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Abstract INTRODUCTION Primary central nervous system lymphoma (PCNSL) in patients (pts) over 65 years old have poorer outcome compared to younger cohorts, as comorbidities, baseline performance status and susceptibility to iatrogenic toxicity impede adequate drug delivery (Kasenda et al, Ann Oncol, 2015). Balancing toxicity against treatment benefits remains a challenge in this age group. Recent trials have attempted to rationalize treatment aiming for reduced toxicity whilst maintaining CNS penetration. Efficacy of additional agents, such as oral alkylators (Fritsch et al, Leukemia 2017) has also been demonstrated. Most clinical trial cohorts underrepresent elderly pts and thus analysis of real-world outcomes and therapeutic practice is warranted. METHODS Consecutively diagnosed pts between 01/10/12 and 01/10/17, ≥65 years old in 14 tertiary UK centres were analysed retrospectively. Radiological exclusion of systemic disease and histological diagnosis were mandatory. Pts receiving any form of 1st line treatment including palliative (whole-brain radiotherapy [WBRT]/oral chemotherapy), best supportive care (BSC) or clinical trial were included. Diagnostic and referral pathways were audited. Baseline patient characteristics and treatment received was recorded in order to document current UK practice. Pts. were stratified into 4 treatment groups: single agent MTX; MTX with oral alkylator; high-intensity HI-MTX (MTX/AraC and MATRix) or palliative intent treatment (WBRT/oral alkylator/BSC). The study primary outcome was overall response rate (ORR) after induction. Secondary outcomes were PFS and OS. Additional variables were MTX clearance and the relative dose intensity (RDI) of MTX normalised with a reference of 14mg/m2. UV/MVA for ORR and Cox-regression for PFS and OS were used for identification of baseline predictors of response and survival. RESULTS 244 pts were included in the analysis with median age 71yrs (range 65-91) and 123 (50%) male. LDH (Elevated:104, 42%) and ECOG performance score (PS) (3-4: 87, 36%) were the only prognostic markers recorded. Median time from presenting scan to treatment was 33 days (IQR 22-48). Demographic characteristics are summarised in table 1. 80% of pts (n=192) received MTX based chemotherapy. 68% of pts >70yr and 50% >75yr received >1 cycle of MTX. MTX median cumulative dose delivered was 10.6 g/m2 (range 1.5-21), median number of cycles was 4 (range 1-6). Dose reductions of MTX occurred in 53/176 pts. (30%). Median time to MTX clearance was 3 days (range 1-18) and median RDI was 0.75 (range 0.11-1.5). TRM for MTX treated pts was 7.2%. 112 pts received rituximab (46%; 11% pre-2015 vs. 64% post-2015). 73 pts. (38%) received <2 cycles of treatment, reasons for dropout were progression (49/73), chemotherapy-related adverse events (13/73) and unknown (11/66); median OS for these pts was 4.1 months. 66 pts received consolidation (15 WBRT, 36 ASCT and 13 oral alkylator) with a median age of 69 (range 65-84). Median OS in this group was 64 months. ORR after induction was 63%. HI-MTX (HR 3.4; CI 95% 1.5 - 7.6; p=0.003) was independently associated with superior ORR compared to HD-MTX alone (Table 1). Median follow up for survival was 25 months. 2-yr PFS and OS were both 39%, median OS after progression was 80 days. MTX RDI (HR 0.18; p<0.001) was the only independent covariate for PFS. Treatment allocation to HI-MTX (HR 0.47; p=0.02), MTX RDI (HR 0.23; p=0.001) and complete response following induction (HR 0.29; p=0.001) were covariates for OS. 52 pts (21%) received upfront palliative treatment and compared to MTX cohort, were older (median 76y vs. 70y), had a poorer PS (ECOG 3-4: 62% vs. 28%) and higher incidence of impaired renal function (GFR < 60ml/min: 15% vs. 5%). CONCLUSION MTX can be delivered to the majority of pts >70 years with manageable TRM rates. Notably, early treatment discontinuation was relatively frequent with outcomes in this group comparable to palliative care. By contrast, pts who completed >3 cycles of HI-MTX and underwent consolidation experienced comparable outcomes to younger trial cohorts. MTX combination chemotherapy and MTX dose intensity were the strongest predictors of survival whilst rituximab was not a covariate for response or survival despite an increase in its use. Maximising cumulative MTX dose, particularly within more intensive protocols, may translate into improved ORR and survival in older pts with PCNSL. Table. Table. Disclosures Kassam: AbbVie: Equity Ownership. Culligan:Merck Sharp & Dohme (MSD): Honoraria; Celgene: Other: Support to attend conferences; Daiichi-Sankyo: Other: Support to attend conferences; JAZZ: Honoraria; Abbvie: Other: Support to attend conferences; Takeda: Honoraria, Other: Support to attend conferences; Pfizer: Honoraria. McKay:Epizyme: Consultancy, Honoraria. Eyre:Roche: Consultancy; Janssen: Consultancy, Other: travel support; Gilead: Consultancy, Other: travel support; Abbvie: Consultancy, Other: travel support; Celgene: Other: travel support. Osborne:Roche: Consultancy, Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Servier: Consultancy; MSD: Consultancy; Celgene: Consultancy; Takeda: Consultancy, Honoraria, Speakers Bureau; Novartis: Other: Travel to conference. Yallop:Servier: Other: Travel funding; Pfizer: Consultancy. Fox:Janssen: Consultancy, Other: Personal fees and non-financial support, Speakers Bureau; AbbVie: Consultancy, Other: Travel support, Research Funding, Speakers Bureau; Celgene: Consultancy, Other: Travel support, Speakers Bureau; Sunesis: Consultancy; Roche: Consultancy, Other: Travel support, Research Funding, Speakers Bureau; Gilead: Consultancy, Other: Travel support, Research Funding, Speakers Bureau. Cwynarski:Roche: Consultancy, Other: Conferences/Travel support, Speakers Bureau; Autolus: Consultancy; Kite: Consultancy; Gilead: Consultancy, Other: Conferences/Travel support, Speakers Bureau; Janssen: Other: Conferences/Travel support.

Abstract Background Visceral leishmaniasis (VL), due to Leishmania infantum, is a persistent intracellular parasitic infection transmitted by the bite of infected sand flies. Symptomatic VL has been reported in U.S. soldiers with Iraq deployment. Untreated symptomatic VL can be fatal; asymptomatic VL (AVL) may establish a lifelong risk of reactivation. We report prevalence and AVL risk factors in Operation Iraqi Freedom (OIF) deployers during 2002–11. Methods Healthy soldiers exposed to VL endemic areas in Iraq and 50 controls who never traveled to endemic regions were recruited through military healthcare facilities (2015–17). Responses to a risk factor survey and blood samples were obtained. Leishmania research diagnostics utilized included enzyme-linked immunosorbent assay (ELISA), rk39 test strips, quantitative polymerase chain reaction (PCR), and interferon gamma release (IGRA) assays. Statistical analyses included Fisher exact test, Pearson χ2 test, Mann-Whitney U test, and logistic regression. Results 200 deployed subjects were enrolled, mostly males (84.0%), of white ethnicity (79.0%), and median age 41 (range 24–61) years. 64% were seropositive for Phlebotomus alexandri saliva antibodies. Prevalence of AVL (any positive test result) was 39/200 (19.5%, 95% confidence interval 14.4%–25.8%). Two (1.0%) PCR, 10 (5%) ELISA, and 28 (14%) IGRA samples were positive. Travel to Ninewa governorate increased risk for AVL (P = .01). Conclusion AVL was identified in 19.5% of OIF deployers; travel to northwest Iraq correlated with infection. Further studies are needed to inform risk for reactivation VL in US veterans and to target additional blood safety and surveillance measures.

Abstract Introduction: Transformed B-cell lymphomas (t-BCL) harbor features of indolent and aggressive disease and it is assumed that transformation conveys an unfavorable prognosis. Because of the ambiguous pathological findings these lymphomas are rarely included into clinical trials. As a result, there is a lack of information about t-BCL patients' short-term and long-term outcomes although very recently a large retrospective analysis detailed the outcomes of transformed follicular lymphoma (t-FL) (Blood June 23, 2015; DOI 10.1182/blood-2015-01-621375). t-BCLs can be separated into a primary type, i.e. transformation at the time of diagnosis, and a secondary type, i.e. transformation after a previous diagnosis of indolent BCL. The present study reports the outcome of patients with t-BCL and also includes indolent lymphomas other than FL. Methods: This is a retrospective, single center analysis of patients with t-BCL seen at the Dept. of Hematology and the Dept. of Medical Oncology at the University Hospital Essen between 1999 and 2015. The departments' archives were screened for patients with primary or secondary t-BCL. A lymphoma was considered transformed when the diagnosis of indolent lymphoma (FL grade 1, 2, 3A; extranodal marginal zone lymphoma (EMZL), nodal marginal zone lymphoma (NMZL), splenic marginal zone lymphoma (SMZL), small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)) preceded a diffuse large B-cell lymphoma (DLBCL) or other aggressive lymphoma or was simultaneously present. Lymphomas were classified according to WHO 2008 terminology whenever possible. FL with simultaneous grade 3A and grade 3B portions were classified as primary t-BCL. Central pathology review was not performed. Demographic parameters, treatment history, response and outcome data were collected. Survival analyses were performed using the Kaplan-Meier method. The log rank test was used to calculate survival differences, p values > 0,05 were considered statistically significant. Multivariable Cox regression analysis was used where appropriate. The ethics committee of the faculty of medicine, University of Duisburg-Essen, approved this study (14-5497-BO). Results: 92 patients treated between 1999 and 2015 were identified. 47 (51 %) were female. 38 (41%) suffered from primary and 54 (59%) from secondary t-BCL. Median age at transformation was 60 years (30-87). For secondary t-BCL, time to transformation spanned 2-275 months with a median of 40.5. The treatment approach influenced time to transformation: 33.3 (median) months for observation only (n=20) and 66 months (median) for chemotherapy or rituximab-chemotherapy (n=20; p=0.02). After radiation therapy (n=10) median time to transformation was 32 months. 4 patients received chemotherapy and radiation therapy. FL grade1-3 was diagnosed in 67 patients (73%). Other diagnoses included EMZL (n=9), LPL (n=5), NMZL (n=3) SLL (n=3), SMZL (n=2) and other low-grade lymphomas (n=3). Histology at transformation was DLBCL in 86 patients. FL grade 3B, Burkitt-like lymphoma and aggressive lymphoma, unclassified, were diagnosed in 2 patients each. In primary t-BCL Ann Arbor stages III or IV were found in 25 patients (63 %), extranodal disease was present in 13 (34%), and 7 (18%) suffered from B symptoms. In secondary t-BCL Ann Arbor stages III or IV were found in 41 patients (66 %), extranodal disease was present in 12 (22%), and 11 (20%) suffered from B symptoms. Follicular Lymphoma International Prognostic Index high risk categories at time of transformation were evaluable for 42/67 FL patients and more frequent in secondary t-FL (n=33 (79%)) than in primary t-BCL (n=9 (21%)). Treatment of primary vs secondary t-BCL included CHOP (5/5), R-CHOP (29/23), R-ASHAP (0/10), Burkitt-type protocol (1/2), R-GemOx (0/2), R-ICE (0/2), radiation only (6/0), BEAM + ASCT (0/8), and other regimens. Overall survival (OS) at 5 years was dependent on remission status after first treatment of transformation with 86% for patients in CR, 66% for PR (CR vs PR p=n.s.) and 6% [CI=4.6-38.3] for PD (CR vs PD: p<0.0001) (Figure; 82 evaluable patients). 5-year OS for primary t-BCL was 73.3% and 47.6% for secondary t-BCL, respectively (p=0.0018) (Figure; 92 evaluable patients). Conclusion: In this study primary t-BCL had a favorable outcome when compared with secondary t-BCL. The assumed adverse prognostic impact of transformation may not hold true for primary t-BCL. Figure 1. Figure 1. Disclosures Dührsen: Alexion Pharmaceuticals: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Amgen: Honoraria, Research Funding. Hüttmann:Roche: Research Funding; Amgen: Consultancy, Research Funding; Gilead: Consultancy; Takeda: Consultancy, Other: Travel support; Celgene: Other: Travel support, Speakers Bureau.

Introduction: A positive interim PET scan (PET2) following 2 cycles of ABVD for Hodgkin lymphoma (HL) is associated with a poor prognosis; several studies in advanced stage demonstrate benefit from escalating therapy. Definition of positivity (Deauville 3 (D3) vs Deauville 4/5 (D4/5)), initial treatment and response adaptive decisions may vary among clinicians. Data examining practice patterns in managing positive PET2 scans is lacking. We report practice patterns and outcomes for patients (pts) with positive PET2 results including D3 and D4/5 outcomes. Methods: Adult pts with classical HL and PET2 findings of D3, D4, and D5 after initial therapy between 01/01/2015 and 07/01/2019 were identified. Pts enrolled in clinical studies were excluded. Retrospective demographic, clinical, and treatment data were obtained and described from 14 academic and community sites across North America (NA). Progression-free survival (PFS) and overall survival (OS) were summarized by Kaplan-Meier curves and compared by log-rank test. Results: 166 PET2 positive pts were identified. Clinical characteristics included 54% (89/166) with advanced stage (III/IV) and 46% (77/166) with early stage (IA-IIB) disease. 152 pts (92%) were treated with initial ABVD like therapy and 14 pts (8%) with an alternate regimen (Table 1). After initial treatment, 163 pts demonstrated PET2 scores of D3 (n=33), D4 (n=99) and D5 (n=31). Of the 130 D4/5 pts; 23% (30/130) underwent therapeutic escalation and 77% (100/130) did not escalate. The complete response rate (CR) at end of treatment (EOT) for all D4/5 patients receiving escalation was 37% (11/30) compared to 45% (45/100) without escalation (p=0.43). (Table 2) The 12 month PFS was 54% (38.2-76.3) versus (vs) 69.2% (60.4-79.2) for escalation and no escalation respectively. Of the 66 D4/5 pts with advanced stage disease; 21% (14/66) had therapeutic escalation and 79% (52/66) did not escalate. CR at EOT was noted in 29% (4/14) with escalation vs 31% (16/52) without escalation (p=0.88). (Table 2) The 12 month PFS was 54.2% (32.9-89.3) vs 57.5% (44.9-73.7) for escalation and no escalation respectively. (Figure 1; Log Rank p=0.38). Of the 64 D4/5 pts with early stage disease; 75% (48/64) did not undergo escalation and 25% (16/64) had escalation. CR at EOT was noted in 44% (7/16) with escalation vs 60% (29/48) without escalation (p=0.26). (Table 2) The 12 month PFS was 54.7% (34.5-86.7) vs 80.8% (70.2-92.9) for escalation and no escalation respectively. Of the 33 D3 pts; 52% (17/33) de-escalated with the remainder (16/33) continuing on initial therapy. No D3 pt underwent escalation. In the 12 D3 pts with early stage disease, 50% (6/12) de-escalated. Of the 21 D3 pts with advanced stage disease; 52% (11/21) had de-escalation and 48% (10/21) did not de-escalate. CR at EOT was noted in 71% (12/17) with de-escalation vs 81% (13/16) without de-escalation (p=0.50). (Table 2) Progression was noted in 29% (5/17) of patients who underwent de-escalation compared to 38% (6/16) without de-escalation. The 12 month PFS was 76.5% (85.8-99.6) vs 72.1% (52.2-99.7) for de-escalation and no de-escalation respectively. Conclusion: This is the first study evaluating clinical practice patterns and outcomes of PET adaptive therapy in NA. In this retrospective study, less than a quarter of advanced stage ABVD-treated D4/5 pts had therapy escalation despite prior studies reporting benefit. Our data suggest that outcomes for advanced stage PET positive pts are suboptimal irrespective of therapeutic escalation. In addition, pts with D3 findings represent a heterogeneous population and demonstrate favorable outcomes compared to D4/5 pts. Longer follow up time and further studies with larger numbers of pts are essential for confirming the reported findings. Disclosures Rutherford: Seattle Genetics: Consultancy, Honoraria; Verastem: Consultancy, Honoraria; Karyopharm: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Heron: Consultancy, Honoraria; Janssen Scientific Affairs: Consultancy, Honoraria; Juno Therapeutics Inc: Consultancy, Honoraria. Bartlett:ADC Therapeutics: Consultancy, Research Funding; Affimed: Research Funding; Forty Seven: Research Funding; Celgene: Research Funding; Bristol-Myers Squibb: Research Funding; Genenetech: Research Funding; Gilead: Research Funding; Immune Design: Research Funding; Janssen: Research Funding; Merck: Research Funding; Millenium: Research Funding; Pfizer: Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Research Funding. Maddocks:Novartis: Research Funding; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees; Merck: Research Funding; BMS: Research Funding; Teva: Membership on an entity's Board of Directors or advisory committees. Feldman:Takeda: Honoraria, Speakers Bureau; Viracta: Research Funding; Trillium: Research Funding; Roche: Research Funding; Portola Pharma: Research Funding; Pfizer: Research Funding; Kyowa Hakko Kirin: Research Funding; Eisai: Research Funding; Corvus: Research Funding; Roche: Research Funding; Cell Medica: Research Funding; Seattle Genetics: Consultancy, Honoraria, Other: Travel expenses, Speakers Bureau; AbbVie: Honoraria, Other: Travel expenses, Speakers Bureau; Pharmacyclics: Honoraria, Other: Travel expenses, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Kite Pharma: Honoraria, Other: Travel expenses, Speakers Bureau; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Celgene: Honoraria, Research Funding, Speakers Bureau. Magarelli:Tevan Oncology: Speakers Bureau. Advani:Merck: Research Funding; Infinity Pharma: Research Funding; Roche/Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celmed: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kura: Research Funding; Kyowa Kirin Pharmaceutical Developments, Inc.: Consultancy; Millennium: Research Funding; Pharmacyclics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Agensys: Research Funding; Seattle Genetics: Consultancy, Research Funding; Stanford University: Employment, Equity Ownership; Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Research Funding; Regeneron: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Cell Medica, Ltd: Consultancy; Forty-Seven: Research Funding; Autolus: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences, Inc./Kite Pharma, Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Research Funding; AstraZeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees. Stephens:Karyopharm: Research Funding; Gilead: Research Funding; Acerta: Research Funding. Patel:Sunesis: Consultancy; Genentech: Consultancy, Speakers Bureau; Pharmacyclics/Janssen: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; AstraZeneca: Consultancy, Research Funding, Speakers Bureau. Tees:Celgene: Speakers Bureau; Pharmacyclics: Speakers Bureau. Karmali:Gilead/Kite; Juno/Celgene: Consultancy, Speakers Bureau; Takeda, BMS: Other: Research Funding to Institution; Astrazeneca: Speakers Bureau. Cheson:Portola: Research Funding; Kite: Research Funding; Gilead: Research Funding; Symbios: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Trillium: Research Funding; Epizyme: Research Funding; Morphosys: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Acerta: Consultancy, Research Funding; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; TG Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol Myers Squibb: Research Funding; Seattle Genetics: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Yazdy:Bayer: Honoraria, Speakers Bureau; Octapharma: Consultancy; Genentech: Research Funding; Abbvie: Consultancy. Pagel:AstraZeneca: Consultancy; Gilead Sciences: Consultancy; Pharmacyclics: Consultancy. Ramchandren:Seattle Genetics, Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Research Funding; Bristol-Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Research Funding; Merck: Research Funding; Sandoz-Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pharmacyclics LLC, an Abbvie company: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.

ABSTRAK Penelitian ini dikembangkan untuk menganalisa faktor yang mempengaruhi keputusan menginap seorang konsumen muslim terhadap Hotel Syariah. Pengambilan data dilakukan pada tahun 2021 dengan 200 responden dengan menggunakan metode purposive sampling. Dari hasil analisa regresi berganda halal awareness dan lifestyle seorang konsumen muslim berpengaruh signifikan dengan keputusan menginap di Hotel Syariah. Dengan demikian, penelitian ini mengungkapkan pentingnya para pelaku bisnis Hotel Syariah untuk menyusun strategi yang sesuai dengan halal awareness dan lifestyle pasar sasaran seorang konsumen muslim. Kata Kunci: Halal awareness, lifestyle, keputusan pembelian, Hotel Syariah. ABSTRACT This study was developed to analyze the factors that influence the decision to stay at a sharia hotel consumer. Data collection was carried out in 2021 with 200 respondents using the purposive sampling method. From the results of multiple regression analysis, halal awareness and lifestyle of a Muslim consumer have a significant effect on the decision to stay at a sharia hotel. Thus, this study reveals the importance of sharia hotel business players to develop strategies that are in accordance with halal awareness and the lifestyle of the target market of Muslim consumers. Keywords: halal awareness, lifestyle, decision to stay, sharia hotel. DAFTAR PUSTAKA Ahmad, N. A., Abaidah, T. N. T., & Yahya, M. H. A. (2013). A study on halal food awareness among Muslim customers in Klang Valley. Proceedings 4th International Conference on Business and Economic Research, 1073–1087. Alam, S. S., Rohani M., & Hisham, B. (2011). Is religiosity an important determinant on Muslim consumer behaviour in Malaysia? Journal of Islamic Marketing, 2(1), 83-96. https://doi.org/10.1108/17590831111115268 Amarul, A., Sukirno, S., & Kurnia, D. (2019). 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Abstract Background: Pomalidomide (POM) in combination with low-dose dexamethasone (LoDEX) is approved for the treatment (Tx) of patients (pts) with multiple myeloma (MM) who have had ≥ 2 prior lines of therapy, including lenalidomide (LEN) and a proteasome inhibitor. Although LEN and POM are both IMiD® immunomodulatory agents, preclinical studies have shown that LEN is not cross-resistant with POM (Ocio et al, Leukemia, 2015) and that LEN-resistant myeloma cells remain sensitive to POM (Lopez-Girona et al, Leukemia, 2012). Furthermore, sub-analyses of the MM-002 and MM-003 trials demonstrated that POM + LoDEX had comparable efficacy in pts refractory to their last prior Tx with LEN as in the overall pt population (San Miguel et al, Lancet Oncol, 2013; Richardson et al, Blood, 2014). Here, we present an updated analysis of MM-014, a single-arm, phase 2 trial of POM + LoDEX in pts with MM relapsed or refractory to LEN-based second-line therapy. Methods: Pts were ≥ 18 years old with a documented diagnosis of MM, measurable disease, 2 prior lines of Tx, and progressive disease after ≥ 2 cycles of second-line Tx with a LEN-based therapy. The Tx regimen was POM 4 mg/day on days 1-21 and LoDEX 40 mg/day (20 mg/day for pts > 75 years old) on days 1, 8, 15, and 22 of a 28-day cycle; thromboprophylaxis was mandatory. Responses were assessed using modified International Myeloma Working Group criteria. The primary endpoint was overall response rate (ORR; ≥ partial response [PR]). Secondary endpoints included time to response (TTR), duration of response (DOR), time to progression (TTP), progression-free survival (PFS), and overall survival (OS). Secondary primary malignancies (SPMs) were monitored and recorded as serious AEs regardless of relationship to Tx. Exploratory endpoints included measures to identify potential molecular, immune, and cellular biomarkers for POM + LoDEX response, resistance, or mechanism of action. Results: Of 51 enrolled pts (N = 85 planned), 16 (31.4%) remain on Tx, and 35 (68.6%) discontinued from Tx (n = 20 due to PD, n = 7 due to withdrawal by pt, and n = 2 each due to adverse event [AE], death, lack of efficacy, and other reasons). The median age was 68.0 years, and most pts (92.2%) had an Eastern Cooperative Oncology Group performance status of ≤ 1; 34 pts (66.7%) were refractory to their last Tx with LEN, and 37 (72.5%), 2 (3.9%), and 1 (2.0%) pts had prior Tx with bortezomib, carfilzomib, or ixazomib, respectively. A total of 33 pts (64.7%) had prior stem cell transplant. The median duration of the most recent prior LEN-containing Tx was 24.6 months, and the median study follow-up time was 11.4 months. The ORR was 31.4%, including 3.9% (n = 2) with complete response, 5.9% (n = 3) with very good PR, and 21.6% (n = 11) with PR. The clinical benefit rate (≥ minimal response) was 41.2%. Of the 16 pts who achieved ≥ PR, 12 (75.0%) have an ongoing response; median TTR in these pts was 1.9 months. The median DOR based on Kaplan-Meier estimates was not reached. The 1-year PFS, OS, and TTP rates were 60.2%, 87.4%, and 64.6%, respectively. Common (≥ 5%) grade 3/4 AEs included anemia (23.5%), neutropenia (13.7%), thrombocytopenia (9.8%), fatigue (7.8%), and infections (19.6%; including pneumonia [7.8%]). AEs of special interest (any grade) included pulmonary embolism (3.9%), deep vein thrombosis (2.0%), and peripheral sensory neuropathy (3.9%); no SPMs were observed. The immune subset analysis showed a significantly elevated proportion of CD3+/CD8+ T cells after Tx (cycle 3, 5, day 1) compared with baseline (37.6% vs 30.5% of total lymphocytes; P < .01). A similar trend toward elevated proportions of CD3+ T cells (73.7% vs 66.6%) was observed; however, the difference was not significant. There was no significant change in CD3+/CD4+ T cells (35.9% vs 35.5%). Conclusions: This updated analysis of the MM-014 trial demonstrates the safety and efficacy of POM + LoDEX in pts who were relapsed or refractory to their last prior Tx with LEN. Results suggest that POM + LoDEX can be used immediately following LEN-based therapy to treat pts with relapsed/refractory MM. The study has been amended to include a cohort of pts treated with POM + LoDEX + daratumumab. Investigations of additional biomarkers, high-risk genetic aberrations, clonal evolution, and minimal residual disease in MM-014 are currently underway. Disclosures Siegel: Novartis: Honoraria, Speakers Bureau; Celgene: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; BMS: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Merck: Honoraria. Schiller:Incyte Corporation: Research Funding. Song:Otsuka: Honoraria; Celgene: Honoraria, Research Funding; Janssen: Honoraria. Kaya:Celgene, Amgen, Takeda: Honoraria. Sebag:Janssen: Honoraria; Celgene: Honoraria; Novartis: Honoraria. Reu:Celgene, Novartis and Takeda: Research Funding; Signal Genetics, Inc.: Consultancy. Mouro:Celgene: Employment, Equity Ownership. Chung:Celgene: Employment. Srinivasan:Celgene: Employment; Individual Patent: Patents & Royalties: US7,495,673B1 Used for MM-Connect Treatment Patterns Abstract.. Qian:Celgene: Employment. Rizvi:Celgene: Employment, Equity Ownership. Thakurta:Celgene: Employment, Equity Ownership. Bahlis:Celgene: Consultancy, Honoraria, Other: Travel Expenses, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Other: Travel Expenses, Research Funding, Speakers Bureau; BMS: Honoraria; Onyx: Consultancy, Honoraria.

У статті досліджено семантику, етимологію та стилістичні функції неологізмів у мові сучасних українських засобів масової інформації. Проаналізовано джерела виникнення нових слів, типологію запозичень. На основі фактичного матеріалу (друкованих та електронних ЗМІ) виділено й досліджено основні стилістичні функції лексичних інновацій у мас-медійному просторі. Вивчено використання різних типів неологізмів у мові сучасних українських ЗМІ. Ключові слова: неологізм, засоби масової інформації, медіадискурс, лексичні інновації, стилістичні функції, неологізація, семантика. Покликання Список використаних джерел Газета по-українськи, № 17(2181), 01 березня 2019 року. Калашник, Павло. «Через хейтерство і образи ми можемо втратити країну». Громадське. URL: https://hromadske.ua/posts/cherez-hejterstvo-i-obrazi-mi-mozhemo-vtratiti-krayinu-radnik-zelenskogo (31.03.2019). День: щоденна всеукраїнська газета, № 159–160, 6–7 вересня 2013 року. Експрес, № 9 (10016), 28 лютого – 07 березня 2019 року. Лисяна, Галина. «Як визначити перед вами психотерапевт чи психогвалтівник?» Українська правда. URL: https://life.pravda.com.ua/columns/2019/03/31/ 236317/. Мазуренко, Альона. «Порошенко пожалівся, що його тролять через телемедицину в селі». Українська правда. URL: https://www.pravda.com.ua/news/2018/06/14/ 7183329/. Олещук, Петро. «Хайп для Мураєва». Українська правда. URL: https://www.pravda. com.ua/columns/2018/06/10/7182917/. «Пранкери намагаються дискредитувати Україну в США». Українська правда. URL: https://www.pravda.com.ua/news/2018/11/19/7198715/. «Профілактика джетлегу, їжа в літаку та ще 5 лафхаків, які допоможуть легше подорожувати». Українська правда. URL: https://life.pravda.com.ua/travel/2018/12/2/234382/. Фірсов, Єгор. «Остаточна відповідь «фейкометам» влади». Українська правда. URL: https://blogs.pravda.com.ua/authors/firsov/5c920dcae6dd3/. Чорновол, Тетяна. «Три завдання «порохоботам», що тендерять харчування армії». Українська правда. URL: https://blogs.pravda.com.ua/authors/chornovol/ 5c8fc2bc0d9dd/. «Стартап з українським корінням залучив 8,4 мільйона доларів». Українська правда. Економічна правда. URL: https://www.epravda.com.ua/news/2018/12/14/643604/. Український тиждень, № 9 (589), 1–6 березня 2019 року. Український тиждень, № 3 (375), 23–29 січня 2015року. Черепова, Тетяна. «Колаборація Google і Міносвіти: що вийшло?» Вежа. URL: https://vezha.net.ua/suspilstvo/kolaboraciya-google-i-minosviti-shho-vijshlo/ (20.11.2018) . Список використаної літератури Бойчук, Марія. Неологізми в заголовках інтернет-видань: структурно-семантичний та функціонально-стилістичний аспекти. Автореф. дис. ...канд. філол. наук: 10.02.01. Харків, 2013. Бойчук, Наталія. «Функціонування неологізмів-телескопізмів в англомовних засобах масової інформації». Науковий вісник Міжнародного гуманітарного університету. Серія: Філологія, вип. №25, т. 1, 2016, с. 164–6. Кузь, Галина. «Українська суспільно-політична неологія: лексика та фразеологія». Наукові записки Тернопільського національного педагогічного університету. Серія: Мовознавство, вип. ІІ (24), 2014, с. 134–9. «Культ мови». Редакторський портал. URL: http://redactor.in.ua/ru/language/ 6516.Kult_movi_Tsirk_na_drot%D1%96_abo_Yak_vi_pishete_slovo_onlayn Пашинська, Людмила. Фразеологічні неологізми в сучасному українському мас-медійному дискурсі. Автореф. дис. ...канд. філол. наук: 10.02.01. Київ, 2011. Селіванова, Олена. Світ свідомості в мові. Черкаси, 2012. Словник іншомовних слів, укл. Л. О. Пустовіт та ін. Київ: Довіра, 2000. Словник української мови, за ред. І. К. Білодіда. В 11 т. Київ: Наукова думка, 1970–1980. Стишов, Олександр. Динамічні процеси в лексико-семантичній системі та в словотворі української мови кінці ХХ ст. (на матеріалі мови засобів масової інформації). Автореф. дис… д-ра філол. наук: 10.02.01. Київ, 2003. Стишов, Олександр. «Семантичні неологізми в дискурсі українськомовних мас-медіа початку ХХІ століття». Філологічні студії. Науковий вісник Криворізького державного педагогічного університету, вип. 13, 2015, с. 364–74. Стишов, Олександр. «Стилістично марковані лексичні неологізми в дискурсі ЗМІ початку ХХІ століття». Лінгвістичні дослідження, вип. 47, 2018, с. 91–8. Сучасна українська літературна мова. Лексикологія. Фонетика, за ред. А. К. Мойсієнка. Київ : Знання, 2010. Ткачук, Ольга. Неологізми в мові хорватських засобів масової інформації 90-х років XX –початку XXI ст. Автореф. дис. ...канд. філол. наук: 10.02.03. Київ, 2011. Українська мова: енциклопедія, за ред. В. М. Русанівського, і О. О. Тараненка. Київ, 2000.

Image 1: “Oklahoma State Highway Re-imagined.” CC BY-SA 4.0 2015 by author, using Wikimedia image by Ks0stm (CC BY-SA 3 2013). Introduction This article is divided in three major parts. First a scenario, second its context, and third, an analysis. The text draws on ethnographic research on security practices in the United States among police and parts of the intelligence community from 2006 through to the beginning of 2014. Real names are used when the material is drawn from archival sources, while individuals who were interviewed during fieldwork are referred to by their position rank or title. For matters of fact not otherwise referenced, see the sources compiled on “The Complete 911 Timeline” at History Commons. First, a scenario. Oklahoma, 2001 It is 1 April 2001, in far western Oklahoma, warm beneath the late afternoon sun. Highway Patrol Trooper C.L. Parkins is about 80 kilometres from the border of Texas, watching trucks and cars speed along Interstate 40. The speed limit is around 110 kilometres per hour, and just then, his radar clocks a blue Toyota Corolla going 135 kph. The driver is not wearing a seatbelt. Trooper Parkins swung in behind the vehicle, and after a while signalled that the car should pull over. The driver was dark-haired and short; in Parkins’s memory, he spoke English without any problem. He asked the man to come sit in the patrol car while he did a series of routine checks—to see if the vehicle was stolen, if there were warrants out for his arrest, if his license was valid. Parkins said, “I visited with him a little bit but I just barely remember even having him in my car. You stop so many people that if […] you don't arrest them or anything […] you don't remember too much after a couple months” (Clay and Ellis). Nawaf Al Hazmi had a valid California driver’s license, with an address in San Diego, and the car’s registration had been legally transferred to him by his former roommate. Parkins’s inquiries to the National Crime Information Center returned no warnings, nor did anything seem odd in their interaction. So the officer wrote Al Hazmi two tickets totalling $138, one for speeding and one for failure to use a seat belt, and told him to be on his way. Al Hazmi, for his part, was crossing the country to a new apartment in a Virginia suburb of Washington, DC, and upon arrival he mailed the payment for his tickets to the county court clerk in Oklahoma. Over the next five months, he lived several places on the East Coast: going to the gym, making routine purchases, and taking a few trips that included Las Vegas and Florida. He had a couple more encounters with local law enforcement and these too were unremarkable. On 1 May 2001 he was mugged, and promptly notified the police, who documented the incident with his name and local address (Federal Bureau of Investigation, 139). At the end of June, having moved to New Jersey, he was involved in a minor traffic accident on the George Washington Bridge, and officers again recorded his real name and details of the incident. In July, Khalid Al Mihdhar, the previous owner of the car, returned from abroad, and joined Al Hazmi in New Jersey. The two were boyhood friends, and they went together to a library several times to look up travel information, and then, with Al Hazmi’s younger brother Selem, to book their final flight. On 11 September, the three boarded American Airlines flight 77 as part of the Al Qaeda team that flew the mid-sized jet into the west façade of the Pentagon. They died along with the piloting hijacker, all the passengers, and 125 people on the ground. Theirs was one of four airplanes hijacked that day, one of which was crashed by passengers, the others into significant sites of American power, by men who had been living for varying lengths of time all but unnoticed in the United States. No one thought that Trooper Parkins, or the other officers with whom the 9/11 hijackers crossed paths, should have acted differently. The Commissioner of the Oklahoma Department of Public Safety himself commented that the trooper “did the right thing” at that April traffic stop. And yet, interviewed by a local newspaper in January of 2002, Parkins mused to the reporter “it's difficult sometimes to think back and go: 'What if you had known something else?'" (Clay and Ellis). Missed Opportunities Image 2: “Hijackers Timeline (Redacted).” CC BY-SA 4.0 2015 by author, using the Federal Bureau of Investigation (FBI)’s “Working Draft Chronology of Events for Hijackers and Associates”. In fact, several of the men who would become the 9/11 hijackers were stopped for minor traffic violations. Mohamed Atta, usually pointed to as the ringleader, was given a citation in Florida that spring of 2001 for driving without a license. When he missed his court date, a bench warrant was issued (Wall Street Journal). Perhaps the warrant was not flagged properly, however, since nothing happened when he was pulled over again, for speeding. In the government inquiries that followed attack, and in the press, these brushes with the law were “missed opportunities” to thwart the 9/11 plot (Kean and Hamilton, Report 353). Among a certain set of career law enforcement personnel, particularly those active in management and police associations, these missed opportunities were fraught with a sense of personal failure. Yet, in short order, they were to become a source of professional revelation. The scenarios—Trooper Parkins and Al Hazmi, other encounters in other states, the general fact that there had been chance meetings between police officers and the hijackers—were re-imagined in the aftermath of 9/11. Those moments were returned to and reversed, so that multiple potentialities could be seen, beyond or in addition to what had taken place. The deputy director of an intelligence fusion centre told me in an interview, “it is always a local cop who saw something” and he replayed how the incidents of contact had unfolded with the men. These scenarios offered a way to recapture the past. In the uncertainty of every encounter, whether a traffic stop or questioning someone taking photos of a landmark (and potential terrorist target), was also potential. Through a process of re-imagining, police encounters with the public became part of the government’s “national intelligence” strategy. Previously a division had been marked between foreign and domestic intelligence. While the phrase “national intelligence” had long been used, notably in National Intelligence Estimates, after 9/11 it became more significant. The overall director of the US intelligence community became the Director National Intelligence, for instance, and the cohesive term marked the way that increasingly diverse institutional components, types of data and forms of action were evolving to address the collection of data and intelligence production (McConnell). In a series of working groups mobilised by members of major police professional organisations, and funded by the US Department of Justice, career officers and representatives from federal agencies produced detailed recommendations and plans for involving police in the new Information Sharing Environment. Among the plans drawn up during this period was what would eventually come to be the Nationwide Suspicious Activity Reporting Initiative, built principally around the idea of encounters such as the one between Parkins and Al Hazmi. Map 1: Map of pilot sites in the Nationwide Suspicious Activity Reporting Evaluation Environment in 2010 (courtesy of the author; no longer available online). Map 2: Map of participating sites in the Nationwide Suspicious Activity Reporting Initiative, as of 2014. In an interview, a fusion centre director who participated in this planning as well as its implementation, told me that his thought had been, “if we train state and local cops to understand pre-terrorism indicators, if we train them to be more curious, and to question more what they see,” this could feed into “a system where they could actually get that information to somebody where it matters.” In devising the reporting initiative, the working groups counter-actualised the scenarios of those encounters, and the kinds of larger plots to which they were understood to belong, in order to extract a set of concepts: categories of suspicious “activities” or “patterns of behaviour” corresponding to the phases of a terrorism event in the process of becoming (Deleuze, Negotiations). This conceptualisation of terrorism was standardised, so that it could be taught, and applied, in discerning and documenting the incidents comprising an event’s phases. In police officer training, the various suspicious behaviours were called “terrorism precursor activities” and were divided between criminal and non-criminal. “Functional Standards,” developed by the Los Angeles Police Department and then tested by the Department of Homeland Security (DHS), served to code the observed behaviours for sharing (via compatible communication protocols) up the federal hierarchy and also horizontally between states and regions. In the popular parlance of videos made for the public by local police departments and DHS, which would come to populate the internet within a few years, these categories were “signs of terrorism,” more specifically: surveillance, eliciting information, testing security, and so on. Image 3: “The Seven Signs of Terrorism (sometimes eight).” CC BY-SA 4.0 2015 by author, using materials in the public domain. If the problem of 9/11 had been that the men who would become hijackers had gone unnoticed, the basic idea of the Suspicious Activity Reporting Initiative was to create a mechanism through which the eyes and ears of everyone could contribute to their detection. In this vein, “If You See Something, Say Something™” was a campaign that originated with the New York City Metropolitan Transportation Authority, and was then licensed for use to DHS. The tips and leads such campaigns generated, together with the reports from officers on suspicious incidents that might have to do with terrorism, were coordinated in the Information Sharing Environment. Drawing on reports thus generated, the Federal Government would, in theory, communicate timely information on security threats to law enforcement so that they would be better able to discern the incidents to be reported. The cycle aimed to catch events in emergence, in a distinctively anticipatory strategy of counterterrorism (Stalcup). Re-imagination A curious fact emerges from this history, and it is key to understanding how this initiative developed. That is, there was nothing suspicious in the encounters. The soon-to-be terrorists’ licenses were up-to-date, the cars were legal, they were not nervous. Even Mohamed Atta’s warrant would have resulted in nothing more than a fine. It is not self-evident, given these facts, how a governmental technology came to be designed from these scenarios. How––if nothing seemed of immediate concern, if there had been nothing suspicious to discern––did an intelligence strategy come to be assembled around such encounters? Evidently, strident demands were made after the events of 9/11 to know, “what went wrong?” Policies were crafted and implemented according to the answers given: it was too easy to obtain identification, or to enter and stay in the country, or to buy airplane tickets and fly. But the trooper’s question, the reader will recall, was somewhat different. He had said, “It’s difficult sometimes to think back and go: ‘What if you had known something else?’” To ask “what if you had known something else?” is also to ask what else might have been. Janet Roitman shows that identifying a crisis tends to implicate precisely the question of what went wrong. Crisis, and its critique, take up history as a series of right and wrong turns, bad choices made between existing dichotomies (90): liberty-security, security-privacy, ordinary-suspicious. It is to say, what were the possibilities and how could we have selected the correct one? Such questions seek to retrospectively uncover latencies—systemic or structural, human error or a moral lapse (71)—but they ask of those latencies what false understanding of the enemy, of threat, of priorities, allowed a terrible thing to happen. “What if…?” instead turns to the virtuality hidden in history, through which missed opportunities can be re-imagined. Image 4: “The Cholmondeley Sisters and Their Swaddled Babies.” Anonymous, c. 1600-1610 (British School, 17th century); Deleuze and Parnet (150). CC BY-SA 4.0 2015 by author, using materials in the public domain. Gilles Deleuze, speaking with Claire Parnet, says, “memory is not an actual image which forms after the object has been perceived, but a virtual image coexisting with the actual perception of the object” (150). Re-imagined scenarios take up the potential of memory, so that as the trooper’s traffic stop was revisited, it also became a way of imagining what else might have been. As Immanuel Kant, among others, points out, “the productive power of imagination is […] not exactly creative, for it is not capable of producing a sense representation that was never given to our faculty of sense; one can always furnish evidence of the material of its ideas” (61). The “memory” of these encounters provided the material for re-imagining them, and thereby re-virtualising history. This was different than other governmental responses, such as examining past events in order to assess the probable risk of their repetition, or drawing on past events to imagine future scenarios, for use in exercises that identify vulnerabilities and remedy deficiencies (Anderson). Re-imagining scenarios of police-hijacker encounters through the question of “what if?” evoked what Erin Manning calls “a certain array of recognizable elastic points” (39), through which options for other movements were invented. The Suspicious Activity Reporting Initiative’s architects instrumentalised such moments as they designed new governmental entities and programs to anticipate terrorism. For each element of the encounter, an aspect of the initiative was developed: training, functional standards, a way to (hypothetically) get real-time information about threats. Suspicion was identified as a key affect, one which, if cultivated, could offer a way to effectively deal not with binary right or wrong possibilities, but with the potential which lies nestled in uncertainty. The “signs of terrorism” (that is, categories of “terrorism precursor activities”) served to maximise receptivity to encounters. Indeed, it can apparently create an oversensitivity, manifested, for example, in police surveillance of innocent people exercising their right to assemble (Madigan), or the confiscation of photographers’s equipment (Simon). “What went wrong?” and “what if?” were different interrogations of the same pre-9/11 incidents. The questions are of course intimately related. Moments where something went wrong are when one is likely to ask, what else might have been known? Moreover, what else might have been? The answers to each question informed and shaped the other, as re-imagined scenarios became the means of extracting categories of suspicious activities and patterns of behaviour that comprise the phases of an event in becoming. Conclusion The 9/11 Commission, after two years of investigation into the causes of the disastrous day, reported that “the most important failure was one of imagination” (Kean and Hamilton, Summary). The iconic images of 9/11––such as airplanes being flown into symbols of American power––already existed, in guises ranging from fictive thrillers to the infamous FBI field memo sent to headquarters on Arab men learning to fly, but not land. In 1974 there had already been an actual (failed) attempt to steal a plane and kill the president by crashing it into the White House (Kean and Hamilton, Report Ch11 n21). The threats had been imagined, as Pat O’Malley and Philip Bougen put it, but not how to govern them, and because the ways to address those threats had been not imagined, they were discounted as matters for intervention (29). O’Malley and Bougen argue that one effect of 9/11, and the general rise of incalculable insecurities, was to make it necessary for the “merely imaginable” to become governable. Images of threats from the mundane to the extreme had to be conjured, and then imagination applied again, to devise ways to render them amenable to calculation, minimisation or elimination. In the words of the 9/11 Commission, the Government must bureaucratise imagination. There is a sense in which this led to more of the same. Re-imagining the early encounters reinforced expectations for officers to do what they already do, that is, to be on the lookout for suspicious behaviours. Yet, the images of threat brought forth, in their mixing of memory and an elastic “almost,” generated their own momentum and distinctive demands. Existing capacities, such as suspicion, were re-shaped and elaborated into specific forms of security governance. The question of “what if?” and the scenarios of police-hijacker encounter were particularly potent equipment for this re-imagining of history and its re-virtualisation. References Anderson, Ben. “Preemption, Precaution, Preparedness: Anticipatory Action and Future Geographies.” Progress in Human Geography 34.6 (2010): 777-98. Clay, Nolan, and Randy Ellis. “Terrorist Ticketed Last Year on I-40.” NewsOK, 20 Jan. 2002. 25 Nov. 2014 ‹http://newsok.com/article/2779124›. Deleuze, Gilles. Negotiations. New York: Columbia UP, 1995. Deleuze, Gilles, and Claire Parnet. Dialogues II. New York: Columbia UP 2007 [1977]. Federal Bureau of Investigation. “Hijackers Timeline (Redacted) Part 01 of 02.” Working Draft Chronology of Events for Hijackers and Associates. 2003. 18 Apr. 2014 ‹https://vault.fbi.gov/9-11%20Commission%20Report/9-11-chronology-part-01-of-02›. Kant, Immanuel. Anthropology from a Pragmatic Point of View. Trans. Robert B. Louden. Cambridge: Cambridge UP, 2006. Kean, Thomas H., and Lee Hamilton. Executive Summary of the 9/11 Commission Report: Final Report of the National Commission on Terrorist Attacks upon the United States. 25 Oct. 2015 ‹http://www.9-11commission.gov/report/911Report_Exec.htm›. Kean, Thomas H., and Lee Hamilton. The 9/11 Commission Report: Final Report of the National Commission on Terrorist Attacks upon the United States. New York: W.W. Norton, 2004. McConnell, Mike. “Overhauling Intelligence.” Foreign Affairs, July/Aug. 2007. Madigan, Nick. “Spying Uncovered.” Baltimore Sun 18 Jul. 2008. 25 Oct. 2015 ‹http://www.baltimoresun.com/news/maryland/bal-te.md.spy18jul18-story.html›. Manning, Erin. Relationscapes: Movement, Art, Philosophy. Cambridge, MA: MIT P, 2009. O’Malley, P., and P. Bougen. “Imaginable Insecurities: Imagination, Routinisation and the Government of Uncertainty post 9/11.” Imaginary Penalities. Ed. Pat Carlen. Cullompton, UK: Willan, 2008.Roitman, Janet. Anti-Crisis. Durham, NC: Duke UP, 2013. Simon, Stephanie. “Suspicious Encounters: Ordinary Preemption and the Securitization of Photography.” Security Dialogue 43.2 (2012): 157-73. Stalcup, Meg. “Policing Uncertainty: On Suspicious Activity Reporting.” Modes of Uncertainty: Anthropological Cases. Eds. Limor Saminian-Darash and Paul Rabinow. Chicago: U of Chicago P, 2015. 69-87. Wall Street Journal. “A Careful Sequence of Mundane Dealings Sows a Day of Bloody Terror for Hijackers.” 16 Oct. 2001.

Image 1: View from Geodha Sgoilt towards the sea stacks, Uig, Isle of Lewis. Image credit: George Jaramillo.IntroductionOver the cliffs of Mangerstadh on the west coast of the Isle of Lewis, is a small plot of land called Geodha Sgoilt that overlooks the North Atlantic Ocean (Image 1). On the site is a small dirt gravel road and the remnants of a World War II listening station. Below, sea stacks rise from the waters, orange and green cliff sides stand in defiance to the crashing waves. An older gentleman began to tell me of what he believed could be located here on the site. A place where visitors could learn of the wonders of St Kilda that contained all types of new storytelling technologies to inspire them. He pointed above the ruined buildings, mentioning that a new road for the visitors’ vehicles and coaches would be built. With his explanations, you could almost imagine such a place on these cliffs. Yet, before that new idea could even be built, this gentleman and his group of locals and incomers had to convince themselves and others that this new heritage centre was something desired, necessary and inevitable in the development of the Western Isles.This article explores the developing relationships that come about through design innovation with community organisations. This was done through a partnership between an academic institution and a non-profit heritage community group as part of growing study in how higher education design research can play an active partner in community group development. It argues for the use of design thinking and innovation in improving strategy and organisational processes within non-profit organisations. In this case, it looks at what role it can play in building and enabling organisational confidence in its mission, as well as, building “beyond the museum”. The new approach to this unique relationship casts new light towards working with complexities and strategies rather than trying to resolve issues from the outset of a project. These enabling relationships are divided into three sections of this paper: First it explores the context of the island community group and “building” heritage, followed by a brief history of St Kilda and its current status, and designation as a World Heritage site. Second, it seeks the value of developing strategy and the introduction of the Institute of Design Innovation (INDI). This is followed by a discussion of the six-month relationship and work that was done that elucidates various methods used and ending with its outcomes. The third section reflects upon the impacts at the relationship building between the two groups with some final thoughts on the partnership, where it can lead, and how this can represent new ways of working together within community groups. Building HeritageCurrent community research in Scotland has shown struggles in understanding issues within community capability and development (Barker 11; Cave 20; Jacuniak-Suda, and Mose 23) though most focus on the land tenure and energy (McMorran 21) and not heritage groups. The need to maintain “resilient” (Steiner 17) communities has shown that economic resilience is of primary importance for these rural communities. Heritage as economic regenerator has had a long history in the United Kingdom. Some of these like the regeneration of Wirksworth in the Peak District (Gordon 20) have had great economic results with populations growing, as well as, development in the arts and design. These changes, though positive, have also adversely impacted the local community by estranging and forcing lower income townspeople to move away due to higher property values and lack of work. Furthermore, current trends in heritage tourism have managed to turn many rural regions into places of historic consumption (Ronström 7) termed “heritagisation” (Edensor 35). There is thus a need for critical reflection within a variety of heritage organisations with the increase in heritage tourism.In particular, existing island heritage organisations face a variety of issues that they focus too much on the artefactual or are too focused to strive for anything beyond the remit of their particular heritage (Jacuniak-Suda, and Mose 33; Ronström 4). Though many factors including funding, space, volunteerism and community capability affect the way these groups function they have commonalities that include organisational methods, volunteer fatigue, and limited interest from community groups. It is within this context that the communities of the Outer Hebrides. Currently, projects within the Highlands and islands focus on particular “grassroots” development (Cave 26; Robertson 994) searching for innovative ways to attract, maintain, and sustain healthy levels of heritage and development—one such group is Ionad Hiort. Ionad Hiort Ionad Hiort is a community non-profit organisation founded in 2010 to assist in the development of a new type of heritage centre in the community of Uig on the Isle of Lewis (“Proposal-Ionad Hiort”). As stated in their website, the group strives to develop a centre on the history and contemporary views of St Kilda, as well as, encouraging a much-needed year-round economic impetus for the region. The development of the group and the idea of a heritage centre came about through the creation of the St Kilda Opera, a £1.5 million, five-country project held in 2007, led by Scotland’s Gaelic Arts agency, Proiseact nan Ealan (Mckenzie). This opera, inspired by the cliffs, people, and history of St Kilda used creative techniques to unite five countries in a live performance with cliff aerobatics and Gaelic singing to present the island narrative. From this initial interest, a commission from the Western Isles council (2010), developed by suggestions and commentary from earlier reports (Jura Report 2009; Rebanks 2009) encouraged a fiercely contentious competition, which saw Ionad Hiort receive the right to develop a remote-access heritage centre about the St Kilda archipelago (Maclean). In 2013, the group received a plot of land from the local laird for the establishment of the centre (Urquhart) thereby bringing it closer to its goal of a heritage centre, but before moving onto this notion of remote-heritage, a brief history is needed on the archipelago. Image 2: Location map of Mangerstadh on the Isle of Lewis and St Kilda to the west, with inset of Scotland. Image credit: © Crown Copyright and Database Right (2017). Ordnance Survey (Digimap Licence).St KildaSt Kilda is an archipelago about 80 kilometres off the coast of the Outer Hebrides in the North Atlantic (Image 2). Over 2000 years of habitation show an entanglement between humans and nature including harsh weather, limited resources, but a tenacity and growth to develop a way of living upon a small section of land in the middle of the Atlantic. St Kilda has maintained a tenuous relationship between the sea, the cliffs and the people who have lived within its territory (Geddes, and Gannon 18). Over a period of three centuries beginning in the eighteenth century an outside influence on the island begin to play a major role, with the loss of a large portion of its small (180) population. This population would later decrease to 100 and finally to 34 in 1930, when it was decided to evacuate the final members of the village in what could best be called a forced eviction.Since the evacuation, the island has maintained an important military presence as a listening station during the Second World War and in its modern form a radar station as part of the Hebridean Artillery (Rocket) Range (Geddes 14). The islands in the last thirty years have seen an increase in tourism with the ownership of the island by the National Trust of Scotland. The UNESCO World Heritage Organisation (UNESCO), who designated St Kilda in 1986 and 2004 as having outstanding universal value, has seen its role evolve from not just protecting (or conserving) world heritage sites, but to strategically understand sustainable tourism of its sites (“St Kilda”). In 2012, UNESCO selected St Kilda as a case study for remote access heritage conservation and interpretation (Hebrides News Today; UNESCO 15). This was partly due to the efforts of 3D laser scanning of the islands by a collaboration between The Glasgow School of Art and Historic Environment Scotland called the Centre for Digital Documentation and Visualisation (CDDV) in 2009.The idea of a remote access heritage is an important aspect as to what Ionad Hiort could do with creating a centre at their site away from St Kilda. Remote access heritage is useful in allowing for sites and monuments to be conserved and monitored “from afar”. It allows for 3D visualisations of sites and provides new creative engagements with a variety of different places (Remondino, and Rizzi 86), however, Ionad Hiort was not yet at a point to even imagine how to use the remote access technology. They first needed a strategy and direction, as after many years of moving towards recognition of proposing the centre at their site in Uig, they had lost a bit of that initial drive. This is where INDI was asked to assist by the Highlands and Islands Enterprise, the regional development organisation for most of rural Scotland. Building ConfidenceINDI is a research institute at The Glasgow School of Art. It is a distributed, creative collective of researchers, lecturers and students specialising in design innovation, where design innovation means enabling creative capabilities within communities, groups and individuals. Together, they address complex issues through new design practices and bespoke community engagement to co-produce “preferable futures” (Henchley 25). Preferable futures are a type of future casting that seeks to strive not just for the probable or possible future of a place or idea, but for the most preferred and collectively reached option for a society (McAra-McWilliam 9). INDI researches the design processes that are needed to co-create contexts in which people can flourish: at work, in organisations and businesses, as well as, in public services and government. The task of innovation as an interactive process is an example of the design process. Innovation is defined as “a co-creation process within social and technological networks in which actors integrate their resources to create mutual value” (Russo‐Spena, and Mele 528). Therefore, innovation works outside of standard consultancy practices; rather it engenders a sense of mutual co-created practices that strive to resolve particular problems. Examples include the work that has looked at creating cultures of innovation within small and medium-sized enterprises (Lockwood 4) where the design process was used to alter organisational support (Image 3). These enterprises tend to emulate larger firms and corporations and though useful in places where economies of scale are present, smaller business need adaptable, resilient and integrated networks of innovation within their organisational models. In this way, innovation functioned as a catalyst for altering the existing organisational methods. These innovations are thus a useful alternative to existing means of approaching problems and building resilience within any organisation. Therefore, these ideas of innovation could be transferred and play a role in enabling new ways of approaching non-profit organisational structures, particularly those within heritage. Image 3: Design Council Double Diamond model of the design process. Image credit: Lockwood.Developing the WorkIonad Hiort with INDI’s assistance has worked together to develop a heritage centre that tries to towards a new definition of heritage and identity through this island centre. Much of this work has been done through local community investigations revolving around workshops and one-on-one talks where narratives and ideas are held in “negative capability” (McAra-McWilliam 2) to seek many alternatives that would be able to work for the community. The initial aims of the partnership were to assist the Uig community realise the potential of the St Kilda Centre. Primarily, it would assist in enabling the capabilities of two themes. The first would be, strategy, for Ionad Hiort’s existing multi-page mission brief. The second would be storytelling the narrative of St Kilda as a complex and entangled, however, its common views are limited to the ‘fall from grace’ or ‘noble savage’ story (Macdonald 168). Over the course of six months, the relationship involved two workshops and three site visits of varying degrees of interaction. An initial gathering had InDI staff meet members of Ionad Hiort to introduce members to each other. Afterwards, INDI ran two workshops over two months in Uig to understand, reflect and challenge Ionad Hiort’s focus on what the group desired. The first workshop focused on the group’s strategy statement. In a relaxed and facilitated space in the Uig Community Hall, the groups used pens, markers, and self-adhesive notes to engage in an open dialogue about the group’s desires. This session included reflecting on what their heritage centre could look like, as well as what their strategy needed to get there. These resulted in a series of drawings of their ‘preferred’ centre, with some ideas showing a centre sitting over the edge of the cliffs or one that had the centre be an integral component of the community. In discussing that session, one of members of the group recalled:I remember his [one of INDI’s staff] interrogation of the project was actually pretty – initially – fairly brutal, right? The first formal session we had talking about strategy and so on. To the extent that I think it would be fair to say he pissed everybody off, right? So much so that he actually prompted us to come back with some fairly hard hitting ripostes, which, after a moment’s silence he then said, ‘That’s it, you’ve convinced me’, and at that point we kind of realised that that’s what he’d been trying to do; he’d been trying to really push us to go further in our articulation of what we were doing and … why we were doing it in this particular way than we had done before. (Participant A, 2016).The group through this session found out that their strategy could be refined into a short mission statement giving a clear focus as to what they wanted and how they wanted to go about doing it. In the end, drawings, charts, stories (Image 4) were drawn to reflect on what the community had discussed. These artefacts became a key role-player in the following months of the development of the group. Image 4: View of group working through their strategy workshop session. Image credit: Fergus Fullarton-Pegg (2014). The second set of workshops and visits involved informal discussion with individual members of the group and community. This included a visit to St Kilda with members from INDI, Ionad Hiort and the Digital Design Studio, which allowed for everyone to understand the immensity of the project and its significance to World Heritage values. The initial aims thus evolved into understanding the context of self-governance for distributed communities and how to develop the infrastructure of development. As discussed earlier, existing development processes are useful, though limited to only particular types of projects, and as exemplified in the Highlands and Islands Enterprise and Western Isles Council commission, it tends to put communities against each other for limited pots of money. This existing system can be innovated upon by becoming creative liaisons, sharing and co-creating from existing studies to help develop more effective processes for the future of Ionad Hiort and their ‘preferable future’. Building RelationshipsWhat the relationship with GSA has done, as a dialogue with the team of people that have been involved, has been to consolidate and clarify our own thinking and to get us to question our own thinking across several different aspects of the whole project. (Participant A, 2016)As the quote states, the main notion of using design thinking has allowed Ionad Hiort to question their thinking and challenge preconceptions of what a “heritage centre” is, by being a critical sounding board that is different from what is provided by consultants and other stakeholders. Prior to meeting INDI, Ionad Hiort may have been able to reach their goal of a strategy, however, it would have taken a few more years. The work, which involved structured and unstructured workshops, meetings, planning events, and gatherings, gave them a structured focus to move ahead with their prospectus planning and bidding. INDI enabled the compression and focus of their strategy making and mission strategy statement over the course of six months into a one-page statement that gave direction to the group and provided the impetus for the development of the prospectus briefs. Furthermore, INDI contributed a sense of contemporary content to the historic story, as well as, enable the community to see that this centre would not just become another gallery with café. The most important outcome has been an effective measure in building relationships in the Outer Hebrides, which shows the changing roles between academic and third sector partnerships. Two key points can be deemed from these developing relationships: The first has been to build a research infrastructure in and across the region that engages with local communities about working with the GSA, including groups in North Uist, Barra and South Uist. Of note is a comment made by one of the participants saying: “It’s exciting now, there’s a buzz about it and getting you [INDI] involved, adding a dimension—we’ve got people who have got an artistic bent here but I think your enthusiasm, your skills, very much complement what we’ve got here.” (Participant B, 2016). Second, the academic/non-profit partnership has encouraged younger people to work and study in the area through a developing programme of student research activity. This includes placing taught masters students with local community members on the South Uist, as well as, PhD research being done on Stornoway. These two outcomes then have given rise to interest in not only how heritage is re-developed in a community, but also, encourages future interest, by staff and students to continue the debate and fashion further developments in the region (GSAmediacentre). Today, the cliffs of Mangerstadh continue to receive the pounding of waves, the blowing wind and the ever-present rain on its rocky granite surface. The iterative stages of work that the two groups have done showcase the way that simple actions can carve, change and evolve into innovative outcomes. The research outcomes show that through this new approach to working with communities we move beyond the consultant and towards an ability of generating a preferable future for the community. In this way, the work that has been created together showcases a case study for further island community development. We do not know what the future holds for the group, but with continued support and maintaining an open mind to creative opportunities we will see that the community will develop a space that moves “beyond the museum”. AcknowledgementsThe author would like to thank Ionad Hiort and all the residents of Uig on the Isle of Lewis for their assistance and participation in this partnership. For more information on their work please visit http://www.ionadhiort.org/. The author also thanks the Highlands and Islands Enterprise for financial support in the research and development of the project. Finally, the author thanks the two reviewers who provided critical commentary and critiques to improve this paper. ReferencesBarker, Adam. “Capacity Building for Sustainability: Towards Community Development in Coastal Scotland.” Journal of Environmental Management 75.1 (2005): 11-19. Canavan, Brendan. “Tourism Culture: Nexus, Characteristics, Context and Sustainability.” Tourism Management 53 (2016): 229-43. ———. “The Extent and Role of Domestic Tourism in a Small Island: The Case of the Isle of Man.” Journal of Travel Research 52.3 (2012): 340-52. Cape, Ruth. Exploring Growth and Empowerment of Communities in the Western Isles. Stornoway, 2013. Bullen, Elizabeth, Simon Robb, and Jane Kenway. “‘Creative Destruction’: Knowledge Economy Policy and the Future of the Arts and Humanities in the Academy.” Journal of Education Policy 19.1 (2004): 3–22. Brown, Tim, and Jocelyn Wyatt. “Design Thinking for Social Innovation.” Stanford Social Innovation Review Winter (2010): 30-35. <https://ssir.org/articles/entry/design_thinking_for_social_innovation>.Briscoe, Gerard, and Mark Plumbley. Creating Cultures of Innovation: The Digital Creative Industries. <https://qmro.qmul.ac.uk/xmlui/bitstream/handle/123456789/11403/Creating%20Cultures%20of%20Innovation.pdf?sequence=7>.Edensor, Tim. Industrial Ruins: Spaces, Aesthetics, and Materiality. Oxford: Berg, 2005. Geddes, George. The Magazine and Gun Emplacement, St Kilda A Conservation Statement. Edinburgh, 2008. Geddes, George, and Angela Gannon. St Kilda: The Last and Outmost Isle. Edinburgh: Royal Commission on the Ancient & Historical Monuments of Scotland, 2015. Gordon, Michel, and Arthur Percival. The Wirksworth Story: New Life for An Old Town. Wirksworth: Civic Trust, 1984. GSAmediacentre. “The Glasgow School of Art Contributes to St Kilda Centre Symposium in Stornoway.” GSA Media Centre, The Glasgow School of Art, 17 Aug. 2016. 6 Apr. 2017 <www.gsapress.blogspot.co.uk/2016/08/the-glasgow-school-of-art-contributes.html>.Henchley, Norman. "Making Sense of Future Studies." Alternatives 7.2 (1978): 24-28. Jacuniak-Suda, Marta, and Ingo Mose. “Social Enterprises in the Western Isles (Scotland) – Drivers of Sustainable Rural Development ?” Europa Regional 19.2011.2 (2014): 23-40. Lockwood, Joseph, Madeline Smith, and Irene McAra-McWilliam. “Work-Well: Creating a Culture of Innovation through Design.” International Design Management Research Conference, Boston, 2012. 1-11. McAra-McWilliam, Irene. “Impossible Things? Negative Capability and the Creative Imagination.” Creativity or Conformity Conference, Cardiff, 2007. 1-8. <https://www.academia.edu/1246770/Impossible_things_Negative_Capability>.McKenzie, Steven. "Opera Celebrates St Kilda History." BBC News 23 Jun. 2007. 6 Apr. 2017 <http://news.bbc.co.uk/1/hi/scotland/highlands_and_islands/6763371.stm>.McMorran, Rob, and Alister Scott. “Community Landownership: Rediscovering the Road to Sustainability.” Lairds: Scottish Perspectives on Upland Management (2013): 20-31. Maclean, Diane. “Bitter Strife over St Kilda Visitor Centre.” The Caledonian Mercury 29 Jan. 2010. 6 Apr. 2017 <http://www.caledonianmercury.com/2010/01/29/bitter-strife-over-st-kilda-visitor-centre/001383>.News Editor. “Double Boost for St Kilda Project.” Hebrides News Today 20 Nov. 2013. 6 Apr. 2017 <www.hebridestoday.com/2013/11/double-boost-for-st-kilda-project/>.Portschy, Szabolcs. “Design Partnerships between Community-Engaged Architecture and Academic Education Programs.” Pollack Periodica 10.1 (2015): 173-180.“Proposal – Ionad Hiort.” Ionad Hiort. 6 Apr. 2017 <http://www.ionadhiort.org/the-proposal>. Rebanks, James. “World Heritage Status: Is There Opportunity for Economic Gain? Research and Analysis of the Socio-Economic Impact Potential of UNESCO World Heritage Site Status.” 2009. <http://icomos.fa.utl.pt/documentos/2009/WHSTheEconomicGainFinalReport.pdf>.Robertson, Iain James McPherson. “Hardscrabble Heritage: The Ruined Blackhouse and Crofting Landscape as Heritage from Below.” Landscape Research 40.8 (2015): 993–1009. Ronström, Owe. “Heritage Production in the Island of Gotland.” The International Journal of Research into Island Cultures 2.2 (2008): 1-18. Russo‐Spena, Tiziana, and Cristina Mele. “‘Five Co‐s’ in Innovating: A Practice‐Based View.” Ed. Evert Gummesson. Journal of Service Management 23.4 (2012): 527-53. “St Kilda.” World Heritage Centre. 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Photo by 14825144 © Alita Xander | Dreamstime.com ABSTRACT The US government's approach to the War on Drugs has created laws to deter people from using illicit drugs through negative punishment. These laws have not controlled illicit drug use, nor has it stopped the opioid pandemic from growing. Instead, these laws have created a negative bias surrounding addiction and have negatively affected particularly vulnerable patient populations, including pregnant women with substance use disorder and newborns with neonatal abstinence syndrome. This article highlights some misconceptions and underscores the challenges they face as they navigate the justice and healthcare systems while also providing possible solutions to address their underlying addiction. INTRODUCTION Pregnant women with substance use disorder require treatment that is arguably for the benefit of both the mother and the fetus. Some suggest that addiction is a choice; therefore, those who misuse substances should not receive treatment. Proponents of this argument emphasize social and environmental factors that lead to addiction but fail to appreciate how chronic substance use alters the brain’s chemistry and changes how it responds to stress, reward, self-control, and pain. The medical community has long recognized that substance use disorder is not simply a character flaw or social deviance, but a complex condition that requires adequate medical attention. Unfortunately, the lasting consequences of the War on Drugs have created a stigma around addiction medicine, leading to significant treatment barriers. There is still a pervasive societal bias toward punitive rather than rehabilitative approaches to addiction. For example, many women with substance use disorder lose custody of their baby or face criminal penalties, including fines and jail time.[1] These punitive measures may cause patients to lose trust in their physicians, ultimately leading to high-risk pregnancies without prenatal care, untreated substance misuse, and potential lifelong disabilities for their newborns.[2] As a medical student, I have observed the importance of a rehabilitative approach to addiction medicine. Incentivizing pregnant women with substance use disorder to safely address their chronic health issues is essential for minimizing negative short-term and long-term outcomes for women and their newborns. This approach requires an open mind and supportive perspective, recognizing that substance use disorder is truly a medical condition that requires just as much attention as any other medical diagnosis.[3] BACKGROUND The War on Drugs was a government-led initiative launched in 1970 by President Richard M. Nixon with the aim of curtailing illegal drug use, distribution, and trade by imposing harsher prison sentences and punishments.[4] However, it is worth noting that one can trace the roots of this initiative back further. In 1914, Congress enacted the Harrison Narcotics Tax Act to target the recreational use of drugs such as morphine and opium.[5] Despite being in effect for over four decades, the War on Drugs failed to achieve its intended goals. In 2011, the Global Commission on Drug Policy released a report that concluded that the initiative had been futile, as “arresting and incarcerating tens of millions of these people in recent decades has filled prisons and destroyed lives and families without reducing the availability of illicit drugs or the power of criminal organizations.”[6] One study published in the International Journal of Drug Policy in the same year found that funding drug law enforcement paradoxically contributed to increasing gun violence and homicide rates.[7] The Commission recommended that drug policies focus on reducing harm caused by drug use rather than solely on reducing drug markets. Recognizing that many drug policies were of political opinion, it called for drug policies that were grounded in scientific evidence, health, security, and human rights.[8] Unfortunately, policy makers did not heed these recommendations. In 2014, Tennessee’s legislature passed a “Fetal Assault Law,” which made it possible to prosecute pregnant women for drug use during pregnancy. If found guilty, pregnant women could face up to 15 years in prison and lose custody of their child. Instead of deterring drug use, the law discouraged pregnant women with substance use disorder from seeking prenatal care. This law required medical professionals to report drug use to authorities, thereby compromising the confidentiality of the patient-physician relationship. Some avoided arrest by delivering their babies in other states or at home, while others opted for abortions or attempted to go through an unsafe withdrawal prior to receiving medical care, sacrificing the mother's and fetus's wellbeing. The law had a sunset provision and expired in 2016. During the two years this law was in effect, officials arrested 124 women.[9] The fear that this law instilled in pregnant women with substance use disorder can still be seen across the US today. Many pregnant women with substance use disorders stated that they feared testing positive for drugs. Due to mandatory reporting, they were not confident that physicians would protect them from the law.[10] And if a woman tried to stop using drugs before seeking care to avoid detection, she often ended up delaying or avoiding care.[11] The American College of Obstetricians and Gynecologists (ACOG) recognizes the fear those with substance use disorders face when seeking appropriate medical care and emphasizes that “obstetric–gynecologic care should not expose a woman to criminal or civil penalties, such as incarceration, involuntary commitment, loss of custody of her children, or loss of housing.”[12] Mandatory reporting strains the patient-physician relationship, driving a wedge between the doctor and patient. Thus, laws intended to deter people from using substances through various punishments and incarceration may be doing more harm than good. County hospitals that mainly serve lower socioeconomic patients encounter more patients without consistent health care access and those with substance use disorders.[13] These hospitals are facing the consequences of the worsening opioid pandemic. At one county hospital where I recently worked, there has been a dramatic increase in newborns with neonatal abstinence syndrome born to mothers with untreated substance use disorders during pregnancy. Infants exposed to drugs prenatally have an increased risk of complications, stillbirth, and life-altering developmental disabilities. At the hospital, I witnessed Child Protective Services removing two newborns with neonatal abstinence syndrome from their mother’s custody. Four similar cases had occurred in the preceding month. In the days leading up to their placement with a foster family, I saw both newborns go through an uncomfortable drug withdrawal. No baby should be welcomed into this world by suffering like that. Yet I felt for the new mothers and realized that heart-wrenching custody loss is not the best approach. During this period, I saw a teenager brought to the pediatric floor due to worsening psychiatric symptoms. He was born with neonatal abstinence syndrome that neither the residential program nor his foster family could manage. His past psychiatric disorders included attention deficit disorder, conduct disorder, major depressive disorder, anxiety disorder, disruptive mood dysregulation disorder, intellectual developmental disorder, and more. During his hospitalization, he was so violent towards healthcare providers that security had to intervene. And his attitude toward his foster parents was so volatile that we were never sure if having them visit was comforting or agitating. Throughout his hospital course, it was difficult for me to converse with him, and I left every interview with him feeling lost in terms of providing an adequate short- and long-term assessment of his psychological and medical requirements. What was clear, however, was that his intellectual and emotional levels did not match his age and that he was born into a society that was ill-equipped to accommodate his needs. Just a few feet away from his room, behind the nurses’ station, were the two newborns feeling the same withdrawal symptoms that this teenager likely experienced in the first few hours of his life. I wondered how similar their paths would be and if they would exhibit similar developmental delays in a few years or if their circumstance may follow the cases hyped about in the media of the 1980s and 1990s regarding “crack babies.” Many of these infants who experienced withdrawal symptoms eventually led normal lives.[14] Nonetheless, many studies have demonstrated that drug use during pregnancy can adversely impact fetal development. Excessive alcohol consumption can result in fetal alcohol syndrome, characterized by growth deficiency, facial structure abnormalities, and a wide range of neurological deficiencies.[15] Smoking can impede the development of the lungs and brain and lead to preterm deliveries or sudden infant death syndrome.[16] Stimulants like methamphetamine can also cause preterm delivery, delayed motor development, attention impairments, and a wide range of cognitive and behavioral issues.[17] Opioid use, such as oxycodone, morphine, fentanyl, and heroin, may result in neonatal opioid withdrawal syndrome, in which a newborn may exhibit tremors, irritability, sleeping problems, poor feeding, loose stools, and increased sweating within 72 hours of life.[18] In 2014, the American Association of Pediatrics (AAP) reported that one newborn was diagnosed with neonatal abstinence syndrome every 15 minutes, equating to approximately 32,000 newborns annually, a five-fold increase from 2004.[19] The AAP found that the cost of neonatal abstinence syndrome covered by Medicaid increased from $65.4 million to $462 million from 2004 to 2014.[20] In 2020, the CDC published a paper that showed an increase in hospital costs from $316 million in 2012 to $572.7 million in 2016.[21] Currently, the impact of the COVID-19 pandemic on the prevalence of newborns with neonatal abstinence syndrome is unknown. I predict that the increase in opioid and polysubstance use during the pandemic will increase the number of newborns with neonatal abstinence syndrome, thereby significantly increasing the public burden and cost.[22] In the 1990s, concerns arose about the potentially irreparable damage caused by intrauterine exposure to cocaine on the development of infants, which led to the popularization of the term “crack babies.”[23] Although no strong longitudinal studies supported this claim at the time, it was not without merit. The Maternal Lifestyle Study (NCT00059540) was a prospective longitudinal observational study that compared the outcomes of newborns exposed to cocaine in-utero to those without.[24] One of its studies revealed one month old newborns with cocaine exposure had “lower arousal, poorer quality of movements and self-regulation, higher excitability, more hypertonia, and more nonoptimal reflexes.”[25] Another study showed that at one month old, heavy cocaine exposure affected neural transmission from the ear to the brain.[26] Long-term follow up from the study showed that at seven years old, children with high intrauterine cocaine exposure were more likely to have externalizing behavior problems such as aggressive behavior, temper tantrums, and destructive acts.[27] While I have witnessed this behavior in the teenage patient during my pediatrics rotation, not all newborns with intrauterine drug exposure are inevitably bound to have psychiatric and behavioral issues later in life. NPR recorded a podcast in 2010 highlighting a mother who used substances during pregnancy and, with early intervention, had positive outcomes. After being arrested 50 times within five years, she went through STEP: Self-Taught Empowerment and Pride, a public program that allowed her to complete her GED and provided guidance and encouragement for a more meaningful life during her time in jail. Her daughter, who was exposed to cocaine before birth, had a normal childhood and ended up going to college.[28] From a public health standpoint, more needs to be done to prevent the complications of substance misuse during pregnancy. Some states consider substance misuse (and even prescribed use) during pregnancy child abuse. Officials have prosecuted countless women across 45 states for exposing their unborn children to drugs.[29] With opioid and polysubstance use on the rise, the efficacy of laws that result in punitive measures seems questionable.[30] So far, laws are not associated with a decrease in the misuse of drugs during pregnancy. Millions of dollars are being poured into managing neonatal abstinence syndrome, including prosecuting women and taking their children away. Rather than policing and criminalizing substance use, pregnant women should get the appropriate care they need and deserve. I. Misconception One: Mothers with Substance Use Disorder Can Get an Abortion If an unplanned pregnancy occurs, one course of action could be to terminate the pregnancy. On the surface, this solution seems like a quick fix. However, the reality is that obtaining an abortion can be challenging due to two significant barriers: accessibility and mandated reporting. Abortion laws vary by state, and in Tennessee, for instance, abortions are banned after six weeks of gestation, typically when fetal heart rhythms are detected. An exception to this is in cases where the mother's life is at risk.[31] Unfortunately, many women with substance use disorders are from lower socioeconomic backgrounds and cannot access pregnancy tests, which could indicate they are pregnant before the six-week cutoff. If a Tennessee woman with substance use disorder decides to seek an abortion after six weeks, she may need to travel to a neighboring state. However, this is not always a feasible option, as the surrounding states (WV, MO, AR, MI, AL, and GA) also have restrictive laws that either prohibit abortions entirely or ban them after six weeks. Moreover, she may be hesitant to visit an obstetrician for an abortion, as some states require physicians by law to report their patients' substance use during pregnancy. For example, Virginia considers substance use during pregnancy child abuse and mandates that healthcare providers report it. This would ultimately limit her to North Carolina if she wants to remain in a nearby state, but she must go before 20 weeks gestation.[32] For someone who may or may not have access to reliable transportation, traveling to another state might be impossible. Without resources or means, these restrictive laws have made it incredibly difficult to obtain the medical care they need. II. Misconception Two: Mothers with SUD are Not Fit to Care for Children If a woman cannot take care of herself, one might wonder how she can take care of another human being. Mothers with substance use disorders often face many adversities, including lack of economic opportunity, trauma from abuse, history of poverty, and mental illness.[33] Fortunately, studies suggest keeping mother and baby together has many benefits. Breastfeeding, for example, helps the baby develop a strong immune system while reducing the mother’s risk of cancer and high blood pressure.[34] Additionally, newborns with neonatal abstinence syndrome who are breastfed by mothers receiving methadone or buprenorphine require less pharmacological treatment, have lower withdrawal scores, and experience shorter hospital stays.[35] Opioid concentration in breastmilk is minimal and does not pose a risk to newborns.[36] Moreover, oxytocin, the hormone responsible for mother-baby bonding, is increased in breastfeeding mothers, reducing withdrawal symptoms and stress-induced reactivity and cravings while also increasing protective maternal instincts.[37] Removing an infant from their mother’s care immediately after birth would result in the loss of all these positive benefits for both the mother and her newborn. The newborns I observed during my pediatrics rotation probably could have benefited from breastfeeding rather than bottle feeding and being passed around from one nurse to the next. They probably would have cried less and suffered fewer withdrawal symptoms had they been given the opportunity to breastfeed. And even if the mothers were lethargic and unresponsive while going through withdrawal, it would still have been possible to breastfeed with proper support. Unfortunately, many believe mothers with substance use disorder cannot adequately care for their children. This pervasive societal bias sets them up for failure from the beginning and greatly inhibits their willingness to change and mend their relationship with their providers. It is a healthcare provider’s duty to provide non-judgmental care that prioritizes the patient’s well-being. They must treat these mothers with the same empathy and respect as any other patient, even if they are experiencing withdrawal. III. Safe Harbor and Medication-Assisted Treatment Addiction is like any other disease and society should regard treatment without stigma. There is no simple fix to this problem, given that it involves the political, legal, and healthcare systems. Punitive policies push pregnant women away from receiving healthcare and prevent them from receiving beneficial interventions. States need to enact laws that protect these women from being reported to authorities. Montana, for example, passed a law in 2019 that provides women with substance use disorders safe harbor from prosecution if they seek treatment for their condition.[38] Medication-assisted treatment with methadone or buprenorphine is the first line treatment option and should be available to all pregnant women regardless of their ability to pay for medical care.[39] To promote continuity of care, health officials could include financial incentives to motivate new mothers to go to follow-up appointments. For example, vouchers for groceries or enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) may offset financial burdens and allow a mother to focus on taking care of her child and her recovery. IV. Mandated Substance Abuse Programs Although the number of people sentenced to state prisons for drug related crimes has been declining, it is still alarming that there were 171,300 sentencings in 2019.[40] Only 11 percent of the 65 percent of our nation’s inmates with substance use disorder receive treatment, implying that the other 89 percent were left without much-needed support to overcome their addiction.[41] It is erroneous to assume that their substance use disorder would disappear after a period without substance use while behind bars. After withdrawal, those struggling with substance use disorder may still have cravings and the likelihood of relapsing remains high without proper medical intervention. Even if they are abstinent for some time during incarceration, the underlying problem persists, and the cycle inevitably continues upon release from custody. In line with the recommendations by Global Commission on Drug Policy and the lessons learned from the failed War on Drugs, one proposed change in our criminal justice system would be to require enrollment and participation in assisted alcohol cessation programs before legal punishment. Policy makers must place emphasis on the safety of the patient and baby rather than the cessation of substance use. This would incentivize people to actively seek medical care, restore the patient-physician relationship, and ensure that they take rehabilitation programs seriously. If the patient or baby is unsafe, a caregiver could intervene while the patient re-enrolls in the program. Those currently serving sentences in prisons and jails can treat their substance use disorder through medication assisted treatment, cognitive behavioral therapy, and programs like Self Taught Empowerment and Pride (STEP). Medication assisted treatment under the supervision of medical professionals can help inmates achieve and maintain sobriety in a healthy and safe way. Furthermore, cognitive behavioral therapy can help to identify triggers and teach healthier coping mechanisms to prepare for stressors outside of jail. Finally, multimodal empowerment programs can connect people to jobs, education, and support upon release. People often leave prisons and jail without a sense of purpose, which can lead to relapse and reincarceration. Structured programs have been shown to decrease drug use and criminal behavior by helping reintegrate productive individuals into society.[42] V. Medical Education: Narcotic Treatment Programs and Suboxone Clinics Another proactive approach could be to have medical residency programs register with the Drug Enforcement Administration (DEA) as Narcotic Treatment Programs and incorporate suboxone clinics into their education and rotations. Rather than family medicine, OB/GYN, or emergency medicine healthcare workers having to refer their patients to an addiction specialist, they could treat patients with methadone for maintenance or detoxification where they would deliver their baby. Not only would this educate and prepare the future generation of physicians to handle the opioid crisis, but it would allow pregnant women to develop strong patient-physician relationships. CONCLUSION Society needs to change from the mindset of tackling a problem after it occurs to taking a proactive approach by addressing upstream factors, thereby preventing those problems from occurring in the first place. Emphasizing public health measures and adequate medical care can prevent complications and developmental issues in newborns and pregnant women with substance use disorders. Decriminalizing drug use and encouraging good health habits during pregnancy is essential, as is access to prenatal care, especially for lower socioeconomic patients. Many of the current laws and regulations that policy makers initially created due to naïve political opinion and unfounded bias to serve the War on Drugs need to be changed to provide these opportunities. To progress as a society, physicians and interprofessional teams must work together to truly understand the needs of patients with substance use disorders and provide support from prenatal to postnatal care. There should be advocation for legislative change, not by providing an opinion but by highlighting the facts and conclusions of scientific studies grounded in scientific evidence, health, security, and human rights. There can be no significant change if society continues to view those with substance use disorders as underserving of care. Only when the perspective shifts to compassion can these mothers and children receive adequate care that rehabilitates and supports their future and empowers them to raise their children. - [1] NIDA. 2023, February 15. Pregnant People with Substance Use Disorders Need Treatment, Not Criminalization. https://nida.nih.gov/about-nida/noras-blog/2023/02/pregnant-people-substance-use-disorders-need-treatment-not-criminalization [2] Substance Use Disorder Hurts Moms and Babies. National Partnership for Women and Families. June 2021 [3] All stories have been fictionalized and anonymized. [4] A History of the Drug War. Drug Policy Alliance. https://drugpolicy.org/issues/brief-history-drug-war [5] The Harrison Narcotic Act (1914) https://www.druglibrary.org/Schaffer/library/studies/cu/cu8.html [6] The War on Drugs. The Global Commission on Drug Policy. Published June 2011. https://www.globalcommissionondrugs.org/reports/the-war-on-drugs [7] Werb D, Rowell G, Guyatt G, Kerr T, Montaner J, Wood E. Effect of drug law enforcement on drug market violence: A systematic review. Int J Drug Policy. 2011;22(2):87-94. doi:10.1016/j.drugpo.2011.02.002 [8] Global Commission on Drug Policy, 2011 [9] Women NA for P. Tennessee’s Fetal Assault Law: Understanding its impact on marginalized women - New York. Pregnancy Justice. Published December 14, 2020. https://www.pregnancyjusticeus.org/tennessees-fetal-assault-law-understanding-its-impact-on-marginalized-women/ [10] Roberts SCM, Nuru-Jeter A. Women’s perspectives on screening for alcohol and drug use in prenatal care. Womens Health Issues Off Publ Jacobs Inst Womens Health. 2010;20(3):193-200. doi:10.1016/j.whi.2010.02.003 [11] Klaman SL, Isaacs K, Leopold A, et al. Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance. J Addict Med. 2017;11(3):178-190. doi:10.1097/ADM.0000000000000308 [12] Substance Abuse Reporting and Pregnancy: The Role of the Obstetrician–Gynecologist. https://www.acog.org/en/clinical/clinical-guidance/committee-opinion/articles/2011/01/substance-abuse-reporting-and-pregnancy-the-role-of-the-obstetrician-gynecologist [13] R. Ghertner, G Lincoln The Opioid Crisis and Economic Opportunity: Geographic and Economic Trends. ASPE. Office of Assistant Secretary for Planning and Evaluation. DHHS Revised September 11, 2018 https://aspe.hhs.gov/reports/economic-opportunity-opioid-crisis-geographic-economic-trends [14] Midon, M. Z., Gerzon, L. R., & de Almeida, C. S. (2021). Crack and motor development of babies living in an assistance shelter. ABCS Health Sciences, 46, e021215-e021215. And for example, see Crack Babies: Twenty Years Later : NPR https://www.npr.org/templates/story/story.php?storyId=126478643 [15] Williams JF, Smith VC, the Committee on Substance Abuse. Fetal Alcohol Spectrum Disorders. Pediatrics. 2015;136(5):e20153113. doi:10.1542/peds.2015-3113 [16] CDC Tobacco Free. Smoking During Pregnancy. Centers for Disease Control and Prevention. Published April 11, 2022. https://www.cdc.gov/tobacco/basic_information/health_effects/pregnancy/index.htm [17] Abuse NI on D. What are the risks of methamphetamine misuse during pregnancy? National Institute on Drug Abuse. https://nida.nih.gov/publications/research-reports/methamphetamine/what-are-risks-methamphetamine-misuse-during-pregnancy [18] CDC. Basics About Opioid Use During Pregnancy | CDC. Centers for Disease Control and Prevention. Published July 21, 2021. https://www.cdc.gov/pregnancy/opioids/basics.html [19] Honein MA, Boyle C, Redfield RR. Public Health Surveillance of Prenatal Opioid Exposure in Mothers and Infants. Pediatrics. 2019;143(3):e20183801. doi:10.1542/peds.2018-3801 [20] Winkelman TNA, Villapiano N, Kozhimannil KB, Davis MM, Patrick SW. Incidence and Costs of Neonatal Abstinence Syndrome Among Infants with Medicaid: 2004–2014. Pediatrics. 2018;141(4):e20173520. doi:10.1542/peds.2017-3520 [21] Strahan AE, Guy GP Jr, Bohm M, Frey M, Ko JY. Neonatal Abstinence Syndrome Incidence and Health Care Costs in the United States, 2016. JAMA Pediatr. 2020;174(2):200-202. doi:10.1001/jamapediatrics.2019.4791 [22] Ghose R, Forati AM, Mantsch JR. Impact of the COVID-19 Pandemic on Opioid Overdose Deaths: a Spatiotemporal Analysis. J Urban Health Bull N Y Acad Med. 2022;99(2):316-327. doi:10.1007/s11524-022-00610-0 [23] Mayes LC, Granger RH, Bornstein MH, Zuckerman B. The Problem of Prenatal Cocaine Exposure: A Rush to Judgment. JAMA. 1992;267(3):406-408. doi:10.1001/jama.1992.03480030084043 [24] NICHD Neonatal Research Network. The Maternal Lifestyle Study. clinicaltrials.gov; 2016. https://clinicaltrials.gov/ct2/show/study/NCT00059540 [25] Lester BM, Tronick EZ, LaGasse L, et al. The maternal lifestyle study: effects of substance exposure during pregnancy on neurodevelopmental outcome in 1-month-old infants. Pediatrics. 2002;110(6):1182-1192. doi:10.1542/peds.110.6.1182 [26] Lester BM, Lagasse L, Seifer R, et al. The Maternal Lifestyle Study (MLS): effects of prenatal cocaine and/or opiate exposure on auditory brain response at one month. J Pediatr. 2003;142(3):279-285. doi:10.1067/mpd.2003.112 [27] Bada HS, Bann CM, Bauer CR, et al. Preadolescent behavior problems after prenatal cocaine exposure: Relationship between teacher and caretaker ratings (Maternal Lifestyle Study). Neurotoxicol Teratol. 2011;33(1):78-87. doi:10.1016/j.ntt.2010.06.005 [28] N, P, R. Crack Babies: Twenty Years Later. NPR. Published May 3, 2010. https://www.npr.org/templates/story/story.php?storyId=126478643 [29] Miranda L, Dixon V, September CRP on, 30, 2015. How States Handle Drug Use During Pregnancy http://projects.propublica.org/graphics/maternity-drug-policies-by-state [30] NCDAS: Substance Abuse and Addiction Statistics [2023]. NCDAS. https://drugabusestatistics.org/ [31] (Tenn. Code Ann. § 39-15-216). [32] Institute G. Interactive Map: US Abortion Policies and Access After Roe. https://states.guttmacher.org/policies/ [33] Whitesell M, Bachand A, Peel J, Brown M. Familial, Social, and Individual Factors Contributing to Risk for Adolescent Substance Use. J Addict. 2013;2013:579310. doi:10.1155/2013/579310 [34] CDC. Five Great Benefits of Breastfeeding. Centers for Disease Control and Prevention. Published July 27, 2021. https://www.cdc.gov/nccdphp/dnpao/features/breastfeeding-benefits/index.html [35] Welle-Strand GK, Skurtveit S, Jansson LM, Bakstad B, Bjarkø L, Ravndal E. Breastfeeding reduces the need for withdrawal treatment in opioid-exposed infants. Acta Paediatr. 2013;102(11):1060-1066. doi:10.1111/apa.12378 [36] Ilett KF, Hackett LP, Gower S, Doherty DA, Hamilton D, Bartu AE. Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment. Breastfeed Med Off J Acad Breastfeed Med. 2012;7:269-274. doi:10.1089/bfm.2011.0096 [37] Pedersen CA, Smedley KL, Leserman J, et al. Intranasal Oxytocin Blocks Alcohol Withdrawal in Human Subjects. Alcohol Clin Exp Res. 2013;37(3):484-489. doi:10.1111/j.1530-0277.2012.01958.x [38] Montana SB0289. https://leg.mt.gov/bills/2019/billhtml/SB0289.htm [39] Mullins N, Galvin SL, Ramage M, Gannon M, Lorenz K, Sager B, Coulson CC. Buprenorphine and Naloxone Versus Buprenorphine for Opioid Use Disorder in Pregnancy: A Cohort Study. J Addict Med. 2020 May/Jun;14(3):185-192. doi: 10.1097/ADM.0000000000000562. PMID: 31567599. [40] Drug Related Crime Statistics [2023]: Offenses Involving Drug Use. NCDAS. https://drugabusestatistics.org/drug-related-crime-statistics/ [41] Association APH. Online only: Report finds most U.S. inmates suffer from substance abuse or addiction. Nations Health. 2010;40(3):E11-E11. [42] Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition) | NIDA Archives. Published January 17, 2018. http://archives.nida.nih.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-edition