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Context: Institutional academic-industry relationships have the potential of creating institutional conflicts of interest. To date there are no empirical data to support the establishment and evaluation of institutional policies and practices related to managing these relationships.Objective: To conduct a national survey of department chairs about the nature, extent, and consequences of institutional-academic industry relationships for medical schools and teaching hospitals.Design, Setting, and Participants: National survey of department chairs in the 125 accredited allopathic medical schools and the 15 largest independent teaching hospitals in the United States, administered between February 2006 and October 2006.Main Outcome Measure: Types of relationships with industry.Results: A total of 459 of 688 eligible department chairs completed the survey, yielding an overall response rate of 67%. Almost two-thirds (60%) of department chairs had some form of personal relationship with industry, including serving as a consultant (27%), a member of a scientific advisory board (27%), a paid speaker (14%), an officer (7%), a founder (9%), or a member of the board of directors (11%). Two-thirds (67%) of departments as administrative units had relationships with industry. Clinical departments were more likely than nonclinical departments to receive research equipment (17% vs 10%, P = .04), unrestricted funds (19% vs 3%, P < .001), residency or fellowship training support (37% vs 2%, P < .001), and continuing medial education support (65% vs 3%, P < .001). However, nonclinical departments were more likely to receive funding from intellectual property licensing (27% vs 16%, P = .01). More than two-thirds of chairs perceived that having a relationship with industry had no effect on their professional activities, 72% viewed a chair's engaging in more than 1 industry-related activity (substantial role in a start-up company, consulting, or serving on a company's board) as having a negative impact on a department's ability to conduct independent unbiased research.Conclusion: Overall, institutional academic-industry relationships are highly prevalent and underscore the need for their active disclosure and management. [ABSTRACT FROM AUTHOR]

Importance: Cancer survivors face ongoing health issues and need access to affordable health care, yet studies examining health care access and affordability in this population are lacking., Objectives: To evaluate health care access and affordability in a national sample of cancer survivors compared with adults without cancer and to evaluate temporal trends during implementation of the Affordable Care Act., Design, Setting, and Participants: We used data from the National Health Interview Survey from 2010 through 2016 to conduct a population-based study of 30 364 participants aged 18 years or older. We grouped participants as cancer survivors (n = 15 182) and those with no reported history of cancer, whom we refer to as control respondents (n = 15 182), matched on age. We excluded individuals reporting a cancer diagnosis prior to age 18 years and those with nonmelanoma skin cancers., Main Outcomes and Measures: We compared issues with health care access (eg, delayed or forgone care) and affordability (eg, unable to afford medications or health care services) between cancer survivors and control respondents. We also explored trends over time in the proportion of cancer survivors reporting these difficulties., Results: Of the 30 364 participants, 18 356 (57.4%) were women. The mean (SD) age was 63.5 (23.5) years. Cancer survivors were more likely to be insured (14 412 [94.8%] vs 13 978 [92.2%], P < .001) and to have government-sponsored insurance (7266 [44.3%] vs 6513 [38.8%], P < .001) compared with control respondents. In multivariable models, cancer survivors were more likely than control respondents to report delayed care (odds ratio [OR], 1.38; 95% CI, 1.16-1.63), forgone medical care (OR, 1.76; 95% CI, 1.45-2.12), and/or inability to afford medications (OR, 1.77; 95% CI, 1.46-2.14) and health care services (OR, 1.46; 95% CI, 1.27-1.68) (P < .001 for all). From 2010 to 2016, the proportion of survivors reporting delayed medical care decreased each year (B = 0.47; P = .047), and the proportion of those needing and not getting medical care also decreased each year (B = 0.35; P = .04). In addition, the proportion of cancer survivors who reported being unable to afford prescription medication decreased each year (B=0.66; P = .004) and the proportion of those unable to afford at least 1 of 6 services decreased each year (B = 0.51; P = .01)., Conclusions and Relevance: Despite higher rates of insurance coverage, cancer survivors reported greater difficulties accessing and affording health care compared with adults without cancer. Importantly, the proportion of survivors reporting these issues continued a downward trend throughout our observation period in the years following the implementation of the Affordable Care Act. Our findings suggest incremental improvement in health care access and affordability after recent health care reform and provide an important benchmark as additional changes are likely to occur in the coming years.

Importance: Estrogen receptor-positive (ER+) tumors of the breast are generally highly responsive to endocrine treatment. Although endocrine therapy is the mainstay of adjuvant treatment for ER+ breast cancer, the role of endocrine therapy in the neoadjuvant setting is unclear., Objective: To evaluate the effect of neoadjuvant endocrine therapy (NET) on the response rate and the rate of breast conservation surgery (BCS) for ER+ breast cancer., Data Sources: Based on PRISMA guidelines, a librarian-led search of PubMed and Ovid MEDLINE was performed to identify eligible trials published from inception to May 15, 2015. The search was performed in May 2015., Study Selection: Inclusion criteria were prospective, randomized, neoadjuvant clinical trials that reported response rates with at least 1 arm incorporating NET (n = 20). Two authors independently analyzed the studies for inclusion., Data Extraction and Synthesis: Pooled odds ratios (ORs), 95% CIs, and P values were estimated for end points using the fixed- and random-effects statistical model., Results: The analysis included 20 studies with 3490 unique patients. Compared with combination chemotherapy, NET as monotherapy with aromatase inhibitors had a similar clinical response rate (OR, 1.08; 95% CI, 0.50-2.35; P = .85; n = 378), radiological response rate (OR, 1.38; 95% CI, 0.92-2.07; P = .12; n = 378), and BCS rate (OR, 0.65; 95% CI, 0.41-1.03; P = .07; n = 334) but with lower toxicity. Aromatase inhibitors were associated with a significantly higher clinical response rate (OR, 1.69; 95% CI, 1.36-2.10; P < .001; n = 1352), radiological response rate (OR, 1.49; 95% CI, 1.18-1.89; P < .001; n = 1418), and BCS rate (OR, 1.62; 95% CI, 1.24-2.12; P < .001; n = 918) compared with tamoxifen. Dual combination therapy with growth factor pathway inhibitors was associated with a higher radiological response rate (OR, 1.59; 95% CI, 1.04-2.43; P = .03; n = 355), but not clinical response rate (OR, 0.76; 95% CI, 0.54-1.07; P = .11; n = 537), compared with endocrine monotherapy. The incidence of pathologic complete response was low (<10%)., Conclusions and Relevance: Neoadjuvant endocrine therapy, even as monotherapy, is associated with similar response rates as neoadjuvant combination chemotherapy but with significantly lower toxicity, suggesting that NET needs to be reconsidered as a potential option in the appropriate setting. Additional research is needed to develop rational NET combinations and predictive biomarkers to personalize the optimal neoadjuvant strategy for ER+ breast cancer.

Importance: Trastuzumab is a life-saving therapy but is associated with symptomatic and asymptomatic left ventricular ejection fraction (LVEF) decline. We report the cardiac toxic effects of a nonanthracycline and trastuzumab-based treatment for patients with early-stage human epidermal growth factor receptor 2 (ERBB2, formerly HER2 or HER2/neu)-positive breast cancer., Objective: To determine the cardiac safety of paclitaxel with trastuzumab and the utility of LVEF monitoring in patients with node-negative, ERBB2-positive breast cancer., Design, Setting, and Participants: In this secondary analysis of an uncontrolled, single group study across 14 medical centers, enrollment of 406 patients with node-negative, ERBB2-positive breast cancer 3 cm, or smaller, and baseline LVEF of greater than or equal to 50% occurred from October 9, 2007, to September 3, 2010. Patients with a micrometastasis in a lymph node were later allowed with a study amendment. Median patient age was 55 years, 118 (29%) had hypertension, and 30 (7%) had diabetes. Patients received adjuvant paclitaxel for 12 weeks with trastuzumab, and trastuzumab was continued for 1 year. Median follow-up was 4 years., Interventions: Treatment consisted of weekly 80-mg/m2 doses of paclitaxel administered concurrently with trastuzumab intravenously for 12 weeks, followed by trastuzumab monotherapy for 39 weeks. During the monotherapy phase, trastuzumab could be administered weekly 2-mg/kg or every 3 weeks as 6-mg/kg. Radiation and hormone therapy were administered per standard guidelines after completion of the 12 weeks of chemotherapy. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year., Main Outcomes and Measures: Cardiac safety data, including grade 3 to 4 left ventricular systolic dysfunction (LVSD) and significant asymptomatic LVEF decline, as defined by our study, were reported., Results: Overall, 2 patients (0.5%) (95% CI, 0.1%-1.8%) developed grade 3 LVSD and came off study, and 13 (3.2%) (95% CI, 1.9%-5.4%) had significant asymptomatic LVEF decline, 11 of whom completed study treatment. Median LVEF at baseline was 65%; 12 weeks, 64%; 6 months, 64%; and 1 year, 64%., Conclusions and Relevance: Cardiac toxic effects from paclitaxel with trastuzumab, manifesting as grade 3 or 4 LVSD or asymptomatic LVEF decline, were low. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year, and our findings suggest that LVEF monitoring during trastuzumab therapy without anthracyclines could be simplified for many individuals.