Clinical Microbiology Issues Update - October/November 2014

PSAB ACTIVITIES

  •  ASM Supports FY 2015 Omnibus Appropriations Bill
  • ASM Supports Emergency Funding to Combat Ebola Virus Outbreak
  • ASM Joins Letter to OMB on Antibiotic Resistance Funding
  • ASM Testifies Before the Federal Experts Security Advisory Panel on Biosafety and Biosecurity
  • ASM Attends CLIAC Meeting
  • ASM Comments on CDC Guidelines to Stop Spread of Ebola
  • ASM Join White House OSTP Ebola Conference Call
  • ASM Staff Attends White House NSC Ebola Meeting
  • ASM Staff Attend Congressional Hearings on Ebola Response
  • ASM Staff Attends JHU Public Health Workshop on Ebola
  • ASM Staff Participate in White House Ebola Conference Call
  • Minority Microbiology Mentor Newsletter

ASM NEWS, JOURNAL ARTICLES AND UPDATES

  • Hot Topics
  • ASM Conferences
  • ASM Journal Articles of Interest
  • ASM Press
  • Articles of Interest

FEDERAL AGENCY UPDATES

  • House Foreign Affairs Subcommittee Holds Ebola Hearing
  • White House Pauses all Gain of Function (GOF) Studies
  • CDC Drafts New PPE Guidance Document
  • CDC Develops a New, Faster Lab Test for Enterovirus D68
  • Get Smart about Antibiotics Week
  • Board of Scientific Counselors Office of Infectious Diseases (BSC, OID) Meeting
  • FDA Issues Additional Guidance for Outsourcing Facilities that Compound Sterile Human Drugs
  • First Vaccine Approved by FDA to Prevent Serogroup B Meningococcal Disease
  • NIH Begins Early Human Clinical Trial of VSV Ebola Vaccine
  • FDA Approves First Combination Pill to Treat Hepatitis C
  • MMWR Articles of Interest

OTHER INFORMATION AND UPDATES

  • International Pathology Day
  • Current Issues in Laboratory Testing for Rheumatoid Arthritis
  • Articles of Interest

 

PSAB ACTIVITIES

ASM Supports FY 2015 Omnibus Appropriations Bill
On November 12, the ASM sent a letter to Harold Rogers, Chair of the House Committee on Appropriations, in support of passage of an FY 2015 Omnibus Appropriations bill to provide sustained and predictable federal funding for life science research and public health programs. To see the letter, please go to http://www.asm.org/index.php/component/content/article/137-policy/documents/statements-and-testimony/93264-fy2015-omnibus.

ASM Supports Emergency Funding to Combat Ebola Virus Outbreak
On November 7, the ASM sent a letter to Senate Appropriations Committee Chair Barbara Mikulski in support of the Administration’s emergency funding request of $6.18 billion to implement a comprehensive strategy to contain and end the Ebola virus outbreak and to strengthen preparedness and response in the United States. To read this letter, go to http://www.asm.org/index.php/component/content/article/137-policy/documents/statements-and-testimony/93257-ebolafunding-2014.

ASM Joins Letter to OMB on Antibiotic Resistance Funding
The ASM and 52 other organizations signed a letter to Shaun Donovan, Director of the Office of Management and Budget (OMB) urging the OMB to provide the resources necessary to implement the President’s Council of Advisors on Science and Technology (PCAST) recommendations on combatting antibiotic resistance. This letter is available at http://www.asm.org/images/PSAB/OMB-CARBFunding.pdf.

ASM Testifies Before the Federal Experts Security Advisory Panel on Biosafety and Biosecurity
Ron Atlas, Chair of the Public and Scientific Affairs Board testified before the Federal Experts Security Advisory Panel Convened by the Department of Health and Human Services and the U.S. Department of Agriculture. To see his presentation, please go to http://www.asm.org/images/PSAB/ASM-FESAP-Presentation-Oct-2014.pdf.

ASM Attends CLIAC Meeting
ASM staff attended the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting on November 6. This meeting included updates from the Food & Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS). Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA Center for Devices and Radiological Health announced a January 2015 meeting with stakeholders to discuss concerns about the FDA draft guidance on laboratory developed tests (LDTs). To read more about the other topics covered in the November meeting, please see http://wwwn.cdc.gov/cliac/    

ASM Comments on CDC Guidelines to Stop Spread of Ebola
On October 29, the ASM issued a statement on the new CDC Interim Guidance on Monitoring and Movement of Persons with Suspected Ebola Contact. To read it, go to http://www.asm.org/index.php/public-policy-2/93-policy/93236-ebola-10-29-14.

ASM Join White House OSTP Ebola Conference Call
On October 23, ASM officers and staff participated in a White House Office of Science and Technology (OSTP) conference call to discuss Administration response to the Ebola crisis and the scientific community’s role in response efforts. To learn more, go to http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93231-ebola-10-28-14.

ASM Staff Attends White House NSC Ebola Meeting
On October 21, ASM staff met with Sarah Charles, National Security Council (NSC) Director for Development and Humanitarian Affairs, Nancy Lindborg, Assistant Administrator, United States Agency for International Development (USAID), and Nancy Abella, NSC Director for Immigration and Visa Security, to discuss the Administration’s efforts to combat and treat Ebola in West Africa. White House Chief of Staff Denis McDonough also addressed the stakeholders and covered developments in connection with the domestic response to Ebola cases.

ASM Staff Attend Congressional Hearings on Ebola Response
ASM Staff attended a number of Congressional hearings covering the national and global response to Ebola virus disease in the West African region comprising Guinea, Sierra Leone and Liberia, and the response in the United States. The November 12 Senate Appropriations Committee hearing “U.S. Government Response: Fighting Ebola and Protecting America” heard testimony from witnesses Sylvia Mathews Burwell, Secretary, U.S. Department of Health and Human Services(HHS), Jeh Johnson, Secretary, U.S. Department of Homeland Security, Heather Higginbottom, Deputy Secretary, Management and Resources, U.S. Department of State, and others. To view the archived hearing, please go to http://www.appropriations.senate.gov/hearings-and-testimony/full-committee-hearing-us-government-response-fighting-ebola-and-protecting. On October 24, the House Committee on Oversight and Government Reform held a four hour hearing, entitled “The Ebola Crisis: Coordination of a Multi-Agency Response.” Witnesses in this hearing included Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response, HHS, Michael Lumpkin, Assistant Secretary of Defense, Special Operations and Low-Intensity Conflict, John Roth, Inspector General, Department of Homeland Security, Major General James Lariviere, USMC, Deputy Director for Politico-Military Affairs (Africa), Joint Chiefs of Staff, and Deborah Burger, CoPresident, National Nurses United. To view segments of this hearing, go to http://oversight.house.gov/hearing/ebola-crisis-coordination-multi-agency-response/. The October 16 hearing, “Examining the U.S. Public Health Response to the Ebola Outbreak” was held by the House Energy and Commerce Subcommittee on Oversight and Investigations. Witnesses included CDC Director Thomas Frieden, Anthony Fauci, Director National Institute of Allergy and Infectious Diseases (NIAID), Luciana Borio, Assistant Commissioner, FDA, and Robin Robinson Director, Biomedical Advanced Research and Development Authority (BARDA). To view the archived hearing in its entirety, please click http://energycommerce.house.gov/hearing/examining-us-public-health-response-ebola-outbreak.

ASM Staff Attends JHU Public Health Workshop on Ebola
On October 14, the “Dean’s Symposium on Ebola: Crisis, Context and Response” was held at the Johns Hopkins Bloomberg School of Public Health. Speakers included Michael Osterholm, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Peter Jahrling, National Institute for Allergy and Infectious Diseases (NIAID) Integrated Research Facility, Joshua Sharfstein, Maryland Secretary of Health & Mental Hygiene, and Nancy Kass, Deputy Director for Public Health, Berman Institute of Bioethics, Johns Hopkins University. You can view the event videos here http://www.jhsph.edu/events/2014/ebola-forum/.    

ASM Staff Participate in White House Ebola Conference Call
On October 23, the White House Office of Science and Technology Policy (OSTP) held a conference call with stakeholders to discuss steps the Administration is taking in response to the Ebola crisis and the scientific community’s role in response efforts. On the call were Jo Handlesman, Assistant Director for Science, OSTP and former ASM President, Beth Bell, Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), CDC,   Arjun Srinivasan, Associate Director for Healthcare Associated Infection Prevention Programs, NCEZID, and Wendy Taylor, Director, Center for Accelerating Innovation and Impact, USAID.

Minority Microbiology Mentor Newsletter
The November issue of the Minority Microbiology Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM). You can read the newsletter by going to this link: http://www.asm.org/index.php/public-policy/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93277-mmm-11-14.

ASM NEWS, JOURNAL ARTICLES AND UPDATES

Free Training Available on the Clinical Microbiology Portal
In December there will be two webinars which may be of interest to clinical scientists:  “Recommendations and New Updates for the Laboratory Detection of Chlamydia trachomatis and Neisseria gonorrhea” on December 10, at 1:00 p.m. ET, and “STDs Amplify the Transmission of HIV: Where do we go from here?” on December 11, at 1:00 p.m. ET. To sign up, please go to https://clinmicro.asm.org/index.php/lab-management/training/432-free-training.  

Hot Topic
The October Hot Topic discussion is entitled "Microbial Biofilms and Central Line-Associated Bloodstream Infections" and was presented by Rodney M. Donlan, Ph.D., Centers for Disease Control and Prevention (CDC). ASM's Hot Topic online occurs every other month when an expert's presentation on a hot topic, current event or controversial issue is posted. Join them at http://clinmicro.asm.org/index.php/portal/hot-topics.

ASM Conferences

@ASM Conference on Mechanisms of Interbacterial Cooperation and Competition
March 13 - 16, 2015
Washington, DC

4th ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens
May 8 - 11, 2015
Washington, DC

For a complete list of upcoming ASM conferences, please see http://conferences.asm.org/.  

ASM Journal Articles of Interest

Enterotoxigenic E. coli worldwide are closely related
Strains of enterotoxigenic Escherichia coli (ETEC) that infect adults and children in Asia, Africa, and the Americas have similar toxins and virulence factors, according to research published ahead of print in the Journal of Bacteriology. This may aid in vaccine development using toxins LT1 and LT2. See https://www.asm.org/index.php/asm-newsroom2/press-releases/92-news-room/press-releases/93276-enterotoxigenic-e-coli-worldwide-are-closely-related for more information.


Filoviruses Edit Genetic Material During Infection

A recent study in MBio® shows that filoviruses like Marburg and the Zaire ebolavirus has determined that there are novel viral and cellular mechanisms that modify the coding and noncoding sequences of viral mRNAs and genomic RNAs. Messenger RNA is edited at a high frequency, providing greater diversity than previously thought. To read more, see http://www.asm.org/index.php/journal-press-releases/93241-ebola-marburg-viruses-edit-genetic-material-during-infection.

 

Study Suggests Altering Gut Bacteria Might Mitigate Lupus

Species of Lactobacillus tested in a mouse GI model show mitigation of lupus symptoms, while Lachnospiraceae worsen lupus symptoms, according to research published ahead of print in Applied and Environmental Microbiology. To read more about this study, go to http://www.asm.org/index.php/journal-press-releases/93229-study-suggests-altering-gut-bacteria-might-mitigate-lupus.

ASM Press

One Health: People, Animals, and the Environment
Editors: Ronald M. Atlas and Stanley Maloy
Softcover, 330 pages, full-color, illustrations, index
(ISBN: 9781555818425) for more information, please visit the e-store at:
http://www.asmscience.org/content/book/10.1128/9781555818432

Molecular Genetics of Mycobacteria, Second Edition
Editors: Graham F. Hatfull and William R. Jacobs
Hardcover, 650 pages, full-color, illustrations, index
(9781555818838) for more information, please visit the e-store at:
http://www.asmscience.org/content/book/10.1128/9781555818845

Journal Articles

Pulsative Flushing as a Strategy to Prevent Bacterial Colonization of Vascular Access Devices
The aim of this study was to prove the efficacy of pulsatile flushing to prevent the bacterial colonization of vascular access devices. One hundred and forty four tests using 576 polyurethane short venous access catheters were performed. Four catheters per test were polluted with a fibronectin-serum albumin solution; three of these were spiked with Staphylococcus aureus. To read more of the study, go to http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4230174/.

Shed GP of Ebola Virus Triggers Immune Activation and Increased Vascular Permeability
Ebola virus causes lethal hemorrhagic fever in man and primates. Viral infection is typified by an excessive systemic inflammatory response resembling septic shock. It also damages endothelial cells and creates difficulty in coagulation, ultimately leading to haemorrhaging, organ failure and death. A unique feature of EBOV is that following infection high amounts of shed GP are released from infected cells and are detected in the blood of patients and experimentally infected animals. The article shows shows that shed GP released from virus-infected cells binds and activates non-infected DCs and macrophages causing the massive release of pro- and anti-inflammatory cytokines and also affects vascular permeability. See the article at http://www.plospathogens.org/article/info%3Adoi%2F10.1371%2Fjournal.ppat.1004509.

Francisella tularensis Bacteria Associated with Feline Tularemia in the United States
Francisella tularensis, a Tier 1 select agent, is one of the most pathogenic bacteria known and the etiologic agent of the zoonotic disease tularemia. Tularemia in the United States was examined by reviewingover 100 Francisella tularensis isolates, mostly from Nebraska, collected during 1998–2012. 48% of Nebraska cases were cat-associated. To read the article, please click http://wwwnc.cdc.gov/eid/article/20/12/13-1101_article.

FEDERAL AGENCY UPDATES

House Foreign Affairs Subcommittee Holds Ebola Hearing
The House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations held a hearing entitled Fighting Ebola: A Ground-Level View on November 18. Rabih Torbay, Senior Vice President for International Operations, International Medical Corps, Brett Sedgewick, Technical Advisor for Food Security and Livelihoods Global Communities, and Darius Mans, President, Africare, addressed the subcommittee. To see the archived videos, go to http://foreignaffairs.house.gov/hearing/subcommittee-hearing-fighting-ebola-ground-level-view.

White House Pauses all Gain of Function (GOF) Studies
The White House announced on October 21 that it is temporarily pausing all federal funding for gain-of-function (GOF) experiments involving influenza, SARS, and MERS viruses. To see the announcement, click http://www.whitehouse.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research.

CDC Drafts New PPE Guidance Document
“Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing)” provides detailed guidance on the types of personal protective equipment (PPE) to be used and on the processes for donning and doffing (i.e., putting on and removing) PPE for all healthcare workers entering the room of a patient hospitalized with Ebola virus disease (Ebola). The guidance in this document reflects concerns from the recent experiences of U.S. hospitals caring for Ebola patients. To read the document, go to http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html.

CDC Develops a New, Faster Lab Test for Enterovirus D68
The Centers for Disease Control and Prevention (CDC) has developed and started using a new, faster lab test for detecting enterovirus D68 (EV-D68) in specimens from people in the US with respiratory illness. This test will allow CDC to more rapidly test remaining specimens received from states since mid-September. CDC’s new lab test is a “real-time” reverse transcription polymerase chain reaction, or rRT-PCR, and it identifies all strains of EV-D68 that have been seen this summer and fall. See http://www.cdc.gov/media/releases/2014/p1014-test-enterovirus-D68.html for more details.

Get Smart about Antibiotics Week
The annual “Get Smart about Antibiotics Week” was observed November 17-23. This is a key component of CDC’s efforts to improve antibiotic stewardship in communities, in healthcare facilities, and on the farm in collaboration with state-based programs, nonprofit partners, and for-profit partners. The one-week observance raises awareness of the threat of antibiotic resistance and the importance of appropriate antibiotic prescribing and use. Go to http://www.cdc.gov/getsmart/week/index.html to see more.

Board of Scientific Counselors Office of Infectious Diseases (BSC, OID) Meeting
On December 10, the Board of Scientific Counselors, of the Office of Infectious Diseases will meet in Atlanta. The meeting will include reports from the BSC, OID working groups; brief updates on priorities/activities of CDC’s infectious disease national centers; and a focused discussion on public health issues arising from long-term outbreak response efforts. To see the Federal Register notice, click on http://www.gpo.gov/fdsys/pkg/FR-2014-11-14/pdf/2014-26912.pdf.

FDA Issues Additional Guidance for Outsourcing Facilities that Compound Sterile Human Drugs
On November 21, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013. To read more, click http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424214.htm

First Vaccine Approved by FDA to Prevent Serogroup B Meningococcal Disease
On October 25, the The U.S. Food and Drug Administration announced the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. To read more, see
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420998.htm.  

NIH Begins Early Human Clinical Trial of VSV Ebola Vaccine
Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are conducting the early phase trial to evaluate the vaccine, called VSV-ZEBOV, for safety and its ability to generate an immune system response in healthy adults who are given two intramuscular doses, called a prime-boost strategy. The Walter Reed Army Institute of Research (WRAIR) is simultaneously testing the vaccine candidate as a single dose at its Clinical Trials Center in Silver Spring, Maryland. To read more, go to http://www.niaid.nih.gov/news/newsreleases/2014/Pages/VSVEbolaVaccine.aspx.  

FDA Approves First Combination Pill to Treat Hepatitis C
On October 10, the U.S. Food and Drug Administration approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. To read more, please click http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm.    

MMWR Articles of Interest

Progress toward Global Eradication of Dracunculiasis
In 1986, the World Health Assembly called for dracunculiasis elimination. The global Guinea Worm Eradication Program, supported by The Carter Center, World Health Organization (WHO), UNICEF, CDC, and other partners, began assisting ministries of health of countries in which dracunculiasis is endemic in meeting this goal. 

Update: Ebola Virus Disease Epidemic, November 2014
According to the latest World Health Organization update on November 14, 2014, a total of 14,383 Ebola cases have been reported as of November 11 from three West African countries (Guinea, Liberia, and Sierra Leone) where transmission is widespread and intense. A total of 5,438 deaths have been reported. Transmission was interrupted successfully in Nigeria (October 19) and prevented in Senegal (October 17). 

Possible Eradication of Wild Poliovirus Type 3 Worldwide, 2012
In 1988, the World Health Assembly resolved to eradicate polio worldwide. Since then, four of the six World Health Organization (WHO) regions have been certified as polio-free: the Americas in 1994, the Western Pacific Region in 2000, the European Region in 2002, and the South-East Asia Region in 2014. Currently, nearly 80% of the world's population lives in areas certified as polio-free. 

Incidence of Hansen's Disease, United States, 1994–2011
Hansen's disease (HD), or leprosy, is caused by the bacterium Mycobacterium leprae and is reportable in many states. Without treatment, it can progress to a severely debilitating disease with nerve damage, tissue destruction, and functional loss. Because HD is rare, clinicians in the United States are often unfamiliar with it; however, to better characterize at-risk U.S. populations, HD trends during 1994–2011 were evaluated by reviewing records from the National Hansen's Disease Program (NHDP).

World Polio Day
World Polio Day was established for annual observance on October 24 by Rotary International more than a decade ago to commemorate the fight against poliomyelitis. As of October 14, a total of 243 polio cases had been reported in 2014, with 92% of the cases reported from Nigeria, Afghanistan, and Pakistan, the only three countries where transmission of indigenous wild poliovirus has continued uninterrupted. 

OTHER INFORMATION AND UPDATES

International Pathology Day
The first annual International Pathology Day took place on November 5, 2014. International Pathology Day is an opportunity to celebrate the vital work of pathologists and to demonstrate to the wider public the important role of pathology in their daily lives. See http://www.ilovepathology.org/events/international-pathology-day for more information.

Current Issues in Laboratory Testing for Rheumatoid Arthritis
December 9, 2014 9:00-10:00 AM
“Current Issues in Laboratory Testing for Rheumatoid Arthritis” is part of the 2014 Clinical Chemistry Series of webinars. What do third-generation anti-CCP, anti-CARP and anti-biological therapeutic immunoassays have to offer in diagnosing and managing RA? Learn in this seminar.

To register, see https://www.aacc.org/store/webinars/8700/current-issues-in-laboratory-testing-for-rheumatoid-arthritis.

Articles of Interest

Madagascar Plague Outbreak Kills 40
The Wall Street Journal
November 24, 2014
Forty people have died from the plague in Madagascar, the World Health Organization said.  The agency said 119 people have been diagnosed with the bacterial disease since August, with two cases found in the densely populated capital, Antananarivo.

USAID Seeks Help from ‘Maker Movement’ in Ebola Outbreak
The Washington Post
November 24, 2014
On a recent Friday, several inventors gathered in downtown Washington with suitcases and coolers full of prototypes designed to prevent the spread of the Ebola virus. A group of Columbia University biomedical engineering students had manufactured protective suits intended to keep health-care workers from overheating.

NIH Proposes Greater Disclosure of Clinical Studies
The Wall Street Journal
November 20, 2014
Federal health officials took steps to compel scientists to make clinical study results public even when the findings cut against the interest of pharmaceutical companies. The National Institutes of Health released a proposed rule that would give federal officials more power to enforce a 2007 law that generally called for results of many medical studies to be published.

Nebraska Patient Case Raises Questions about Ebola Test
USA Today
November 19, 2014
The death of physician Martin Salia from Ebola has raised questions about the tests and drugs used in the disease. Salia, a surgeon who was flown from Sierra Leone to Omaha's Nebraska Medical Center Saturday, had two negative tests for Ebola before testing positive

Latest Ebola Fear: Safety of Lab Equipment
USA Today
November 6, 2014
When physicians at the Nebraska Medical Center got their first Ebola case in September, they knew they'd rely heavily on sophisticated blood-test machines to monitor the man's condition. They didn't expect the virus might leave the machines incapacitated for longer than the patient.

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