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Outlines the legal framework for analyzing pre-closing conduct by businesses proposing to merge under the Hart-Scott-Rodino Act, the Sherman Act and the Federal Trade Commission Act of the U.S. Regulations imposed by the U.S. Federal Trade Commission concerning merger activities; Concept of beneficial ownership; Process of ownership and operational control transference.

Discusses relevant United States (US) Supreme Court precedents, economic theory and government guidelines relevant to vertical mergers as well as the government enforcement actions. Details on the case United States versus E.I. du Pont de Nemours & Co.; Vertical merger guidelines.

Editorial. Comments on American Institute of Biological Sciences review of textbooks and accompanying instructional materials which are used in year-long courses in biological sciences in secondary schools. Goal of the review, which was to help teachers make informed decisions about instructional material; Effects of the review.

Background: Despite a higher risk of classical Hodgkin lymphoma (cHL) in people with HIV and the demonstrated safety and efficacy of PD-1 blockade in cHL, there are limited data on the use of these agents in HIV-associated cHL (HIV-cHL)., Patients/methods: We retrospectively identified patients with HIV-cHL from the "Cancer Therapy using Checkpoint inhibitors in People with HIV-International (CATCH-IT)" database who received nivolumab or pembrolizumab, alone or in combination with other agents, and reviewed records for demographics, disease characteristics, immune-mediated adverse events (imAEs), and treatment outcomes. Changes in CD4 + T-cell counts with treatment were measured via Wilcoxon signed-rank tests. Overall response rate (ORR) was defined as the proportion of patients with partial or complete response (PR/CR) per 2014 Lugano classification., Results: We identified 23 patients with HIV-cHL who received a median of 6 cycles of PD-1 blockade: 1 as 1st-line, 6 as 2nd-line, and 16 as ≥3rd-line therapy. Seventeen (74%) patients received monotherapy, 5 (22%) received nivolumab plus brentuximab vedotin, and 1 received nivolumab plus ifosfamide, carboplatin, and etoposide. The median baseline CD4 + T-cell count was 155 cells/µL, which increased to 310 cells/µL at end-of-treatment (P = .009). Three patients had grade 3 imAEs; none required treatment discontinuation. The ORR was 83% with median duration of response of 19.7 months. The median progression-free survival was 21.2 months and did not differ between patients with <200 versus ≥200 CD4 + cells/µL (P = .95)., Conclusion: Our findings support the use of PD-1 blockade in HIV-cHL for the same indications as the general population with cHL., Competing Interests: Disclosure KL and RR: Bristol Myers Squibb-Celgene, Merck, EMD-Serono, Eli Lilly, Janssen, Lentigen, and CTI BioPharma research support through CRADAs with the NCI. DBJ: BMS, Catalyst Biopharma, Iovance, Mallinckrodt, Merck, Mosaic ImmunoEngineering, Novartis, Oncosec, Pfizer, Targovax, and Teiko—advisory boards or consultancy; BMS and Incyte—research funding. NAW: ChemoCentryx—consultancy and speaker honoraria CK: Ad board/Consulting fee: Novartis, Regeneron, Janssen, Eisai, Daiichi Sankyo, Jazz Pharmaceuticals, Arcus Biosciences, Mirati Therapeutics, Sanofi, Diffuse Pharmaceuticals; Grant Support: Blueprint Medicines, Bristol-Myers Squibb, Daiichi Sankyo, Inc., Debiopharm, Genentech, Inc., Janssen, Karyopharm, Lyell, Novartis Pharmaceuticals, Regeneron, Spectrum TF: ADC therapeutics—speakers bureau; Astrazeneca—Consultancy and Speakers Bureau; Daiichi—Speakers Bureau; Sankyo—Speakers Bureau; Genmab—Consultancy and Speakers Bureau; Karyopharm—Speakers Bureau; Kite/Gilead—Honoraria and Speakers Bureau; MorphoSys—Speakers Bureau; Secura Bio—Speakers Bureau; Juno/Bristol Myers Squibb (BMS)—Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees and Research Funding; Celgene Corporation—Membership on an entity's Board of Directors or advisory committees; Janssen—Membership on an entity's Board of Directors or advisory committees; Pharmacyclics LLC/Janssen—Honoraria and Membership on an entity's Board of Directors or advisory committees; Seattle Genetics—Membership on an entity's Board of Directors or advisory committees and Research Funding; Takeda—Honoraria, Membership on an entity's Board of Directors or advisory committees and travel expenses; Abbvie—Consultancy and Honoraria; Seagen—Consultancy, Honoraria, travel expenses, and Speakers Bureau; Bayer—honoraria; Portola Pharmaceuticals—research funding; Eisai—research funding; Kyowa Kirin—research funding; Amgen—research funding; Viracta Therapeutics—research funding; Cell Medica—research funding; Roche—research funding; Trillium Therapeutics—research funding; Pfizer—research funding AD: Athos Therapeutics—Current Employment, Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees and Patents & Royalties; Attica Sciences—Current Employment, Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees and Patents & Royalties; Dyania Health—Consultancy, Current Employment and stocks; Urogen Pharma- Stocks; Alimera Sciences—stocks; Kyn Therapeutics—stocks; Moderna Therapeutics—stocks; Proteas Bioanalystics—stocks and patents and royalties; BMS—consultancy and research funding; AstraZeneca—Consultancy, Other: Travel, accommodations, expenses and Research Funding; Radmetric—consultancy; Seagen—Consultancy and travel, accommodations, expenses; Janssen—consultancy; PACT Pharma—consultancy; Merck—Consultancy and Research Funding; Roche/Genentech—Consultancy and Research Funding; Exelixis—consultancy; Aveo—consultancy; Kite/Gilead—research funding; Jounce Therapeutics—Research funding; Infinity Pharmaceutics—research funding; Seattle Genetics/Astellas—research funding; Immunomedics/Gilead—research funding; Harvard Medical School—patents and royalties to spouse; UCLA—patents and royalties to spouse; Eli Lilly—travel, accommodations, expenses MM: Genentech/Roche—honoraria and speakers bureau, Novartis—honoraria, Sanofi—honoraria, Lexicon—honoraria and Research Funding, Ipsen—Honoraria and Speakers Bureau, Bayer—honoraria, Taiho Pharmaceutical—Honoraria and speakers bureau, Boehringer Ingelheim—honoraria, Eisai—Honoraria, Research Funding and Speakers Bureau, Merck—Honoraria and Research Funding, Exelixis—Honoraria and Speakers Bureau, AstraZeneca/Daiichi Sankyo—Honoraria and Speakers Bureau, Servier—Honoraria and Speakers Bureau, Tersera—Honoraria, QED Therapeutics—Honoraria, Precision Biologics—Research Funding, BMS—research funding, Onyx—research funding, Advanced Accelerator Applciations—research funding, AlphaVax—Research Funding, Duke University—Patents and Royalities DBJ: Advisory boards/consultancy: BMS, Catalyst Biopharma, Iovance, Jansen, Mallinckrodt, Merck, Mosaic ImmunoEngineering, Novartis, Oncosec, Pfizer, Targovax, and Teiko; Research funding: BMS and Incyte AM: Research funding: Nektar, Tracon Pharma, Regeneron, Tempu slabs; Consultancy and research funding: SpringWorks Therapeutics; Honoraria: Targeted Oncology CD: Advisory Board: GenMab; BeiGene; ADC Pharmaceuticals Research funding: Genentech; Seagen; Astrazeneca AL: Advisory Board—Seagen, Kite Pharma; Consultancy—Research to Practice GS: Advisory Board: BMS, Genentech, EMD Serono, Merck, Sanofi, Seattle Genetics/Astellas, Astrazeneca, Exelixis, Janssen, Bicycle Therapeutics, Pfizer, Gilead, Scholar Rock, G1 Therapeutics, Eli Lilly/Loxo Oncology, Infinity Pharmaceuticals, Lucence Health, IMV, Vial, Syapse, Tempus, Ellipses Pharma; Consultant/Scientific Advisory Board (SAB): Suba Therapeutics, Syapse, Servier, Merck Research Support to institution: Sanofi (iaward), Astrazeneca, Gilead, Helsinn, Lucence, BMS, EMD Serono, Jazz Therapeutics; Speaker: BIO—INFORMAÇÃO BRASILEIRA DE ONCOLOGIA Ltda, OLE Forum (Mexico), Seagen, Gilead, Natera, Exelixis, Janssen, Bayer; Data safety monitoring committee honorarium: Mereo; Employment: Spouse employed by Myriad; Writing/Editor fees: Uptodate, Onviv PR: research funding (to institution)—Lilly, Bayer, Telix; speaker's fees—OncLive ARN: Funding to Institution for Trials he is PI on: Loxo@Lilly, Surface Oncology, ADC Therapeutics, IGM Biosciences, EMD Serono, Aravive, Nikang Therapeutics, Inspirna, Exelexis, Revolution Medicine, Jacobio, Pionyr, Jazz Pharmaceuticals, NGM Biopharmaceuticals; Consultant Editor Compensation: JCO Precision Oncology; Travel Compensation from: SITC/ AACR/ Conquer Cancer Foundation/BinayTara Foundation and Foundation Med/Caris Life Sciences; Advisory Board : Foundation Med AFH: Bristol Myers Squibb—research funding, consultancy; Genentech—research funding, consultancy; Merck—research funding, consultancy; Seattle Genetics—research funding, consultancy; KiTE Pharma—research funding; Gilead Sciences—research funding; AstraZeneca—research funding, consultancy; Karyopharm—consultancy; ADC Therapeutics—research funding, consultancy; Takeda—consultancy; Tubulis—consultancy; Regeneron—consultancy; Genmab—consultancy; Pfizer—consultancy; Caribou Biosciences—consultancy; Adicet Bio—consultancy; Abbvie—consultancy; Allogene Therapeutics—consultancy All other authors have nothing to disclose., (Published by Elsevier Inc.)

Chronic kidney disease is an important clinical condition beset with racial and ethnic disparities that are associated with social inequities. Many medical schools and health centres across the USA have raised concerns about the use of race - a socio-political construct that mediates the effect of structural racism - as a fixed, measurable biological variable in the assessment of kidney disease. We discuss the role of race and racism in medicine and outline many of the concerns that have been raised by the medical and social justice communities regarding the use of race in estimated glomerular filtration rate equations, including its relationship with structural racism and racial inequities. Although race can be used to identify populations who experience racism and subsequent differential treatment, ignoring the biological and social heterogeneity within any racial group and inferring innate individual-level attributes is methodologically flawed. Therefore, although more accurate measures for estimating kidney function are under investigation, we support the use of biomarkers for determining estimated glomerular filtration rate without adjustments for race. Clinicians have a duty to recognize and elucidate the nuances of racism and its effects on health and disease. Otherwise, we risk perpetuating historical racist concepts in medicine that exacerbate health inequities and impact marginalized patient populations., (© 2021. Springer Nature Limited.)

Declaring racism a public health crisis has the potential to shepherd meaningful anti-racism policy forward and bridge long standing divisions between policy-makers, community organizers, healers, and public health practitioners. At their best, the declarations are a first step to address long standing inaction in the face of need. At their worst, the declarations poison or sedate grassroots momentum toward anti-racism structural change by delivering politicians unearned publicity and slowing progress on health equity. Declaring racism as a public health crisis is a tool that must be used with clarity and caution in order to maximize impact. Key to holding public institutions accountable for creating declarations is the direct involvement of Black and Indigenous People of Color (BIPOC) led groups and organizers. Sharing power, centering their voices and working in tandem, these collaborations ensure that declarations push for change from the lens of those most impacted and authentically engage with the demands of communities and their legacies. Superficial diversity and inclusion efforts that bring BIPOC people and organizers into the conversation and then fail to implement their ideas repeat historical patterns of harm, stall momentum for structural change at best, and poison the strategy at worst. In this paper we will examine three declarations in the United States and analyze them utilizing evaluative criteria aligned with health equity and anti-racism practices. Finally, we offer recommendations to inform anti-racist public health work for meaningful systematic change toward decentralization and empowerment of communities in their health futures., Competing Interests: CA works as a consultant for the CDC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Paine, de la Rocha, Eyssallenne, Andrews, Loo, Jones, Collins and Morse.)

Importance: Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients., Objective: To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement., Design, Setting, and Participants: In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data., Exposures: Mitral valve-in-valve for degenerated bioprosthetic mitral valves., Main Outcomes and Measures: The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance., Results: A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg., Conclusions and Relevance: Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

Objective: To characterize the calcium intake in a racially mixed cohort of pregnant women, including the contribution of supplementation and antacids., Methods: A cohort of women was interviewed twice during their pregnancies. The interviews included a food frequency questionnaire and questions on calcium supplementation and antacid intake. Pregnant women seeking prenatal care at a Pittsburgh hospital in the first trimester were enrolled. 454 women were enrolled and did not miscarry; 385 completed two interviews and were of white or African-American race., Results: Mean and median intakes of calcium were 1671 mg/day and 1482 mg/day. 36% of the women were under the former RDA level (1200 mg/day) for calcium, while 26% were under the current AI (1000 mg/day). Six percent were taking in less than 600 mg/day, and 15% over 2500 mg/day, the tolerable upper limit. Young women were particularly likely to have low intakes (12% of those less than 21 years of age had less than 600 mg/day). Black women were slightly overrepresented among those with low intake (8% vs. 5% of whites), but, overall, their intake was quite similar to whites. Milk and cheese provided more calcium than other food items. Many women took antacids, especially during the second half of pregnancy, and these were a major source of calcium for some members of the cohort., Conclusions: Although mean and median calcium intake in the cohort were above the AI, many women had calcium intakes that were too high or low. Dairy products provided the most calcium for most pregnant women, and antacids were an important source for many.

An observation method for measuring the rate of medication errors, which can be used as an outcome indicator of a medication system's quality, was evaluated in a national sample of long-term care facilities (LTCFs) and small hospitals. Trained nurse and pharmacist observers observed nurses administer medications during the three-hour period surrounding the peak medication workload on one day in national sample of 58 LTCFs and 10 hospitals. Opportunity-for-errors (OE), defined as the total number of doses ordered plus the unauthorized doses given, were counted, as well as all medication errors. The error rate was calculated as the proportion of errors in total OEs. The reliability of the method was evaluated on seven days by comparing the results of a researcher and observer, who were observing the same nurse. The mean-medication-error rate was 12.2 and 11.0% in the LTCFs and hospitals studied, respectively. Three LTCFs and four hospitals had error rates of zero. Only 31% of the LTCFs and 40% of the hospitals would pass a medication-error limit standard of 6%. The authors concluded that the observation method was promising. Recommendations for further study included: (1) implementation of a one-year project to evaluate observer efficiency after becoming proficient with the method, (2) improvement of the reliability measure, and (3) examination of the relationship of medication errors with structure and process variables.

Many studies of drug utilization have suffered from the absence of information on the indications for therapy. A few data sets on drug utilization are available which include indication information. In addition, a number of computerized collections of medical billing data now exist in North America which can be used for such studies. These include data from the Kaiser Permanente Medical Plan; the Group Health Cooperative of Puget Sound; the Commission on Professional and Hospital Activities' Professional Activity Study; the U.S. state of Rhode Island; the Saskatchewan Health Plan in Canada; and Medicaid, the state run but federally financed health insurance plan for economically or medically needy individuals in the United States. These databases have a number of general advantages and disadvantages, which are reviewed. In addition, the differences among these databases are also explored. Finally, examples are presented demonstrating how these databases can be used for: 1) descriptive research on drug utilization, 2) evaluating the appropriateness of drug utilization, and 3) interventions designed to improve the appropriateness of prescribing.