SUNDAY EDITION

WH: President Donald J. Trump's Weekly Address
Posted on the White House page 9/ 15/ 17 (link source)

Transcript:

My fellow Americans,

I would like to begin by continuing to send our prayers to all of those affected by Hurricanes Harvey and Irma.  From Texas to Louisiana to Florida, Alabama, South Carolina, the Virgin Islands, and Puerto Rico, we are coordinating closely with local authorities to help everyone impacted by these catastrophic storms.  When Americans are in need, America pulls together.  And we will not rest until everyone is safe, sound, and secure.  We will be there tomorrow and the day after, as we work to respond, recover, and rebuild.

When Americans are united, no force on earth can break us apart.

This week, the United States celebrates the 230th Anniversary of the signing of our remarkable Constitution.

The fifty-five Delegates to the Grand Convention in Philadelphia met from May to September of 1787.  They gave us an incredible gift: a vision of the sovereign and self-governing people to control their own affairs.  And they gave us a Constitutional system that protected our liberties by enshrining the Rule of Law.

Patriots like Washington, Madison, Hamilton, Franklin, and so many others had already achieved immortality through their victory in the Revolution.  But soon after, these extraordinary leaders faced another task unlike any other—the task of building a brand new nation.  So they designed a system of government, rooted in common laws, history, and traditions that would secure the liberty, equality, and rights they had fought for and fought to defend in the American Revolution.

The Framers of our Constitution triumphantly declared to whom the government of the United States belonged: it was “WE THE PEOPLE.”  These three beautiful words are among the most important ideas in our nation’s history: the idea that government’s power is vested in the nation’s citizens – the people to whom we owe our ultimate and sacred allegiance.  Our soldiers fight and die to protect our citizens, and our government is forever duty bound to safeguard their sovereignty and their freedom.

For 230 years, we have governed ourselves and planned our own destiny, guarded all the way by the Constitution of the United States.

On this Sunday, Constitution Day, let us recommit ourselves to our Founding Principles, and rededicate ourselves to our glorious heritage.  We have inherited a birthright of freedom – we must defend it dearly, protect it jealously, and promote it proudly, as one nation under God.  We must rise to the task of self-governance, prove worthy of the sacrifices made to carve out this magnificent nation, and we must give our loyalty to our Republic and its citizens in all that we do.

So let us pledge allegiance to our flag, devote our hearts to our country, and demonstrate our love for one another—as Americans, as Patriots, and as the children of God.
Thank you.


OUR HEALTH AND WELL BEING....

FDA approves new treatment for adults with relapsed follicular lymphoma
PRESS RELEASE ISSUED 9/ 14/ 17 (link source)

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” 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. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”

Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system. The lymph system is part of the body’s immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow. The National Cancer Institute at the National Insititutes of Health estimates that approximately 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year; approximately 20,140 patients with non-Hodgkin lymphoma will die from the disease in 2017.

Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.

Aliqopa received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Aliqopa’s clinical benefit and the sponsor is currently conducting these studies.

Today’s approval of Aliqopa was based on data from a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 59 percent of patients had a complete or partial response for a median 12.2 months.

Common side effects of Aliqopa include high blood sugar levels (hyperglycemia), diarrhea, decreased general strength and energy, high blood pressure (hypertension), low levels of certain white blood cells (leukopenia, neutropenia), nausea, lower respiratory tract infections, and low levels of blood platelets (thrombocytopenia).

Serious side effects include infections, high blood sugar levels (hyperglycemia), high blood pressure (hypertension), inflammation of the lung tissue (non-infectious pneumonitis), low levels of certain white blood cells (neutropenia), and severe skin reactions. Women who are pregnant or breastfeeding should not take Aliqopa because it may cause harm to a developing fetus or newborn baby.

Aliqopa was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

Aliqopa also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
PRESS RELEASE ISSUED 9/ 14/ 17 (link source)

This is the first time that two category 4 storms have hit the U.S. back-to-back, and the effects have been devastating. At FDA we have a large team working on providing assistance to those affected by these storms, including American farmers who have suffered crop losses. You’ll be hearing a lot from us in the coming weeks, as we do our part to help people continue to recover from these tragic events. Today, we’re providing more information for farmers and food producers who’ve been impacted by these storms, and in particular, the proper handling of crops that have been exposed to floodwaters.
The FDA has longstanding experience responding to flooding and storms. We play an integral role, working with states, in protecting the safety of the food supply – both human and animal food. We recognize that these hurricanes have presented unique challenges for farmers, and the FDA is committed to work with growers, as well as with our federal and state partners, to ensure that the food we serve our families is safe and that consumers have confidence in the products they consume.

We’ve been in close discussion with farmers, consumer representatives, and state officials regarding concerns about how crops may be impacted by these storms. One crop for which there have been a high number of inquiries is rice. This owes, in particular, to the impact of Hurricane Harvey on the large rice crop in Texas. I want to make it clear that the FDA has not issued a ban on rice or any other food crops. Rice grown in normal conditions and rice that has not been exposed to contaminated floodwaters from the recent hurricanes may enter commerce. Also, rice and other crops that were harvested and stored safely before storms hit should not be considered impacted by these events. The documents we’re issuing today, as well as the direct consultations we’re continuing to have with state officials and with farmers directly, are aimed at providing our most up-to-date, science-based information on which crops can enter commerce without creating risks to consumers or animals who may be fed crops as part of animal feed.

However, I recognize that crops have been and will continue to be impacted in a variety of ways by these storms. There have been substantial crop losses from both storms. Crops may be submerged in flood water, exposed to contaminants, or susceptible to mold. Some of the major concerns for crop safety are heavy metals, chemical, bacterial, and mold contamination. In many cases, it is challenging to determine what contaminants are in crops that were submerged by floodwaters. Both human and animal food must meet well-established safety requirements. FDA has experts that are working closely with state regulators and directly with producers to address questions and concerns.

The FDA takes seriously our obligation to provide guidance to support farmers and food producers, who are responsible for the safety of their products. Many of these resources are already available on FDA’s website. Others will be revised in the coming days and issued directly by the agency, as part of our ongoing effort to provide more timely advice for our stakeholders.

My staff and I are continuing to work with USDA, state partners, extension services and other stakeholders to help producers as they work to evaluate the safety of their crops. We recognize that in many cases, it is those on the ground who can best advise farmers and help producers evaluate specific concerns and conditions. We have experts in the affected regions who can help provide direct assistance and we are taking additional steps to support recovery efforts. We also understand that state Departments of Agriculture may have specific requirements regarding any attempt to clean, process, test, use or sell crops for human or animal food.

I recently had the opportunity to tour farms and packing facilities in Georgia. That trip reminded me of how farms are different than the other entities we regulate. Farms are not just a place of business. Many are homes. Most farms have been in families for generations. As a result, the impact of floods on farms and farmers is especially concerning to me. It has hit many farmers hard, destroying their homes and their livelihoods. We are leaning forward in our efforts to make sure that we’re providing timely assistance, and that our advice on crop safety reflects our most up-to-date, science based analysis. Our primary mission is the protection and promotion of the public health. We’re committed to making sure food is safe for consumers. But we recognize there are hard questions that must be quickly answered about crops affected by these storms, or else crops that might be safe -- because they were not exposed to contaminated floodwaters -- could age past their point of use. We recognize the tremendous impact this storm had on region’s farming families. We’re working diligently to provide them with timely guidance. My staff and I are committed to doing our part to help farmers get back to work.

More detailed information on the impacts of flooding on human and animal crop uses can be found here:

General information on evaluating the safety of food and animal food crops exposed to flood waters
Q & A on crops harvested from flooded fields intended for animal food


FDA approves first biosimilar for the treatment of cancer
PRESS RELEASE ISSUED 9/ 14/ 17 (link source)

The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, M.D. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”

Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Specifically, the approved indications include:

Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
Metastatic renal cell carcinoma, in combination with interferon alfa.
Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA's approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Mvasi include nose bleeds (epistaxis), headache, high blood pressure (hypertension), inflammation of the nasal cavity (rhinitis), high levels of protein in the urine (proteinuria), taste alteration, dry skin, rectal bleeding (hemorrhage), excessive tear production (lacrimation disorder), back pain and skin irritation (exfoliative dermatitis).

Serious expected side effects of Mvasi include holes in or abnormal connection between two organs (perforation or fistula), blood clot formation (arterial and venous thromboembolic events), hypertension, problems in brain function or structure (posterior reversible encephalopathy syndrome), high levels of protein in the urine (proteinuria), infusion-related reactions and loss of function of the ovaries (ovarian failure). Patients should stop using Mvasi if these side effects become severe or life-threatening. Women who are pregnant should not take Mvasi because it may cause harm to a developing fetus.

Like Avastin, the labeling for Mvasi contains a Boxed Warning to alert health care professionals and patients about an increased risk of holes in the stomach and intestines (gastrointestinal perforations); surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding (hemorrhage). Patients should stop using Mvasi if gastrointestinal perforation occurs. Patients should not take Mvasi in the 28 days prior to and after elective surgery, and until the surgical wound is fully healed. Patients should stop using Mvasi if a surgical incision breaks open (wound dehiscence). Mvasi should not be given to patients with severe hemorrhage or in patients who cough up blood (hemoptysis).

The FDA granted approval of Mvasi to Amgen, Inc. Avastin was approved in February 2004 and is manufactured by Genentech, Inc.

WORLD & NATIONAL NEWS BRIEFS

CNN: As UN meets, some ask, 'Where's Rex?'
When Trump administration officials arrive next week at the United Nations General Assembly --- the high-powered conclave for global leaders to grip, grin and get things done -- the world will be watching very closely.

REU: Iran leader Khamenei warns against U.S. 'wrong move' on nuclear deal
Iran would react strongly to any "wrong move" by the United States on Tehran's nuclear deal, Supreme Leader Ayatollah Ali Khamenei said, after President Donald Trump accused Iran of violating the "spirit" of the agreement.

WP: How a convicted pedophile brought down Iceland’s government
In 2004, Hjalti Sigurjon Hauksson was imprisoned for raping his stepdaughter nearly every day for 12 years, starting when she was just 5. Thirteen years later, his crime has helped bring down Iceland's government.

NATIONAL

NEWSWEEK: Wife of American Held By Iran Says U.S. Should Do More
When Xiyue Wang sleeps in his cell in Iran's Evin Prison, he sometimes dreams he is back at Princeton University, working in the school's main library on his dissertation comparing governance systems in Central Asia.

NBC NEWS: DACA Immigrants Who Have Health Coverage Worry About Its Fate
BOSTON, Mass. — Young immigrants with DACA status who have been able to get health insurance are worried about what happens next if the program is indeed eliminated, as the Trump administration announced. For those with serious or chronic conditions, the prospect of losing coverage is especially alarming.

CBS NEWS: Protesters, counter-protesters converge at Confederate statue rally
Protesters defending Confederate statues surrounded a monument of Confederate Gen. Robert E. Lee in Richmond, Virginia, Saturday, but counter-protesters far outnumbered them, forming a crowd of several hundred people, CBS News' Paula Reid reports. 


NEWS STORY COMMENTARY

From the New York Times: Kim Jong-un of North Korea Vows ‘Equilibrium’ With U.S. Military
SEOUL, South Korea — The leader of North Korea said his country was nearing its goal of military “equilibrium” with the United States, which he said would deter talk about a “military option” to resolve the current standoff, according to remarks carried by the North’s official news agency on Saturday.

Editorial Comment: Sounds like many of these media outlets are trying to play psychoanalysis on the behalf of a crazed dictator bent on starting a war no one wants. He uses his toy rocket to commit international blackmail. That isn't something to right heartfelt sympathic stories about a man to starves his own people for the sake of his lust of nukes. This kind of journalism isn't new papers often side with the outlaw in order to make a thug into a iconic hero, prime example news articles back in the 1870's about Jesse James, and later with Billy the Kid. All one needs to look back on what the media painted killers and criminals into some sick twisted hero, in order to make a quick buck!



THIS WEEK'S BIBLE STUDY
From Gospel Way: Denominational Division or Unity in Christ?
Is Jesus pleased by the existence of so many different denominations? Is it true, as we often hear, that all the denominations are following Jesus, so just "join the church of your choice"?
If all the churches are following Jesus, why are they going in different directions? Is Jesus leading them in different directions? And why do denominations so often contradict one another? Is Jesus teaching them contradictory things? What kind of teacher would He be if He did that? If a preacher knowingly teaches contradictory things, we call him a hypocrite! Is Jesus a hypocrite?
https://www.gospelway.com/topics/church/denominations-unity.php