07/18/17

Opana Cold Turkey

© brm 1949 | stockfresh.com

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.

07/7/17

More Equal Therapies than Others, Part 2

© Allan Swart | 123rf.com

In his introduction to ”The Doctor’s Opinion” in the A.A. Big Book, Bill W. said A.A. favored initial hospitalization for the alcoholic who was “jittery or befogged.” It was imperative that the person’s brain was cleared so he then had a better chance “of understanding and accepting what we had to offer.” The reason to include Dr. Silkworth’s endorsement in Alcoholics Anonymous was to document a “medical estimate” of the A.A .12-Step plan of recovery.  “Convincing testimony must surely come from medical men who have had experience with the sufferings of our members and have witnessed our return to health.” But that was almost eighty years ago; and there have been some radical changes in the receptiveness of 12-Step recovery.

In modern addiction treatment there are a growing number of voices saying A.A.’s 12-Step approach should either be taken out of the treatment game or sidelined as a “recovery support service” (RSS) instead of being an integral part of the addiction treatment process. However, it would restrict or bench a valuable asset to addiction recovery. The rationales given for this generally follows two lines of argument.

One way is to portray A.A. and other 12-Step groups as religious or cultish in nature. This distortion stems from the secularization of American culture since the late 1930s when A.A. began, as well the failure to make a distinction between spiritual and religious consistent with 12-Step philosophy. See “Spiritual not Religious Experience” for a discussion of this distinction and a response to the accusation that the spiritual nature of A.A. disqualifies it from being used within addiction treatment. The second route is to suggest the 12-Step approach does not fit with the modern medical model of addiction treatment.

In the first ten years of A.A.’s existence the fellowship became convinced that organizationally it had to permanently remain nonprofessional. This was eventually formalized in Tradition Eight. Concurrent with that realization, was the origin of what would be called the Minnesota Model of addiction treatment. The Hazelden Foundation (now the Hazelden Betty Ford Foundation) blended professional and trained nonprofessional staff within a treatment approach based on the 12-Step philosophy of A.A. Throughout the 1950s, Hazelden honed it treatment model on three working principles.

First, alcoholism was seen as a primary condition and not just a symptom of an underlying disorder. Second, alcoholism was a disease and should be treated as such. The American Medical Association (AMA) officially identified alcoholism as a disease in 1956. Third, following the A.A. idea of the alcoholic suffering physically, mentally and spiritually, alcoholism was said to be a multiphasic illness. “Therefore treatment for alcoholism will be more effective when it takes all three aspects into account.” Abstinence was an integral goal of treatment.

These principles set the stage for a model that expanded greatly during the 1960s—one that has been emulated worldwide and has merged the talents of people in many disciplines: addiction counselors, physicians, psychologists, social workers, clergy, and other therapists. These people found themselves working on teams, often for the first time. And what united them was the notion of treating the whole person—body, mind and spirit.

Cracks began to appear in the dominance of the Minnesota Model of addiction treatment even as its hegemony grew in the 1960s. Methadone maintenance as a treatment for heroin addiction arose in the early 1960s. In the 1980s, the biological model of psychiatry began its ascendency and in 1991 the AMA took the further step of endorsing a dual classification of alcoholism as both a psychiatric and a medical disease. In 1992 SMART Recovery began. “SMART Recovery is based on scientific knowledge, and is intended to evolve as scientific knowledge evolve.” In 1994 Moderation Management became a self-help group for individuals who wanted to moderate, not abstain from alcohol.

Addiction professionals developed diverse alternatives to addiction treatment centered on 12-step philosophy. Stanton Peele developed Life Process Program as an alternative to 12-Step treatment, which he now offers as an online program. Marc Lewis wrote The Biology of Desire, refuting the medical view of addiction as a brain disease. He conceived it as an extreme form of learning.

Lance Dodes wrote The Sober Truth, purportedly debunking the bad science behind 12-Step programs and the Rehab industry. It claimed to be an expose of Alcoholics Anonymous, Twelve Step programs and the rehab industry—how “a failed addiction-treatment model” came to dominate America.

David Sinclair developed the Sinclair Method, which conceived of alcoholism as a learned behavior, one that can be removed by the behavior modification principle of extinction. “The solution discovered by Sinclair effectively means you have to drink yourself sober!” And there are others. But the medical model, although it has been modified, remains supreme in addiction treatment.

In the 1990s, a movement began in medicine to develop evidence-based practices (EBP). A widely accepted definition of EBP by Dr. David Sackett is that EBP is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”  When applied to addiction treatment, the principle is generally referred to as evidence-based treatment (EBT). The National Institute on Drug Abuse (NIDA) simply referred to EBTs as treatment approaches “that have an evidence base supporting their use.” The website GoodTherapy.org elaborated, saying that EBT was “treatment that is backed by scientific evidence.” This referred to extensive research, which has been documented and demonstrated to be effective on a particular treatment.

Consistent with this understanding, NIDA listed a manualized Twelve Step based treatment model called Twelve Step Facilitation (TSF) as an evidence-based behavioral therapy. TSF actively seeks to engage substance abusers in becoming involved in 12-Step groups, “thereby promoting abstinence.” However, a writer and researcher for Handshake Media, Laurel Sindewald, concluded in her article, “AA Is not Evidence-Based Treatment,” that NIDA wrongly listed TSF as evidence-based.

In Part 1 of this article, “More Equal Therapies than Others,” is a description of TSF and a discussion of how Sindewald’s critique wrongly and inconsistently grouped A.A. and other 12-Step groups with treatment approaches like the Minnesota Model and TSF that use 12-Step philosophy. Her provocative title is the result of mistakenly grouping A.A. and treatment approaches based on 12-Step philosophy together; and then illegitimately transferring her critique of these 12-step treatment approaches to A.A. A.A. sees itself as a fellowship and not a treatment. Here we will briefly look at how Sindewald’s narrowing of the NIDA sense of “evidence-based treatment” allowed her to conclude TSF was not evidence-based.

As was described in Part 1, Sindewald gave a biased description of 12-Step philosophy, stating it viewed addiction as merely “a spiritual disease born of defects of character.” Twelve Step groups supposedly said they were the only cure, “involving faith in a higher power, prayer, confession, and admission of powerlessness.” Contrasted with the NIDA definition of addiction as a disease of the brain, she asked how TSF as a professional medical treatment could be based on an understanding of addiction as a spiritual disease. Note the rhetorical sleight-of-hand in how she conveniently left out the A.A. and 12-Step understanding of addiction as a physical, mental and spiritual illness/disease.

Another place Sindewald used the same tactic was where she defined evidence-based. “In this article, I define ‘evidence-based’ to mean any treatment supported by numerous scientific experiments with rigorous methods that include control groups, randomization of patients to treatments, and bias-free samples. Note how her sense of “evidence-based” is more restrictive than NIDA, GoodTherapy.org and even Sackett’s widely acknowledged sense of evidence-based practice for medicine.  Her criteria seem to be even more restrictive than the American Psychological Association’s criteria for well-established “empirically validated treatment” in the “APA Task Force on Promotion and Dissemination of Psychological Procedures” Refer to Table 1 for the criteria.

Gianluca Castelnuovo wrote an article for Frontiers in Psychology on “Empirically Supported Treatments in Psychotherapy.” Consistent with the broader NIDA sense of evidence-based, he said the term evidence does not have one single definition. “evidence-based practice (EBP) includes many forms of evidence other than data from RTCs [randomized control trials].” There are two contradictory visions of what causes change in psychotherapy. One approach emphasizes the primacy of therapist and technique. The second vision focuses of the patient-therapist relationship and what the client brings to the therapeutic relationship.

The first vision sees the specific methods used by the psychotherapist as accounting for, by far, most of the changes in therapy. “Other factors (e.g., therapist relational qualities, patient–therapist relationship) are secondary, at best. This viewpoint is seen most notably in what have been termed the EST and EBP movements.” This approach conducts tightly controlled outcome studies, where specific treatments are pitted against one another or a control group and applied to specific disorders, usually as defined in the DSM. This describes the Project MATCH study, for which TSF was developed. This first sense proceeds from a medical model of “diagnosis plus prescriptive treatment equals symptom amelioration.”

The second view of psychotherapeutic change attributes most positive therapeutic outcomes to client factors (40%) and the therapeutic relationship between client and therapist (30%). The technique used and the skill of the therapist accounts for the remaining 30% of positive therapeutic outcomes. This so-called “common factors approach” then discourages attempts to pit one therapy against another or against a placebo group of no treatment (clients placed on a waiting list) as ultimately doomed to failure, since all therapies have the same potential for positive outcomes (the dodo bird effect).

When discussing the significance of common factors in “The Legacy of Saul Rosenzweig: The Profundity of the Dodo Bird,” Barry Duncan noted how experienced therapists know psychotherapy requires the unique tailoring of a therapeutic approach to a particular client and circumstance. And if a therapist attempts to do therapy by the book, it often doesn’t go very well. There are limitations to manualized therapies, even TSF.

The structure minimizes the factors brought to therapy by the client. It restricts or eliminates the therapeutic relationship between client and therapist. And it emphasizes the factors (therapist and technique), which typically have the least positive outcome effects. If you want to determine whether a therapeutic approach is “evidence-based” or “more equal” than other therapies when treating a designated DSM disorder, you will likely use a structured, manual-based treatment.

For more information of the therapeutic power of common factors and the dodo bird effect, see the above-linked article by Barry Duncan. Also read the Wampold et al. article, “A Meta-analysis of Outcome Studies Comparing Bona Fide Psychotherapies: Empirically, ‘All Must Have Prizes’”; or “The Dodo Bird Effect” and “Another Brick in the Wall” on this website. If you are interested in exploring “the science behind 12 Step recovery,” try If You Work It, It Works! by Joseph Nowinski.

06/27/17

More Equal Therapies than Others, Part 1

© Allan Swart | 123rf.com

In the classic novella, Animal Farm, by George Orwell, the animals of Manor Farm revolted and drove the drunken and irresponsible farmer Mr. Jones from the farm. They renamed it “Animal Farm” and adopted the Seven Commandments of Animalism, the most important of which was the seventh: “All animals are equal.” Eventually the pigs cemented their role as the leaders of Animal Farm, and this commandment was modified to say: “All animals are equal, but some animals are more equal than others.”  Barry Duncan adroitly applied this example of double-speak in his discussion of those who apply the medical model of “diagnosis plus prescriptive treatment equals symptom amelioration” to declare that some psychotherapies were more equal than others.

Two other articles, “The Dodo Bird Effect” and “Another Brick in the Wall” explored Duncan’s argument for the power of common factors in psychotherapy and the dodo bird effect, an alternate way of understanding the process of therapeutic change from the dominant medical model of therapeutic change described above. He developed this position in: “The Legacy of Saul Rosenzweig: The Profundity of the Dodo Bird” and a book he coauthored: The Heart & Soul of Change.” Here I want to explore how the Orwellian sense that some therapies are more or less equal than others runs wild in addiction treatment.

The National Institute on Drug Abuse (NIDA) defined addiction as “a chronic, relapsing brain disease” because drugs changed the brain—its structure and how it worked. Here is a short YouTube video of the Director of NIDA, Nora Volkow, discussing this view of addiction. This definition was purely a physiological, biomedical understanding of addiction. Philosophically, it also seems Volkow assumed there is no mind; that human traits like “free will” were products of the biology of the brain. Note where she said “free will” was a product of the biology of the brain.

As in medical practice, addiction treatments are quantified according to an evidence-base of effectiveness. Here, the buzzword is “evidence-based treatment.” NIDA has a listing of  “Evidence-Based Approaches to Drug Addiction Treatment,” which it categorized as “Pharmacotherapies” and “Behavioral Therapies.” The NIDA introduction said the section “presents examples of treatment approaches and components that have an evidence base supporting their use.” One of the behavioral therapies NIDA listed as “effective in addressing substance abuse,” was “12-Step Facilitation Therapy” (TSF).

This 12-Step-based treatment approach was developed by Joseph Nowinski, a clinical psychologist as part of the Project MATCH study into the effectiveness of three different perspectives on how to treat alcohol use disorders (then described as alcohol abuse and alcohol dependence in the DSM, the psychiatric Diagnostic and Statistical Manual). In his book, If You Work It, It Works!, Nowinski said many academic researchers were highly skeptical that TSF would work at all, as A.A. and the Twelve Step approach was poorly understood. “Many academic researchers inclined to think of it more as a cult or quasi-religion than a serious programmatic approach to recovery from addiction.”

The two other interventions, Cognitive Behavioral Therapy (CBT) and Motivational Enhancement Therapy (MET) had been extensively studied. But Twelve-Step interventions had not been the subject of significant, rigorous research. So Nowinski developed TSF, a psychosocial treatment manual based on engaging the individual in 12 Step support groups such as Alcoholics Anonymous (A.A.).

In 1997 published results from the MATCH Research Group showed that all three interventions (CBT, MET and TSF) were effective in reducing drinking and increasing abstinence after treatment. One year after completing treatment those who were in the outpatient section of MATCH were sober over 80% of the time. And TSF was found to be equally effective for individuals who had been diagnosed as an alcohol abuser rather than as alcohol dependent.

These findings were so unexpected that some long-standing critics of AA and its Twelve Step program went so far as to question whether the MATCH data were somehow falsified. Of course, nothing could be further from the truth. The reality, rather, was what some skeptics could not abide: the idea that the Twelve Step approach works.

Nowinski said his goal in writing If You Work It, It Works was to make information on the effectiveness of Twelve Step recovery, now documented in academic journals, available to the general public. His goal was “to stand for the Twelve Step model in the face of long-standing and unchallenged criticism and skepticism, much of which is not based in fact.” Equally important, he hoped that people on the fence about going to an A.A. meeting “will benefit from learning about the science (as opposed to the myths) of Twelve Step recovery.”

Nowinski referred to a long-standing bias against the Twelve Step approach to recovery. He said it was regularly portrayed as a quasi-religious approach, and then rejected because it is not a structured treatment approach. Therefore it lacked a clear demonstration of its scientific, evidence-based effectiveness. If an addiction treatment approach, like TSF, used the 12 Steps or actively encouraged clients to participate in 12 Step groups like Alcoholics Anonymous (A.A.) or Narcotics Anonymous (N.A.), it was often judged to be “a less equal treatment” than others. An article by Laurel Sindewald for The Fix, “AA Is not Evidence-Based Treatment,” illustrates this bias.

The author said she had previously done a literature review that found insufficient evidence to support the use of 12-step groups as treatment, so she was surprised the Surgeon General included TSF as an evidence-based behavioral treatment for addiction in Facing Addiction in America. She admitted to a personal bias, which apparently was against the spirituality of 12-step groups and what she referred to as “12-step philosophy.” It seems that since TSF encouraged participation in 12-Step self-help groups, it was suspect as a “less equal” treatment approach, because it retained “ the spiritual emphasis of 12-step philosophy.” However, she would “set aside her bias” in her assessment of TSF, in order to give it a scientific, objective assessment. But that does not seem to have been the case.

Sindewald noted where the Surgeon General’s Report classified TSF as a “professional behavioral treatment,” but then immediately asked: “How could a professional medical treatment be based on a definition of addiction as a spiritual disease?” She stated (without any supportive citation) that Twelve-Step philosophy stipulated that addiction was a spiritual disease born of defects of character; and that 12-step groups were the only cure. She later compared Twelve-Step literature to religious literature like the Bible and the Qur’an and contrasted Twelve-Step philosophy with medical science. She gave an extended quote from the A.A. “Big Book” of Alcoholics Anonymous, which she said represented Twelve-Step philosophy saying it can never be wrong. Her bias against spiritual/religious philosophy was all through her critique.

The AA pamphlet “How AA Members Cooperate with Professionals,” stated that A.A. is not in competition with anyone. “Our ability to help other alcoholics is not based on scientific or professional expertise.” Unpacking principles articulated in AA’s Twelve Traditions, the pamphlet also said: “A.A. is not allied with any sect, denomination, politics, organization or institution; does not wish to engage in any controversy; neither endorses nor opposes any causes.” In his essay on Tradition Six in Twelve Steps and Twelve Traditions, Bill W. gave a brief history of early A.A.including attempts to institute A.A. hospitals and get involved in education. He noted where these activities raised confusion. “Did A.A. fix drunks or was it an educational project? Was A.A. spiritual or was it medical? Was it a reform movement?”

These adventures implanted a deep-rooted conviction that in no circumstances could we endorse any related enterprise, no matter how good. We of Alcoholics Anonymous could not be all things to all men, nor should we try.

In the same chapter of the A.A. Big Book, which Sindewald cited and linked, “How It Works,” there is a discussion of resentment being the “number one” offender, destroying more alcoholics than anything else. “From it stem all forms of spiritual disease, for we have been not only mentally and physically ill, we have been spiritually sick. When the spiritual malady is overcome, we straighten out mentally and physically.” So there is an understanding of alcoholism as a spiritual, mental and physical illness/disease.

Also in that chapter you will find the 12 Steps described as a suggested program of recovery. “The principles we have set down are guides to progress. We claim spiritual progress rather than spiritual progression.” So it seems that AA does not present itself as the only cure; nor does it describe alcoholism merely as “a spiritual disease born of defects of character.”

A clear distinction by the author between TSF, A.A., and rehab programs using the 12-Steps isn’t maintained in her critique. In her article for The Fix, she said she used “12-step approaches” to refer to all 12-step self help groups, all 12-step-based rehab programs and TSF. However, in another article she wrote previously for Handshake Media (linked as her literature review), she said: “TSF is distinct from AA and other 12-step support groups.” Yet in her conclusion for “AA Is not Evidence-Based Treatment” Sindewald said “after exhaustive research” she could assert with confidence that 12-step approaches—including TSF—were not evidence-based treatments. She called for the reallocation of funds away from these approaches to those “that can be studied rigorously and without such crippling methodological limitations.”

With regard to A.A .and other 12 Step groups, she was right when she said they were not treatment approaches to addiction recovery. A.A. is not developed as a treatment approach and doesn’t claim to be a treatment approach. The A.A. website said: “Alcoholics Anonymous is an international fellowship of men and women who have had a drinking problem.” It is also self consciously nonprofessional, stating in Tradition Eight, “Alcoholics Anonymous should remain nonprofessional.” As fellowship organizations, A.A. and other 12-Step self-help groups are not structured in ways that can be easily studied by researchers who want to assess their effectiveness within a structured medical model of therapeutic change.

But Twelve Step Facilitation is considered to be a treatment approach. According to the NIDA description of “12-Step Facilitation Therapy,” TSF is a manual-based, structured treatment approach. It is “designed to increase the likelihood of a substance abuser becoming affiliated with and actively involved in 12-step self-help groups, thereby promoting abstinence.” And TSF is listed by NIDA as an evidence-based treatment approach, the same organization, by the way, that Sindewald referenced as defining addiction as a brain disease. Apparently NIDA doesn’t agree with her that TSF is not an evidence-based treatment approach.

It seems Sindewald’s failure to acknowledge the difference of A.A. and other 12-Step groups from the various addiction treatment approaches that apply “Twelve-Step philosophy” was intentional. It sets up a straw man argument that illegitimately transfers a critique of the TSF treatment approach onto 12-Step groups. It also seems that Sindewald’s claim to have set aside her bias while she examined Twelve Step treatment philosophy and TSF was not true.

06/16/17

Something Old is New

© Chonlawit Boonprakob | 123rf.com

Police in Reynoldsburg Ohio, a suburban community in the Columbus Ohio metropolitan area, were called to the local high school when some students were acting dazed and disoriented. This kind of news is not unusual these days, but what they were using was—betel nut. Several news outlets picked up the story, including The News Herald, the CBS affiliate Cleveland 19, and The Fix. Although betel nut or areca nut is not well known in the U.S., it is the fourth most commonly used “social” drug worldwide, after nicotine, ethanol, and caffeine. Over 600 million people—10 percent of the world’s population—presently use some form of areca/betel nut.

Technically the areca nut is the seed of the areca palm, which grows in the tropical Pacific, parts of Africa, Southeast and South Asia. It’s not a true nut, but rather a berry. It is commercially available in dried, cured and fresh forms. Usually chewed, a few slices of areca nut are wrapped in a betel leaf containing calcium hydroxide (slaked lime) and mixed with clove, cinnamon or other spices. It gives the users a warming sensation and a heightened sense of alertness, but the effects vary from person to person. A BBC news report said it gives a buzz equivalent to about six cups of coffee.

Its use dates back thousands of years in the above noted areas of Asia and the Pacific. It isn’t known how or when the psychoactive properties of combining the areca nut and the betel leaf were discovered. However, archaeological evidence in Thailand, Indonesia and the Philippines suggests they have been used together for at least 4,000 years. A Report by the World Health Organization (WHO) noted there is evidence of betel nut use in Guam and the Northern Mariana Islands for 2,000 years and the Solomon Islands for at least 1,000 years.

There is a Vietnamese myth about the betel leaf and areca nut that goes like this. There were twin brothers, Tan and Lang who were benig tutored by a Taoist named Chu Chu. The tutor had a beautiful daughter, who he gave in marriage to Tan. The two of them were very happy together. But Tan grew apart from Lang after he was married. So Lang decided to go away and wander around the country.

Finally he reached a large river, but could not cross it. There was no boat to transfer him to the other side. Lang was so sad that he kept crying until he died. Then he was transformed into a lime-stone by the river. Troubled by Lang’s absence, Tan went looking for him. When he reached the river, Tan sat on the lime-stone and died from exhaustion and weariness. “He was transformed into an areca tree.” The young woman in turn went looking for her husband when he did not return. When she reached the place where the areca tree grew, she leaned against the tree and died. And she was transformed into the betel vine.

The local inhabitants set up a temple to their memory, commemorating this tragic love story. One day, King Hung went to the temple and heard this tragic love story. He ordered his men to ground together a leaf of betel, an areca nut and a piece of lime. A juice, as red as human blood, was formed out of the mixture. He tasted it, found that it was delicious, Then the king recommended the mixture be used at every marriage ceremony from then on.

The leaves and juices are used in Vietnamese weddings, symbolizing the idealized married couple. Guests to a Malay house are offered a try of areca nuts and betel leaves like drinks are offered in other cultures. See the following link for more information on the variety of cultures using the areca nut.

So what’s not to like? WebMD reported that eating 8 to 30 grams of betel nut could cause death. Your mouth, lips and stool can turn red. It can cause diarrhea, vomiting, gum problems, chest pain, abnormal heartbeats, low blood pressure, shortness of breath, rapid breathing, heart attack and coma. Interactions with some medications can be problematic, decreasing the effectiveness of antidepressants and antihistamines. It can interact with medications used for glaucoma and Alzheimer’s disease. “Stay on the safe side and avoid using betel nut if you are pregnant or breast-feeding.”

Gang et al. did a systematic review of the adverse effects of betel nut. The authors said it affects almost all the organs of the human body, “including the brain, heart, lungs, gastrointestinal tract and reproductive organs.” It causes or aggravates several medical conditions including asthma, type II diabetes, infertility, and heart problems such as myocardial infarction and cardiac arrhythmias. It affects the immune system leading to suppression of T-cell activity and decreased release of cytokines. See the following link to Table 1 in the article for a summary of the systematic effects.  “Thus, areca nut is not a harmless substance as often perceived and proclaimed by the manufacturers of areca nut products such as Pan Masala, Supari Mix, Betel quid, etc.”

The effects of areca nut are mainly on the central and autonomic nervous systems from the alkaloid arecoline. There is a dependency syndrome associated with the use of areca nut that includes increased concentration, mild euphoria, relaxation and withdrawal. The withdrawal syndrome is associated with insomnia, mood swings, irritability and anxiety. The severity is comparable to that of amphetamine use. “Areca nut leads to palpitation, increased blood pressure, increased body temperature, flushing and sweating within minutes of consumption.” And there is substantial evidence that it is a carcinogen, contributing to cancers of the mouth, esophagus, liver and uterus.

A 2010 study by Bhat et al. (reload link) looked specifically at areca nut dependency among a South Indian community. Fifty-nine daily chewers from Karanatka State in southwest India were surveyed. Questionnaires assessed their chewing history, pattern of use and adapted measures developed for assessing nicotine/tobacco dependence to assess areca dependence. There were low levels of dependency observed, but about 44% of chewers endorsed at least one of the following items: continued use despite illness or wounds, difficulty refraining from chewing in forbidden places, or craving during periods of abstinence.

At least 15% of respondents had intentionally made a quit attempt [ an attempt to quit]. During periods of abstinence for any reason, 27% reported feelings of discomfort or craving. Many of these participants were those who scored high on the dependence measures and/or reported a high frequency of use. Of the 13 informants who reported the highest number of nuts chewed/day (i.e., 5), nine had scores ≥ 16 on the CDS-5. These individuals also reported the greatest number of use episodes/day, with 6–15 chews daily.

Many chewers started as adolescents of young adults; 52.5% started before the age of 30. Reasons for starting to chew areca nut included boredom (39.0%) and as an aid in socialization (28.8%). Many respondents also said it helped them at work. “Chewing helps me to think what to do next, or how to do other work.”  They also reported using areca nut as a mouth and breath freshener.

At this point in time, betel/areca nut use is not a drug of concern outside of the Western Pacific Region, highlighted in the above graphic. In the US, betel nut is not a controlled substance and can even be found in some Asian grocery stores. The Reynoldsburg Police Chief, Jim O’Neill, said they would like to keep this out of the hands of students, which may be difficult. Although it’s illegal to import, betel nut is readily available online—“a loophole law enforcement agencies want to see shut.” Health inspectors in Ohio are searching markets to remove betel nuts from shelves; and the FDA was said to be investigating into betel nut use.

In writing this article, particularly in light of the Vietnamese legend described above, I thought of the bridal rhyme that goes “Something old, something new, something borrowed, something blue.” Well, at least the first half of it. Betel nut use has an old, long history; and yet, is being investigated as a new, potentially harmful substance by the FDA. It seems that betel nut use and misuse is something old that became something new in the ongoing American cultural wars against mind altering-mood changing substances.

06/6/17

Preventing the Relapse Process, Part 2

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Recovery can be likened to walking up a down escalator. Imagine an escalator that stretches so far up that it disappears in the distance. As every child knows the trick to walking up one is to climb faster than the escalator is pulling you back. You could climb so far up this imaginary escalator, that you would no longer see the bottom. But the moment your climbing effort is less than the downward pull of the escalator, you begin moving back towards that bottom. That’s what relapse is like.

You might even be objectively climbing up the escalator, but if it isn’t enough to counter the downward pull, you have only delayed the inevitable. You have to be climbing as least as fast as the escalator is pulling you back to not lose ground. And that is what relapse prevention is like.

Relapse is a process, not an event. The last thing that happens in a relapse process is resuming alcohol or drug use. Depending on the effort you made to progress up the escalator of recovery, your relapse process could take a long time to play out. I’ve known people who identified patterns of relapse that stretched over years of their abstinent lives before they resumed active drinking or drugging. Perversely, this can be a message of hope and not hopelessness. If your relapse process takes months or years to lead you back to active drinking or drug use, then you have months or even years to recognize the problem and prevent it from getting any worse.

In the first part of this article we looked at coping with problems or stuck points in recovery and the high risk factors and trigger events that increase the likelihood of relapse if they are handled incorrectly.  This discussion on relapse applies the thinking of Terence Gorski on relapse and relapse prevention, particularly his use of the Relapse/Recovery Grid in Passages Through Recovery and the booklet, The Relapse/Recovery Grid.  There are also several articles using this material available on his blog, Terry Gorski’s Blog, including: “Understanding Relapse and Relapse Prevention.”

“The general direction towards relapse is from denial and evasion to high-risk lifestyle factors.” We left off a discussion of the relapse process in Part 1 with a description of high-risk situations and trigger events. High-risk factors make you vulnerable to trigger events, which can be “anything that causes sudden stress, pain, or discomfort.” They can be internal or external triggers. The interaction of high-risk situations and trigger events determines how the Relapse Process advances.

When there are relatively few high-risk factors in a person’s life, it will take a greater stressor to trigger the internal dysfunction of relapse. Conversely, with more high-risk factors, even a minor event can trigger internal dysfunction. “As internal dysfunction increases, the ability to manage reality gets worse, and more problems develop.” This internal dysfunction in early recovery is post acute withdrawal (PAW). See “Recognize Your PAWS” and “Manage Your PAWS.” Or you can read Gorski’s Comprehensive Guide to PAW here.

Internal Dysfunction

When under high stress, many recovering people begin to have difficulty thinking clearly, managing feelings and emotions, and remembering things. One of the main culprits leading to these problems appears to be a tendency to overreact to stressors. . . . Eventually the ability to sleep restfully is disrupted. This heightens stress and fatigue to the point where people become accident-prone.

Thinking problems can range from difficulty concentrating or thinking logically, to racing, repetitive thoughts. The person isn’t always clear about how things affect or relate to each other. “They have difficulty deciding what to do next to manage their lives and recovery.”

Feelings and emotions can range from being very sensitive to being numb. Strange or “crazy feelings” can occur for no apparent reason, leading the person to think they are going crazy. “These problems in managing feelings can cause recovering people to experience mood swings, depression, anxiety, and fear. Sometimes in this situation a mood disorder is diagnosed and treated with medication. Ironically, this could exacerbate the internal dysfunction of relapse. The person often doesn’t trust their emotions and seeks to ignore, stuff or forget them.

Memory problems interfere with learning new skills and retaining new information. Remembering what you just read can be difficult. “The new things they learn dissolve or evaporate from their mind within minutes.” Taking classes or learning a new job skill can be tough when this is happening.

Sleep-related problems can crop up. This could mean trouble falling asleep, trouble staying asleep, and even unusual or disturbing dreams. Restful sleep may be difficult to come by, leading to exhaustion or tiredness during the day.

Problems managing stress begin with a failure to recognize the minor signs of daily stress. So when stressors become evident, there is a tendency to overreact to them. “Stress sensitivity causes them to amplify, magnify, and intensify whatever feeling they are experiencing.” At times, they get so tense and the strain is so severe, they can’t function normally.

This internal dysfunction can lead to feelings of shame and guilt; feeling you are doing something wrong in recovery or not working a good program. This can lead to not talking honestly about what you are experiencing. These warning signs of relapse get stronger the longer they remain hidden. “Secrets keep you sick.” If you try and fail to manager them alone, you may begin to feel hopeless.

External Dysfunction

Problems in living emerge from a failure to manage the internal dysfunction issues of a relapse process. “Now problems arise at work, at home, with friends, and with fellow members of the program.” If there is a person (like a sponsor) or a situation (like a meeting) that might call on you to take an honest look at yourself, you begin to avoid them and isolate. If asked how you’re doing, you get defensive or lie. Impulsive actions, doing things without thinking them through can happen.

Confusion, overreaction and crisis building occur. “Here, people may begin to have problems cause by denying their feelings, isolating themselves, and neglecting their recovery.” You get upset with yourself and others. You can be irritable and overreact to little things. Relationships become strained; conflicts arise. Stress and anxiety increases. At this stage, denial locates the problems in others or outside situations.

Loss of Control

Active addiction is often described as a loss of control. I find it helpful to distinguish between two kinds of loss of control: the loss of control over thinking, feeling or behavior; and the loss of control over drug or alcohol intake. Here the first sense of loss of control is activated. I describe this stage of the relapse process as feeling like a deer caught in the headlights. There is poor judgment; an inability to take action; an inability to resist destructive impulses.

Recovering people lose their ability to control their thinking and behavior. Judgment is impaired. They often know what they need to do but can’t do it. They begin to have cravings and self-destructive impulses and find the more and more difficult to resist. They consciously recognize the loss of control, but believe they can’t do anything about it.

Far too often, this is the first awareness the person has that they have slipped into “relapse mode.” They see how severe their problems have become; how unmanageable life has become and how little power they have to solve their problems. “By this time, they have become so isolated that it seems there is no one to turn to for help.” Feelings of powerlessness to resolve problems leads to believing you are useless and incompetent.

Feeling trapped by pain and inability to manage life, they feel their options are reduced to going insane, committing suicide or using drugs or alcohol. There is no sense that anyone or anything can help. Twelve Step meeting attendance stops, if it hasn’t already. Tension can lead to terminating a relationship with a sponsor of counselor that used to be helpful.

People can only live with debilitating stress for so long before they collapse. Some people collapse physically and develop stress-related illnesses such as ulcers, gastritis, back pain, hear disease, or cancer. Others collapse emotionally … [or] become suicidal.

Lapse/Relapse

“When faced with the limited alternatives of physical or emotional collapse, suicide or chemical use, using can seem like the sanest choice.” Assumed here is the person does know, or did know from experience when they were using in the past, that it’s likely they would again lose control over their use. Either they are so desperate that they convince themselves they will only use for a short while in a controlled way, or they impulsively act when an opportunity to use presents itself. This initial use will often produce intense feelings of guilt and shame for the individual.

Sometimes active using is a lapse—a short time period, perhaps even one night or a few drinks. Other times the active use spirals out of control and can go for months or years. Returning to a loss of control over use can be slow or rapid. Often the person quickly returns to using as much as they did before.

The goal of relapse prevention is to interrupt the above-described process as quickly as possible. The further the relapse process progresses, the more difficult it is to stop. Identifying and resolving stuck points (see part 1), avoiding as many high-risk factors as possible, and neutralizing trigger events are the best interventions. Next would be catching and addressing internal dysfunction, then external dysfunction and finally loss of control before the relapse into active chemical use. Remember that when you successfully intervene in a relapse process at the beginning, you need never risk actually picking up.

This is part 2 of my article, “Preventing the Relapse Process.” Part 1 describes stuck points, high-risk factors and trigger events connected to the relapse process and it can be found here.

I have read and used Terence Gorski’s material on relapse and recovery for most of my career as an addictions counselor. I’ve read several of his books and booklets; and I’ve completed many of his online training courses. He has a blog, “Terry Gorski’s Blog”, where he graciously shares much of what he has learned, researched and written over the years. This is one of a series of articles based upon the material available on his blog and websites.

05/26/17

Preventing the Relapse Process, Part 1

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Relapse is a terrifying experience for an addict or alcoholic to go through. And what seems to be most terrifying, is not being able to see it coming. Hindsight will recognize a few obvious mistakes, but often there is a haunting question: “What am I missing?” Learning to understand relapse and how to prevent it are essential pieces to the recovery puzzle. Relapse doesn’t have to be part of recovery, but recognizing the process when it occurs is essential.

Gerald finally agreed to admit himself to an addictions treatment center. He had relapsed into active drug and alcohol use two years ago after having eight years of abstinence. At the time of his relapse, he was the manager of a sober living residence that housed 10 to 12 men who needed a supportive living environment in early recovery. He didn’t recognize any one thing or event that triggered his relapse. But the guilt after picking up was more intense then he imagined was possible. He was the guy at meetings who always said he put his recovery first.

He acknowledged he had been going through the motions for a while. But that had happened to many others he knew who didn’t pick up. There was the usual recognition of slacking off on going to meetings and growing more impatient with others asking him if he was “all right.” But he honestly couldn’t pick out any one thing or a series of events that led to his relapse.

He had wracked his brains trying to think of what he should have done differently, but he couldn’t see where he went wrong. Privately he was terrified. What if it happened again and he didn’t see it coming that time either? He was afraid he wouldn’t make it back again.

There is no better place to start helping Gerald than with the resources developed by Terence Gorski for understanding and preventing relapse. His Relapse/Recovery Grid has been one of my most regularly used tools when I work with individuals to address their alcohol or drug problems. You will find it in at least two places. The first is within his book, Passages Through Recovery and the second is in his booklet, The Relapse/Recovery Grid. Another helpful resource is Terry Gorski’s Blog, where Terry has made a wealth of his material available. I haven’t seen a reproduction of the 8 ½ by 11 inch Relapse/Recovery Grid available on his blog, but in several articles like “Understanding Relapse and Relapse Prevention,” you will get a good synopsis of the Relapse Process summarized on the bottom half of the Relapse/Recovery Grid.

Gorski said relapse is like knocking over a line of dominoes. It is a process of one unresolved problem leading to another, and then another and another—until you have a major crisis, where using alcohol or drugs to deal with the pain seems like a reasonable choice. “The answer to avoiding relapse is to learn how not to tip over the first domino, and take care of the little problems in life.” If the dominoes have already begun to fall by the time you realize what’s going on, then you want to stop the chain reaction quickly, “before the dominoes start getting so big and heavy that they become unmanageable.”

One way the domino analogy is not always accurate is in the amount of time involved in a relapse process. Someone with stable recovery can take a long time to move through the stages of a relapse process before they ultimately use drugs or alcohol. By stable recovery, I mean someone who is in what Gorski calls the Maintenance Stage of the recovery process. This is where the person is maintaining a recovery program, coping effectively with day-to-day issues in life, continuing to grow personally and spiritually, and coping effectively with the crises and transitions that occur in life. I’ve known an individual who said her relapse process started four years before she actually used drugs again.

Perhaps a bit counter intuitively, this longer time for relapse to result in active drinking or drug use can be helpful IF the person recognizes the problem (or stuck point in Gorski’s discussion of the relapse process) and copes effectively with it. This necessitates the use of RADAR to address the stuck point: Recognizing there is a problem; Accepting that it’s normal to have problems and get stuck in recovery; Detaching or backing off to gain perspective on an unsolved problem; Accepting help from others—asking them for help with your problem; and Responding with positive action will help you get over the stuck point and avoid a further slide into the relapse process.

Failing to address a stuck point leads to ESCAPE: Evading or denying the problem or stuck point; failing to cope with the Stress that comes with evading the problem; turning to Compulsive behaviors to cope with the pain and stress; Avoiding others, especially those who see and tell you about your ineffective strategies for dealing with the problem; developing new Problems from the process of stress, compulsive behavior and isolation; and ultimately Evasion and denial of the new problems—see how it’s been working so well for you so far.

Instead of recognizing you are stuck and need help, you try to tell yourself everything is okay; you are coping effectively. But there is a buildup of pain and stress that can result in using other compulsive behaviors to cope.

To cope with the pain and stress, we begin to use other compulsive behaviors. We may begin overworking, over-eating, dieting, or over-exercising. We can get involved in addictive relationships and distract ourselves with sex and romance.  These behaviors make us feel good in the short run by distracting us from our problems.  But they do nothing to solve the problem.  We feel good now, but we hurt later.  This is a hallmark of all addictive behaviors.

Then something happens. Usually it’s something you would handle without getting upset. But this time you’ve had it; you’ve hit your limit and something snaps inside. Gorski said one person said it was like a trigger going off in your gut and you go out of control. But this is not actively drinking or using … yet. “When the trigger goes off, our stress increases, and our emotions take control of our minds. . . . When emotion gets control of the intellect we abandon everything we know, and start trying to feel good at all costs.”  There was just one too many stressors that weren’t addressed, so a trigger event initiates the internal dysfunction of the Relapse Process.

The Relapse/Recovery Grid lists several high-risk lifestyle factors that increase the likelihood of something triggering the Relapse Process. “These high-risk factors don’t cause relapse; they simply increase the likelihood that it will occur” by making you vulnerable to trigger events. The high-risk factors include personality stressors (perfectionism; or controlling); high-risk lifestyles (trying to do too much or doing too little; or doing the wrong things); social conflict and change; poor health maintenance (poor nutrition, a lack of exercise, relaxation or socializing) or other illness; an inadequate recovery program. “The ‘wrong things’ could be occupations, activities, and people that don’t fit with natural preferences and talents.” Gorski said these high-risk factors were identified from research into the lifestyles of people who had relapsed.

The trigger events listed in the Relapse/Recovery Grid include: high stress thoughts, painful emotions, painful memories, stressful situations and stressful interactions with others. Gorski said that just about anything could become a trigger event, but these five things trigger internal dysfunction more than others.

Some recovering people put themselves under increasing amounts of stress, and they keep adapting to it as they go along. As their tolerance goes up, they block their awareness of stress. Suddenly they hit their limit. They experience one stressor too many, and become dysfunctional.

Irrational thinking is the most common trigger. All-or-nothing thinking, black-and-white thinking fits here. When something goes wrong, you think Nothing ever goes right. If there is a risk of failure in doing something, you quit before it happens. This kind of thinking is irrational.

Emotional pain can point to something wrong with how you are thinking or acting. It signals “a need to examine what is wrong.” If you dismiss painful emotions for too long, they often come back with a vengeance.

People will often experience stressful or traumatic events in an active addiction that cause them extreme emotional or physical pain.  Being reminded of these events can lead to disorientation, confusion, anxiety or other symptoms for no apparent reason. This will then increase stress and trigger internal dysfunction.

“Any situation that a person is not prepared to cope with may be stressful.”  Recognize this reality and seek to avoid them, if at all possible, by being prepared. The level of stress is inversely related to your preparation: it goes down as your preparation goes up. In situations where you can’t be prepared, learn some stress reduction skills, such as relaxation breathing. See “Using Stress Management in Relapse Prevention Therapy (RPT)” and  “Stress Self-Monitoring and Relapse” for more on this.

Stressful interactions with others are common for recovering addicts and alcoholics. They often have high stress people in their lives, meaning people who cause them stress. Often these high stress interactions occur with family members or people the addict or alcoholic is close to. Their stressful behavior, ironically, is often caused by their fear of a relapse with the addict.

This is the first part of my article, “Preventing the Relapse Process.” Part two will describe the four phases of the Relapse Process and it can be found here.

I have read and used Terence Gorski’s material on relapse and recovery for most of my career as an addictions counselor. I’ve read several of his books and booklets; and I’ve completed many of his online training courses. He has a blog, “Terry Gorski’s Blog”, where he graciously shares much of what he has learned, researched and written over the years. This is one of a series of articles based upon the material available on his blog and websites.

05/16/17

Trouble with Tramadol

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Regularly in the U.S. we hear news about the opioid epidemic. There is an ever-growing use of powerful opioids such as fentanyl, which is 50 to 100 times the strength of morphine; and carfentanyl (used as a sedative for large land animals) whose strength is 10,000 times that of morphine. Recent CDC data released on December 30, 2016 indicated that 60.9% of the overdose deaths in 2014 involved an opioid. Between 2014 and 2015 drug overdose deaths increased by: 11.4%.  The CDC suggested this increase was largely driven by synthetic opioids, most likely fentanyl, and heroin. While the opioid epidemic is not uniquely a US problem, it has a different face in other countries, such as Egypt, where the opioid of choice for abusers is tramadol. Yes tramadol, which is one-tenth the potency of morphine.

The Economist said tramadol use in Egypt was everywhere. Taxi drivers used them to stay awake. Wedding guests receive them as token gifts. Petty government officials even accept them as bribes. “Tramadol has become Egypt’s favourite recreational drug, supplanting heroin and cannabis.” Taha, a bank teller, said the drug helps him work. “It just makes you feel relaxed. Even if there are two men fighting to the death beside you, you wouldn’t care.”

There is no social stigma attached to tramadol use. It’s seemingly more religiously acceptable than alcohol or marijuana. Ibrahim began using half a tablet of tramadol because he felt socially awkward at the age of seven. “I found myself feeling unusually outgoing and positive.” Ten years later, he was using ten tablets daily.

Until recently, tramadol sold for the equivalent of 15 to 30 cents per pill. Tramadol use accelerated after the 2011 uprising in Egypt, partly because of the weakened state controls. Ehab El-Kharrat, an Egyptian doctor, said the tramadol came largely from India or China. Customs inspections began to tighten and the price rose sharply. At one point the price reached $1 to $3 a pill. “Since then we have seen a flood of people seeking help.”  The head of a Cairo rehabilitation center said at least 40% of those attending his clinic are addicted to tramadol.

Yet enforcement is poor. Court cases are thrown out because of shoddy police work. Officers are often in cahoots with the drug dealers, or are themselves drug-users. And even if the government succeeds in restricting the supply of tramadol, there may be unintended consequences. If the pills become more expensive, users may switch to stronger heroin. Some worry that the worst of Egypt’s drug problem is yet to come.

The Daily Beast also reported on the tramadol problem in Egypt. A taxi driver threw up the first time he tried tramadol. But now he takes for or five doses daily. He justified his use by saying its one of the few ways to dull the pain of Egypt’s weak economy and trying political circumstances. “Food, gas, everything is so expensive. People are exhausted and take things like tramadol just to keep going.” Young cash strapped males form the core of its users.

A UNODC (United Nations Office on Drug and Crime) official estimated that 90% of the illicit tramadol in Egypt is produced in India, and then smuggled into the country. One supplier said it’s never been easier to keep stocked up on tramadol. Because of its ready availability, its use has begun to spread from younger working class males into the more affluent areas of Cairo, which doesn’t make drug dealers very happy. “It’s not good when [those] people buy tramadol, because it means they won’t buy more expensive things. . . But with the economy and everything, this seems to be what Egyptians want right now.”

The Expert Committee on Drug Dependence of the World Health Organization (WHO) gave an Updated Review Report on tramadol at its thirty-sixth meeting in June of 2014. The report noted how Egypt had up-scheduled tramadol in 2009 because of its increasing rate of abuse. There was also growing evidence of tramadol abuse in other African and West Asian countries, including: Egypt, Gaza, Jordan, Lebanon, Libya, Mauritius, Saudi Arabia and Togo. In most countries it is a prescription-only medicine.

Marketing authorizations for tramadol are held by dozens of companies. The WHO Report listed around thirty-five companies as examples. Corresponding to this, it also goes by dozens of trade names, literally from A (i.e., Acerna, Amanda, or Astradol) to Z (i.e., Zamadol, Zentra, or Zodol). The common formulas in the US are: ConZip, Ryzolt and Ultram.

Overall, tramadol has been seen as having a low potential for drug dependence. However, in the last few years, new data suggests that dependence may occur when it is used daily for more than a few weeks or months. The WHO finding here is consistent with the above reported abuse of Tramadol in Egypt. It is listed as a controlled or scheduled substance in several countries, including: Australia, Iran, Sweden, Venezuela, Ukraine, China, the United Kingdom, Jordan, Saudi Arabia, and Egypt. Since the WHO Report was published, tramadol has become a Schedule IV controlled substance in the U.S.

In summary, the data on the dependence potential of tramadol show that tramadol has a relatively low dependence potential and that dependence is associated with the use of tramadol over an extended period of time (more than a few weeks to months). The data also show a higher risk profile in former drug abusers and in medical staff personnel than in pain patients. Several studies indicate that the incidence of tramadol dependence may differ between countries and within different regions of countries, which may be associated with the availability and prescription practice for tramadol, and with the availability of alternative psychoactive substances for drug abusers.

DrugAbuse.com described tramadol as a fully synthetic opioid originally synthesized by a German company in 1962. It was finally brought to market as Tramal in 1977. It was not until 1995 that it became available in the U.S. as “Ultram.” Initially it was not a controlled substance. By 1996 the FDA revised the product label to require warnings about the potential for abuse. In 2009, the FDA again changed the product warning, now the alert of the possibility of a life-threatening condition, serotonin syndrome.

Between 2005 and 2011, emergency department visits related to non-medical tramadol use rose over 250%. Between 2008 and 2013, prescriptions for tramadol increased by 20 million. In 2014 another increase of 44 million prescriptions of tramadol occurred, possibly a reaction to the rescheduling of Vicodin from Schedule III to Schedule II. Also in 2014, tramadol was made a Schedule IV controlled substances by the DEA.

In 2009, Sansone and Sansone gave a good summary of some of the health risks with tramadol, including a description of serotonin syndrome (SS), and the risk of seizures if it was used concurrently with antidepressants, both tricyclics and SSRIs. There was a “Dear Healthcare Professional” letter distributed by the manufacturer warning of the potential adverse drug event of seizures when using tramadol and antidepressants. A follow up study noted a small and insignificant change in the prescribing habits after the release of the warning letter.

Serotonin syndrome was more common with excessive use/overdose of tramadol or coadministration with other medications, particularly antidepressants among the elderly. SS has been reported with combinations of tramadol and the following: fluoxetine (Prozac),sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa),  fluvoxamine (Luvox),venlafaxine (Effexor),and TCAs (tricyclics). Rimeron was implicated in one case study of tramadol use with elderly residents in a long-term care facility. They summarized their conclusions as follows:

In primary care settings, tramadol is a commonly prescribed synthetic analgesic. Two potential adverse reactions of tramadol are seizures and SS. Either of these reactions may occur with tramadol monotherapy, but both appear to be much more common with either abuse/overdose or in combination with other drugs, particularly antidepressants. These adverse reactions appear to be more common in the elderly. The majority of commonly prescribed antidepressants have been implicated in both of these adverse reactions. Clinicians are advised to be mindful of these potential adverse sequelae when prescribing antidepressants to patients on tramadol, particularly in the elderly and/or those who might be at a heightened risk (i.e., individuals with epilepsy, head injuries, neurological dysfunction). If coadministration is undertaken, we advise careful monitoring for these two particular hazards. Tramadol is a remarkable drug, but like all drugs, effective use entails balancing the benefits versus the risks.

Then on April 20, 2017, the FDA restricted the use of tramadol (and codeine) in children. They also recommended against the use of these medicines in breastfeeding mothers. Tramadol is contraindicated (the FDA’s strongest warning) to treat pain in children younger than 12 years old and for pain in children younger than 18 after surgery to remove tonsils and/or adenoids. “These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.”

05/5/17

The Evolution of Neurontin Abuse

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Not long ago a Columbus Ohio television station, Fox 28, noted the Ohio Substance Abuse Monitoring Network (OSAM) issued an alert about a pill doctors say is now being abused by heroin addicts. It’s not an opioid or a benzodiazepine; it’s not even a controlled substance. Yet it was the number one dispensed medication in Ohio in December of 2016, “at a 30 percent higher rate than Oxycodone.” Can’t guess? Would you be surprised to know that drug was Neurontin?

In February of 2017 OSAM published “Neurontin© Widely Sought for Illicit Use.” The OSAM report said Neurontin (gabapentin) was first identified as drug of abuse by law enforcement in January of 2014, in Dayton, Ohio. Over the last three years of reports there has been illicit gabapentin use in seven of eight urban regions in Ohio. See Table 1 in the OSAM bulletin for more information.

Preliminary analysis of OSAM’s most recent data for July to December 2016, found street availability and illicit use of Neurontin® to be moderate to high in six of the eight OSAM regions. In Athens, a participant commented, “It seems like everyone is on Neurontin®.” A law enforcement officer noted, “Enormous Neurontin® abuse right now.”

Gabapentin, known by its brand name of Neurontin®, is an anticonvulsant medication approved by the FDA as adjunctive treatment of partial seizures and to manage neuropathic pain from shingles. It has a variety of touted off label uses, and was referred to as “the snake oil of the 20th century” in an internal Pfizer email.  It is currently seen as having a low abuse profile and is not scheduled as a controlled substance by the DEA. But that may need changing.

It is also used to by opioid users to self-medicate through withdrawal and as a high in itself. One individual in Ohio said his attraction to Neurontin® was that it intensified his methadone: “So if you take your methadone and you go buy 10 Neurontin® and you take all 10, it’s sort of like you tripled your dose.” Others said they get a “semi-euphoric feeling” if they abuse it. Some recent studies: “Abuse and Misuse of Pregabalin and Gabapentin” and “Gabapentin Misuse, Abuse and Diversion: a Systematic Review” said gabapentin is most often abused by individuals with a history of drug abuse, especially opioids. And it is “being misused internationally.”

An article in Pharmacy Times indicated the number of prescriptions written for gabapentin was at an all time high. “According to a report by IMS Health, 57 million prescriptions for gabapentin were written in the United States in 2015, a 42% increase since 2011.” Alone it has a low abuse potential, but when combined with muscle relaxants, opioids of anxiety medications “gabapentin’s potential for abuse and addiction significantly increasing and ultimately gets those individuals high.” A study of Florida inmates found it was being crushed and snorted like cocaine. “Out of 96 prescriptions, only 19 were actually in the hands of an inmate that was actually prescribed that drug.”

An article in Pain News Network noted a study of urine samples from patients being treated at pain clinics found that 22% (70 out of 323) were taking gabapentin without a prescription. Researchers found of those patients taking gabapentin illicitly, 56% were taking it with an opioid; 27% with an opioid and a muscle relaxant or anxiety medications like benzodiazepines. The medical director of ARIA Diagnostics in Indianapolis, Indiana said the high rate of misuse was surprising as well as a wake up call for prescribers. Doctors don’t usually screen for gabapentin abuse when making sure patients are taking medications as prescribed.

Little information exists regarding the significance of Gabapentin abuse among clinical patients. Until recently, it was considered to have little potential for abuse however this review has shown that a significant amount of patients are taking Gabapentin without physician consent. This could be due to the fact that recent studies have revealed that Gabapentin may potentiate the ‘high’ obtained from other central nervous system acting drugs.

In the UK, gabapentin and pregabalin (Lyrica) prescribing is getting scrutinized more closely. At least 38 deaths involving pregabalin and 26 involving gabapentin were reported in the UK between 2012 and the end of 2015. The UK Advisory Council on the Misuse of Drugs (ACDMD) recommended they be reclassified as Class C controlled substances. “Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death.”

Pregabalin may have a higher abuse potential than gabapentin because of its rapid absorption, faster onset of action and higher potency. It also causes a high or elevated mood in users. The side effects can include chest pain, wheezing, changes in vision and less frequently, hallucinations, Gabapentin was said to produce feelings of relaxation, calmness and euphoria. If snorted, its high is similar to using a stimulant.

The use of gabapentin and pregabalin by the opioid abusing population either together or when opioids are unavailable reinforces the behavior patterns of this high-risk population. There is a high risk of criminal behavior stimulated by the wish to obtain gabapentin and pregabalin.

Lyrica (pregabalin) is Pfizer’s top selling drug, with $6 billion in 2014 sales. Pfizer said reclassifying its drugs could harm patients. “Controlling the supply of these products across the whole UK, would be a disproportionate measure that would impact on patients and their quality of life.” An Irish study found pregabalin abuse a “serious emerging problem.” Recreational users in Belfast call the drug “Budweisers because it induces a state similar to drunkenness.” Gabapentin has received more attention as a potential drug of abuse in the US.

In 2012, “Has Gabapentin Become a Drug of Abuse?” appeared in Medscape, but the problem seems to have been somewhat downplayed. The article said: “a small number of postmarketing cases report gabapentin misuse and abuse,” but went on to say the rationale for abuse was unknown. Yet one of cited references for the Medscape article, “Abuse, dependency and withdrawal with gabapentin: a first case report,” did note that consumer websites reported several experiences of gabapentin misuse in order to feel high. “According to these consumer reports, gabapentin effects are close to those of marijuana and can appear with low doses.” Then the article reviewed several articles noting problems with abuse, misuse and withdrawal with gabapentin, essentially what has been reported above. In its conclusion, the article said:

 On the basis of case reports and postmarketing reports, there appears to be potential for abuse, dependency, and withdrawal symptoms associated with gabapentin use. Patients involved in this misuse and abuse were using gabapentin at doses greater than those recommended, to relieve symptoms of withdrawal from other substances, and for uses that are not FDA-approved.Providers should assess patients for drug abuse history when prescribing gabapentin, as well as monitor patients for any signs of misuse or abuse. Prescribers and pharmacists should monitor patients for the development of tolerance, unauthorized escalation of dosing, and requests for early refills or other aberrant behavior. Prescribers should consider requesting testing for the presence of gabapentin in urine drug screens if abuse is suspected.

I’ve personally been hearing reports from individuals in treatment for opioid drug problems consistent with the above information for several years. On one occasion, a woman said after she had told a psychiatrist she has a history of abusing gabapentin, but he prescribed it to her anyway. If you’re interested, a previous article I wrote, “Twentieth Century Snake Oil” reviews a history of Neurontin (gabapentin) that may surprise you. Another article, “The Dark Side of a Pill to Cure Addiction” reviewed mixed findings when gabapentin was used to treat alcohol withdrawal.

04/25/17

Pesticides, Fungi and Pot

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In 2015, two Colorado marijuana users sued the state’s largest marijuana grower, claiming it used a dangerous agricultural fungicide on its pot plants. The fungicide, Eagle 20, contains the chemical myclobutanil, which becomes poisonous when ignited. The allegations were that while Eagle 20 is approved for certain edible products, it is not approved for smokable products like marijuana and tobacco. The lawsuit said: “Persons who smoke cannabis that has been sprayed with Eagle 20 inhale … poisonous hydrogen cyanide.” The company, LivWell, maintained its plants are safe.

The two individuals alleged they were not aware of LivWell’s use of Eagle 20 on their cannabis when they bought it. Had they known, they would not have smoked LivWell’s cannabis. They were asking for a monetary reimbursement for their unused product and were also demanding that LivWell stop using the Eagle 20 fungicide on its cannabis. The plaintiff’s lawyer said that to his knowledge, this was the first product liability action filed against the legal marijuana industry. LivWell’s owner said: “Testing of our finished product by an independent, state-licensed lab approved by the City of Denver showed that our products are safe – as we have always maintained.”

In the end, the lawsuit was dismissed. The Denver judge who heard the case said the plaintiffs couldn’t sue because they were not actually harmed. They bought and then consumed the pot without any repercussions. The written opinion noted there were no allegations that the cannabis did not perform as it was supposed to; and both consumers smoked it without harm. LivWell’s owner said this had been a ploy intended to smear the company’s name. “The people behind this case do not want the commercial cannabis industry to succeed and will try anything to bring down the industry.”

Setting aside the rhetoric from the lawyers on both sides of the dismissed lawsuit and LivWell’s owner, the use of pesticides on marijuana is a growing concern for the industry. The marijuana website The Cannabist has an archived page on marijuana pesticides with fourteen articles published between December 4, 2015 and July 29, 2016. Their titles range from: “Check Your Stash: Are you consuming pesticide-peppered pot? Full recall list” to “State releases hundreds of recalled pot batches after they tested pesticide-free.”

Ricardo Baca and others, writing for The Cannabist, said Denver’s Department of Environmental Health has issued 26 recalls of marijuana and pot products since September of 2015. The Colorado Marijuana Enforcement Division has issued 26 recalls in the form of administrative holds between February and July of 2016. The recalls originated from an executive order issued by the governor of Colorado in November of 2015. Within the order, the governor said: “Until scientific assessment establishes which additional pesticides can be safely applied to marijuana, marijuana contaminated by an Off-Label Pesticide shall constitute a threat to the public safety.”

At the core of legal cannabis’ pesticide problem in Colorado is the state’s lack of a pesticide certification for marijuana testing labs. So while cannabis testing facilities are certified by the state’s health department to test for potency and contaminants, the Colorado Department of Public Health and Environment is still working with other agencies, labs and industry to develop proficiency standards and testing certification requirements for pesticide tests.

Reporting originally for The Denver Post, David Migoya and Ricardo Baca, noted how The Post revealed in its own testing that a number of marijuana-infused products contained high levels of pesticides that shouldn’t be used on cannabis. The Catch-22 is that there is no pesticide specifically approved for use with marijuana, because pesticide chemicals are regulated by the EPA. And since cannabis is illegal under federal law, there are no federal standards. “As a result, there have been no tests to show how pesticides used on marijuana could affect consumers or whether their use is safe.” Colorado state agriculture officials have allowed certain pesticides to be used on marijuana as long as it does not violate the restrictions of the product’s label.

Ron Kammerzell, a senior director in the Colorado Department of Revenue, which oversees the state Marijuana Enforcement Division (MED), said the state’s responsibility was to make sure the marijuana is safe for the consumer and not contaminated by pesticides. The top priority is to keep pesticide-contaminated products from getting to consumers. He added that pesticides were a challenging area fro testing, so they wanted to be sure they did it right. “Once we have mandatory testing for pesticides, that will be a game-changer in terms of making sure that we’re minimizing these types of contaminations.” Kammerzell hopes to have the state’s pesticide testing certification program implemented sometime in 2017.

Writing for Slate, Rachel Gross noted how cannabis vendors are pitching healthier, organic marijuana to their customers. “Like wine aficionados, certain weed smokers have always had a reputation for being connoisseurs.” The U.S. legal cannabis industry was projected to bring in almost $7 billion in 2016. The founder of Clean Green, a marijuana-certifying program, said: “These are sophisticated buyers, the same people who are buying organic food and organic coffee.” The industry is becoming more industrialized and corporate and the fear is that industrial pot is laced with pesticides.

Consider the gram of weed you can buy, right now, in the four states (Washington, Oregon, Colorado, and Alaska) and Washington, D.C., where recreational marijuana is legal (or the 24 states where it’s available for medical purposes). Before it was sealed in that baggie, it was a plant. That plant likely got sprayed with fungus-, insect-, and disease-killing chemicals. Before it was a plant, it was a seedling. That seedling may have sat in soil that had been fumigated with even more pesticides. And before that seedling got planted, the grow room that would one day be its home was probably bug-bombed and lined with pest strips, which are laced with chemicals that linger in enclosed spaces.

Thanks to the series of recalls, like those noted above in Colorado, consumers are becoming more aware of the pesticide issues in the marijuana industry. The Oregonian found abnormally high levels of pesticides in nearly half the products sold in state dispensaries. “Those pesticides included a common roach killer, half a dozen human carcinogens, and a fungicide [myclobutanil] that allegedly turned into hydrogen cyanide when heated.” The dose is the issue. Even a toxic substance like hydrogen cyanide could be harmless in a small enough dose. Oregon is working closely with the state of Washington and Colorado to coordinate which pesticides should be tested for in cannabis.

Researchers at UC Davis recently announced a study that found medical marijuana contained “multiple bacterial and fungal pathogens that may cause serious and even fatal infections.” Smoking, vaping or inhaling aerosolized marijuana may pose a serious health risk to individuals, especially those with impaired immune systems. George Thompson, one of the study’s authors, noted where patients with impaired immune systems are routinely advised to avoid exposure to plants and certain raw foods because of the risk of infection. “But at the same time, they are increasingly turning to medical marijuana to help them with symptom control. Because microorganisms known to cause serious infections in immunocompromised patients were found to be common on marijuana, we strongly advise patients to avoid it.”

They publically voiced their concerns in a letter to the editor of the journal Clinical Microbiology and Infection. There is a copy of the letter here. The news media also picked up on the study. Claudia Black, writing for The Sacramento Bee, said the uneasy news comes as a majority of states have eased laws on medical and recreational marijuana, and a majority of U.S. doctors support the use of medical marijuana for symptoms such as pain, nausea and loss of appetite during chemotherapy and other treatments. George Thompson was quoted as saying it was a big oversight to not warn patients with compromised immune systems to avoid marijuana. “It’s basically dead vegetative material and always covered in fungi.”

The study gathered marijuana from 20 Northern California growers and dispensaries. The analysis of marijuana for the study was done by Steep Hill Labs, a cannabis testing company. “The analysis found numerous types of bacteria and fungi, including organic pathogens that can lead to a particularly deadly infection known as Mucor.” There is a misconception that if it is from a dispensary, the marijuana must be safe. But that’s not the case, according to Joseph Tuscano, another one of the researchers. “This is potentially a direct inoculation into the lungs of these contaminated organisms, especially if you use a bong or vaporization technique.” You can watch a CBS Sacramento news video on the study posted on YouTube here.

So it’s not just that the anti-pot people are out to sink the industry. Its customers are concerned about the presence of pesticides in their pot. Researchers are finding that some marijuana contains common bacteria and fungi that poses a danger to individuals with compromised immune systems. The marijuana industry is going through some serious growing pains. But the question begs to be asked, did the states that legalized recreational and medical marijuana run ahead of the regulatory and bureaucratic changes needed to support it?

04/14/17

An Opioid Shell Game

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Heroin sales and overdoses get a significant mount of attention, but we need to also remember that since 2002, the number of deaths related to controlled prescription drugs (CPD) have outpaced those for cocaine and heroin COMBINED. And the number of individuals who report current use of CPDs is more than those reporting use of cocaine, heroin, methamphetamine, MDMD and PCP (phencyclidine) combined. Each day, 129 individuals die from a drug overdose in the U.S. And yes, five of the seven most prescribed CPDs are opioids. The other two are amphetamine (i.e., Adderall) and methylphenidate (i.e., Ritalin and Concerta).

This information was taken from a yearly statistical summary published by the DEA called the National Drug Threat Assessment (NDTA). The 2016 NDTA Summary covers a wide range of data and classes of drugs. There’s even information on the various drug cartels operating in the U.S. This article will focus on CPDs.

The first figure (Figure 26) gives a comparison of the drug poisoning deaths for prescription drugs, cocaine and heroin from 2007 to 2014. Then Figure 29 shows the top five CPDs distributed nationwide in the BILLIONS of dosage units. Far and away from all the other CPDs, hydrocodone and oxycodone are the most prescribed drugs in the U.S. Both of these figures were taken from the 2016 NDTA Summary.

Not surprisingly, the number of admissions to publically funded treatment facilities for non-heroin opiate/synthetic abuse was 24% higher in 2013 than in 2008. The number of admissions has declined since 2011, but that has been offset by an increase in heroin use between 2011 and 2013.

Recently there has been an increase in the abuse of stimulant medications, specifically amphetamine. Between 2006 and 2011 the nonmedical use of Adderall increased by 67%.  Emergency department visits related to Adderall almost tripled between 2005 and 2010. Misuse of ADHD medications as a class resulted in a 76% increase in poison control interventions from 2005 to 2010.

Young adults 18-25 years old represent the majority of the increase in Emergency Department visits, despite children comprising the largest subset of ADHD diagnoses. Many high school and college age students display limited knowledge of either the side effects or the addictive nature of Adderall. This coincides with the popular reputation of the drug on college campuses as a study-aid to improve concentration, and not something harmful or addictive. This contributes to the increased rate of non-medical use among adults.

Looking at concerns with prescription drug use and misuse from another perspective, a report by Quest Diagnostics suggested many Americans are misusing their prescription drugs. In their 2016 Prescription Drug Monitoring Report, Quest Diagnostics found that 54% of patient specimens showed signs of prescription drug misuse. For the purposes of their analysis, a consistent result was when a patient was taking a prescribed drug appropriately. An inconsistent result meant the patient was either not taking their prescribed drug, was taking drugs in addition to those that were prescribed, or was taking drugs that hadn’t been prescribed to them. These three combined causes of “inconsistent test results” indicated potential drug misuse in the Quest report.

About 45% of the inconsistent specimens showed evidence of patients taking drugs in addition to what was prescribed to them, “suggesting the potential for dangerous drug combinations in a sizeable number of patients.” This 2015 finding was considerably higher than other years. STAT News quoted Quest’s medical affairs director as saying, ““The discovery that a growing percentage of people are combining drugs without their physician’s knowledge is deeply troubling, given the dangers.” Of particular concern is the combination of opioids and sedatives, which can lead to respiratory depression, coma and death. The following graphic was taken from the Quest Diagnostics report.

Quest also examined the drug groups associated with the highest number of inconsistencies, by age groups. Unfortunately, given their composite sense of “inconsistent test results,” it is not clear what caused the top inconsistent drug classes. For example, we can speculate that in the under age 10 category, the top two drug inconsistent classes (amphetamine and methylphenidate) were likely due to no drug found, meaning those children were prescribed, but not taking their ADHD medications. The same can be said for the various places that “marijuana metabolite” appeared. However, the inconsistent classes for benzodiazepines, opiates and oxycodone are not distinguished by cause. So while benzodiazepines are noted as the top inconsistent drug class for every age group over 25, it is not clear if that meant they were taken in addition to what was prescribed or not.

One exception to this was with heroin and benzodiazepines. Quest found 1.56% of their tests were positive for heroin. Among adults who tested positive for heroin, 28.6% were also positive for benzodiazepines. Among those who combined these two drugs, 92.3% of the benzodiazepines were not prescribed.

The Fix, an addiction and recovery website, enlisted Peter Grinspoon, the author of Free Refills: A Doctor Confronts His Addiction, to look at the study. Dr. Grinspoon observed that Quest Diagnostics is in the business of doing urine drug testing, so they are interested in promoting drug testing. He went on to say:

Drug tests simply aren’t that accurate. They’re subject to human and lab error, and are rife with both false positives and false negatives. Savvy drug users can outsmart these tests. Any drug testing needs to be interpreted in the context of who is using the drug and why they are using it.

It is true that Quest Diagnostics makes money by increasing the amount of urine testing it does; that it is interested in promoting and highlighting drug-testing. But this was the fifth Prescription Drug Monitoring Report done by Quest. Additionally, Quest provides testing services to about half of all physicians and hospitals in the U.S. So the claim in the report, that it is “well positioned to identify trends in prescription drug monitoring and misuse” is legitimate.

Further, Dr. Grinspoon’s comments on the inaccuracy of urine testing seem overstated. Yes, there are false positives and negatives; and labs can make mistakes. But he gave the impression these errors happen so often that drug testing was a questionable, unreliable procedure. The FDA, among other sources, considers laboratory testing of urine samples to be the most reliable way to confirm drugs of abuse.

He also seems to assume the testing in the Quest report included drug users given urines as part of their treatment within drug treatment programs, which is not the case. Quest specifically stated that drug rehabilitation clinics and addiction specialists were excluded from the analysis “given the higher rates of testing and potentially higher rates of inconsistency.” There is no reason for a drug user to want to outsmart a urine test done in conjunction with their ongoing medical treatment that I can imagine.

The bottom line is that I think the Quest Prescription Drug Monitoring Report still provides helpful and valuable information on the dangerous practice of combining prescription medications. But prescription drug misuse is just one third of a kind if opioid shell game. Along with heroin and fentanyl, it keeps us trying to guess where the next opioid crisis will be.