two years. Bill W. and Lois eventually led a respectable, middle class lifestyle, but that wasn’t what it was like for them in the beginning of A.A.

This history is found in Pass It On, published by Alcoholics Anonymous World Services, Inc. In the early days of A.A., Bill W. repeatedly turned down offers to professionalize his work with A.A. This doesn’t entirely sound like a movement trying to gain white, middle class respectability. The Traditions of A.A., formally adopted in July of 1950, articulated this philosophy of non-professionalism and a focus on helping other alcoholics in the fifth, sixth and eighth Traditions.

Tradition Five Reads: “Each group has but one primary purpose—to carry its message to the alcoholic who still suffers.” Tradition Six reads: “An A.A. group ought never endorse, finance, or lend the A.A. name to any related facility or outside enterprise, lest problems of money, property, and prestige divert us from our primary purpose.” Tradition Eight reads: “Alcoholics Anonymous should remain forever non-professional, but our service centers may employ special workers.”

Alternative addiction treatment ideologies regularly attack A.A. as “religious,” ignoring or rejecting the spiritual-religious distinction A.A. made within the Twelve Steps from the very beginning. The abstinent-based recovery philosophy embedded in the Twelve Steps seems to be the primary target of these critiques. I see the same tendency in “Dying To Be Free.” The first part of this article addressed the biased portrayal of abstinent-based addiction treatment by Jason Cherkis in “Dying To Be Free.” The third and final part will address how it skimmed over the problems with MAT, specifically Suboxone.

10/3/17

Feuding Ideologies, Part 1

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In August of 2017, the now former Health and Human Services Secretary, Tom Price, said he didn’t think it was necessary to declare the opioid epidemic to be a national emergency. This was despite the president’s own opioid commission recommending it as the “first and most urgent recommendation.” Two days later, the President reversed Price’s statement, saying: “The opioid crisis is an emergency, and I’m saying officially right now it is an emergency.” The response was mixed. While President Trump’s announcement could be used to help free up federal resources and help to prioritize responses to the disaster, it could also permit the administration to push for new sentencing legislation in order to get “tough on crime” related to drug use.

What isn’t disputed is that the U.S. does have a serious opioid problem and something needs to be done about it. Drug overdose is the leading cause of death in Americans under the age of fifty. Forecasts by STAT News are the annual death rate will increase by at least 35 percent by 2027. The CDC reported that from 2002 to 2015 there was a 5.9-fold increase in the overdose deaths from heroin and non-methadone synthetic opioids.

The latest statistics for the U.S. opioid epidemic is now available in the 2016 National Survey on Drug Use and Health (NSDUH). Among the myriad of statistics reported there was news that heroin users increased 230% from 2002 to 2016, while heroin deaths increased 630%. An estimated 948,000 people aged 12 or over reported they used heroin in the past year. That translates to .4% of the country’s population. There were also an estimated 11.5 million people who misused pain relievers in the past year, 4.3% of the population aged 12 or over. Combined, there are 11.8 million people who misused opioids, 4.4% of the population, in 2016.

The 2016 NSDUH Report can be accessed here. A shorter, graphic-based report of key findings, including those noted above, is here.

One of the treatment approaches often touted to address the opioid crisis is medication-assisted treatment (MAT) with Suboxone. In January of 2015, Jason Cherkis wrote “Dying To Be Free.” His subtitle asked why we weren’t using a treatment for heroin addiction—Suboxone—that actually worked. The opioid problem in Kentucky was the focus of his article, which I found to be rhetorically persuasive and well written. You are introduced to individual after individual who wouldn’t or couldn’t use Suboxone and ended up dead from an eventual overdose.

“Dying To Be Free” was a finalist for a Pulitzer in 2016 for its “deeply researched reporting on opioid addiction” that showed how many drug overdoes deaths could have been prevented. The cover letter submitted for its entry for the Pulitzer by The Huffington Post said it triggered a series of state and federal policy changes that rejected abstinence for opioid misuse and embraced medication-assisted treatment. “‘Dying To Be Free’ offered readers an immersive experience that included audio and video documentaries and photo and data displays.”

This was not fake news. “Dying to Be Free” captured the agony of individuals and families who struggle with opioid misuse. But it also made abstinence-based approaches to treatment and recovery a bogeyman responsible for many of the unnecessary deaths from opioid overdoses. The rhetoric of the article was a straw man attack on abstinent-based treatment while it extolled MAT. Its biomedical treatment bias seemed to dismiss or ignore many of the problems with Suboxone as a MAT for opioid addiction. Nor did it tell the whole story behind Suboxone. It also misrepresented the recovery philosophy of self-help groups like Alcoholics Anonymous. Here’s what I mean.

In the last paragraph of his second chapter, Cherkis said: “There’s no single explanation for why addiction treatment is mired in a kind of scientific dark age, why addicts are denied the help that modern medicine can offer.” This succinctly captures the problem as he sees it with existing treatment approaches to the opioid crisis. Heroin addiction is a medical disease and should be treated as a medical disease. Modern medicine has a scientific treatment for heroin addiction that is resisted because of stigma, a deep-rooted adherence to self-help, and the criminalization of heroin addiction. If you question or oppose MAT, you are apparently mired in a kind of scientific dark age.

To enter the drug treatment system, such as it is, requires a leap of faith. The system operates largely unmoved by the findings of medical science. Peer-reviewed data and evidence-based practices do not govern how rehabilitation facilities work. There are very few reassuring medical degrees adorning their walls.

Dr. Mary Kreeft, one of the pioneers of methadone maintenance, was liberally quoted to support the medical model of addiction. She noted how opioid addiction alters multiple regions in the brain, including those that regulate reward, memory, learning, stress, hormonal response and stress sensitivity. According to Dr. Kreeft, after a long cycle of opiate addiction, a person needs specific medical treatment. Some people may be OK in time. But “the brain changes, and it doesn’t recover when you just stop the drug because the brain has been actually changed.”

An abstinence-only treatment that may have a higher success rate for alcoholics simply fails opiate addicts. “It’s time for everyone to wake up and accept that abstinence-based treatment only works in under 10 percent of opiate addicts,” Kreek said. “All proper prospective studies have shown that more than 90 percent of opiate addicts in abstinence-based treatment return to opiate abuse within one year.” In her ideal world, doctors would consult with patients and monitor progress to determine whether Suboxone, methadone or some other medical approach stood the best chance of success.

This is a rigid, strict medical model of opioid addiction. And it gives a mixed message regarding whether or not the individual will ever be able to stop taking Suboxone or methadone. Neither drug, said Cherkis, is a miracle cure. But they buy addicts time to fix their lives, seek counseling and allow their brains to heal. So far, so good. But here comes the caution: Doctors recommend tapering off the medication cautiously. The process could take years, as addiction is a chronic disease and effective therapy takes time. Then comes the typical analogy of the pure medical model of addiction:

Doctors and researchers often compare addiction from a medical perspective to diabetes. The medication that addicts are prescribed is comparable to the insulin a diabetic needs to live.

There is no mention of neuroplasticity—the brain’s ability to reorganize itself by forming new neural connections. “Neuroplasticity allows the neurons (nerve cells) in the brain to compensate for injury and disease and to adjust their activities in response to new situations or to changes in their environment.”

Jeffrey Schwartz and Rebecca Gladding use an almost identical description of neurological action to that given above by Dr. Kreeft to describe how to change the brain; to modify bad habits (including addiction) and unhealthy thinking. In You Are Not Your Brain, they describe how we teach our brains to act in unhealthy ways. The brain does not distinguish between beneficial and destructive habits, “it just responds to how you behave and then generates strong impulses, thoughts, desires, cravings, and urges that compel you to perpetuate your habit, whatever it may be.”

Clearly, the brain can exert a powerful grip on one’s life—but only if you let it. The good news is that you can overcome the brain’s control and rewire your brain to work for you by learning to debunk the myths it has been so successfully selling you and by choosing to act in healthy, adaptive ways.

Neuroplasticity, as described by Schwartz and Gladding, does not reject Kreeft’s neurological description of addiction.  But it does say it isn’t the whole story. An ideology of addiction as a purely biomedical condition seems to permeate “Dying To Be Free.” Addiction, when conceived strictly as a brain disease, rejects or ignores the non-scientific construct of mind. If we are conceived as only biological beings, then addiction is explained and treated within a biomedical worldview. Any treatment approach to addiction not based on this premise is therefore faulty.

Drug treatment facilities were said in “Dying To Be Free” to “generally” fail to distinguish between addictions. They have a one-size-fits-all approach.  Addicts in residential treatment experience a “hodgepodge” of drill-instructor tough love and self-help lectures. Programs appear simultaneously excessively rigid and wildly disorganized. “And with roughly 90 percent of facilities grounded in the principle of abstinence, that means heroin addicts are systematically denied access to Suboxone and other synthetic opioids.”

After describing two older, drug treatment programs with a therapeutic community model of care that used coercive techniques—Synanon and Daytop (Drug Addicts Yield TO Persuasion)— he said:

The number of drug treatment facilities boomed with federal funding and the steady expansion of private insurance coverage for addiction, going from a mere handful in the 1950s to thousands a few decades later. The new facilities modeled themselves after the ones that had long been treating alcoholics, which were generally based on the 12-step methodology. Recovering addicts provided the cheap labor to staff them and the evangelism to shape curricula. Residential drug treatment co-opted the language of Alcoholics Anonymous, using the Big Book not as a spiritual guide but as a mandatory text — contradicting AA’s voluntary essence. AA’s meetings, with their folding chairs and donated coffee, were intended as a judgment-free space for addicts to talk about their problems. Treatment facilities were designed for discipline.

In support of this claim, Cherkis referred to a 2012 study conducted by the National Center on Addiction and Substance Abuse at Columbia University. It apparently was a reference to “Addiction Medicine: Closing the Gap between Science and Practice.” He said the study concluded the U.S. treatment system was in need of a “significant overhaul” and questioned whether the low levels of care received by addiction patients constituted a from of medical malpractice.

While medical schools in the U.S. mostly ignore addictive diseases, the majority of front-line treatment workers, the study found, are low-skilled and poorly trained, incapable of providing the bare minimum of medical care. These same workers also tend to be opposed to overhauling the system. As the study pointed out, they remain loyal to “intervention techniques that employ confrontation and coercion — techniques that contradict evidence-based practice.” Those with “a strong 12-step orientation” tended to hold research-supported approaches in low regard.

The Columbia University study did state a significant overhaul was needed in current treatment approaches; and it raised the question if the insufficient care received by addiction patients constituted “a form of medical malpractice.” It also pointed to the need for medical schools to “educate and train physicians to address risky substance use and addiction.” Unsurprisingly, it went on to say that all aspects of stabilization and treatment with addictions should be managed by a physician “as is the case with other medical diseases.” Remember that the Columbia study and Cherkis were both advocating for a physician-centered, medical model approach to addiction treatment.

However, I couldn’t find where it was supposed to have said the majority of front-line treatment workers were low-skilled and poorly trained. There was a section stating that physicians and other health professionals should be on the front line addressing addiction. Then it said: “Paraprofessionals and non-clinically trained and credentialed counselors can provide auxiliary services as part of a comprehensive treatment and disease management plan.”

It did not say the majority of front-line treatment workers were low-skilled and poorly trained “incapable of providing the bare minimum of medical care.” Yet in the case study examples found in “Dying To Be Free,” that is what Cherkis presented. The Columbia study did cite another study, which found that recovering support staff had little enthusiasm for evidence-based practices. “They also were more likely to support intervention techniques that employ confrontation and coercion–techniques that contradict evidence-based practices.” But these paraprofessionals only made up “24 percent of the treatment provider workforce.”

Cherkis seems to have mis-remembered what the Columbia study actually claimed in this matter. I wonder if, because of his commitment to a strictly medical model ideology for opiate treatment, he was reading into the study. His quote above supported the description of the treatment facilities he highlighted in his article, but wasn’t found by me in the article he cited on the Columbia study.

Another example of how his treatment ideology distorted his portrayal of Suboxone treatment was with how he described Hazelden’s Suboxone treatment program. “Dying To Be Free” mentioned that Hazelden, now the Hazelden Betty Ford Foundation, developed its own Suboxone treatment program for opioid addicts. But it failed to note this wasn’t accompanied by a rejection of “Twelve Step practices.” Within “The History of Hazelden,” on the Hazelden Betty Ford Foundation website, was the statement of how it “integrates the cornerstone Twelve Step practices of mutual support along with multidisciplinary clinical care, evidence-based therapies and the latest research in brain science.” Why weren’t there some case study examples from Hazelden in “Dying To Be Free”?

The facilities Cherkis highlighted in Kentucky were not representative of abstinent-based addiction treatment centers in the U.S.; ones that use the 12 Steps to structure their treatment program. In reading “Dying To Be Free” I see an underlying ideology of conceiving and treating addiction, specifically opiate addiction, through a strict biomedical lens. That is not the whole story of addiction. As a result, the rhetoric of the article constituted a straw man attack on abstinent-based treatment while it extolled MAT. This bias presents readers with an implied choice, a dichotomy, between Suboxone as an MAT for addiction and 12 Step, abstinent-based treatment. Ironically, Hazelden, an historically important treatment center that pioneered 12 Step, abstinence-based treatment, did not choose MAT over the 12 Step-based treatment, but combined the two. But you don’t get that information in “Dying To Be Free.”

Parts 2 and 3 of this article will look at how “Dying To Be Free” misrepresented the recovery philosophy of self-help groups like Alcoholics Anonymous; and skimmed over the problems with MAT, specifically Suboxone.

09/22/17

Be Careful Out There

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Recently, around 6 a.m. on a Wednesday, several law enforcement agencies executed federal search warrants at three locations in the West End area of Pittsburgh. In one home, when the SWAT team members entered, one of the suspects was trying to escape through a back window. Another one of the suspects knocked over a table where they had been bagging drugs, “causing the powder narcotics to become airborne” and exposing the SWAT officers to the airborne drug. Eighteen of them were taken to the hospital suffering from various symptoms.

According to Brenda Waters of KDKA, the CBS Pittsburgh affiliate, all eighteen were medically cleared. “None of the … law enforcement officers taking part in the early morning raid were adversely affected by the drugs.” The agencies participating in the raid included Pittsburgh Police, Pittsburgh SWAT, U.S. Immigration and Customs, state police and Homeland Security. In addition to the airborne substance, they found more than 1,000 stamp bags, 250 grams of unpackaged drugs and a “significant quantity of white powder” on a plate in the kitchen. The airborne substance was probably fentanyl; maybe carfentanil.

Dr. Tureurro, the chief of Emergency Services at UPMC Mercy Hospital, where the officers were treated, said they were fortunate to get out of the situation quickly, thus minimizing their symptoms. They had burning sensations in their throats; some became lightheaded; others were nauseous. “The big thing that we did for them is we basically decreased the chance that they could be exposed to anything that was laying on their bodies or on their clothes.” By removing their clothes, then showering and decontaminating themselves, the officers decreased their chances of exposure to any of the substance. The Justice Department press release said:

Fentanyl exposure is an all too real risk to law enforcement as we learned this morning. Quick and professional action by first responders helped avert a potential catastrophe.

The Pittsburgh Post-Gazette reported that the raid originated from a May investigation by Customs and Border Protection when agents intercepted a fentanyl package marked as “plastic fittings” that was shipped from Hong Kong. The accused leader of the drug operation had a history of repeated arrests for felony drug convictions and disregarding bond conditions in his repeated arrests for drug related charges. He had been initially arrested for possession and distribution on June 1st in relation to the intercepted package of fentanyl from Hong Kong. He was rearrested on July 20th, discarding a brick of fentanyl on the floor of a police car taking him to jail, and then again on August 2nd. Each time he was released on bond he resumed his criminal activities. This time he did not receive bail.

This is not an isolated or freak occurrence. In September of 2016, The Washington Post reported on a raid in Harford Connecticut when 11 SWAT officers were exposed to airborne fentanyl and heroin. The powder may have blown into the air after the tactical team tossed a flash-bang grenade, or the suspects could have swept the table where they were packaging the drugs. The officers moved through a “cloud of dust in the air.” Several officers were lightheaded, nauseous; they had sore throats and headaches. As a precaution, the entire team went to a local hospital for treatment.

Jim Pasco, executive director of the National Fraternal Order of Police, said this has been an inherent risk for law enforcement for decades, beginning with “The granddaddy of all problems—being exposed to meth labs.” A DEA spokesperson said law enforcement officers are concerned with protecting themselves and the public.

Law enforcement officers do carry a bigger burden than ever — we are fighting to protect the American public from poisons that bring death and destruction to our communities — but we are also faced with challenges of educating the public as to the deadly risks of these substances and about the inextricable links between misuse of prescription opioids to heroin and fentanyl use and addiction.

Kelly Burch reported for The Fix that in May of 2017 when an East Liverpool Ohio police officer helped in the arrest of drug suspects, they tore open bags of the drugs in an attempt to destroy evidence. Back at the station, the officer noticed a white powder on his uniform and tried to brush it away. “I had placed my thumb, and index finger in it and tried to brush it off. I don’t know if it went through my skin or if it became airborne when I wiped it off, or a combination of both.” Within a few minutes, he didn’t feel like himself. The last thing he remembered was falling backwards into the door.

He received a dose of Narcan at the station and a few more at the hospital. “Never in a million years did I think I would be in the hospital for something that serious, for overdosing.” He knew the job was dangerous and might encounter guns and knives. But “you’re not thinking that a particle of dust or drug killing you.” The experience made him even more determined to keep these powerful drugs off the streets: “I am not letting drug dealers win, you may have almost killed me, but you’re not going to win, you’re not going to come to this city and bring that poison.”

Another Ohio encounter with fentanyl took place in early August of 2017 in Massillion, about 50 miles south of Cleveland. Three nurses at the Affinity Medical Center in Massilon lost consciousness while they were cleaning a room where an overdose victim had been treated. All three were treated with naloxone and are said to have recovered. The nurses union at the hospital  wanted to meet with hospital officials to discuss protocols for environmental contamination, but the hospital declined, saying it already has effective policies. Hmmm … with three nurses becoming unconscious, it seems a review of the policies woudn’t hurt.

CTV Vancouver reported in October of 2016 that the CBSA, Canada’s Border Services Agency advised its officers to avoid contact with a package they suspect contains fentanyl. The president of Canada’s Customs and Immigration Union said: “What we’re telling our officers at this time, from a health and safety point of view, is that if there’s a package and they think there could fentanyl, they shouldn’t touch it. They shouldn’t approach it.” If an agent believes a package contains the drug, they are advised to give it to supervisors. “We need to approach this so our officers have the right tools, right training and the right equipment.”

In a June 2016 press release, the DEA announced they had released a short Roll Call Video to all law enforcement agencies about the dangers of improperly handling fentanyl. You can watch the video here. The press release said the DEA was concerned about law enforcement coming in contact with fentanyl on the streets in the course of enforcement activities, such as buy-walk or buy-bust operations. “Officers should be aware that while unadulterated fentanyl may resemble cocaine or heroin powder, it can be mixed with other substances which can alter its appearance.” The report noted the current outbreak involved not just fentanyl, but fentanyl compounds (like carfentanil) as well.

Universal precautions must be applied when conducting field-testing on drugs that are not suspected of containing fentanyl. Despite color and appearance, you can never be certain what you are testing. In general, field-testing of drugs should be conducted as appropriate, in a well ventilated area according to commercial test kit instructions and training received. Sampling of evidence should be performed very carefully to avoid spillage and release of powder into the air. At a minimum, gloves should be worn and the use of masks is recommended. After conducting the test, hands should be washed with copious amounts of soap and water. Never attempt to identify a substance by taste or odor.

The DEA published “A Briefing Guide for First Responders” on fentanyl. It contained a history of fentanyl, a description of illicit forms of fentanyl and fentanyl-related substances, the risks of exposure and treatment, as well as decontamination recommendations.

Fentanyl was first synthesized in 1959 by a Belgian chemist. Other forms of pharmaceutical fentanyl were developed for pain management, including a transdermal patch, a nasal spray, a sublingual tab and a flavored lollipop—yes a fentanyl lollipop. While pharmaceutical fentanyl is diverted on a small scale, the current problem is due to transnational criminal organizations competing for the U.S. market.

China and Mexico appear to be the main source countries for illicit fentanyl smuggled into the United States for domestic‐based processing and distribution. Seizures indicate that China supplies lower volumes of high‐purity fentanyl, whereas fentanyl seizures from Mexico are higher volume but lower in purity. Fentanyl is also routed and smuggled through Canada. China‐based trafficking organizations have also been known to use the internet to distribute fentanyl, fentanyl‐related substances, and synthetic opioids globally.

Among the current fentanyl-related substances on the illicit market are: 4‐fluoroisobutyryl fentanyl, furanyl‐fentanyl, acryl‐fentanyl, acetyl‐fentanyl, carfentanil, and 3‐methylfentanyl, and other synthetic opioids such as U‐47700. I’ve written previously on this website about the fentanyl-related substance, carfentanil (“The Devil in Ohio”). Recently I received an unsolicited email from a “company” in Shanghi offering to send me a free sample of carfentanil. The DEA “Briefing Guide for First Responders” warned that some organizations are distributing pure fentanyl.

During the first quarter of 2017 the DEA indentified 230 instances of fentanyl, fentanyl-related substances and other synthetic opioids in seized drug evidence. The following graphic illustrates the results of their analysis. Fentanyl accounted for about 58% of the identifications. Of those 134 fentanyl identifications, 61% of the samples were combined with heroin; 28% were fentanyl alone. Carfentanil was found in six identifications. U-47700, alprazolam (Xanax) and cocaine’s were found in others.

Because of their hazardous nature, fentanyl and fentanyl-related substances are a serious threat to the health and safety of law enforcement officers and other first responders, such as EMTs. As little as 2-3 milligrams of fentanyl could bring on respiratory depression and possibly death. “When visually compared 2 to 3 milligrams of fentanyl is about the same as five to seven individual grains of table salt.” See the above photo of a penny.

The “Briefing Guide for First Responders” went on to describe treatment for any exposure to fentanyl, repeating some of the actions taken in the above situations:

  • seek immediate medical attention.
  • remove the person from the contaminated environment, preferably where there is fresh air.
  • If a suspected fentanyl-related substance has been inhaled, move the person to fresh air.
  • If there are overdose symptoms, immediately administer naloxone, which can quickly reverse an opioid overdose.
  • Multiple doses may be necessary, depending upon the drug’s purity and potency. Continue to administer a dose of naloxone every 2-3 minutes until the individual is breathing on their own for at least 15 minutes or until EMS arrives.
  • Someone who entered a badly contaminated area or was otherwise exposed to a suspected fentanyl-related laboratory or milling operation without wearing the proper protective clothing should undress and shower with soap and water as soon as possible.
  • If a suspected fentanyl-related substance was ingested through the mouth or eyes and the person is conscious, rinse their eyes and mouth with cool water.
  • When there has been any skin contact, wash the exposed area immediately with soap and water.
  • Do NOT use hand sanitizer, as it may contain alcohol, which is a skin penetrant. This may increase the absorption of fentanyl through the skin.

So if you are a first responder or law enforcement officer—or if for some reason you find yourself exposed to fentanyl—remember the above advice. And first responders and law enforcement officers, remember the safety call given by Michael Conrad, who played the role of Sergeant Phil Esterhaus in Hill Street Blues: “Let’s be careful out there.”

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.

08/29/17

Zombie Drug

© Andrey Kiselev | 123rf.com

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.

08/18/17

Public Health Time Bomb

© Lightsource | stockfresh.com

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.

08/8/17

Kratom: Part of the Problem or a Solution?

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In August of 2016 the DEA announced that it would temporarily classify kratom as a Schedule I substance. The public outcry against this plan influenced the DEA to reverse itself and delay scheduling kratom in October of 2016. The DEA announcement said before taking further action, it would solicit public comments and review the FDA’s “scientific and medical evaluation” of the proposed scheduling of kratom. Once the DEA has received and considered the information, it would decide how to proceed. But while we await the DEA’s decision, kratom is being sold in vending machines.

Advocates for kratom were overjoyed with the DEA’s decision. Chris Ingraham reported for The Washington Post that researchers welcomed the decision to delay scheduling kratom, but were concerned that the future of their research was still up in the air. After its October 2016 announcement, the DEA set a period for public comments on the potential scheduling of kratom until December 1st of 2016. As of August 6th, 2017, there has not been a public announcement about its decision or its review of the FDA report on kratom.

Since the DEA delayed a decision on kratom, it is still unregulated and will remain available for anyone to use without a prescription. And research into the risks and benefits of kratom can continue unhindered by a temporary Schedule I classification.

Andrew Kruegel of Columbia University is working to develop new painkillers from compounds contained in kratom. He commented: “I am encouraged that they will now be having more serious input on this important policy decision.” While the DEA announcement might be good news for now, studies with the methodology of rigorous, controlled trials typical of FDA evaluations don’t exist for kratom. So will the DEA wait for the months or years it could take to complete rigorous kratom studies before deciding whether or not to schedule it?

According to the American Kratom Association (here) and PinneyAssociates (here), Jack Henningfield did an “8-factor analysis” with kratom, which is the legal framework used by the FDA to assess the abuse potential of substances. Henningfield concluded that kratom had a low toxicity level; and that scheduling it as a controlled substance was not warranted.

It’s important to understand that although kratom has some mild effects similar to opioids, its chemical make-up is different, and it appears overall much safer, with apparently relatively small effects on respiration. In fact, kratom’s analgesic effects and impact on energy, combined with its favorable safety profile supports continued access by consumers to appropriately regulated kratom products while research on its uses continues.

STAT News identified another person doing research with kratom, Edward Boyer, who is currently at UMass Memorial Medical Center and Boston Children’s Hospital. Boyer has been interested in kratom since 2006. Even then there was a Catch-22 of sorts when trying to get government funding for kratom. “The National Institute on Drug Abuse didn’t want to fund kratom projects, saying it was a complementary and alternative medicine, while the National Center for Complementary and Integrative Medicine didn’t want to fund them because it was a drug of abuse.”

In 2008, Boyer and two colleagues filed a patent to use kratom or its chemical compounds as a new treatment method for opioid withdrawal, one of the ways it is currently used informally and non-medically. Two large freezer bags of kratom he obtained still sit in a cabinet of the UMass Memorial Medical Center’s toxicology office. Boyer said the bureaucratic nightmare of running the FDA gauntlet to do a clinical trial stopped them cold.

Andrew Kruegel’s research has had some promising initial results. His team was able to demonstrate that the main components of kratom primarily stimulated the painkilling response, while having minimal effects on the proteins that caused other side effects. But these findings need to be repeated in mice and then humans, “before they could claim that they have used kratom to create an opioid-like painkiller without as many risky side effects.” But there is a problem obtaining kratom of the quality needed for his research and the red tape involved in the process of obtaining it. “There is nowhere to buy the plant unless I am going to go to Indonesia and contact plantation owners.”

In the mean time, you can order kratom on the Internet from several vendors. And if you live near the East Coast Super Subs shop in Tucson Arizona, you can buy it out of a vending machine. Eric Boodman reported for STAT News that the vending machine there attracted five customers in an hour. The servers at the sub shop said it gets even busier around opening and closing time. Using cash or a credit card, a customer can buy as little as 10 grams for $5, or up to 120 grams for $50.

The almost-scheduling of kratom seems to have been good advertising for the herbal product. Drew Pickett, the owner of a second kratom vending machine company, Arizona Kratom, said many people discovered kratom because of the bad publicity. “People were like, ‘Wow, if the government doesn’t want me to have it, I want to try it.’” He estimated the aborted ban triggered a 400% boost in his sales.

One person said kratom helped him stop using heroin six years ago. Last year he relapsed, and was back using heroin for several months before he used kratom to wean himself off heroin for the second time. He found the Tucson Kratom vending machine when the kratom he used to get from head shops became too pricey. Now he wants to wean off of kratom as well. “I start with a lot of it initially … and then I taper down. I’ve been doing it very gradually and probably in the next two or three months, I’ll be done with it.”

But things aren’t all sunshine and happiness with the kratom vending machine. Dr. Mazda Shirazi, the medical director of the Arizona Poison and Drug information Center first heard about the machine when a patient of his began to show signs of liver toxicity from using kratom from the machine on a daily basis. He’s worried about the lack of regulation with kratom, meaning you can’t be sure of the purity of what you are buying.  He’s also concerned that using kratom to wean off of opioids will give some addicts false hope. “I think it actually prolongs the addiction cycle and puts the patient in a dangerous situation, whereas by getting help they might be better off.”

Susan Ash, the founder of the American Kratom Association, saw the vending machine as a sign of how pervasive the opioid epidemic has become. “Maybe a person who is going to walk into that sandwich store and has never heard of kratom — maybe that will be their first day off of opiates.” She liked the idea of people not having to wait a day or longer for their kratom to arrive in the mail. But she worried the vending machine made kratom available to children under 18. “There’s not enough research to know how the substance affects developing brains.”

And there’s the rub: there simply isn’t enough reliable, replicated research with kratom to make an informed decision on how to use it or whether to schedule kratom. Henningfield’s study is suggestive of a good safety profile for kratom, but can’t be regarded as conclusive since it was funded by the American Kratom Association. In contrast to Henningfield’s safety assessment of kratom, others have said there is a real probability of becoming addicted with kratom.

The National Institute on Drug Abuse (NIDA) noted how two compounds in kratom, mitragynine and 7-hydroxymitragynine, interact with opioid receptors in the brain, and produce the same effects of sedation, pleasure and decreased pain as opioids. There are symptoms of withdrawal when an individual stops using kratom and some users have reported becoming addicted to kratom. Adverse health effects from kratom use include: sensitivity to sunburn, nausea, sweating, loss of appetite, and sometimes psychotic symptoms. Chronic use of kratom has been linked with liver problems, as noted above. Kratom by itself hasn’t been linked with deaths, but if mixed with other substances, it has been part of a fatal drug cocktail. See “Krypton Can Kill You” and  “The Secret of Kratom” for more on this.

While it isn’t a federally controlled substance at this time, six U.S. states and three cities have listed kratom as a Schedule I substance. Globally, several countries have either regulated or banned kratom. In Europe, kratom is a controlled substance in Denmark, Latvia, Lithuania, Poland, Romania, Sweden and the UK. It is a controlled narcotic in Australia and New Zealand. Possession of kratom is illegal in Thailand and its use is prohibited in Malaysia. Canada has made it illegal to market it for human consumption.

What is clear is the need for reliable, replicated research with kratom. Edward Boyer said: “Is it an effective treatment for opioid withdrawal, or is it another pathway to addiction? I don’t think anybody has a defined concept of where it actually lies on that continuum.” Nevertheless, it seems there is growing anecdotal evidence of some level of dependence or addiction with kratom. If the DEA delays its decision to regulate kratom much longer, it might become part of the problem instead of a solution to the opioid epidemic.

07/28/17

The Open Secret of K2 in Prisons

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Early Wednesday morning on April 19, 2017, Aaron Hernandez was found dead in his prison cell. He hung himself by wrapping a bed sheet around his neck and tying it to a bar on the window of his cell. The former tight end for the New England Patriots was found guilty of first-degree murder in 2015 and was sentenced to serve life in prison without the possibility of parole. Investigators suggested Hernandez killed Odin Lloyd because he didn’t want information about his bisexuality to become public knowledge. He had slicked the floor of his cell with liquid soap, probably in case he lost his nerve in the midst of his suicide attempt.

While the eternal spiritual state of his soul can’t be known with any certainty, what is known for sure is there was K2, a form of synthetic marijuana, in him when he died. Writing for Newsweek, Michelle McPhee reported Hernandez had a Bible open to John 3:16 in his cell and had scrawled the verse in red ink on his forehead. He also made red ink marks on his hands and feet, mimicking the stigmata of the crucifixion of Christ. He wrote three notes—one to his fiancée, the mother of his daughter, one to his daughter and one to a man identified as his prison boyfriend.

In a second article, McPhee said verifying the presence of K2 in Hernandez’s system led to a State Police raid at the Souza Baronwski Correctional Center (SBCC), the prison facility where Hernandez died. Department of Correction sources confirmed a wide-scale investigation was underway at the prison, as well as a warehouse used to store dry goods before they went into the prison. But this is not just freak occurrence within a single Massachusetts state prison. Aaron Hernandez’s tragic death spotlighted a serious problem with synthetic marijuana in prisons.

Writing for The Fix on April 19th, Seth Ferranti described how the U.S. Bureau of Prisons (BOP) has a synthetic marijuana problem. The problem is twofold. First, the BOP doesn’t regularly test for synthetic marijuana. Prisoners are tested for illicit drugs such as heroin and marijuana, but the standard urines tests don’t screen for the metabolites from synthetic marijuana. However, there is technology available to test for synthetic marijuana. Google “synthetic marijuana urine tests.” You can even order the kits through Amazon.

Second, if an inmate is caught with synthetic marijuana, it is a relatively minor offense—a 300 series incident report—equivalent to illicit tobacco possession. Possession of illicit drugs like heroin or marijuana or a positive urine test for those substances is a series 100 offense, the most serious incident report. A series 100 offense could result in 60 days in Disciplinary Segregation (the hole), or the loss of good time, commissary, or visiting and phone privileges for up to one year. The punishment for synthetic marijuana is essentially a slap on the wrist. “By switching their illicit smuggling ventures to K2 or Spice they’re lessening the consequences that they’ll face when caught.”

The Federal Correction Institution (FCI) in Forrest City Arkansas was given as an example. A prisoner said after the 9:30 pm count, the bathrooms and shower stalls fill up with prisoners smoking some version of K2 or Spice. It can be hard to find an open shower stall to take a shower. On the recreation yard at dusk, clouds of smoke appear over the bleachers from all the people smoking K2. “With endless amounts of time and little fear of consequences, inmates are smoking nonstop.”

The effects of synthetic marijuana on an individual can vary widely.  One man began to dance around like a ballerina. As guards tried to subdue him, he resisted yelling that it was their fault. “You let it in, you bring it in. It’s all a conspiracy to get everyone to tell on each other.” Another person started hugging his bunk, while “screaming like a banshee.” When other prisoners tried to quiet him, it only became worse.

I talked to one dude and he said he hit it and he started rapping. He told me he never rapped in his life, but that was all he could do to not lose his mind. Then another dude smoked some and crawled under the bunk. When we got locked down this guy went totally … crazy. He kicked a C/O and went absolutely insane, screaming and running, all kinds of crazy shit. Another guy thought he was God and that the end of the world was coming, slobbering and acting like a five year old. It’s all bad man.

Smuggling K2 into prisons is done by a variety of methods, but visitation is the primary method. Guards will smuggle K2 in, seeing it as a lesser evil and as a way to make some easy money. The main way it came into Forrest City was over the fences, which are low. “Campers or free world people throw packages over the recreation yard fence.” At FCI Beckley in West Virginia the regulr smuggling gauntlet is through the mailroom. K2 begins as a liquid that can be sprayed on any kind of paper product, like letters. Inmates then smoke or ingest pieces of the soaked paper, or sell it to other inmates. Chris said: “It’s becoming an issue at every institution. It’s crazy here.”

While U.S. media coverage of this problem was scarce before Hernandez’s death, it has been regularly noted as a concern in U.K. prisons for several years. In October of 2015, BBC News reported how investigators concluded the use of Spice in an Oxfordshire prison contributed to an increase in violence. A November 2106 article in The Daily Mail described a documentary, the “Secret Life of Prisons,” that said drugs (particularly Spice) are widely available. The drugs are smuggled in with drones, hidden in trainers, and even on children’s drawings.

A Vice article on January 29, 2016, reported how prison officers said they are getting involuntary hallucinations after entering cells where inmates had recently smoked Spice (it’s odorless). Another BBC News article reported officers at HMP Holme House complained of feeling dizzy after entering cells where inmates had smoked Spice. One officer they believe was exposed had a fierce burning sensation in his head, “which felt like his head was covered with nits, and [he] spent the night tearing at the top of his head.” One former inmate said he’s seen men go berserk, turning on their best friends. “I’ve also seen it where lads have dropped down dead, had heart attacks, gone into comas, gone loopy and ended up being sectioned because of it.”

An April 19, 2017 article on Devon Live described the problem with synthetic marijuana at another British prison, HMP Dartmoor. Here, like the U.S. prison in Forest City Arkansas, the drugs mostly come into the prison is as “throwovers” tossed over the prison wall. An ex-offenders’ organization called User Voice surveyed nine jails on their use of Spice. One third reported using Spice in the previous month. User Voice said the use and popularity of Spice contributed to an increase of violence, bullying, mental and physical ill health concerns, and even death within British prisons.

Writing for the Pittsburgh Post-Gazette, Rich Lord described the K2 problem at the Pennsylvania State Correctional Institution – Huntingdon. Inmates have written to the Post-Gazette, saying they don’t like seeing their neighbor passed out from the drugs they buy in the prison yard. A member of the security team at the prison said these guys who use K2 are often zombie-like: “They’re just groaning, moaning and not able to understand anything that’s being said to them.” SCI Huntingdon first noticed K2 about eighteen months ago.

When an inmate’s belongings test positive for K2, he typically gets 90 days in restricted housing, meaning he spends 23 hours a day locked in a Spartan cell. The restricted housing unit at Huntingdon is largely filled with prisoners whose belongings tested positive for K2. Some inmates claim they were wrongly identified as having K2. One prisoner wrote how he received a misconduct report accusing him of having K2 in a bottle he said held only shampoo. The misconduct could stymie his bid for boot camp and early parole. He said: “I’ve made mistakes, but I don’t deserve this.”

There is regular reporting on the growing presence of K2, Spice and other new psychoactive substances in the U.S. So the apparent silence on the extensive the use of synthetic marijuana use in U.S. prisons is curious to me. It was encouraging to see the coverage given to it by the Pittsburgh Post-Gazette. But it seems the methods used to uncover K2 use need to be more accurate, as the negative consequences to inmates for false positives are so serious. The ready availability of these substances in prisons seems to be an open secret—we know they are in there, but just don’t want to think about it.

See other articles on new psychoactive substances (NPS) on this website such as: “Not Meant for Human Consumption.”

07/18/17

Opana Cold Turkey

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On June 8, 2017, the FDA did something it had never done before. It formally requested that a pharmaceutical company voluntary remove its opioid pain medication from the market. The company was Endo Pharmaceuticals and the opioid was Opana ER. “Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval.” Way to go FDA.

The FDA decision was based on a review of post marketing data, which showed a drastic shift in the route of Opana ER abuse after the drug was reformulated in 2012. This review demonstrated that instead of crushing and snorting Opanas, individuals abusing the drug were now dissolving and injecting it. The FDA’s decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that “the benefits of reformulated Opana ER no longer outweigh its risks.” The newly appointed FDA Commissioner, Scott Gottlieb said:

We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse. . . . We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.

The NPR program, All Things Considered, interviewed Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research about the decision on June 9th. She said the decision was made due to the risks of abusing the product. An outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy), were associated with individuals injecting the reformulated Opana ER. The request to remove Opana ER from the market is not an outright ban. When asked what the response from Endo Pharmaceutials has been, Dr. Woodcock said the company is evaluating the request.

Well, FDA does not have the authority for drugs to immediately remove them from the market. Generally we ask companies to voluntarily pull their drug off the market. If they are not willing to do that, we will issue a notice of a hearing, and we have to go through a judicial type of process.

Another NPR report on April 1, of 2016 said that the reformulation in 2012 effectively stopped people from snorting Opana, which had been the preferred method of abuse. “But the change also led a significant number of people to abuse the drug by injection.” Endo said the company’s decision to reformulate Opana was “a well-intentioned attempt to prevent abuse.” But there seems to have been an additional motivation for the action. According to NPR, “interviews with experts, court filings, documents from the FDA, as well as Endo’s own statements, suggest the company’s decision to reformulate Opana was also motivated in large part by financial interests.”

Soon after its release in 2006, there were reports of abuse and overdose deaths with Opana from around the country. But the painkiller was a major moneymaker for the company. It accounted for 14% of Endo’s total revenue; $384 million in net sales in 2011. In late 2011 the FDA approved Endo’s reformulated version of Opana and Endo began replacing the old version of Opana in pharmacies. That August, Endo filed a petition with the FDA (available in the NPR article), arguing that it removed the crushable version of Opana because it was a safety hazard. It also asked that the FDA refuse or withdraw the approval of generic versions of Opana because they were not crush-resistant.

In 2012 Endo filed a lawsuit to compel the FDA to speed up its review of their petition, predicting a spike of misuse and abuse if generic, crush-resistant versions of Opana went to market. It also estimated that if a generic version went to market, “annualized net sales will decrease by an amount up to $135 million.”

This was nothing new. In 2010 Purdue Pharmaceuticals reformulated OxyContin to make it crush resistant. And the FDA determined the reformulated version was much safer and that the benefits of the original no longer outweighed the risks. The agency blocked generic versions of OxyContin, which made Purdue billions. Dr. Anna Lembke, an assistant professor of psychiatry at Stanford University Medical Center said: “We see this again and again in the pharmaceutical industry. . . . They come up with some new fancy formulation of basically the same old drug … and then that way they have a new drug that they can charge a lot of money for.”

But on May 10, 2013, the FDA decided Endo’s tamper-resistant formula didn’t actually prevent drug abuse better than earlier versions of Opana without the abuse-deterrent feature. That day the price of Endo shares dropped more than 5 percent. The FDA said the reformulated version could be compromised when it was subjected to “cutting, grinding and chewing.” It could be “readily prepared for injection.” The agency also warned the preliminary data suggested the possibility “that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.”

The FDA said Endo could not refer to Opana ER as “abuse deterrent.” Writing for FiercePharma, Emily Wasserman quoted Douglas Throckmorton, a deputy director for the FDA’s Center for Drug Evaluation and Research, as saying: “We think the public health would not be served if a company can market itself as ‘abuse deterrent,’ if the scientific evidence did not support that claim.” The problems with Opana seemed to put the FDA on alert that abuse-deterrent technology may not be all that effective. An FDA spokesperson, Sarah Peddicord said: “The FDA is very concerned about potential unintended consequences of abuse-deterrent opioids (and purportedly abuse-deterrent opioids) and it is something we are actively looking at.”

FDA is requiring all sponsors of opioids with approved abuse-deterrent labeling to conduct long-term epidemiological studies to assess their effectiveness in reducing abuse in the real world. . . . Abuse-deterrent does not mean abuse-proof.

So while the June 8th request by the FDA may be unprecedented, it seems to have been coming for a few years. Then a week after the FDA request, Scott Gottlieb ordered a review of all opioid pain relievers with abuse-deterrent formulas to see if they actually help prevent abuse and addiction. In a statement released on June 13th, Gottlieb said there would be a public meeting to discuss whether they have the right information to determine if the abuse-deterrent products “are having their intended impact on limiting abuse and helping to curb the epidemic.”

The FDA, he said, recognizes there is a gap in their understanding of whether these products have a real-world, meaningful effect on opioid misuse and abuse. At the July 10-11 meeting, the FDA will engage external thought leaders to discuss how to better “evaluate the impact of these products in the real world.” There is a link in the statement to an issues paper that outlines some of the existing regulatory and public health challenges they face.

Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction. Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations; and I look forward to a productive discussion on how to best tackle this challenge.

Sidney Wolfe, the founder of and senior advisor to Public Citizen’s Health Research Group supported the FDA request for Endo to remove Opana ER from the market. He also said the FDA had enough information before its approval in late 2011 to “reject the drug as possibly more dangerous than its older … version.” He was a member of the FDA’s Drug Safety and Risk Management Advisory Committee at the time, but for some reason, the approval decision was not presented to the Committee. Had the Committee advised rejecting the drug, and the FDA followed the Committee’s advice in 2011, the adverse effects leading the current request could have been avoided.

In addition to FDA’s serious mistake in approving the OPR version, Endo’s defiant response yesterday that they would not necessarily take this more dangerous form of the drug off the market is reckless. In proportion to how many people will use and, in many cases abuse the drug, causing deaths, hospitalizations and other preventable between yesterday’s FDA decision and the ultimate, but certain forced removal of the drug, Endo will be exposed to many product liability lawsuits from those damaged or their surviving families.

Endo suffered some significant financial withdrawal symptoms after the FDA request. The company’s shares were down more than 12% afterwards, according to Fortune. A financial analyst for RBS Capital Markets referred to Opana ER as a “declining asset” with sales expected to fall to $97 million in 2019 from an estimated $134 million in 2017. But Endo seems to have counted the potential future cost if it challenged the FDA recommendation and fought to keep Opana ER on the market. On July 6, 2017, Endo International announced it would voluntarily withdraw Opana ER from the market.

Ed Silverman reported for STAT News that Endo executives “blinked” by saying they were reconsidering their initial statement that they would review the FDA request and evaluate “the full range of potential options.” Silverman noted Opana ER hadn’t been a huge seller for Endo. And it seems the FDA request would impact sales even further. It only generated around $159 million in revenue in 2016. Through the first quarter of 2017, sales were $35.7 million, down from almost $44.7 million in the first quarter of 2016. Given the adverse impact on public health, and the potential for future product liability lawsuits, Endo did the right thing in deciding to go “cold turkey” with Opana.