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Boxed warnings-also known as "black box" warnings-can be a powerful tool in communicating drug risks to physicians and patients. The overall number of boxed warnings has grown in recent years as the US Food and Drug Administration (FDA) has approved more drugs on the basis of limited pre-marketing information and as new safety issues for marketed drugs have been identified. Two recent manufacturers' petitions to remove boxed warnings on the drugs rosiglitazone (Avandia) and varenicline (Chantix) have led to divergent FDA decisions and revealed different considerations involved in boxed warning imposition and removal. For ethical and practical reasons, the FDA is justified in applying a higher standard for boxed warning removal than for imposition, as removal of a boxed warning may have unintended effects on physician and patient behavior. However, no guidelines on boxed warning removal currently exist. To promote safe use of approved prescription drugs, the FDA should adopt a uniform and transparent process governing decisions to impose or remove boxed warnings. [ABSTRACT FROM AUTHOR]

The article offers information on the rise in racism and hate crime in the U.S. Topics discussed include racial experience of his mother when priest refused to shake her mother's hand during communion; standing over the swastika in my parents' neighborhood and interview a psychologist on the effects of experiencing indirect racism and voted for the Democratic candidate because of do not want to be ashamed to be American; and thoughts on immigration reform and rally for Republican candidate's sold-out event at the local civic center.

Many people with depression recognize their symptoms as depression, but fail to seek treatment for a number of years. We aimed to explore the reasons for this. Thirty primary care patients who screened positive for depression participated in semistructured, face-to-face interviews. Transcripts were analyzed using grounded thematic analysis. Patients who sought depression treatment emphasized their understanding of depression, their belief that treatment would work, and the negative consequences that would ensue if they did not seek treatment. Patients who did not seek treatment emphasized that treatment would not be effective, thought that depression would not last very long, and believed that depression did not affect their everyday lives. Patients’ illness perceptions of depression were represented by and organized using the framework of the Self-Regulation Model of Illness Behavior. This model might be useful for planning patient activation intervention studies to increase the uptake of depression treatment in primary care. [ABSTRACT FROM PUBLISHER]

Background: Clinical reports link specific medications with the development of antinuclear antibodies (ANA), but population-based evidence is limited., Objective: The present study investigated associations between prescription medication use and ANA in a representative sample of the adult noninstitutionalized US population, first focusing on medications previously related to ANA and then considering all medications reported in the National Health and Nutrition Examination Survey (NHANES)., Methods: Based on NHANES data (1999-2004) for 3608 adults (ages ≥18 years), we estimated odds ratios (ORs) and 95% confidence intervals (CIs) to assess associations between recent medication use and ANA (overall and in sex and age subgroups), adjusted for potential confounders and the survey sampling design., Results: We found no evidence that most medications previously associated with ANA in specific individuals were risk factors for ANA in the general population, although statistical power was limited for some medications. Overall, ANA were less prevalent in adults who recently used any prescription medications compared with those who did not (OR = 0.73; CI = 0.57,0.93), and likewise several classes of medications were inversely associated with ANA, including hormones (OR = 0.73; CI = 0.55,0.98), thiazide diuretics (OR = 0.43; CI = 0.24,0.79), sulfonylureas (OR = 0.41; CI = 0.19,0.89), and selective serotonin reuptake inhibitor antidepressants (OR = 0.65; CI = 0.42,0.98). Positive associations with ANA were seen for loop diuretics (OR = 1.72; CI = 1.03,2.88) in all adults, and for benzodiazepines (OR = 2.11; CI = 1.09,4.10) and bronchodilators (OR = 1.83; CI = 1.00,3.38) in older (ages ≥60) adults. Estrogens were positively associated with ANA in older women (OR = 1.80; CI = 1.00,3.23) but inversely associated with ANA in younger (ages 18-59) women (OR = 0.43; CI = 0.20,0.93). Regarding individual medications, ANA were positively associated with ciprofloxacin (OR = 4.23; CI = 1.21,14.8), furosemide (OR = 1.79; CI = 1.09,2.93), and omeprazole (OR = 2.05; CI = 1.03,4.10) in all adults, and with salmeterol (OR = 3.76; CI = 1.66,8.52), tolterodine (OR = 6.64; CI = 1.45,30.5), and triamterene (OR = 3.10; CI = 1.08,8.88) in older adults. Also, in younger adults, hydrochlorothiazide was inversely associated with ANA (OR = 0.44; CI = 0.20,0.98)., Conclusions: Our findings in the general population do not confirm most clinically reported positive associations between specific medications and ANA in some individuals. However, novel positive ANA associations with other medications, as well as unexplained inverse associations with certain classes of medications and overall medication use, deserve further research to clarify the possible roles of medications as risk and protective factors in the development of autoantibodies and autoimmune disease., (Copyright © 2018. Published by Elsevier Ltd.)

Background: The prevalence of opioid use disorder (OUD) has increased sharply. Office-based opioid treatment with buprenorphine (OBOT) is effective but often underutilized because of physicians' lack of experience prescribing this therapy. Little is known about US residency training programs' provision of OBOT and addiction medicine training., Methods: The authors conducted a survey of residency program directors (RPDs) at all US residency programs in internal medicine, family medicine, and psychiatry to assess the frequency with which their residents provide care for OUD, presence and features of curricula in OBOT and addiction medicine, RPDs' beliefs about OBOT, and potential barriers to providing OBOT training., Results: The response rate was 49.5% (476 of 962). Although 76.9% of RPDs reported that residents frequently manage patients with OUD, only 23.5% reported that their program dedicates 12 or more hours of curricular time to addiction medicine, 35.9% reported that their program encourages/requires training in OBOT, and 22.6% reported that their program encourages/requires obtaining a Drug Enforcement Administration (DEA) waiver to prescribe buprenorphine. Most RPDs believe that OBOT is an important treatment option for OUD (88.1%) and that increased residency training in OBOT would improve access to OBOT (73.7%). The authors also found that programs whose RPD had favorable views of OBOT were more likely to provide OBOT and addiction medicine training. Psychiatry programs were most likely to provide OBOT training and their RPDs most likely to have beliefs about OBOT that were positive. Commonly cited barriers to implementing OBOT training include a lack of waivered preceptors (76.9%), competing curricular priorities (64.1%), and a lack of support (social work and counseling) services (54.0%)., Conclusions: Internal medicine, family medicine, and psychiatry residents often care for patients with OUD, and most RPDs believe that increased residency training in OBOT would increase access to this treatment. Yet, only a minority of programs offer training in OBOT.

Background: Medical students attending schools with policies limiting industry/student interactions report fewer relationships with pharmaceutical representatives., Objective: To investigate whether associations between students' medical school policies and their more limited industry interaction behaviors persist into residency., Methods: We randomly sampled 1800 third-year residents who graduated from 120 allopathic US-based medical schools, using the American Medical Association Physician Masterfile. We surveyed them in 2011 to determine self-reported behavior and preferences for brand-name prescriptions, and we calculated the strength of their medical schools' industry interaction policies using the 2008 American Medical Student Association and Institute on Medicine as a Profession databases. We used logistic regression to estimate the association between strength of school policies and residents' behaviors with adjustments for class size, postresidency career plan, and concern about medical school debt., Results: We achieved a 44% survey response rate (n = 739). Residents who graduated from schools with restrictive policies were no more or less likely to accept industry gifts or industry-sponsored meals, speak with marketing representative about drug products, attend industry-sponsored lectures, or prefer brand-name medications than residents who graduated from schools with less restrictive policies. Residents who correctly answered evidence-based prescription questions were about 30% less likely to have attended industry-sponsored lectures (OR = 0.72, 95% CI 0.56-0.98)., Conclusions: Any effect that medical school industry interaction policies had on insulating students from pharmaceutical marketing did not persist in the behavior of residents in our sample. This suggests that residency training environments are important in influencing behavior.

Background: Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors., Methods and Findings: Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty-industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50-2.00] versus 1.77 [1.50-2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11-0.44; marketing representative access policies, r = 0.51, 95% CI 0.36-0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19-0.72; IMAP score, OR 0.45, 95% CI 0.19-1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15-0.69; IMAP score, OR 0.37, 95% CI 0.14-0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis., Conclusions: As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions. Please see later in the article for the Editors' Summary.

Objectives: African Americans (AA) have substantially lower levels of circulating 25-hydroxyvitamin D (25(OH)D) than whites. We compared population-based samples of 25(OH)D in women of African descent from Nigeria and metropolitan Chicago., Methods: One hundred women of Yoruba ethnicity from southwest Nigeria and 94 African American women from metropolitan Chicago were recruited and compared using a standardized survey protocol and the same laboratory assay for 25(OH)D., Results: Mean 25(OH)D levels were 64 nmol/l among the Nigerians and 29 nmol/l among the AA. Only 10% of the values were shared in common between the groups, and 76% of the Nigerians were above the currently defined threshold for adequate circulating 25(OH)D compared to 5% of the AA. Modest associations were seen between 25(OH)D and measures of obesity, although adjustment for these traits did not materially affect the group differences., Conclusion: These data support the presumption that skin color is an adaptive trait which has evolved in part to regulate 25(OH)D. It remains undetermined, however, whether lower values observed in AA have negative health consequences., (Copyright © 2013 Wiley Periodicals, Inc.)