Monitoring International Trends posted August 2015

16^ Sonja M. Swenson; Lisa J. Chamberlain, Lee M. Sanders; Vandana Sundaram, Paul H. Wise, “Outpatient Pharmacy Expenditures for Children With Serious Chronic Illness in California, 2010-2012”, published in the Journal of the American Medical Association, 28 July. JAMA. 2015;314(4):405-407. doi:10.1001/jama.2015.7169.

17^ Stein J. Janssen, Yvonne Braun, Kirkham B. Wood, Thomas D. Cha, Joseph H. Schwab, “Allogeneic blood transfusions and postoperative infections after lumbar spine surgery”, DOI: http://dx.doi.org/10.1016/j.spinee.2015.02.010The Spine Journal, Vol. 15, Issue 5, p901–909. DOI: http://dx.doi.org/10.1016/j.spinee.2015.02.010

18^ Neely RC, Boskovski MT, Gosev I, Kaneko T, McGurk S, Leacche M, Cohn LH., “Minimally invasive aortic valve replacement versus aortic valve replacement through full sternotomy: the Brigham and Women's Hospital experience.” Ann Cardiothoracic Surg. 2015 Jan;4(1):38-48. doi: 10.3978/j.issn.2225-319X.2014.08.13.

19^ A sternotomy is an incision in the centre of the chest that separates the sternum) to allow access to the heart.

20^ Minimally invasive aortic valve replacement is an alternative to conventional full sternotomy for patients with isolated pathology of the aortic valve and ascending aorta without coronary artery disease.

21^ Joseph S. Gondusky, Kevin A. Pinkos, Leera Choi, Jay J. Patel, Steven Barnett, Robert S. Gorab, “Simultaneous Bilateral Anterior Approach Total Hip Arthroplasty”,Orthopedics, July 2015-Volume 38 Issue 7: e611-e615. DOI: 10.3928/01477447-20150701-60

22^ Julia L Finkelstein, Saurabh Mehta, Shobha A Udipi, Padmini S Ghugre, Sarah V Luna, Michael J Wenger, Laura E Murray-Kolb, Eric M Przybyszewski, and Jere D Haas, “A Randomized Trial of Iron-Biofortified Pearl Millet in School Children in India”, J. Nutr. July 1, 2015 vol. 145 no. 7 1576-1581. doi: 10.3945/​jn.114.208009

23^ The fortified grain was developed by the HarvestPlus program, in partnership with the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) in India.

24^ Joshua N Goldstein, Majed A Refaai, Truman J Milling Jr, Brandon Lewis, Robert Goldberg-Alberts, Bruce A Hug, and others, “Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial”, The Lancet, Volume 385, No. 9982, p2077–2087, 23 May 2015. DOI: http://dx.doi.org/10.1016/S0140-6736(14)61685-8

25^ Vox Sang 2010;99:251-260),

26^ Globally, over 6 million platelet doses are transfused annually. Estimates suggest 1 in 2,000 doses exhibit bacterial contamination which can cause sepsis and death.

27^ Sylvia T. Gunawan, Kristian Kempe, Thomas Bonnard, Jiwei Cui, Karen Alt, Lok S. Law, Xiaowei Wang, Erik Westein, Georgina K. Such, Karlheinz Peter, Christoph E. Hagemeyer, and Frank Caruso, “Multifunctional Thrombin-Activatable Polymer Capsules for Specific Targeting to Activated Platelets”, Advanced Materials, first published online: 3 August 2015. DOI: 10.1002/adma.201502243

28^ Continuing military research on the use of platelets which have been frozen then thawed includes a US Army Medical Research and Materiel Command clinical trial, Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets (CPP1-05), to "evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion."

29^ A Master File for BloodStor 27 NaCl will be submitted to the US Food and Drug Administration (FDA) for customers to cross reference in regulatory filings. BloodStor 27 NaCl is labelled For Research Use, For Human Cell and Tissue Preservation. Customers who incorporate the product into their frozen storage protocol for cells and tissues intended for human clinical uses are responsible for validation and fulfilling any required regulatory requirements related to the use of the product.

30^ published in the journal PLOS ONE. Researchers came from Oregon State University and the federal Agency for Healthcare Research and Quality. Previously Veronica Irvin and Robert M Kaplan worked together in the National Institutes of Health's Office of Behavior and Social Science Research. Now Irvin is an assistant professor in Oregon State University's College of Public Health and Human Sciences, while Kaplan is with the Agency for Healthcare Research and Quality

31^ affiliated with the Institute for Neurology at the University of Zurich in Switzerland.

32^ Including Anja Boeckmann, from the Institute for Biology and Chemical Proteins at the University of Lyon in France

33^ Uli S. Herrmann, Anne K. Schütz, Hamid Shirani, Danzhi Huang^,, Dino Saban, Mario Nuvolone, Bei Li, Boris Ballmer, Andreas K. O. Åslund, Jeffrey J. Mason, Elisabeth Rushing, Herbert Budka, Sofie Nyström, Per Hammarström, Anja Böckmann, Amedeo Caflisch, Beat H. Meier, K. Peter R. Nilsson, Simone Hornemann, and Adriano Aguzzi, “Structure-based drug design identifies polythiophenes as antiprion compounds”, Science Translational Medicine 05 Aug 2015: Vol. 7, Issue 299, pp. 299ra123
DOI: 10.1126/scitranslmed.aab1923

34
^ Seleeke Flingai, Emily M.Plummer, Ami Patel, Sujan Shresta, Janess M.Mendoza,Kate E.Broderick, Niranjan Y.Sardesai, Kar Muthumani, David B Weiner, “Protection against dengue disease by synthetic nucleic acid antibody prophylaxis/immunotherapy”, Scientific Reports 5, Article number 12616 (2015) doi:10.1038/srep12616

35
^ Monoclonal antibodies (mAbs) are manufactured in a large-scale cell culture laboratory. Since antibodies break down over time, mAbs in the clinic require frequent repeat administrations. DMAbs are produced in the body and have the potential to reduce cost barriers.

36
^ Additional authors were Emily M. Plummer, Ami Patel, Sujan Shresta, Kar Muthumani, all from Penn, and Janess M. Mendoza, Kate E. Broderick, and NiranjanY. Sardesai, from Inovio Pharmaceuticals, Blue Bell, Pennsylvania. The work was funded by the National Institute of Allergy and Infectious Diseases, the Defense Advanced Research Projects Agency, and Inovio Pharmaceuticals. 

37

38
^ See the Journal of the American Medical Association (JAMA). Lisa A.Jackson, James D.Campbell, Sharon E.Frey, Kathryn M.Edwards, Wendy A.Keitel, Karen L.Kotloff, Andrea A.Berry, Irene Graham, Robert LAtmar, C. Buddy Creech, Isaac P. Thomsen, Shital M.Patel, Andres F.Gutierrez, Edwin L.Anderson, Hana M.El Sahly, Heather Hill, Diana L.Noah, Abbie R.Bellamy, “Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial”, doi:10.1001/jama.2015.7916.

39
^ With Novartis's MF59

40
^ With GSK’s AS03

41
^ Louis M. Schwartzman, Andrea L. Cathcart, Lindsey M. Pujanauski, Li Qi, John C. Kash, Jeffery K. Taubenberger, “An Intranasal Virus-Like Particle Vaccine Broadly Protects Mice from Multiple Sub-types of Influenza A Virus”, 21 July 2015 mBio vol. 6 no. 4 e01044-15. doi: 10.1128/mBio.01044-15

42
^ Carlos A. DiazGranados, Corwin A. Robertson, H. Keipp Talbot, Victoria Landolfi, Andrew J. Dunning, David P. Greenberg, "Prevention of serious events in adults 65 years of age or older: a comparison between high-dose and standard-dose inactivated influenza vaccines", Vaccine, Volume 33, Issue 32 (2015). DOI: http://dx.doi.org/10.1016/j.vaccine.2015.07.006

43
^ In the trial, 31,989 adults 65 years plus were randomly assigned to receive either Fluzone High-Dose vaccine or Fluzone vaccine. They were then monitored for six to eight months post-vaccination for the occurrence of influenza and serious events. (events leading to death or hospitalization, life-threatening or medically important events, or events resulting in disability). For the supplementary analysis now reported, cardio-respiratory events were grouped into seven categories: pneumonia, asthma, chronic obstructive pulmonary disease or bronchial events, influenza (laboratory-confirmed influenza), other respiratory events, coronary artery events, congestive heart failure, and cerebrovascular events.

44

45
^ H3N2v, a virus normally circulating in swine but on this occasion in a human, hence variant

46
^ Shamsudeen F. Fagbo, Leila Skakni, Daniel K.W. Chu, Musa A. Garbati, Mercy Joseph, Malik Peiris and Ahmed M. Hakawi, “Molecular Epidemiology of Hospital Outbreak of Middle East Respiratory Syndrome, Riyadh, Saudi Arabia, 2014”, Emerg Infect Dis, 2015 Volume 21, Number 11 2015 http://dx.doi.org/10.3201/eid2111.150944

47
^ Davide Corti, Jincun Zhao, Mattia Pedotti, Luca Simonelli, Sudhakar Agnihothram, Craig Fett, Blanca Fernandez-Rodriguez, Mathilde Foglierini, Gloria Agatic, Fabrizia Vanzetta, Robin Gopal, Christopher J. Langrish, Nicholas A Barrett, Federica Sallusto, Ralph S. Baric, Luca Varani, Maria Zambon, Stanley Perlman, and Antonio Lanzavecchia, “Prophylactic and post exposure efficacy of a potent human monoclonal antibody against MERS coronavirus”, Proceedings of the National Academy of Sciences, Published online before print July 27, 2015, doi: 10.1073/pnas.1510199112

48
^ Lingshu Wang, Wei Shi, M. Gordon Joyce, Kayvon Modjarrad, Yi Zhang, Kwanyee Leung, Christopher R. Lees, Tongqing Zhou, Hadi M. Yassine, Masaru Kanekiyo, Zhi-yong Yang, Xuejun Chen, Michelle M. Becker, Megan Freeman, Leatrice Vogel, Joshua C. Johnson, Gene Olinger, John P. Todd, Ulas Bagci, Jeffrey Solomon, Daniel J. Mollura, Lisa Hensley, Peter Jahrling,^, Mark R. Denison, Srinivas S. Rao, Kanta Subbarao, Peter D. Kwong, John R. Mascola, Wing-Pui Kong and Barney S. Graham^, et al. “Evaluation of candidate vaccine approaches for MERS-CoV”,Nature Communications 6, article no. 7712. doi:10.1038/ncomms8712:

49
^ Three CIADM were established as public-private partnerships with BARDA in 2012 to respond rapidly to national needs for medical countermeasures.

50
^ BARDA is part of HHS’ Office of the Assistant Secretary for Preparedness and Response

51
^ Monoclonal antibodies can neutralize a virus by binding to key viral proteins. This decreases the amount of the virus patients’ immune systems need to conquer.

52
^ Made by Mapp Pharmaceuticals of San Diego)

53
^ Boisen serves as the consortium’s development director of in vitro diagnostics. He is program director of infectious diseases and emerging technologies at Corgenix, a medical diagnostics company based in Denver, Colorado.

54
^ The presentation was entitled “Clinical Outcome-Focused Patient Care.”

55
^ Mara Jana Broadhurst, John Daniel Kelly, Ann Miller, Amanda Semper, Daniel Bailey, Elisabetta Groppelli, Andrew Simpson, Tim Brooks, Susan Hula, Wilfred Nyoni, Alhaji B Sankoh, Santigi Kanu, Alhaji Jalloh, Quy Ton, Nicholas Sarchet, Peter George, Mark D Perkins, Betsy Wonderly, Prof Megan Murray, Dr Nira R Pollock, “ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study”, The Lancet, Published Online: 25 June 2015. DOI: http://dx.doi.org/10.1016/S0140-6736(15)61042-X

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