Veterans Seminar by TCDLA

VETERANS SEMINAR CO-SPONSORED WITH SBOT MILITARY AND VETERANS LAW SECTION SEMINAR INFORMATION Date Location Course Directors Total CLE Hours

February 3, 2022 Holiday Inn Austin Midtown |6000 Middle Fiskville Road Austin, Texas John Convery, Jon Shelburne, and Terri Zimmermann 7.0 Ethics: 1.0

Thursday, February 3, 2022 Time

CLE

Daily CLE Hours: 7.0 Topic

Speaker

7:30 am

Registration and Continental Breakfast

8:00 am

Opening Remarks

Jon Shelburne

Veterans, Violence, PTSD, TBI, and Legal Defenses

John Matthew Fabian, PSY.D., J.D., ABPP

8:15 am

1.5

9:45 am 10:00 am

Break 2.0

12:00 pm 12:15 pm 1:15 pm

4:00 pm

Tips for Practicing in Veterans Court

Staci Biggar, Adam Brown, Mario Cicconetti and Dr. George Nadaban

Lunch Line 1.0 Lunch Presentation: Representing Veteran NonEthics Profits and the Legal Ethics of Doing So 1.0

2:15 pm 2:30 pm

Ethics: 1.0

Treatment of Moral Injuries to Veterans

Lee Thweatt Dr. Duane Larson

Break 1.5

Interpretative Toxicology in Urine Drug Testing or Medical Cannabis

Dr. Marisol Castaneto

Adjourn

TCDLA • 6808 Hill Meadow Drive • Austin, Texas 78736 • 512.478.2514 p • 512.469.9107 f • www.tcdla.com

Texas Criminal Defense Lawyers Association

Veterans Seminar Co-Sponsored with SBOT Military and Veterans Law Section Table of Contents Speaker

Topic Thursday, February 3, 2022

Staci Biggar, Adam Brown, Mario Cicconetti and Dr. George Nadaban Lee Thweatt Dr. Duane Larson Dr. Marisol Castaneto

Tips for Practicing in Veterans Court Representing Veteran Non-Profits and the Legal Ethics of Doing So Treatment of Moral Injuries to Veterans Interpretative Toxicology in Urine Drug Testing or Medical Cannabis

6808 Hill Meadow Dr :: Austin, Texas :: 512.478.2514 p :: 512.469.9107 f :: www.tcdla.com

Texas Criminal Defense Lawyers Association

Veterans Seminar February 3, 2022

Topic: Tips for Practicing in Veterans Court Speaker:

Staci Biggar

1221 Studewood St Houston, TX (713) 869-3600 Phone (866) 300-1033 Fax Staci@biggarlawfirm.com email

Adam Brown

adambrownlaw@yahoo.com email

Mario Cicconetti

CICCONETTI_MARIO@dao.hctx.net email

Dr. George Nadaban

George.Nadaban2@va.gov email

6808 Hill Meadow Dr :: Austin, Texas :: 512.478.2514 p :: 512.469.9107 f :: www.tcdla.com

Harris County Veterans’ Treatment Court By: Harris County Veterans Court Team

The Problem

There is an ever increasing number of untreated veterans entering the criminal justice system

Harris county jail- 800 veterans detainees Number of incarcerated veterans increased 25% of veterans incarcerated in local jails have mental illness vs. 15% of non veteran population

*Source: Bureau of Justice Statistics' Special Reports: Veterans in Prison and Jail (2000)

Creation of Veterans Court

In 2009, Harris County Judge Marc Carter went to the legislator and created the first Veterans Treatment Court in the State of Texas

Mission ● ● ● ● ● ●

Identify eligible veterans now in the criminal justice system Diverting veterans directly into VA treatment Reducing jail time and costs Reduce criminal recidivism Improving mental health recovery Successful re-entry into the community

Veterans Court Overview

Harris County ● Misdemeanor Veterans Court (founded 2014) ● Felony Veterans Court (founded 2009) ● County fundeded through CSCD (Community Supervision Corrections Department) ● Sequential Interception Model

Collaborative Team

● Judge (District and County Court) ● Prosecutors ● Defense Attorneys ● Program Coordinator ● Case Managers/Liasion ● Mentors ● Veterans Justice Outreach (VJO)

Coordinator ● Forensic Psychiatrist ● Clients

Eligibility Veteran must meet following criteria: ● Honorable or General Discharge, on active duty or in reserves ● Have pending eligible misdemeanor or felony offense (no 3G, No sex assault, No deceased victims) ● Be a legal resident of or citizen of the United States of America ● Be a resident of Harris County/or surrounding counties ● Service-connected disability with a nexus to the offense ● Be eligible for VA services ● Be 1st offender and/or served in combat and /or hazardous duty

Referral Process Referral

Assessment

Entry

Eligibility and Suitability Orientation

Referral • Initiated by defense attorneys completing a Veterans’ Court referral form, which can be found in all courts. • Case is screened for initial criteria on merits. • Referrals must be approved by the assigned court’s judge and chief prosecutor. • Referral request form should be forwarded to the Veterans’ Court program manager: • - ARIEL SANCHEZ: ArielSanchez@justex.net/832-927-4331 • - S. MICHELLE BARNETT: sara.barnett@csc.hctx.net/713-755-2559 • Client is then sent for an assessment = clinical evaluation

Assessment and Eligibility

● VTC coordinator sends ROI to VJO to clear for eligibility ● VJO schedules client for forensic evaluation ● Forensic psychiatrist with the VA does an evaluation and determines if there is a Nexus between offense and diagnosis ● Forensic Evaluation sent to team for acceptance ● DA makes offer to the defense attorney for probation, DADJ or PTI

Clinical Assessment

● ●

Independent Evaluation Servicing 8 contiguous counties Document Review Waiver of confidentiality and HIPAA In-person assessment Clinical determination

●

Challenges ○

Clinical Assessment

Cont.

○

Communication issues Conflicts with other clients Elements that process unsuccessful

○

Trust

○

Lack of nexus

○

Subjectivity

Orientation and Entry

● ● ● ● ●

One-on-one meeting Explain contract Treatment plan Expectations Meet Defense Attorney ● Legal Issues ● Voice in staffing ● Raises issues with judge and staff ● Works with team

●

Case is scheduled to plea before the court ● Outcomes (PTI, DADJ,

probation)

Program

● Intensive supervision and

addressing a range of factors: ● service-related PTSD ● damaged relationships due to ● ● ●

their time in the service chronic unemployment and homelessness history of domestic violence substance abuse history other mental health issues

● Staffing ● 4 Phases ● Rewards ● Sanctions ● Graduation

Program

Graduation ● End goal ● Typically Minimum of 18 months to complete full treatment ● Response phases of the program ● Ceremony ● ●

Flag Recognition

Aftercare ● 6 months continued treatment ● Re-entry programs ● Vocational skills ● Housing and job opportunities ● Mentorship

VIGNETTE #1

VIGNETTE #2

VIGNETTE #3

VIGNETTE #4

QUESTIONS?

•

Staci Biggar staci@biggarlawfirm.com Mario Cicconetti cicconetti_mario@dao.hctx.net Adam Brown adambrownlaw@yahoo.com Dr. George Nadaban george.nadaban2@va.gov

Texas Criminal Defense Lawyers Association

Veterans Seminar February 3, 2022

Topic: Representing Veteran Non-Profits and the Legal Ethics of Doing So Speaker:

Lee Thweatt (713) 600-4710 Phone (713) 600-4706 Fax lthweatt@terrythweatt.com email

6808 Hill Meadow Dr :: Austin, Texas :: 512.478.2514 p :: 512.469.9107 f :: www.tcdla.com

Representing Veteran NonProfits and Legal Ethics L. Lee Thweatt Terry & Thweatt, P.C. 114 Byrne Street Houston, Texas 77009 (713) 600-4710 lthweatt@terrythweatt.com

My Client

Remember, you represent the entity

What My Client Does

Eligibility Requirements

The Lawsuit Toribio Reyes vs. Fidelity Investments vs. Marine Corps Scholarship Foundation 239th District Court of Brazoria County, Texas

Thomas Marvin Jones, Age 83

The Facts

Police find Jones driving erratically

Jones’ mental decline

Jones’ mental decline at the nursing home

Jones’ mental condition on June 3, 2016

The Plot Thickens on June 3, 2016…

Where did Jones sign the new beneficiary form? Who typed the new form?

Who signed Jones out of the nursing home?

Execute an Engagement Letter with the Client

Can you change the pro bono deal?

Texas Disciplinary Rules of Professional Conduct

What is an unconscionable fee?

Conflicts of Interest Exceptions

Can you threaten criminal charges?

Are you competent in this area of the law?

Lee Thweatt Honorary Scholarship Recipient

Texas Criminal Defense Lawyers Association

Veterans Seminar February 3, 2022

Topic: Treatment of Moral Injuries to Veterans Speaker:

Dr. Duane Larson (563) 599-5224 larsondh@gmail.com Phone larsondh@gmail.com email

6808 Hill Meadow Dr :: Austin, Texas :: 512.478.2514 p :: 512.469.9107 f :: www.tcdla.com

Discerning and Healing Moral Injury of Military Service Members and Veterans A Presentation for the Texas Criminal Defense Association Austin, TX, February 3, 2022 By Rev. Duane H. Larson, Ph.D. Princeton, IA and Houston, TX Introduction Thank you for the invitation to speak with and learn from you today. I never imagined that I would be speaking to a group like you, though, perhaps, had I thought more carefully about it, I might have discerned earlier that I should not be surprised. As a matter of some further background, I am trained both as a practical pastor and as an academic systematic theologian. Systematic theologians and attorneys may well have more in common than you yourselves had imagined, perhaps now to your own collective surprise. What is a systematic theologian, you ask? A personal favorite joke about the so-called ivory tower out-of-touch theologian may illumine. There once were three famous theologians: one a Presbyterian strong on predestination; another an Episcopalian strong on liturgy; the third a hyper-confessional, orthodox, conservative, Lutheran theologian, not to put too fine a point on it. To their dismay they die rather simultaneously and find themselves together at the pearly gates. To their further dismay they learn that they must pass an exam to be able to stay. After a breath, the first predestinarian theologian says that this should be no problem. After all, he was predestined to be there. So he walks in rather confidently. Only five minutes later he comes walking out, bewildered, saying that everything he had taught and wrote was wrong. He didn’t understand. He did not pass the exam. He could not stay. So away he went. The second liturgical theologian had been intoning psalms to himself and chanted lauds as he entered. Ten

2 minutes later he came shuffling out, crying profusely, beating his chest, and chanting, “I did not pass the exam. I cannot stay.” The third one, that rigorously orthodox hyper confessional conservative Lutheran theologian (not to put too fine a point on it), stood up, back straight and chin out, walked in, and fifteen minutes later, God walked out. I like to use that joke to reorient people to what theology should be about. It is not about religion as having “the” right answers, and surely not about having and requiring abusively right answers, of which we have much too much. It is the relationship to one’s spiritual center, one’s commitment to a transcendent source and meaning for one’s life, that counts above all else, and that in virtually all respects is signaled in one’s claim and practice of moral convictions. In other words, the “right” theologian and pastor would seek to sustain peoples’ relationship with that which they understand to be sacred. And, indeed, however differentiated your terminology from divine causality might be—the work of defense lawyers is similar, surely so when caring for persons wounded by Moral Injury. So, surprise! We theologians and criminal defense lawyers gathered here, thankfully, at not quite the pearly gates have much in common. From my perch as a pastor and theologian, I perceive that we together are not interested only in defending walking sacks of flesh. And we are not about asserting or defending God, because God can assert or defend God’s self, if that is ever an issue. But we are defending the innate divine dignity in the neighbor, including each other as neighbor, by the way. These are my terms and necessarily not your terms. Your terms are more public and necessarily respectful of both of secularity and pluralism. But we stand on common ground

3 even if named differently, which is why I am grateful to be here. And therefore we each and all are deeply invested in recognizing and healing moral injury, not a least part of which is to defend and heal the guilty, because misplaced guilt and consequent maladaptive behavior is at the core of Moral Injury. Definition and Characteristics of Moral Injury Moral Injury (MI) is a relatively recent adopted term for a classic dis-ease that western society had forgotten or neglected for the last, shall we say, 500 years, if not much longer. It returned to our collective screen in psychiatrist Jonathan Shay’s work with military returnees, most notably in what counts now as standard required literature, his Achilles in Vietnam.1 Therein Shay defines MI as “the betrayal of ‘what’s right’ in a high stakes situation by someone who holds power.” This definition summarizes “the betrayal model” of MI which Shay refined in his subsequent book, Odysseus in America.2 You can see already that Shay’s creative re-reading of Homer is compelling. He reads that Agamemnon betrayed Achilles by taking away Achilles’ prize of war, a captive woman named Briseis. We’re talking about relative cultural understandings here, and surely Briseis was morally abused by her and our standards. But it is Agamemnon’s betrayal that injures Achilles’ moral center and sends him on a long odyssey of maladaptive behavior. In other words, Achilles was deeply morally betrayed for which he was not objectively guilty, but subjectively felt so. In turn, this caused maladaptive behavior (however elegantly poeticized by Homer!) for which Achilles consequently was indeed objectively guilty.

1 2

Shay, Achilles in Vietnam: Combat Trauma and the Undoing of Character (New York: Simon and Shuster, 1994). Odysseus in America: Combat Trauma and the Trial of Homecoming (New York: Scribner, 2002).

4 We call this “the betrayal model of MI.” You readily recognize examples from military culture and history with the name of My Lai and in civilian culture with priests who betray personal boundaries and bad cops who summarily execute without fair trial. Witnesses with a conscience likely are outraged. Some, not all, may experience moral betrayal and subsequently act out, having theretofore trusted the person or system in authority. There is also a yang to the yin of the betrayal model. This is the perpetrator model, clarified by psychiatrist Bret Litz. This model is as important as the betrayal model and may even be more influential. In 2009 Litz and his team defined MI as “the lasting psychological, biological, spiritual, behavioral, and social impact of perpetrating, failing to prevent, or bearing witness to acts that transgress deeply held moral beliefs and expectations.” 3 The actions of the individual are central here. The actions may be militarily or legally necessary, such as a sniper’s killing of a young child because she wears an explosive-laden vest as military unit approaches her. The guilt is both objective and subjective, but the MI is discerned in the dominance of the subjective. I have heard this guilt so often from vets, usually at a reception following a battle buddy’s funeral, when a vet with the third beer in his hand says to me, “Padre [a personal address I’ve come to deeply value as an honorific], God will never forgive me for the things I saw and had to do.” When left unaddressed, this signal of MI that one is “unworthy of forgiveness” can lead to withdrawal from relationships, poor self-care, chronic anger, self-handicapping behaviors, over self-medicating, depression, self-loathing, and self-harm. There are no data about the

Brett T. Litz et al, “Moral Injury and Moral Repair in War Veterans: A Preliminary Model and Intervention Strategy,” Clinical Psychology Review 29 (2009) 697.

5 matter, but I and most students of MI believe that it is a causal factor in at least some of the 22 veterans and service-members who on average daily commit suicide. Let me be clear. MI is not just a reaction to a traumatizing event. It is a full-de-centering. As Litz and William Nash emphasize, Central to the concept of moral injury is an event [or the final event in an aggregation of such events that is not only inconsistent with previous moral expectations, but which has the power to negate them. Moral Injury is not merely a state of cognitive dissonance, but a state of loss in previously deeply held beliefs about one’s own or others’ ability to keep our shared moral covenant.4 Further definitions of MI abound and there is no one such summary as yet that might gain attention enough for it to be entered into the DSM. The lines between the betrayal and perpetrator definitions are blurred, but they are the normative operators now in the theory and treatment of MI. There are at least 18 further appreciated definitions, mine with co-author Jeff Zust among them. I regard them as nuances of the Yin and Yang paradigm I have summarized here.5 The perpetrator model, also, should make it clear that while situations that cause PTSD may also be generate MI, PTSD and MI are not the same. PTSD is about physical trauma that can cause maladaptive behaviors. MI is distinctly moral. A good slogan about the difference is this; “PTSD is about damage to one mortality and MI is about damage to one’s morality.” Or as

William P. Nash and Brett T. Litz, “Moral Injury: A Mechanism for War-Related Psychological Trauma in Military Family Members,” Clinical Child and Family Psychology Review 16 (2013) 368. 5 Duane Larson and Jeff Zust,, Care for the Sorrowing Soul: Healing Moral Injuries from Military Service and Implications for the Rest of Us (Eugene: Cascade, 2017). Also, see especially Nancy Sherman, After War: Healing the Moral Wounds of Our Soldiers (Oxford: Oxford University Press, 2015); Rita Nakashima Brock and Gabriella Lettini, Soul Repair: Recovering from Moral Injury after War (Boston: Beacon, 2012); Brandon J. Griffin, Natalie Purcell, Kristine Burjman, Brett T. Litz, Craig J. Bryan, Martha Schmitz, Claudia Villierme, Jessica Walsh, and Shira Maguen, “Moral Injury: An Integrative Review,” Journal of Traumatic Stress 32 (June, 2019) 350-62.

6 US Army veteran Michael Yandell put it, with MI “The spiritual and emotional foundations of the world disappeared…What I lost was a world that makes moral sense.”6 I am only speaking of MI specific to military service persons and veterans, not the world beyond military culture of diverse circumstances and causalities in and by which MI occurs. Primary “universals” are unique bodies and minds that generally suffer similarly and yet also particularly uniquely. MI, whether in military or civilian contexts, is substantively different when the trauma targets race or gender or age or worldview. So, of course, how we address moral injury in specific cases is related to how caregivers and the cared for each understand their particular spiritual and moral universe. This is likely why, also, there is no universal definition for MI. As Gabriella Lettini says, “Multiple approaches are needed for the specificity of different contexts and lived experiences, as well as peoples’ different spiritual, religious, and philosophical belief systems.”7 Also, it is no afterthought for me to state clearly per my own faith tradition and the philosophy of law since the Magna Carta is that the principle to which I is that every human being bears divine dignity. Which brings me to one other necessary caveat before I proceed to treatment strategies and programs specifically. When we recognize that a person has been morally injured, we have something good to work with. That person’s exigency, assuming she or he above all wants to redress it, happens because there is a moral core—a conscience, if you will—that still drives that person’s desire toward healing. As Viktor Frankl observed from his dire post-concentration camp experience that human beings can only truly live by hope, so also we infer that hope is

6 7

Michael Yandell, “The War Within: A Veteran’s Moral Injury,” Christian Century 132, no 1 (January7, 2015) 12. Lettini, “Moral Injury and Its Causes, Symptoms, and Responses,” in Kelle (ed.) op.cit., 41.

7 driven by conscience still beating no matter how beaten. That is the premise from which all more good with hard work will grow, like new shoots from a desiccated tree trunk. For those who are so inclined, the language of a spirituality appropriate to the person and circumstances can hence guide conversation. Having Seen the Signs, How to Help Heal? Given the matter of diversity, of course I cannot here give you a short list of programs that treat everyone alike. I can suggest, kinds and trajectories of extant and emerging care. While treatment can and does center on strictly clinical approaches, because of the uniquely moral qualifier it is not rare to find chaplains or other religious professionals trained for MI care as partners with the clinicians. It is also recognized in the literature that leaders who are respected for spiritual authority and expertise pertinent to MI even may be necessary partners for effective care, while the spiritual accents are never (and must never be) sounded in proselytizing or religiously hegemonic tones. Most any VA center will have capacity for clinical individual and group work with vets who suffer MI.8 The preferred modality is Cognitive Processing Therapy (CPT, sometimes elided with Cognitive Behavior Therapy, CBT). CPT is a manualized evidence-based treatment for PTSD, and has been used increasingly for MI. It uses cognitive restructuring and behavioral exercises To help individuals change how they think about the even(s) that precipitated their MI.

I here follow and summarize the work of Katy Barrs, Psy.D., and Carrie Doehring, PhD in their article, “An Intercultural Approach to Spiritually Oriented Therapy of Military Moral Injury,” in Steven J. Sanadage and Brad D. Strawn (eds.), Spiritual Diversity in Psychotherapy; Engaging the Sacred in Clinical Practice (Engels: 2021).

8 Special focus is given to “stuckpoints” in the individual’s perception/recall of events. Use of resources like Jonathan Haidt’s work on moral tastes and structures helps the counselor socratically with the individual to author a new narrative frame for him/herself. But latitudinal studies suggest that CPT on its own does not ensure long-lasting results. A “third-wave” behavioral intervention called ACT (Acceptance Commitment Therapy) shows itself to be better suited to treating spiritually related psychological or emotional struggles like MI. ACT is value-driven, as commended by use of Haidt, et al, and clearly implies that previous techniques (like CBT alone) that try to avoid or suppress inner experiences actually exacerbate the distress. A type of CBT intentionally allied with other modalities, called Trauma Informed Guilt and Shame Reduction Therapy, is the focus of a research team at the San Diego VA Medical Center led by Dr. Sonya Norman. Without using the term “Moral Injury,” they use Shay’s definition to introduce possible clients to that team’s work. Their method is among the first transdiagnostic interventions and is intended as a brief therapeutic regimen for use in a variety of clinical settings, particularly military venues where servicemembers are preparing to redeploy. With Dr. Arial Lang, the program also teaches “Cognitively Based Compassion Training,” a form of meditation to address the needs of Veterans with PTSD as well as MI. It would appear, at least from an informal survey, that the modality now most used is Adaptive Disclosure Therapy, refined, published, and practiced by Brett Litz and his team at the Boston University Medical Center.9 10 While anticipated in many converging ways by the above

See https://profiles.bu.edu/BrettLitz. Litz, et al. Adaptive Disclosure: A New Treatment for Military Trauma, Loss, and Moral Injury (Guilford, 2016).

9 noted techniques, ADT “promotes coming to terms with the meaning and implication of traumatic war experiences” like MI. Further, ADT seeks to reduce the damaging ways by which individuals construe MI’s long-term impact.11 ADT’s uniqueness lies in its use of multiple other strategies, including CBT, to address traumatic loss and guilt in addition to the presenting trauma. The service member or veteran sets the agenda by answering the question “What do you need to heal and recover from the three different harms” of life threat, loss, and moral injury. And so begins a journey with the care-giver that includes experiential and emotional processing precedent to the emergence of new understanding and one’s new personal narrative. Of course, as with any modality, ADT does not “stand alone.” It centers most clinical MI treatment programs and is accompanied by other approaches and persons appropriate to an individual’s circumstances. For example, the Clinical Psychiatry department of the San Diego Navy Medical Center more expressly researches and treats MI with the partnership of chaplains trained in the subject and the department uses ADT along with other techniques, with Prolonged Exposure Therapy as a favored partner modality. We are beginning now to see such programs duplicated and/or adapted at many more VA centers. I count a leader (if not the leading) program at VA medical centers to be that led by the Rev. Chris Antal at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia. Himself a former front-line chaplain with the Army in Afghanistan and a Unitarian Universalist minister, Chris developed a group program in partnership with the center’s psych department. The program last several weeks. It includes group and individual work and is comfortable with

Ibid.,1-3.

10 occasional use of inter-religiously sensitive language. Each iteration of the program culminates with a Community Healing Ceremony that has become so well-attended by program participants, hospital staff and the public that ticketed reservations are required. This success provides a platform for further training for spiritual leaders who want to build their own capacities for similar work. In sum, the Philadelphia program and others employ adaptive disclosure, mindfulness training and TRE (Trauma Release Exercises), opportunities for self-expression through the arts,12 Ritual Community Building, and a concluding ritual. Within and beyond such programs, too, program participants are encouraged to do community service. As General James Mukiyama (Ret.), founder of Military Outreach, USA, with any MI treatment, service members, veterans, and their families must (1) come to understand their struggles, (2) experience forgiveness, and (3) reclaim self-worth by serving others. Members of military culture, after all, respond well when they are given a mission.13 I am happy to say that the recognition and treatment of MI in veterans especially has grown over the last several years. I was not happy to learn firsthand in 2016, for example, that facility chaplains were not acquainted with MI and that they were not able at length to work with PTSD patients. That has changed. More centers are acquainted with or conduct programs like those in San Diego or Philadelphia. As impressively, clinical recognition of MI in VA Centers has grown well with the use of a tool called The Military Version Short Form of the Moral Injury

Notably, the Moral Injury Association of America sponsors a writing group in Kansas City that helps veterans treat their MI with poetry and prose. See The Texas Standard news program of December 28, 2021. 13 Duane Larson, “Spiritual Formation and Pastoral Care Approaches to Moral Injury,” in Brad Kelle, (ed.). Moral Injury, A Guidebook for Understanding and Engagement (Lanham: Lexington Books, 2020) 130.

11 Symptom Scale (MISS-M-SF). In the research toward adopting the instrument, test-retest reliability scored at 0.87 accuracy and convergent reliability with the larger scale was 0.92. In this instrument, over 70% scored a 9 or 10 (the highest possible) on at least one item in the 10item scale. This provides a baseline from which any VA Center can at least assess a prospective client and provide further treatment or suggested treatment. A partnership where the clinical allies with socio-religious therapies is a good criterion for effective treatment programs. 14 Governmental recognition of the importance of spiritual components in MI (and PTSD) recovery is also signaled in the work of Dr. Irene Harris at the Veteran’s Medical Center in Minneapolis. There she and her team have developed a set of training materials for chaplains in multiple VA settings called “Building Spiritual Strengths.” “Communalization of Trauma” As one could (and should) infer from above, the most effective treatment programs so far include individual and communal work, recognizing that access to spiritual care also is integral. One might justifiably argue that the accent is on a spirituality, however inchoate, in a communal setting. MI sufferers need battle buddies who understand the plight and the language. This is a matter, it seems, that Homer and colleague writers from the beginning of articulated war cultures understood, as did the leaders of such societies too. It was a requirement after a war’s conclusion that the whole city-state attend a ritual play, written for that time—in which all, the good and the evil—was narrativized. Privates sat next to generals, as it were, if even vicariously by way of such liturgy to witness moral evil and moral good, to

See Wyatt R. Evans, et al., “Morally injurious events and psychological distress among veterans: Examining the mediating role of religious and spiritual struggles, in Psychological Trauma: Theory, Research, Practice, and Policy, 2018, Vol. 10 No. 3 (May) 360-367. https://doi.org/10.1037/tra0000347. Also,

12 lament and confess, together to know catharsis (if not forgiveness) and then all returned to civilian life. Our forbearers, in other words, knew that trauma must be communalized. At least that sentiment is returning via effective research and therapy. It is made most explicit in the pioneering work, for example, of Edward Tick15 and in American culture has been arguably bestpreserved among Native Americans, wherein the return to from US military service to one’s tribe is normatively met with a re-communalization of member to tribe and tribe to member in ritual and much conversation. Tick’s work adapted such insight and is now carried forward by its influence on successor programs throughout the country, particularly that of his longtime protégé, Charlie Pacello, who leads “The Warrior’s Heart Retreat regularly in Colorado. 16 The work is adapted in John Schluep’s “Warrior’s Journey Home”17 and informs the pioneering efforts of Rev John Sippola, a retired Naval chaplain. Sippola’s program is a pioneering immersive five-day retreat, following an adapted Alcoholics meeting style, intended primarily for blue-collar vets and their families. It is unique, too, in that it is structured to generate more trained teams and healing events. Retreats include the sharing of vivid trauma narratives after some formal presentations to frame the days together. Large group discussion of the primary participants requires lay civilian attendees (leaders in training) to “eavesdrop,” after which sometime, often informally, civilians will share their own trauma stories, having perhaps for the first time “discovered” influential occasions of

Edward Tick, War and the Soul, Healing Our Nation’s Veteran’s from Post-Traumatic Stress Disorder (Quest Books, 1995); Warrior’s Return, Restoring the Soul after War (Sounds True: 2014). 16 www.coresoulhealing.com 17 See https://warriorsjourneyhome.org.

13 trauma in their own lives. No formal religious or denominational terms are used until and unless a primary participant is disposed to use them. “Real work” will happen though, with the informal private conversations that occurs after trust has been well established. Sippola’s efforts continue, especially with the priority of duplication. The COVID pandemic, of course, has slowed efforts. I regard Sippola’s program as one that should be duplicated and allied with many faith-based communities., were the training (including help from higher education, as with seminaries) made available, even curricularly. The communalization priority finds another analog in the work of Rev. Scott Hutchinson, who has also worked with Chris Antal in Pennsylvania. Hutchinson’s parlayed his training in veteran trauma care into religious congregational ownership with a “Veteran’s Ministry Team” at his parish. Since 2014, his congregation has sponsored Soldier’s Heart retreats and committed to further developing larger “Circles of Trust” beyond the particular parish in partnership with the Veterans’ Community Network. One example of a deeply meaningful consequence of these efforts is the ritual of “The Witting Tree” begun at Hutchinson’s congregation. Inspired by the ancient Greek civic practices, each morning of eleven days leading to and including Veteran’s Day, a brief public ritual is held with prayer and the hanging of twenty-two dog tags, representing the daily average of militaryrelated suicides. The church then hosts an inter-religious service on Veterans Day evening. A similar service is held on Memorial Day. A similar practice with a congregation in Houston three years ago. While adoption and growth is slow, the congregational and larger public need for communalization is with deliberateness being met.

14 An unanticipated result of such efforts is that congregations discover and begin to care more intentionally for the veterans the congregation had not recognized in its own ranks. This discovery was formalized when the US Department of Veterans Office of Rural Health found that twenty-four members of the average rural congregation are veterans. With the help of the commercial sector, the department produced training videos for clergy focused on 1) description of military culture and wounds of war; 2) the needed shape of pastoral care for veterans and families; 3) mental health resources and references; 4) building broader community partnerships. High demands on clergy and other local religious leaders make it very difficult for them to be more than advocates and overseers, but the roles are necessary even so and their presence could indicate to us healthy places and people to which and whom we could turn for further help with clients who suffer MI.18 It is not possible here to name, detail, and assess every available treatment program for MI. I have given more attention by example to the sorts of programmatic components that one should consider when identifying and recommending such programs. In sum, the should integrate a number of therapeutic approaches centered by the narrative midwifery of adaptive disclosure or similar techniques. They should loosely offer a spiritual sensitivity not unlike, at least, that of AA and be devoid of any evangelistic or proselytizing practices. They are better conducted as a lengthy series or an intensive retreat experience. Above all, they offer the “communalization of trauma” wherein the shared experience of each other’s stories finds

See Keith Ethridge and Steve Sullivan, “Rural Promising Practice Issue Brief: Training and Connecting Community Clergy Partners to Increase Access to Care for Rural veterans, U.S. Department of veterans’ Affairs Office of Rural Health,” (November 2016) www.ruralhealth.va.gov.

15 consonance and the compassionate room for new self-understanding and sense of purpose to grow.

Conclusion There is one further matter that one must assure is not included in recovery programs. Just as overt sectarian religiosity is unhelpful, it is also true that any components of “civil religion” and popular patriotism are counter-effective. The wounded warrior soul is not comforted by mere words of thanks for service and not by patriotic rallying of any sort when in the healing context. The point when a sufferer of MI is there is to find a new way to understand one’s self and one’s purpose in life, to be forgiven for evil done no matter how necessarily, subsequently to be able to forgive one’s self, and then to practice a renewed mindful life in which the herky-jerky growth spurts of real human life are celebrated and in which lament and confession in life’s inevitable sorrowing moments can be practiced as portals back toward gratitude and compassion, including compassion for one’s self. And, of course, every person’s journey, necessarily communal if healthy, is also unique and very personal. Just as the body carries and remember the accumulated weight of all its psychic and physical traumas, so also each body/psyche is further differentiated by its gender, color, class, religiosity, and more. 19 We are, after all, mutually in-forming as human beings. We are braided selves, given and building

Very useful sources here include the work of Carol Gilligan, Serene Jones, and many others on feminist trauma theory. Besser Van Der Kolk’s How the Body Keeps the Score has been a game changer for many who practice law. Resmaa Menakem has recently become well-known about racialized trauma, including racial factors in moral injury. A psychotherapist and consultant to the Minneapolis Police Department, the importance of his work cannot be overstated. See his award-winning My Grandmother’s Hands: Racialized Trauma and the Pathway to Mending our Hearts and Bodies (Central Recovery Press: 2017).

16 identity in every moment by each other and circumstances, whatever the time or wherever the place given us. Which is also to say, very directly and very compassionately, do not neglect, dear colleague stakeholders in guilt and forgiveness, that you yourselves may discover injuries in your own lives you’d rather not recall. But they are necessary to name, and so necessary to share with trusted fellow travelers. When I asked via my social media accounts recently for more current information about the state of care for MI, one colleague wrote that he couldn’t imagine any audience more exposed as candidates for collateral moral damage as you. You see and have seen a lot. It can be the stuff of dark humor (yes, clergy know that too!), which is an okay way in trusting collegiality to deal with it. And if you discern something more in need of compassionate care, as I’ve here suggested, there are many ways institutionally and personally now effectively to name newly for yourself the injury and to heal. In other words, you have some basic clues, if you need them, that the lead character of “Better Call Saul” did not know or access. I’ve hardly scratched the surface here. But I hope I’ve said what is most important to introduce you to the matter, on which basis you can learn more and do so with dispatch when necessary. Thank you so very much for the invitation to share this. Thank you especially for the essential work you do for personal human health and for the sustenance of the social contract unique to our free democratic society and the de facto moral covenant that guides us all. In any other ethos we likely would not have even the opportunity to treat moral injury, much less to name it.

Texas Criminal Defense Lawyers Association

Veterans Seminar February 3, 2022

Topic: Interpretative Toxicology in Urine Drug Testing or Medical Cannabis Speaker:

Dr. Marisol Castaneto DOD Food Analysis and Diagnostic Laboratory 2899 Schofield Road San Antonio, TX 78234 (210) 295-4732 Phone (210) 295-4732 marisol.s.castaneto.mil@mail.mil email

6808 Hill Meadow Dr :: Austin, Texas :: 512.478.2514 p :: 512.469.9107 f :: www.tcdla.com

INTERPRETATIVE TOXICOLOGY IN URINE DRUG TESTING LTC MARISOL S. CASTANETO, PHD, F-ABFT CHIEF QUALITY ASSURANCE DOD FOOD ANALYSIS & DIAGNOSTIC LABORATORY

Disclaimer This certifies that the views expressed in this presentation are those of the author and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.

HISTORY OF DRUG TESTING • HAVE BEEN AVAILABLE FOR ALMOST 50 YEARS • 1984: WORKPLACE DRUG TESTING WAS ESTABLISHED IN THE MILITARY • 1986: EXECUTIVE ORDER INITIATED THE FEDERAL DRUG-FREE WORKPLACE PROGRAM • 1987: PUBLIC LAW 100-71 OUTLINED THE PROVISIONS FROM DRUG TESTING IN THE FEDERAL SECTOR • 1988: FEDERAL MANDATORY GUIDELINES SET SCIENTIFIC AND TECHNICAL STANDARDS FOR TESTING FEDERAL EMPLOYEES • 1989: US DEPT. OF TRANSPORTATION (DOT) REQUIRED TESTING OF NEARLY 7 MILLION PRIVATE-SECTOR TRANSPORTATION WORKERS IN DOT-REGULATED INDUSTRIES • FEDERAL GUIDELINES COVERED PROCEDURES, REGULATIONS AND CERTIFICATION REQUIREMENTS FOR LABORATORIES AND MANDATORY MEDICAL REVIEWS BY A MEDICAL REVIEW OFFICER (TRAINED PHYSICIAN). • TESTING COMPRISE OF INITIAL AND CONFIRMATORY DRUG (ANALYTE) ANALYSES 3

TITLE 21 USC CONTROLLED SUBSTANCES ACT The CSA places all substances which were in some manner regulated under existing federal law into one of five schedules. • Schedule I: no currently accepted medical use, lack of accepted safety for use under medical supervision and a high potential for abuse •

•

• •

– E.g. THC, heroin, LSD, cannabis, peyote, MDMA/MDA (“Ecstacy”), synthetic cannabinoids Schedule II/IIN: have a high potential for abuse which may lead to severe psychological or physical dependence – E.g. cocaine, hydromorphone/hydrocodone, methadone, oxycodone, fentanyl, morphine, codeine

Schedule III/IIIN: have a high potential for abuse lesser than Schedule I and II substances and may lead to moderate or low physical dependence or high psychological dependence – E.g. products containing not more than 90 mg of codeine per dosage unit (Tylenol with Codeine), buprenorphine, ketamine, anabolic steroids Schedule IV: have a low potential for abuse relative to Schedule III substances – E.g. benzodiazepines Schedule V: have a low potential for abuse relative to Schedule IV substances and consist primarily of preparation containing limited quantities of certain narcotics – E.g. preparations with no more than 200 mg of codeine per 100 mL or per 100 gm

DRUG TESTING APPLICATIONS • WORKPLACE DRUG TESTING (PRE-EMPLOYMENT AND DURING) • HUMAN PERFORMANCE (ANTI-DOPING, DUI/D) • CRIMINAL OR CIVIL INVESTIGATIONS (MVA, SUICIDE, HOMICIDE (OR ATTEMPTED), ASSAULTS, CHILD ENDANGERMENT/ABUSE, ETC.) • ENVIRONMENTAL EXPOSURE AND TRAINING ACCIDENTS • PAIN MANAGEMENT AND COMPLIANCE INCLUDING THOSE ENROLLED IN SUBSTANCE ABUSE PROGRAM AND ON PAROLE • ACUTE INTOXICATION (EMERGENCY ROOM VISITS) AND POSSIBLE CHRONIC EXPOSURES TO AN UNKNOWN AGENT • MATERNAL AND PRE-NATAL EXPOSURE 5

HUMAN MATRICES

Source: DHHS, Clinical Drug Testing in Primary Care (TAP 32), Ch. 2, page 12 6

HUMAN MATRICES - STABILITY • DRUGS IN BLOOD COLLECTED WITH PRESERVATIVES (IN GRAY TOP) CAN BE STABLE FOR A FEW DAYS TO A WEEK AT ROOM TEMPERATURE; LONGER IF REFRIGERATED OR FROZEN. • DRUGS IN URINE CAN BE STABLE FOR MANY DAYS AT ROOM TEMPERATURE, BUT CAN BE AFFECTED BY MICROBIAL (ENZYMATIC) ACTIVITIES, URINE PH AND EXPOSURE TO LIGHT (E.G. LSD, COCAINE METABOLITE). • DRUGS IN ORAL FLUIDS (SALIVA) IS STABLE IN A BUFFER WHEN STORED REFRIGERATED AND LONGER IF FROZEN. • DRUGS IN HAIR IS STABLE AT ROOM TEMPERATURE; UNLESS EXPOSE TO THE ELEMENT THAT CAN DETERIORATE THE CONDITION OF THE HAIR/ 7

LABORATORY INITIAL TESTING METHODS Testing Method

Description

Enzyme-Multiplied Immunoassay Technique (EMIT)

• • •

Immunoassay Competitive binding between drug in specimen and drug-labeled enzyme. Enzyme activity decreases when bound to the antibody.

Cloned Enzyme Donor Immunoassay (CEDIA)

• • • •

Immunoassay Enzyme donor (ED) and acceptor fragments, inactive when separated (bacterial beta galactosidase) Competitive binding between drug in specimen and ED Enzyme activity decreases when ED is bound to the antibody

Enzyme-Linked Immunosorbent Assay (ELISA)

• • •

Immunoassay Interaction between immobilized antigen and antibody Direct, Indirect or Capture Assay (“sandwich”)

Lateral Flow Assay

• • •

Immunoassay Competitive binding between the drug in specimen and colored conjugate Antigen binds to the antibody preventing the conjugate to produce a signal (color) in the test line

Biochip Array Technology

• Immunoassay • Competitive binding between drug in specimen and enzyme-labeled conjugate • Enzyme activity (chem-illuminescence) decreases when drug is bound to the antibody

Mass spectrometry (interfaced with direct injection, liquid or gas chromatography)

• Relies on molecular formula and fragmentation pattern of the target drugs • Triple quadrupole, or high resolution (e.g. time-of-flight, Obitrap) • Typically performed as a full-scan (qualtitative)

CUTOFF CONCENTRATIONS Cutoff values are the drug concentrations above which the presence of a drug will be reported. Concentrations < cutoff values will not be reported. Cutoff values can be set by regulation, laboratory or manufacturer.

SAMHSA – Substance Abuse and Mental Health Services and Administration

Source: https://www.samhsa.gov/sites/default/files/workplace/2010GuidelinesAnalytesCutoffs.pdf

IMMUNOASSAY (IA) APPROACH ADVANTAGES o FULLY AUTOMATED, GREAT FOR HIGH THROUGHPUT o MINIMAL OR NO SAMPLE PREPARATION REQUIRED o CALIBRATION STABLE FOR MANY DAYS OR WEEKS o INSTRUMENTS OPERATED BY MEDICAL TECHNICIANS

o o o

o GOOD SENSITIVITY (MULTI-POINT CALIBRATORS) o BROAD SPECIFICITY, I.E. ABLE TO IDENTIFY DRUGS IN THE SAME DRUG CLASS o MULTIPLEX-TESTING CAPABILITIES (BIOCHIP ALLOWS MULTI-ANALYTE TESTING FROM A SINGLE SAMPLE)

CAN IA CAUSE A “FALSE POSITIVE” UA?

Answer: NO for confirmation. It may trigger the IA. 11

Compounds that could result to positive IMMUNOASSAY (screening) results. NH 2

NH 2

NH 2 H 3C

CH 3

S(+)-amphetamine (D-AMP)

R(-)-amphetamine (L-AMP)

CH 3

S(+)-methamphetamine (D-METH)

CH3 CH 3

CH 3

Methylhexanamine (DMAA)

NH2

R(-)-methamphetamine (L-METH) NH 2

CH 3

3,4-methylenedioxyamphetamine (MDA)

O O

CH 3

Phentermine HO

NH CH3 CH3

3,4-methylenedioxymethamphetamine (MDMA)

NH CH 3 CH3

S,S-(+)-Pseudoephedrine 12

CONFIRMATORY TESTING BY GCMS OR LCMS/MS o

GAS CHROMATOGRAPHY (GC): A CHROMATOGRAPHY TECHNIQUE THAT SEPARATE AND ANALYZE VOLATILE COMPOUNDS IN A GAS PHASE

LIQUID CHROMATOGRAPHY (LC): AN ANALYTICAL CHROMATOGRAPHY TECHNIQUE THAT SEPARATE IONS OR MOLECULES DISSOLVED IN SOLVENTS

MASS SPECTROMETRY (MS): AN ANALYTICAL TECHNIQUE USED TO IDENTIFY THE MOLECULAR MASS OF UNKNOWN COMPOUND, QUANTIFY KNOWN COMPOUND, AND ELUCIDATE STRUCTURE OF COMPOUND

LIMIT OF DETECTION (LOD): AN ESTIMATE OF THE LOWEST ANALYTE CONCENTRATION THAT CAN BE RELIABLY DIFFERENTIATED FROM A BLANK MATRIX FOR A GIVEN ANALYTICAL METHOD. IT IS THE LOWEST CONCENTRATION FOR WHICH THE ION RATIOS AND RELATIVE RETENTION TIMES ARE WITHIN ACCEPTANCE CRITERIA, BUT THE CONCENTRATION MAYBE OUTSIDE THE ACCEPTANCE CRITERIA FOR QUANTITATION.

LIMIT OF QUANTITATION (LOQ): LOWEST CONCENTRATION OF AN ANALYTE THAT CAN BE ACCURATELY AND RELIABLY MEASURED WITH ACCEPTABLE BIAS AND IMPRECISION.

LIMITS OF LINEARITY (LOL)/WORKING RANGE: THE CONCENTRATION RANGE, INCLUDING LOQ, WHICH THE INSTRUMENT CAN ADEQUATELY DETERMINE AND/OR QUANTIFY WITH ACCEPTABLE ACCURACY AND PRECISION WITHIN THE LINEAR RESPONSE REGION.

GCMS Schematic (Chromacademy, 2016)

LCMS/MS Schematic (Ostman M, 2018, Antimicrobial in Sewage Treatment Plants, Doctoral Thesis)

GCMS/LCMSMS ADVANTAGES

LIMITATIONS

o SENSITIVITY AND SELECTIVITY BETTER THAN IA

o EXTRACTED SAMPLES STABLE FOR 24-48 HOURS AT ROOM TEMP, UP TO 5 DAYS REFRIGERATED

SAMPLE PREPARATION MAY BE NECESSARY AND CAN BE LABORIOUS

INTERFERENCE MAY LEAD TO FALSE-NEGATIVE IF SEPARATION IS NOT RESOLVED

o TARGET ANALYTES CAN BE ADDED WITH MINIMAL CHANGE TO THE METHOD

REQUIRES HIGHLY-TECHNICAL TECHNICIANS TO OPERATE AND MAINTAIN INSTRUMENTS

o CAN EMPLOY DILUTE-AND-SHOOT (LCMSMS) WITH MINIMAL LOSS TO SENSITIVITY

SAMPLE THROUGHPUT MAY BE LIMITED DEPENDING ON THE NUMBER OF DRUGS INCLUDED IN THE METHOD

o REQUIRES MINIMAL SAMPLE VOLUME (>100UL)

o HIGHLY ACCURATE WITH THE USE OF CERTIFIED CAL, IS AND QC MATERIALS

DRUG TESTING FLOW CHART (WORKPLACE DRUG TESTING) Sample collection & accessioning

Initial Screen (Immunoassay)

≥ Cutoff

Confirmation GC or LC-MS

≤ Cutoff

≥ LOD/LOQ or Cutoff

≤ LOD/LOQ or Cutoff

NEGATIVE

Positive 16

DRUG TESTING FLOW CHART (PAIN MANAGEMENT) a. Negative for Target Drug

Sample collection & accessioning

Initial Screen (Immunoassay)

b. Positive for Amphetamine Class* c. Positive for Illicit Drug or non-Rx’d

Positive for Rx’d drugs

Compliant

*Only if the immunoassay cannot distinguish between d-amphetamine and dmethamphetamine

Confirmation GC or LC-MS a.

Positive for Target Drug

Positive for Illicit or NonRx’d Drug and/or

b. Negative for Rx’d Drug

Non-compliant

TEST RELIABILITY • TRADITIONALLY INVOLVES A TWO-STEP PROCESS • INITIAL DRUG SCREEN: IDENTIFIES POTENTIALLY OR PRESUMPTIVELY POSITIVE OR NEGATIVE SPECIMENS • CONFIRMATORY TEST: EITHER VERIFY OR REFUTE THE RESULT OF THE SCREENING ASSAY

• TWO MEASURES OF RELIABILITY: • SENSITIVITY: INDICATES THE PROPORTION OF POSITIVE RESULTS THAT A TESTING METHOD OR DEVICE CORRECTLY IDENTIFIES. • SPECIFICITY: IS THE TEST’S ABILITY TO EXCLUDE SUBSTANCES OTHER THAN THE ANALYTE OF INTEREST OR ITS ABILITY NOT TO DETECT THE ANALYTE OF INTEREST WHEN IT IS BELOW THE CUTOFF CONCENTRATION OR DECISION POINT.

• RESULTS ARE REPORTED IN FOUR POSSIBLE WAYS: • TRUE POSITIVE: TEST CORRECTLY DETECTED THE PRESENCE OF DRUG • FALSE POSITIVE: TEST INCORRECTLY DETECTED THE DRUG WHEN NONE IS PRESENT • TRUE NEGATIVE: TEST CORRECT CONFIRMS THE ABSENCE OF DRUG OR METABOLITES • FALSE NEGATIVE: TEST FAILS TO DETECT THE PRESENCE OF DRUG OR METABOLITES 18

Component

Federal Workplace Drug Testing

Clinical Testing

Specimen

Urine, oral fluids

Urine, oral fluid, blood

Collection Procedures

Federal mandated requirements, e.g. chain of custody, observed collection, etc.

Hospital policy-driven, CAP compliant for specimen collection, handling and storage protocols

Specimen Validity Testing

Extensive to ensure no adulterated or substituted specimen

Not as extensive as federal; some pain management clinics may required creatinine, specific gravity, pH and/or oxidants in place

Confirmatory Methods

GC/MS or LCMS/MS

GC/MS, LCMS, LCMS/MS

Drug analytes

Federally mandated drugs

No set drug testing panel

Cutoff concentrations

Established for each drug

Vary, depends on the method validation

Laboratory certification

DOD and/or HHS SAMHSA-certified

HHS certification not required, but must be a registered with CLIA; kits validated by manufacturers does not required CLIA certification

Medical Review

MRO must interpret and report results

MRO review not required 19

False negative can be attributed to: dilution, adulteration, and substitution. Specimen Validity Testing (SVT) is assessed any potential tampering with the urine sample. A urine sample is reported as substituted if:

Conclusion: All synthetic urine samples passed the SVT. 23

LABORATORY ACCREDITATION • FORENSIC LABORATORIES – FALL UNDER ISO 17025:2012 (DOD 1010.16 FOR MILITARY) • WORKPLACE DRUG TESTING LABORATORIES (UNDER SAMHSA) – NATIONAL LABORATORY CERTIFICATION PROGRAM • CLINICAL LABORATORIES – FALL UNDER ACCREDITED UNDER CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) OR CLINICAL LABORATORY IMPROVEMENT PROGRAM (CLIP) • ACCREDITATION INVOLVES EVALUATING THE LABORATORY’S QUALITY MANAGEMENT SYSTEM, PERSONNEL COMPETENCY AND CERTIFICATION, LABORATORY PERFORMANCE (E.G. PROFICIENCY TESTING), ADDRESSING NON-CONFORMING WORK, LABORATORY IMPROVEMENTS, DOCUMENT CONTROL, FACILITY INTEGRITY (INCLUDING LABORATORY INFORMATION MANAGEMENT SYSTEM).

MEDICAL AND RECREATIONAL CANNABIS

THC PHARMACOLOGY • THC binds to two cannabinoid receptors: CB1 and CB2 – CB1: Central nervous system, cardiovascular system, reproductive system – CB1: Lymphatic system and very low abundance in brain

THC PSYCHOLOGICAL AND PHYSIOLOGICAL EFFECTS • When smoked, produce subjective effects within few minutes after intake; subjective effects are delayed when THC is taken orally • Short-term effects: altered sense and hallucinations, altered time perception, impaired body movement, impaired memory and learning skills, vasodilation and tachycardia, reddening of the eyes, loss of convergence, Nystagmus (ability of the eye to track smoothly), dry throat and mouth • Long-term effects: hypotension, bradycardia, temporary paranoia and hallucinations, exacerbated or worsened schizophrenia, depression/anxiety, drug dependence, lung disease, immunosuppression • Prolonged use can lead to both physiological and psychological drug dependence and impaired cognitive functions • Acute intoxication are typically treated symptomatically under observation; THC has been indirectly linked to fatalities, in particular, users jumping off high ledges or involved in a motor vehicle accidents

TITLE 21 USC CONTROLLED SUBSTANCES ACT Section 201 (c), [21 USC § 811(c)] list factors on considering whether a substance should be decontrolled or schedule/reschedule: (1) Its actual or relative potential for abuse. (2) Scientific evidence of its pharmacological effect, if known. (3) The state of current scientific knowledge regarding the drug or other substance. (4) Its history and current pattern of abuse. (5) The scope, duration, and significance of abuse. (6) What, if any, risk there is to the public health. (7) Its psychic or psychological dependence liability. (8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

CSA AND MARIHUANA • Congress specifically placed “marihuana” in Schedule I of the CSA in 1970 and defined “marihuana” as all parts of the plant Cannabis sativa L., with certain exceptions for the parts of the plant that are not the source of cannabinoids. Among the parts of the cannabis plant included in the definition of marihuana are: the flowering tops, the leaves, viable seeds, and the resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. 21 U.S.C. § 812(c) Schedule I; 21 U.S.C. § 802(16); 21 C.F.R. § 1308.11(d).

CSA AND MARIHUANA • Agriculture Improvement Act of 2018 (Dec. 20, 2018) – Provided definition of “hemp” and amended “marihuana”

– Excluded “hemp” from “marihuana” CSA – Added the definition of “hemp” to 7 USC 1639o, “The term ‘hemp’ means the plant Cannabis sativa L. and any part of the plant including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9tetrahydrocannabinol concentration of not more than 0.3% on a dry weight basis.”

CANNABIS LEGAL STATUS IN THE US (AS OF JUNE 2021) Legalized ( n = 18) Medical and Decriminalized (n = 11) Medical (n = 7/7*) Decriminalized (n = 2) Fully Illegal (n = 5) NOTE: * represents CBD only

https://disa.com/map-of-marijuana-legality-by-state

CANNABIS FOR MEDICAL USE: CONDITIONS Cannabis Plant (e.g. Utah)

CBD only (e.g. Texas) • • • • • • •

Epilepsy or seizure disorder Multiple sclerosis Spasticity Amyotropic lateral sclerosis Autism Terminal cancer Incurable degenerative disease

• • • • • • • • • • • • • • • •

Condition resulting in hospice care A rare disease affecting less than 200,000 in US Terminal illness with <6 months life expectancy Alzheimer’s disease Amyotrophic lateral sclerosis Autism Cachexia Cancer Crohn’s disease or ulcerative colitis HIV or AIDS Multiple sclerosis Unmanageable pain lasting longer >2 weeks Persistent nausea except due to pregnancy or Cannabinoid hyperemesis syndrome Post-traumatic disorder (diagnosed by VA or psychiatrist, Licensed clinical psychologist or social worker)

www.potguide.com

CANNABIS COMMERCIAL USE

FLOWER BUDS & LEAVES Main source of THC and CBD

SEEDS Main source of Hemp oil

STALK Main source of fibers and pulp

CANNABIS COMMERCIAL USE • Buds/Flowers source of THC and CBD: sold as “edibles”, oil tincture, and CBD or THC-infused drinks, etc. • Seeds: incorporated in food (‘KIND’ bars), hemp hearts, hemp protein shakes, bird feeds, hempseed oil for salad, butter, cooking oil, hygiene products, and industrial products (varnish, paint, solvent, etc.) • Stalks: fibers used in textile manufacturing; pulp for building materials, insulation, animal bedding, etc.

HEMP OIL VS CBD OIL

https://www.minthilltimes.com/columns/green-news-now-by-get-me-some-green-apothecary/green-newsnow-cbd-oil-vs-hemp-oil/

CBD PHARMACOLOGY • CBD originally isolated by Adam et al. in 1940s and stereochemistry elucidated by Mechoulam et al. in 1960s • CBD has limited to no interaction with cannabinoid receptors CB1 and CB2 – Have shown to potentiate THC effects and lessened its undesirable effects such as anxiety, panic, sedation, dysphonia, and tachycardia • Observed to have anticonvulsant effects (decrease in neuoronal excitability) through transient receptor potential (TRP) vanilloid channels; antagonist to orphan receptor GPR55; adenosine modulation – Well studied in reducing epilepsy episodes in children with Lennox-Gastaut (LGS) and Dravet syndromes (DS) – Have been used under the open-label Expanded Access Programs for managing patients with treatment-resistant epilepsy (TRE). • Observed to interact with serotonin 1A (5-HT1A) receptors in rodents proposing it has anxiolytic effects 36

CBD Potential Therapeutic Effects • • • • • • • •

Anti-epileptic Anxiolytic Antipsychotic Neuroprotection Reduced spasticity Treatment for chronic pain Anti-cancer Addiction Disorder 37

CBD ADVERSE EFFECTS: PRE-CLINICAL (ACUTE)

CBD ADVERSE EFFECTS: PRE-CLINICAL (CHRONIC)

CBD ADVERSE EFFECTS: CLINICAL

CBD ADVERSE EFFECTS: CLINICAL (CONTINUATION)

PRESCRIPTION THC AND CBD

Epidiolex 100mg/mL CBD

Marinol (Dronabinol) 2.5, 5.0, and 10mg THC Sativex (Nabiximols) 27mg/mL THC + 25mg/mL CBD

MARKETING OF THC AND CBD Smoked (cigarette), Vaporized (e-Cig) and Tinctures (Sublingual), Edibles (food products with THC and/or CBD)

Images retrieved on Google using keywords: “Cannabis joint” + “CBD e-Cig” + “Cannabis Edibles”

METABOLISM OF THC AND CBD 7 CH3 1 2 6

OH 7

CH3

7 CH3 1 2

H2C

6-OH-CBD (minor)

CH3

3' 1"

CH3

OH 7

HO CH3

7-OH-CBD

OH 1'

3' 5"

HO CH3

CBD (cannabidiol)

HO CH3

H2C

2' 3' 5"

H2C

HO CH3

7-COOH-CBD (7-carboxy CBD)

Glucuronide conjugates

METHODS IN CBD AND THC DETECTION • •

•

Biological Matrices: Blood, Oral Fluids, Urine, Hair, Sweat Screening: Antibody-based approach (Homogenous, Heterogenous), Thin-Layer Chromatography (TLC) – Limited sensitivity and specificity (“YES” or “NO”) – Skillset: medical technician level – Designed for high-throughput automation Confirmation: – Qualitative: High-resolution Mass Spectrometry (HRMS) e.g. Time-of-Flight MS, Orbitrap-MS – Quantitative: Gas Chromatography Mass Spectrometry (GCMS) and tandem GCMS (GCMS/MS), Liquid Chromatography tandem Mass Spectrometry (LCMS/MS) • Improved sensitivity and specificity • Able to determine accurate levels or concentrations • Require highly-skilled technicians and laborious method validation • Prone to matrix effects • May not be as fast as automated immunoassay analyzers

ANALYTICAL CHALLENGES • Question 1: Are federal employees allowed to consume THC and CBD products if they are working in a state that legalized cannabis for recreational and medicinal use? • Question 2: Are all commercial CBD products sold as THC-free really free of THC? • Question 3: Can taking CBD produce a false-positive drug result for THC? • Question 4: Can consuming hemp oil produce a false-positive for THC or CBD?

QUESTION 1: ARE FEDERAL EMPLOYEES ALLOWED TO CONSUME THC AND CBD PRODUCTS IF THEY ARE WORKING IN A STATE THAT LEGALIZED CANNABIS FOR RECREATIONAL AND MEDICINAL USE? • US Office of Personnel Management “Federal law on marijuana remains unchanged. Marijuana is categorized as a controlled substance under Schedule I of the Controlled substance Act. Thus knowing or intentional marijuana possession is illegal, even if an individual has no intent to manufacture, distribute, or dispense marijuana. In addition, Executive Order 12564, Drug-Free Federal Workplace, mandates that (a) Federal employees are required to refrain from use of illegal drugs; (b) the use of illegal drugs by Federal employees, whether on or off duty, is contrary to the efficiency of the service…” • Air Force (AFI 90-507): “In order to ensure military readiness, the ingestion of products containing or products derived from hemp seed or hemp seed oil is prohibited.” • Army (AR 600-95): “…this regulation prohibits Soldiers from using Hemp or products containing Hemp oil…” • Navy (ALNAV 057/19): “…the knowing ingestion (orally, intravenously, through smoking/vaporization, or through other means) of products containing, or products derived from, hemp is prohibited.” • Coast Guard (COMDTINST M1000.10A): “…does not tolerate the intentional use of illegal drugs, illicit chemical analogues, or prescription drug misuse. This includes ingestion of hemp oil or products made with hemp seed oil; however, does not include food items regulated and approved by the Food and Drug Administration (FDA) that contain hemp ingredient. 48

QUESTION 2: ARE ALL COMMERCIAL CBD PRODUCTS SOLD AS THC-FREE REALLY FREE OF THC? “Labeling Accuracy of Cannabidiol Extracts Sold Online.” JAMA (2017) 318 (17):1708-1709

QUESTION 3: CAN TAKING CBD PRODUCE FALSE-POSITIVE DRUG RESULT FOR THC? Study Conditions 1: Oral Placebo CBD + inhalation 100 mg vaporized CBD 2: Oral 100-mg CBD + inhalation of vaporized placebo cannabis 3: Oral Placebo CBD + inhalation of CBD-dominant cannabis 4: Oral Placebo CBD + inhalation of vaporized placebo cannabis Experimental sessions were in randomized order and dose administration separated by 1 week between session

QUESTION 3: CAN TAKING CBD PRODUCE FALSE-POSITIVE DRUG RESULT FOR THC? (Spindle et al. cont.) • Urine samples collected at baseline and 1, 2, 3 & 4 h after oral dosing. Following 4 h, urine voids were pooled at 2-4 h increments up to 54-58 h after post-oral dose. • Urine samples were initially analyzed via immunoassay (DRI Cannabinoid Assay) calibrated at 50 ng/mL ∆9-THCCOOH. Creatinine, specific gravity, and pH were also acquired. • Urine samples were subjected to solid phase extraction and drug confirmation via LC-MS/MS. – Confirmation method included the detection for the following analytes with corresponding limits of detection (LOD) in ng/mL: • LOD (0.25 ng/mL): ∆9-THC, 11-OH-THC, THCV (cannabivarin), CBD, THCVA (1.0), CBN (cannabinol) • LOD (1.0 ng/mL): ∆8-THCCOOH, 8-11,diOH-∆9-THC, 8--OH-∆9-THC, ∆9-THCCOOH

QUESTION 3: CAN TAKING CBD PRODUCE FALSE-POSITIVE DRUG RESULT FOR THC? (Spindle et al. cont.)

Highest ∆9-THC-COOH quantitated was 29.9 ng/mL collected after 4 h after vaporized cannabis with 100 mg CBD/3.7mg THC 52

QUESTION 4: CAN CONSUMING HEMP OIL PRODUCE A FALSEPOSITIVE FOR THC OR CBD? Leson et al. “Evaluating the Impact of Hemp Food Consumption on Workplace Drug Tests” (2001) J Analyt Tox 25:691697 Study Design: • 15 adult volunteers (29-84 y/o, 10 F, 5 M, average wt. 72.9 kg) • Confirmed negative for THC metabolite prior to study • Volunteers ingested four different THC doses, each for a 10-day period ranging from 0.09 to 0.6mg and were increased stepwise 53

QUESTION 4: CAN CONSUMING HEMP OIL PRODUCE A FALSEPOSITIVE FOR THC OR CBD?

Leson et al. continuation

• Urine specimens (n=160) were analyzed first using Immunalysis Direct RIA Cannabinoid kit with calibrators at: 0, 10, 20, 50, and 100 ng/mL THC-COOH. • Urine specimens were confirmed with GCMS using calibrators at 2.5, 5.0, 10, and 50 ng/mL THC-COOH. 54

QUESTION 4: CAN CONSUMING HEMP OIL PRODUCE A FALSE-POSITIVE FOR THC OR CBD?

Leson et al. continuation

NOTE: Workplace confirmation cutoff for the metabolite of THC is 15 ng/mL THCCOOH In this study, none tested above the cutoff.

QUESTION 4: CAN CONSUMING HEMP OIL PRODUCE A FALSE-POSITIVE FOR THC OR CBD? Leson et al. continuation

https://www.google.com/url?sa=i&url=http%3A%2F%2Fwww.ethnoherbalist.com%2Fdelta-8-cannabinoid%2F&psig=AOvVaw1xV2ihFdccmvQLVKd8tlN&ust=1642908636569000&source=images&cd=vfe&ved=0CAsQjRxqFwoTCIixk9-1xPUCFQAAAAAdAAAAABAN 57

HOW IS DELTA-8 THC SYNTHESIZED? • Can be found naturally in Cannabis sativa but in very small amount. • Can be synthetically created using CBD as the starting material and can also produce delta-9-THC and delta-10-THC with the same method. • Drug Enforcement Agency consider delta-8-THC as scheduled drug; however, states have argued that the starting material is CBD extracted from Hemp with less than 0.3% THC and therefore, is covered under Hemp Farming Act of 2018. • For federal employees (including uniformed service) are prohibited from the consumption of cannabisextracted material even if it comes from hemp due to potential contamination or impurities.

https://dailycbd.com/en/how-to-make-delta-8-thc/

Controlled Substances Act (alphabet listing)

https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_al pha.pdf (as of 18 Nov 2021) 59

1. Delta-8-THC products have not been evaluated or approved by the FDA for safe use and maybe marketed in ways that put the public health at risk. 2. The FDA has received adverse event reports involving delta-8-THCcontaining products. 3. Delta-8-THC products often involve use of potentially harmful chemicals To create the concentrations of delta-8 THC claimed in the marketplace. 4. Delta-8 THC has psychoactive and intoxicating effects. 5. Delta-8-THC products should be kept out of the reach of children and pets. https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc

SUMMARY • The majority of drug testing techniques incorporate immunoassay screening and confirmatory testing. • Cutoffs vary by drug classes and what concentrations are typically found in acute or chronic exposure per biological matrices. • Sample stability can be affected by storage conditions and type of matrices. • Similar drug classes can have shared metabolites and must be carefully considered for polydrug use. • Legalization of cannabis and hemp can complicate source of positive THC; delta-8THC is CSA Schedule I per the DEA.

Questions? Thank you!