PRESS RELEASE POSTED 9/ 1/ 17 (link source)
Transcript:
My fellow Americans,
The heartbreaking devastation and suffering caused by Hurricane Harvey has profoundly affected our entire nation. Many homes and communities have been destroyed, many lives have been upended, and tragically, some have lost their lives in this catastrophic storm.
We pray for the victims and their families—and all of those who have been displaced from their homes.
At this very moment, heroic efforts continue to keep safe those threatened by this natural disaster.
I want to say a special word of thanks to our amazing first responders—our police and law enforcement officers, firefighters, Coast Guard, National Guard, EMS, doctors, nurses, hospital workers, and volunteers who have traveled from all across the country. Thousands of people have come together to prevent loss of life and ensure safety, and we are incredibly grateful for their courage, their professionalism, and their sacrifice.
They are an inspiration to all of us.
To the people affected by Hurricane Harvey: we are with you every single step of the way. We will help you recover. We will help you rebuild. We will support you today, tomorrow, and the day after.
We have been working closely with local authorities, and I remain in close communication with Governor Abbott of Texas and Governor Edwards of Louisiana.
At the request of Governor Abbott, I declared a major disaster in the State of Texas to ensure that federal aid is available for state and local recovery efforts. I also approved a disaster declaration for Louisiana.
Organizations like the Red Cross, the Salvation Army, and faith-based organizations are actively assisting on the ground and they are doing a fantastic job. I want to recognize the millions of citizens across the country who are contributing in every way they can—with their time, their resources, and their prayers.
When one part of America hurts, we all hurt. When we see neighbors in need, we rush to their aid. We don't ask their names or where they are from—we help our fellow Americans every single time.
This is the spirit of America. It is exactly what I saw while in Texas this week—a spirit of love, determination, and resolve. A spirit, that even when wounded, never gives up—never gives in—never loses hope. We just keep fighting—we just keep pushing on, for the people we love, and for the nation we call home.
All American hearts are with the people of Texas and Louisiana. We mourn and pray and struggle through the hardships—together.
We know that a long and difficult path lies ahead to get our neighbors back in their homes and on their feet. But we also know that we are stronger than the obstacles in our path. Arm-in-arm, we will strive, we will endure, and we will emerge stronger than ever before.
Thank you. God Bless You. And God Bless the United States of America.
Remarks by President Trump at Signing of Day of Prayer Proclamation
PRESS RELEASE ISSUED 9/ 1/ 17 (link source)
THE PRESIDENT: Thank you very much. Americans have always come to the aid of their fellow countrymen. Friend helping friend, neighbor helping neighbor, stranger helping stranger -- we’ve seen it perhaps more so than at any time, so vividly at least, during Hurricane Harvey.
From the beginning of our nation, Americans have joined together in prayer during times of great need to ask for God’s blessing and God’s guidance. When we look across Texas and Louisiana, we see the American spirit of service embodied by countless men and women.
Brave first responders have rescued those stranded in drowning cars and rising water, and I have to tell you that I’ve watched the Coast Guard -- thousands of lives have been saved by our great Coast Guard. They have done incredible work in the most vicious seas that they’ve seen in many, many years.
Families have given food and shelter to those in need. Houses of worship have organized efforts to clean up communities and repair damaged homes. People have never seen anything quite like this. Individuals of every background are striving for the same goal: to aid and comfort people facing devastating losses. As Americans, we know that no challenge is too great for us to overcome -- no challenge.
We invite all Americans to join us as we continue to pray for those who have lost family members and friends, and for those who are suffering from this great crisis.
And behind me, we have faith-based people who are highly respected, and especially so in their communities where they’re not only respected, but they’re loved -- evangelical leaders, Christian leaders -- many people of faith. And I just want to thank you all for being with us today because we’re going to be signing a Day of Prayer, and that will be on Sunday. It will be a very special day. And I don’t know when this was done last, but it’s been a longtime coming. It’s been a longtime coming.
So I’m going to sign it, and then a few of the folks will say a few words, and Pastor Jeffress will say a prayer for not only the people so affected -- so horribly affected by Hurricane Harvey, but for the people of the nation and, in fact, the people of our world.
OUR HEALTH & FITNESS
FDA clears mammography device with option for patient-assisted compressionPRESS RELEASE ISSUED 9/ 1/ 17 (link source)
Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.
"Regular mammograms are an important tool in detecting breast cancer," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. "However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam."
Mammograms can help detect breast cancer when it is in its early, most treatable stages. A conventional mammogram is a low-dose 2D x-ray picture of the breast. Digital mammograms use a computer along with x-rays to make and show breast pictures, which are taken in the same way as a conventional mammogram. The resulting images are evaluated by a physician qualified under the Mammography Quality Standards Act to identify any abnormalities that might warrant additional work-up.
The Senographe Pristina with Self-Compression is a digital mammography system designed to give the patient an active role in the application of compression. The system has a handheld wireless remote control that patients can use to adjust the compression force after breast positioning. During a mammography exam, the technologist positions the patient and initiates compression. The technologist then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted.
The Senographe Pristina with Self-Compression was reviewed through the premarket notification 510(k) pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
The FDA determined that the Senographe Pristina with Self-Compression is substantially equivalent to the predicate device Senographe Pristina. A clinical validation demonstrated that the addition of a remote to allow self-compression did not negatively impact image quality. Additionally, performing a mammogram with patient-assisted compression compared to compression solely applied by the technologist did not significantly increase the time of the exam.
The FDA granted premarket clearance of the Senographe Pristina with Self-Compression to GE Healthcare.
FDA approves Mylotarg for treatment of acute myeloid leukemia
PRESS RELEASE ISSUED 9/ 1/ 17 (link source)
The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).
Mylotarg originally received accelerated approval in May 2000 as a stand-alone treatment for older patients with CD33-positive AML who had experienced a relapse. Mylotarg was voluntarily withdrawn from the market after subsequent confirmatory trials failed to verify clinical benefit and demonstrated safety concerns, including a high number of early deaths. Today’s approval includes a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population.
“We are approving Mylotarg after a careful review of the new dosing regimen, which has shown that the benefits of this treatment outweigh the risk,” 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. “Mylotarg’s history underscores the importance of examining alternative dosing, scheduling, and administration of therapies for patients with cancer, especially in those who may be most vulnerable to the side effects of treatment.”
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute of the National Institutes of Health estimates that approximately 21,380 people will be diagnosed with AML this year and that 10,590 patients with AML will die of the disease.
Mylotarg is a targeted therapy that consists of an antibody connected to an anti-tumor agent that is toxic to cells. It is thought to work by taking the anti-tumor agent to the AML cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death.
The safety and efficacy of Mylotarg in combination with chemotherapy for adults were studied in a trial of 271 patients with newly diagnosed CD33-positive AML who were randomized to receive Mylotarg in combination with daunorubicin and cytarabine or to receive daunorubicin and cytarabine without Mylotarg. The trial measured “event-free survival,” or how long patients went without certain complications, including failure to respond to treatment, disease relapse or death, from the date they started the trial. Patients who received Mylotarg in combination with chemotherapy went longer without complications than those who received chemotherapy alone (median, event-free survival 17.3 months vs. 9.5 months).
The safety and efficacy of Mylotarg as a stand-alone treatment were studied in two, separate trials. The first trial included 237 patients with newly diagnosed AML who could not tolerate or chose not to receive intensive chemotherapy. Patients were randomized to receive treatment with Mylotarg or best supportive care. The trial measured “overall survival,” or how long patients survived from the date they started the trial. Patients who received Mylotarg survived longer than those who received only best supportive care (median overall survival 4.9 months vs. 3.6 months). The second trial was a single-arm study that included 57 patients with CD33-positive AML who had experienced one relapse of disease. Patients received a single course of Mylotarg. The trial measured how many patients achieved a complete remission. Following treatment with Mylotarg, 26 percent of patients achieved a complete remission that lasted a median 11.6 months.
Common side effects of Mylotarg include fever (pyrexia), nausea, infection, vomiting, bleeding, low levels of platelets in the blood (thrombocytopenia), swelling and sores in the mouth (stomatitis), constipation, rash, headache, elevated liver function tests, and low levels of certain white blood cells (neutropenia). Severe side effects of Mylotarg include low blood counts, infections, liver damage, blockage of the veins in the liver (hepatic veno-occlusive disease), infusion-related reactions, and severe bleeding (hemorrhage). Women who are pregnant or breastfeeding should not take Mylotarg, because it may cause harm to a developing fetus or a newborn baby. Patients with hypersensitivity to Mylotarg or any component of its formulation should not use Mylotarg.
The prescribing information for Mylotarg includes a boxed warning that severe or fatal liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease or sinusoidal obstruction syndrome), occurred in some patients who took Mylotarg.
Mylotarg received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA granted the approval of Mylotarg to Pfizer Inc.
CDC Emergency Operations Center activates to support response to Hurricane Harvey
PRESS RELEASE ISSUED 9/ 1/ 17 (link source)
CDC’s Emergency Operations Center (EOC) is now activated to bring together CDC staff to work efficiently in responding to public health needs in the aftermath of Hurricane Harvey and to deploy resources and personnel as requested. Elements of CDC’s emergency response have been in place since August 25, 2017. However, as the need for resources has increased so has CDC’s need to increase the agency’s response.
CDC has deployed pharmacy supplies and six 250-bed medical stations. Two stations each are located in Baton Rouge, Louisiana, and Houston and Dallas, Texas. The two medical stations in Houston are operational; the remaining four are at their respective locations and will be set up, if needed. As of September 1, 34 CDC staff members have been deployed including to Dallas and to Washington, DC, to serve as liaisons with other federal agencies.
The EOC is the command center for monitoring and coordinating CDC activities along with other U.S. government agencies to respond to public health threats, including drowning and floodwater safety, carbon monoxide poisoning, downed power lines, unsafe food and water, mold, and other health risks. CDC’s EOC coordinates with the HHS Secretary’s Operations Center in DC to ensure situational awareness and a cohesive public health and medical response.
ON THE STATE LEVEL from DOH
DOH urges recreational shellfish harvesters to follow ‘Three Cs’
PRESS RELEASE ISSUED 8/ 31/ 17 (link source)
OLYMPIA – Washington State Department of Health is urging recreational shellfish harvesters to take extra precautions and check, chill, and cook – the Three Cs – over the Labor Day weekend and into September.
The combination of hot weather, low tides, and little rain have contributed to more than 10 reports of vibriosis illnesses from people who ate raw or undercooked oysters they collected themselves. Vibrio parahaemolyticus bacteria is found naturally in the environment and thrives in warm temperatures.
“The shellfish industry follows special control measures during the summer months to keep people who choose to eat raw oysters from getting sick. For those who enjoy collecting and consuming their own shellfish, it’s important that they follow a few simple measures to stay healthy,” said Rick Porso, director of the Office of Environmental Health and Safety.
Before heading to the beach, people who gather their own shellfish should check the DOH Shellfish Safety Map to determine if any areas are closed. Shellfish gathered from open and approved areas should be harvested as the tide goes out, chilled as soon as possible, and cooked at 145 F for 15 seconds to destroy Vibrio bacteria.
Vibriosis symptoms include diarrhea, abdominal cramps, nausea, vomiting, headache, fever, and chills. The illness is usually mild or moderate and runs its course in two to three days.
WORLD AND NATIONAL NEWS BRIEFS
NEWS REPORT COMMENTARY
From the Peninsula Daily News headline: Port of Port Angeles focus no longer on Sea-Tac as destination for commercial passenger air service.
Quote: " Burke said Wednesday in an email that the port is “still in touch” with Mokulele Airlines of Hawaii, which did not return a call for comment Wednesday.
“We’re not saying no to Sea-Tac, but until [carriers] come back and say they can do it, we’re not going to be putting any effort into it,” Burke said Wednesday in an interview.
Sea-Tac could handle 92 flight operations an hour and was averaging 88, “which only leaves a couple of spaces per hour,” Dan Gase, the port’s real estate and business manager, said Wednesday.
“In a broad, technical sense, yes, they might have room if everything is working perfectly,” he said, adding that bad-weather days could cause lengthy landing and take-off delays.
Sea-Tac spokesman Perry Cooper said flight delays were not an issue in Port Angeles being unable to obtain air service."
Editorial Comment: Wasn't the whole point of having an air service was to provide service to Sea tac? And didn't they cut down trees at Lincoln park to better secure a air carrier to Sea tac?
WORLD AND NATIONAL NEWS BRIEFS
NYT: North Korea Says It Tested a Hydrogen Bomb Meant for Missiles
SEOUL, South Korea — North Korea carried out its sixth and most powerful nuclear test in an extraordinary show of defiance against President Trump on Sunday, saying it had detonated a hydrogen bomb that could be mounted on an intercontinental ballistic missile.
AFP: International community condemns North Korea nuclear test
Countries around the world swiftly condemned North Korea's announcement that it had tested a hydrogen bomb Sunday, with South Korea calling for the "strongest punishment" against Pyongyang while key ally China strongly condemned it.
NATIONAL
Rolling Stone: The Battle Over White Nationalism at Texas A&M
Wearing cowboy boots and jeans, Preston Wiginton has stepped onto the Texas Capitol lawn to denounce the recent move by Texas A&M University to prohibit a "White Lives Matter" rally he had planned for September.
Houston Chronicle: Harvey's displaced persons proving hard to track down
Among the hundreds of missing persons displaced by Harvey's wrath was Greg Connelly, a bipolar schizophrenic who left his parents' house in Pearland last week just as Hurricane Harvey struck the region.
THIS WEEK'S BIBLE STUDY
Gospel Way: Teaching Young People about Marriage and Divorce
Nearly one half of all marriages in our country end in divorce. This is one of the clearest signs of decay in our family life. But does the fact that society winks at divorce necessarily prove that God accepts it? What does the Bible say?
https://www.gospelway.com/topics/family/divorce-youth.php
