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Month: May 2018


Why Is the Study of Ebola & Marburg a Priority for NIAID?
Marburg hemorrhagic fever was first recognized in 1967, when laboratory workers in Germany & Yugoslavia developed a hemorrhagic illness after handling tissue from green monkeys. The outbreak resulted in 31 infections and 7 deaths. Researchers later identified the cause as a never-before-seen filovirus, termed “Marburg” after one of the outbreak locations.
Eleven years later, Ebola virus was identified when two outbreaks of hemorrhagic fever occurred in northern Zaire (now the Democratic Republic of Congo) and southern Sudan. The causes of the outbreaks were identified as two different species of another book filovirus, called “Ebola” after a river in northern Zaire. Both species proved to be highly lethal, as 90 percent of the Zairian cases & 50 percent of the Sudanese cases resulted in death. …

Sugarfina, Inc. Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product

Sugarfina, Inc. is recalling its Sugar Cookies product because the label does not declare that this product contains egg. People who have allergies or severe sensitivities to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
Sugar Cookies were sold in Sugarfina, Inc. retail stores throughout the U.S., and select Nordstrom Department stores in Oregon, Arizona, California, Texas, Illinois,Washington, & other boutique retail stores. The miniature, white-chocolate coated cookies were most commonly sold in a clear lucite cube that held approximately 3.5 ounces (UPC: 840278113725 | SKU #K1175), or sold in a blue plastic bag that contains approximately 2.5 lbs (UPC: 840278122123| SKU #K1016), & in a clear plastic bag that contains approximately 0.8 oz. (UPC: 840278109414 | SKU #K0521).
No illnesses or adverse reactions have been reported to date. Sugarfina decided to initiate the voluntary recall of all lots shortly after an internal label review identified that the labeling statement did not identify eggs. The product is otherwise safe to consume.
Sugarfina takes the safety & integrity of the products it sells seriously. If customers have product affected by this voluntary recall, they should discard it immediately or return it to their local store for a full refund, or contact their sales representative.
Costumers with questions may contact the company at 1-855-784-2734 from 8:00 AM to 5:00 PM PST Monday to Thursday & 8:00 AM to 2:00 PM PST on Friday.
Sugarfina sincerely regrets any inconvenience and concern this voluntary recall may cause.
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NLM Staff Dr. Stephen J. Greenberg & Web Collecting & Archiving Working Group Honored by the Archivists & Librarians in the History of the Health Sciences (ALHHS)

On May 10, 2018, the professional association Archivists & Librarians in the History of the Health Sciences (ALHHS) recognized NLM staff with two prestigious awards.
Stephen J. Greenberg, MSLS, PhD, Head of the NLM Rare Books & Early Manuscripts section received the 2018 Lisabeth M. Holloway Award for his significant contributions through leadership & service to ALHHS and to the profession.
ALHHS also awarded the NLM Web Collecting & Archiving Working Group—including Delia Golden, MS/LIS; Christie Moffatt, MLIS; John Rees, MA, MLS; & Kristina Womack, MA, MLS—its 2018 Publication Award in the category of “Electronic Resource” for the NLM HIV/AIDS Web Archive Collection.
About Stephen J. Greenberg, MSLS, PhD
Stephen J. Greenberg, MSLS, PhD

Since joining the staff of the National Library of Medicine’s History of Medicine Division in 1992, & becoming a member of ALHHS the same year, Dr. Greenberg has demonstrated superior public service now recognized with the prestigious ALHHS Holloway Award.
Dr. Greenberg has an impressive record of service with both ALHHS and NLM, including service as the ALHHS president from 2010 to 2012 and his current position as Head of the Rare Books & Early Manuscripts Section in the NLM History of Medicine Division. During his twenty-five years with the NLM, Dr. Greenberg has authored several important historical articles based on NLM collections, including a noteworthy 2009 article, co-authored with Patricia E Gallagher, entitled “The Great Contribution: Index Medicus, Index-Catalogue, IndexCat” (Journal of the Medical Library Association 97:2 (April, 2009), 108-13). Here, years ahead of others in the field of digital humanities,…

'Gluten-Free' Means What It Says

This gluten-free banana bread was made with almond flour instead of regular flour. Plain nuts are also a gluten-free option.

 Subscribe: FDA Consumer Health Information 
In August 2013, the Food & Drug Administration issued a final rule that defined what characteristics a food has to have to bear a “gluten-free” claim. The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard.
Manufacturers had one year to bring their labels into compliance. Any food product bearing a gluten-free claim on or after August 5, 2014 must meet the rule’s requirements.
This rule was welcomed by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat gluten, typically found in breads, cakes, cereals, pastas, and many other foods.
There is no cure for celiac disease & the only way to manage the disease is to avoid eating gluten. Without a standardized definition of “gluten-free,” these consumers could never really be sure if their body would tolerate a food with that label.
As one of the criteria for using the claim “gluten-free,” FDA set a limit of less than 20 ppm (parts per million) for the unavoidable presence of gluten in foods that carry this label. That is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries & international bodies that set food safety standards.

Study Upends Conventional View of Opioid Mechanism of Action

News Release
Thursday, May 10, 2018 NIH-funded scientists find new molecular target for developing safer pain medications. A new discovery shows that opioids used to treat pain, such as morphine & oxycodone, produce their effects by binding to receptors inside neurons, contrary to conventional wisdom that they acted only on the same surface receptors as endogenous opioids, which are produced naturally in the brain. However, when researchers funded by the National Institute on Drug Abuse (NIDA) used a novel molecular probe to test that common assumption, they discovered that medically used opioids also bind to receptors that are not a target for the naturally occurring opioids. NIDA is part of the National Institutes of Health.
This difference between how medically used & naturally made opioids interact with nerve cells may help guide the design of pain relievers that do not produce addiction or other adverse effects produced by morphine & other opioid medicines.
“This ground-breaking study has uncovered important distinctions between the opioids that our brain makes naturally & therapeutic opioids that can be misused,” said NIDA Director Nora D. Volkow, M.D. “This information can be mined to better understand the potential adverse actions of medically prescribed opioids & how to manipulate the endogenous system to achieve optimal therapeutic results without the unhealthy side effects of tolerance, dependence, or addiction.”
Naturally occurring opioids and medically used opioids alike bind to the mu-opioid receptor, a member of a widespread family of proteins known as G protein-coupled receptors (GPCRs). Recent advances in understanding the three-dimensional structure of…

More Than One Day of Early-Pregnancy Bleeding Linked to Lower Birthweight

News Release
Wednesday, May 9, 2018 NIH study cautions that more research is needed to determine if this small difference in weight poses a health risk. Women who experience vaginal bleeding for more than one day during the first trimester of pregnancy may be more likely to have a smaller baby, compared to women who do not experience bleeding in the first trimester, suggest researchers at the National Institutes of Health. On average, full-term babies born to women with more than one day of bleeding in the first trimester were about 3 ounces lighter than those born to women with no bleeding during this time. Additionally, infants born to women with more than a day of first trimester bleeding were roughly twice as likely to be small for gestational age, a category that includes infants who are healthy but small, as well as those whose growth has been restricted because of insufficient nutrition or oxygen or other causes.
The study appears in Obstetrics & Gynecology & was conducted by researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) & other U.S. research institutions.
The authors caution that the decrease in birthweight of infants born to women with vaginal bleeding was small. More studies are needed to determine if these infants are at risk for any additional health risks in infancy or later in life.
“The good news is that only one day of bleeding was not significantly associated with reduced growth,” said the study’s Elder author, Katherine L….

NIH Clinical Trial to Track Outcomes of Kidney Transplantation From HIV-Positive Donors to HIV-Positive Recipients

News Release
Monday, May 7, 2018 Study follows passage of HOPE Act of 2013, allowing people with HIV to become organ donors. The first large-scale clinical trial to study kidney transplantations between people with HIV has begun at clinical centers across the United States. The HOPE in Action Multicenter Kidney Study will determine the safety of this practice by evaluating kidney recipients for potential transplant-related & HIV-related complications following surgery. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
While organ transplants between donors & recipients with HIV have been successfully completed in South Africa since 2008, such transplants were illegal in the United States until the passage of the HIV Organ Policy Equity (HOPE) Act in 2013. The HOPE Act permits U.S. transplant teams with an approved research protocol to transplant organs from donors with HIV into qualified recipients with end-stage organ failure who are also living with HIV, a practice that may shorten the time people living with HIV wait to receive a transplant. The transplantation of organs from donors who have HIV to individuals uninfected with HIV remains illegal in the United States.
Individuals living with HIV have a higher risk of end-stage liver & kidney diseases because of damage caused by HIV & its coinfections & associated comorbidities, such as hepatitis B & C viruses, hypertension & diabetes mellitus, as well as toxicity from certain antiretroviral drugs used to treat HIV infection. In the early decades of…

NIAID-Sponsored Trial of a Universal Influenza Vaccine Begins

News Release
Friday, May 4, 2018  A Phase 2 clinical trial of an investigational universal influenza vaccine intended to protect against multiple strains of the virus has begun in the United States. The study is sponsored by the National Institute of Allergy & Infectious Diseases (NIAID), part of the National Institutes of Health, & is being conducted at four U.S. sites that are part of the NIAID-funded Vaccine & Treatment Evaluation Units (VTEUs). The trial is testing an experimental vaccine called M-001 for safety & its ability to produce potentially broad protective immune responses, both on its own & when followed by a standard, licensed seasonal influenza vaccine.
Influenza viruses mutate constantly, resulting in the emergence of viruses that may not always match those targeted by seasonal and pre-pandemic influenza vaccines. Seasonal influenza vaccines are made anew each year to match the strains predicted to circulate in the upcoming season. To receive the best protection against influenza, people must be vaccinated annually. However, if a particular influenza strain changes in an unanticipated way, or a different strain from that included in the vaccine spreads widely, the seasonal influenza vaccine may not be sufficiently protective. Each year, seasonal influenza sickens millions in the United States & results in 140,000 to 710,000 hospitalizations & between 12,000 & 56,000 deaths, according to the Centers for Disease Control & Prevention.
Influenza pandemics occur when a book influenza strain for which people have little to no protection begins to spread among humans & present a greater public health…

Bacteria Therapy for Eczema Shows Promise in NIH Study

News Release
Thursday, May 3, 2018 Topical treatment with live Roseomonas mucosa — a bacterium naturally present on the skin — was safe for adults & children with atopic dermatitis (eczema) & was associated with reduced disease severity, according to initial findings from an ongoing early-phase clinical trial at the National Institutes of Health. Preclinical work in a mouse model of atopic dermatitis had suggested that R. mucosa strains collected from healthy skin can relieve disease symptoms. The new findings, published May 3 in JCI Insight, support further evaluation of this potential new therapy.
Atopic dermatitis is an inflammatory skin disease that can make skin dry & itchy, cause rashes & lead to skin infections. The disease is linked to an increased risk of developing asthma, hay fever & food allergy. Atopic dermatitis is common in children & sometimes resolves on its own, but it also can persist into or develop during adulthood.
“Living with atopic dermatitis can be physically & emotionally challenging. While treatment can help manage the symptoms, currently available therapies can be time-consuming — requiring multiple daily applications — & costly,” said Anthony S. Fauci, M.D., director of NIH’s National Institute of Allergy & Infectious Diseases (NIAID). “New, inexpensive therapies that require less frequent application are needed to expand the options available for atopic dermatitis treatment.”
The cause of atopic dermatitis is unknown, but studies suggest that the skin microbiome—the community of bacteria & other microbes living on the skin—plays a key role. For years, scientists have known that people with atopic…

NLM Technical Bulletin, May-Jun 2018, NLM VSAC Publishes Updated Electronic Clinical Quality Measure Value Sets for 2019 Reporting

NLM VSAC Publishes Updated Electronic Clinical Quality Measure Value Sets for 2018 Reporting. NLM Tech Bull. 2018 May-Jun;(422):e2.
On May 4, 2018, the National Library of Medicine (NLM) Value Set Authority Center (VSAC), in collaboration with the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), published the electronic clinical quality measure (eCQM) annual update for the 2019 reporting period for Eligible Hospitals & Critical Access Hospitals (CAH) & the 2019 performance period for Eligible Professionals and Eligible Clinicians. CMS updates the specifications annually to align with current clinical guidelines and code systems so they remain relevant & actionable within the clinical care setting. These updated eCQMs are fully specified & are to be used to electronically report 2019 clinical quality measure data for CMS quality reporting programs. Measures will not be eligible for 2019 reporting unless and until they are proposed & finalized through notice-and-comment rulemaking for each applicable program.
VSAC eCQM Value Set Resources
Where to Find the 2019 eCQM Value Sets
Access to these resources requires a Completely free Unified Medical Language System® Metathesaurus License.
VSAC Downloadable Resources: Prepackaged downloadable files (.xlsx & .xml) for the entire set of the updated 2019 eCQM Value Sets.
NEW! Direct Reference Codes: Single terminology codes, specified within the Data Criteria section of an eCQM Health Quality Measure Format (HQMF) file, that describe data elements. CMS includes single direct reference codes in addition to the specified value sets. These direct reference codes are not included within the value sets….

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