PRESS RELEASE ISSUED 8/ 17/ 17
As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.
“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, M.D. “By providing manufacturers of these tests with standardized patient samples to use in properly validating these diagnostics, we will be able to better assess how well their tests perform. This is part of our effort to ultimately bring these tests through the FDA’s formal review process to better ensure their reliability, and to enable broader access to Zika diagnostic testing.”
There are two primary blood diagnostic tests: nucleic acid tests that identify infection by confirming the presence of a virus’ genetic material (RNA) and serological tests that identify proteins (antibodies) produced by the body's immune system when it detects harmful organisms, such as Zika virus, in the blood. Serological tests are especially important because there is often a small window when the virus’ genetic material is detectable. However, development of these types of tests has been particularly challenging because antibodies produced by the body to fight Zika virus are difficult to differentiate from antibodies produced to fight related viruses, such as dengue and West Nile viruses.
The FDA’s sample panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses. Although the panel is not for research purposes, diagnostic developers can use these samples to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue viruses. Using the same serological panel to evaluate different devices available under Emergency Use Authorization (EUA) will help public health professionals compare the performance of different Zika virus tests.
The FDA panel is available to developers who have interacted with the FDA through the pre-EUA process and have devices that are in the final stages of validation. To date, the FDA has granted EUAs to three serological tests for detection of recent Zika virus infection (in chronological order): Zika MAC-ELISA, ZIKV Detect IgM Capture ELISA, and LIAISON XL Zika Capture IgM Assay. Other developers interested in requesting a panel may contact the agency.
The panel was prepared using samples from Zika virus-infected individuals provided by Blood Systems Research Institute (BSRI) from a study supported by Contract No. HHSN268201100001I from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). The content of this press release is solely the FDA’s responsibility and does not necessarily represent the official views of BSRI, the NHLBI, or the NIH. The samples from individuals infected with dengue and West Nile virus were obtained separately by the FDA.
FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia
PRESS RELEASE ISSUED 8/ 17/ 17
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
“For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”
B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year and approximately 1,440 will die from the disease.
Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells.
The safety and efficacy of Besponsa were studied in a randomized trial of 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments. Patients were randomized to receive treatment with Besponsa or an alternative chemotherapy regimen. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR). Of the 218 evaluated patients, 35.8 percent who received Besponsa experienced CR for a median 8.0 months; of the patients who received alternative chemotherapy, 17.4 percent experienced CR for a median 4.9 months.
Common side effects of Besponsa include low levels of platelets (thrombocytopenia), low levels of certain white blood cells (neutropenia, leukopenia), infection, low levels of red blood cells (anemia), fatigue, severe bleeding (hemorrhage), fever (pyrexia), nausea, headache, low levels of white blood cells with fever (febrile neutropenia), liver damage (transaminases and/or gamma-glutamyltransferase increased), abdominal pain and high levels of bilirubin in the blood (hyperbilirubinemia).
The prescribing information for Besponsa includes a boxed warning that severe liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease [VOD] or sinusoidal obstruction syndrome), occurred in some patients who took Besponsa. If hepatotoxicity occurs, doctors should pause treatment or reduce the dose of Besponsa. If VOD occurs, patients should stop taking Besponsa and be given standard VOD treatment, if severe.The boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.
Other serious side effects of Besponsa include a decrease in blood cell and platelet production (myelosuppression), infusion-related reactions and problems with the heart’s electrical pulses (QT interval prolongation). Women who are pregnant or breastfeeding should not take Besponsa because it may cause harm to a developing fetus or a newborn baby.
The FDA granted this application Priority Review and Breakthrough Therapy designations. Besponsa also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
USDA BLOG: Packed Lunches: Cutting Corners, But Not Food Safety
POSTED 8/ 15/ 17
As a working mom of four boys, ages 8 and under, I’m asked on a near-daily basis: “how do you DO it?!” It’s a carefully orchestrated dance: keeping my family fed, healthy, dropped off at school and daycare at the appropriate times, with their respective accompaniments, whether homework, snacks or lunches. And then in the evening, allowing opportunity to focus on homework and dinner, without sacrificing quality family time. Making this happen on a daily basis takes a keen attention to detail, a little luck and some advanced planning.
I’m game to try anything to help our daily routine run smoothly, and will cut any corners I can. However, one corner I won’t cut is safe food handling and preparation. Because let’s face it—a houseful of children in the throes of foodborne illness is no one’s idea of a good time.
Advanced Planning
To keep our household running as efficiently as possible, I prep the boys’ lunches a few days in advance. I pre-portion snack size bags of baby carrots for two to three meals and place those in the fridge with the other vegetables. On a clean and separate cutting board, I make enough ham sandwiches for two to three lunches. The prepped sandwiches go back into the fridge in a designated spot.
The Morning Of
In the morning, I pack each soft-sided cooler lunch bag with a napkin, cold sandwich, cold baggie of carrots, any other non-perishable sides and either a frozen water bottle or a frozen tube of yogurt. I also slide an ice pack on top of the lunch contents so each bag has two cold sources that keep the contents out of the Danger Zone (temperatures between 40°F and 140°F at which bacteria grows most rapidly) until lunch time. The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has great resources on safe food handling, particularly for bag lunches.
After Lunch
We’ve taught our boys to throw out their leftovers and not eat anything from their lunches later in the day. When they arrive home from school, they promptly discard anything that didn’t make it into the trash can in the cafeteria. I wipe out their lunch bags with a disinfectant wipe and leave to air dry overnight.
By prepping a few days of lunches in a session, I save quite a bit of time. Mornings run smoother because there’s no shuffling and rummaging for something to eat. Knowing that the food was safely prepared, stored and packed in their lunch boxes gives me the peace of mind that I’ve reduced the risk of foodborne illness in my kids, while carving out a little more quality time to spend with them in the evenings.
ON THE STATE LEVEL OUR HEALTH
DOH: Pierce Co. paramedic suspended on allegations of diverting controlled substances
PRESS RELEASE ISSUED 8/ 16/ 17
OLYMPIA -- The Washington State Secretary of Health, Emergency Medical Services and Trauma Systems program immediately suspended the credential of Pierce County paramedic Jeremy Aaron Johansen (ES.60016043) pending further legal action.
Charges say Johansen diverted fentanyl and morphine for his own use. He has 20 days to respond to the charges and request a hearing.
The legal documents on this case can be seen online by clicking the link on Provider Credential Search on the Department of Health website; copies can be requested by calling 360-236-4700. Anyone who believes a health care provider acted unprofessionally is encouraged to call the number above to report their complaint.
The Emergency Medical Services and Trauma System protects and promotes public health, safety, and welfare in Washington by regulating the competency and quality of licensed Emergency Medical personnel. The Secretary of health establishes, monitors, and enforces qualifications for licensing, consistent standards of practice, continuing competency mechanisms, and discipline. Rules, policies, and procedures promote the delivery of quality healthcare to people in Washington.
WORLD POVERTY THE REAL CRISIS
HUD AND CENSUS BUREAU REPORT
RESIDENTIAL CONSTRUCTION ACTIVITY IN JULY 2017
PRESS RELEASE ISSUED 8/ 16/ 17
WASHINGTON – The U.S. Department of Housing and Urban Development (HUD) and the U.S. Census Bureau jointly announced the following new residential construction statistics for July 2017.
Building Permits: Privately owned housing units authorized by building permits in July were at a seasonally adjusted annual rate of 1,223,000. This is 4.1 percent (±0.9 percent) below the revised June rate of 1,275,000 and is 4.1 percent (±1.8 percent) above the July 2016 rate of 1,175,000. Single-family authorizations in July were at a rate of 811,000; this is unchanged from the revised June figure of 811,000. Authorizations of units in buildings with five units or more were at a rate of 377,000 in July.
Housing Starts: Privately owned housing starts in July were at a seasonally adjusted annual rate of 1,155,000. This is 4.8 percent (±10.2 percent)* below the revised June estimate of 1,213,000 and is 5.6 percent (±8.5 percent)* below the July 2016 rate of 1,223,000. Single-family housing starts in July were at a rate of 856,000; this is 0.5 percent (±8.5 percent)* below the revised June figure of 860,000. The July rate for units in buildings with five units or more was 287,000.
Housing Completions: Privately owned housing completions in July were at a seasonally adjusted annual rate of 1,175,000. This is 6.2 percent (±14.3 percent)* below the revised June estimate of 1,252,000 and is 8.2 percent (±12.6 percent)* above the July 2016 rate of 1,086,000. Single-family housing completions in July were at a rate of 814,000; this is 1.6 percent (±11.9 percent)* below the revised June rate of 827,000. The July rate for units in buildings with five units or more was 354,000.
The August report is scheduled for release on September 19, 2017.
Read more about today's release of housing construction activity.
EXPLANATORY NOTES
In interpreting changes in the statistics in this release, note that month-to-month changes in seasonally adjusted statistics often show movements which may be irregular. It may take three months to establish an underlying trend for building permit authorizations, six months for total starts, and six months for total completions. The statistics in this release are estimated from sample surveys and are subject to sampling variability as well as nonsampling error including bias and variance from response, nonreporting, and undercoverage. Estimated relative standard errors of the most recent data are shown in the tables. Whenever a statement such as “2.5 percent (±3.2 percent) above” appears in the text, this indicates the range (-0.7 to +5.7 percent) in which the actual percentage change is likely to have occurred. All ranges given for percentage changes are 90 percent confidence intervals and account only for sampling variability. If a range does not contain zero, the change is statistically significant. If it does contain zero, the change is not statistically significant; that is, it is uncertain whether there was an increase or decrease. The same policies apply to the confidence intervals for percentage changes shown in the tables. On average, the preliminary seasonally adjusted estimates of total building permits, housing starts and housing completions are revised 3 percent or less. Explanations of confidence intervals and sampling variability can be found at the Census Bureau’s website.
* The 90 percent confidence interval includes zero. In such cases, there is insufficient statistical evidence to conclude that the actual change is different from zero.
UN NEWS CENTER: Emergency food distributions launched to assist thousands displaced in DR Congo – UN agency
16 August 2017 – Food assistance will be provided to food insecure people displaced by conflict in the Kasai region of the Democratic Republic of the Congo (DRC), says the United Nations food agency.
UN NEWS CENTER: Protecting aid workers ‘paramount,’ UN relief chief says ahead of World Humanitarian Day
17 August 2017 – As conflicts around the world continue to take a massive toll on people’s lives, the top United Nations relief official stressed the importance of ensuring that the brave men and women who risk their lives to help those in need are not themselves a target.
WORLD & NATIONAL NEWS BRIEFS, and NEWS STORY COMMENTARY
UN NEWS CENTER:
Marking World Humanitarian Day, UN urges protection for civilians in armed conflict
18 August 2017 – Civilians in conflict are not a target, top United Nations officials today stressed at a special event marking World Humanitarian Day, which honours aid workers and pays homage to those killed in service, while also drawing attention to the millions of people today living in war zones.
More than 350,000 children vaccinated against polio in hard to reach areas of Syria – UN
18 August 2017 – A United Nations polio vaccination campaign in Syria has provided protection to more than 355,000 children under age five in two governorates, where violence has made access especially difficult.
NATION
REU: Thousands take to streets in Boston protest against hate speechBOSTON, Aug 19 (Reuters) - Thousands of people in Boston protested a "Free Speech" rally featuring right-wing speakers on Saturday, with hundreds of police mobilized to prevent a recurrence of violence that left a woman dead at a Virginia white-supremacist protest last week.
AP: Duke University removes statue of Confederate general
DURHAM, N.C. — Duke University has removed a statue of Confederate Gen. Robert E. Lee days after it was vandalized.
NEWS STORY COMMENTARY:
From the Patroit Post: Historical Revisionism
Posted 8/ 18/ 17
Quote:" Of course, the focus of today’s hysteria are Southerners who led the Confederate States of America. Given the centrality of slavery to the Civil War, history has rightly judged the Confederacy harshly. Yet even its leading figures were complex. Robert E. Lee opposed slavery and secession before the Civil War and promoted reconciliation afterwards."
WE ARE ALL SLAVES...MOSTLY SLAVERY OF SIN
By, Peter Ripley
Readers, this week was bounty of reflection, not only on a personal level, since Friday happened to be my birthday, as I mention it was a day which how my life personally been going. But, this week we as a nation have been doing a lot of reflection of our checkerd past. Which was the act of ensalvement of others, on account of the color of skin. Earlier this week while I was at the local swimming pool, after I did me usual routine, and in the shower room, I was apporched by a elderly man, asking me about the events of Charlottesville. He mention the Rush Limbuagh radio show, saying on the show Limbaugh all of the viloence had to do with slavery, which ended in America after the civil war, over 150 years ago.
I answered we all are slaves in some way, slave to our jobs, slaves mostly to sins we hold on to. There were other guys in the room listening to my little speech I was giving to the elderly gent. I said it is only through faith in Christ we are freed from sin, and we have true liberty only through God. I thought it was very apt considering the topic of slavery was mentioned. Something to ponder folks, what is more important? Some bad habit, job, sexual sins? Or taking time to know God? Which is more important? Now as for the monuments, Do these vandals really think tearing down statues, or desiccating graves of confederate soldiers going to change history? What I've been seeing that two groups who are slaves of hatred, one group of haters on racial grounds, the other group haters of this country.
BIBLE STUDY FOR THIS WEEK
GOSPEL WAY: Are Schools Destroying Young People's Faith?
One of the most popular philosophies of education is called "Humanism." The Humanist Manifestos inform us what Humanists generally believe.
