Sunday, August 6, 2017

US ATTORNEY GENERAL SESSIONS SCOLDS WASH. STATE ON POT

 HEALTH WATCH

AG FERGUSON STATEMENT ON SESSIONS LETTER
PRESS RELEASE ISSUED 8/ 4/ 17

OLYMPIA — In response to a letter from U.S. Attorney General Jeff Sessions regarding Washington's marijuana regulations, Attorney General Bob Ferguson offered the following statement:

“I was disappointed by Attorney General Sessions’ letter, which relies on incomplete, inaccurate and out-of-date information on the status of Washington’s marijuana regulations. I'm also disappointed that he has yet to accept my repeated invitations to meet in person to discuss this critical issue face to face. If he does accept, I look forward to providing him with a more complete picture of the robust regulatory program that exists in our state.

“Any action from the Department of Justice short of allowing our well-regulated, voter-approved system to continue is unacceptable. I will continue to defend the will of Washington voters.”
Following is the text of the letter from the US Attorney General

Dear Governor Inslee and Attorney General Ferguson:
Thank you for your letters of February 15, 2017, April 3, 2017, and May 8, 2017, which I have attached to this letter as Exhibits A, B, and C for your convenience. I was pleased to read that you share my concern for public health and safety and my belief that the federal and state governments should work together to address our country's concerns with marijuana.
Congress has determined that marijuana is a dangerous drug and that the illegal distribution and sale of marijuana is a crime. The Department remains committed to enforcing the Controlled
Substances Act in a manner that efficiently applies our resources to address the most significant threats to public health and safety. I look forward to working with you on these issues.
I also read with interest the statement in your letter that you "have worked ... to establish robust regulatory structures that prioritize public health and public safety," and that you believe
that the 2013 Cole Memorandum, its eight enforcement priorities, and related memoranda are an "indispensable" part of the "framework" in your state. In that regard, I would note the
concluding paragraph: "nothing herein [in the Cole Memorandum] precludes investigation or prosecution, even in the absence of any one of the factors listed above, in particular circumstances where investigation and prosecution otherwise serves an important federal interest." Thus, the memorandum "does not alter in any way the Department's authority to enforce federal law, including federal laws relating to marijuana, regardless of state law."
I also recently read the 2016 report by the Northwest High Intensity Drug Trafficking Area (HIDTA), entitled "Washington State Marijuana Impact Report." (.A copy of this report is
attached as Exhibit D.) This report raises serious questions about the efficacy of marijuana
"regulatory structures" in your state, including findings that:
• "[T]he medical market [for marijuana] is considered `grey' due to the lack of regulation and oversight" and, furthermore, aspects of Washington's regulatory structure for the "medical market" have "unintentionally led to the growth of black market enterprises";
• The "recreationally licensed" marijuana market also is incompletely regulated: the leading regulatory violation in that market has been the "failure to utilize and/or maintain traceability" of marijuana products;
• "Since legalization in 2012, Washington State marijuana has been found to have been destined for 43 different states";
• 90% of public safety violations of the state's marijuana "regulatory structures" for
"recreational licensees" involved minors, according to data from the first year of
Washington's "recreational marijuana" laws. Violations include, for example, sales to minors and employment of minors;
• "One in five l O'hgrade students reported riding with a driver who had used marijuana — 9% reported driving within three hours of consumption," according to the most recent data in the report;
• "49% of young adult drivers who used marijuana in the past month had driven a car within three hours after using marijuana" and 64% of marijuana DUIs in Spokane Valley
involved youth, according to data from the first year of Washington's "recreational marijuana" laws;
• "61.9% of drivers do not believe marijuana makes a difference in their driving ability" and "[d]rivers with active THC in their blood involved in a fatal driving accident have increased 133.2% from 2010 (16) to 2014 (23)";
• In 2014 alone, 17 THC extraction labs exploded; and
• There was a 54% increase in the number of marijuana calls to the State Poison Center from 2012-2014.
These findings are relevant to the policy debate concerning marijuana legalization. I appreciate your offer to engage in a continuing dialogue on this important issue. To that end,
please advise as to how Washington plans to address the findings in the Northwest HIDTA report, including efforts to ensure that all marijuana activity is compliant with state marijuana
laws, to combat diversion of marijuana, to protect public health and safety, and to prevent marijuana use by minors. I also am open to suggestions on marijuana policy and related matters
as we work to carry out our duties to effectively and faithfully execute the laws of the United States. You may direct your response and suggestions to the Intergovernmental Affairs and
Public Liaison within the Office of Legislative Affairs, which can help coordinate any communications logistics. I look forward to your response.

Drug related story from the DOJ: Attorney General Sessions Announces Opioid Fraud and Abuse Detection Unit
PRESS RELEASE ISSUED 8/ 2/ 17

Attorney General Jeff Sessions today announced the formation of the Opioid Fraud and Abuse Detection Unit, a new Department of Justice pilot program to utilize data to help combat the devastating opioid crisis that is ravaging families and communities across America.

Speaking at the Columbus Police Academy today, Attorney General Sessions said that the new Opioid Fraud and Abuse Detection Unit will focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to this prescription opioid epidemic.

Additionally, as part of the program, the Department will fund twelve experienced Assistant United States Attorneys for a three year term to focus solely on investigating and prosecuting health care fraud related to prescription opioids, including pill mill schemes and pharmacies that unlawfully divert or dispense prescription opioids for illegitimate purposes.

The following districts have been selected to participate in the program:

Middle District of Florida,
Eastern District of Michigan,
Northern District of Alabama,
Eastern District of Tennessee,
District of Nevada,
Eastern District of Kentucky,
District of Maryland,
Western District of Pennsylvania,
Southern District of Ohio,
Eastern District of California,
Middle District of North Carolina, and
Southern District of West Virginia.
In his speech, the Attorney General discussed the new program:

“First, I am announcing a new data analytics program – the Opioid Fraud and Abuse Detection Unit. I have created this unit to focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to this opioid epidemic. This sort of data analytics team can tell us important information about prescription opioids—like which physicians are writing opioid prescriptions at a rate that far exceeds their peers; how many of a doctor's patients died within 60 days of an opioid prescription; the average age of the patients receiving these prescriptions; pharmacies that are dispensing disproportionately large amounts of opioids; and regional hot spots for opioid issues.

“With this data in hand, I am also assigning 12 experienced prosecutors to focus solely on investigating and prosecuting opioid-related health care fraud cases in a dozen locations around the country where we know enforcement will make a difference in turning the tide on this epidemic. These prosecutors, working with FBI, DEA, HHS, as well as our state and local partners, will help us target and prosecute these doctors, pharmacies, and medical providers who are furthering this epidemic to line their pockets. These prosecutors will be based in several states across the country, including Kentucky, West Virginia, Tennessee, and right here in Southern Ohio.

“With these new resources, we will be better positioned to identify, prosecute, and convict some of the individuals contributing to these tens of thousands of deaths a year. The Department is determined to attack this opioid epidemic, and I believe these resources will make a difference.”


OTHER HEALTH RELATED NEWS

UN HEALTH NEWS:
Head of UN drug body urges greater access to treatment for women
Posted 8/ 1/ 17

1 August 2017 – Women continue to be disproportionately affected by drug use, and face obstacles in accessing treatment, compared to men, according to the President of the United Nations International Narcotics Control Board (INCB).

Viroj Sumyai, who presented the Board's Annual Report on 6 July to the UN Economic and Social Council (ECOSOC), urged Member States to integrate gender perspectives in the elaboration of their drug policies to address this discrepancy.
According to the report, drug-related harms to women and the resulting consequences for communities are often “sorely under-studied,” and gender-disaggregated data on drug use are rarely collected.
“There are also inadequate budget allocations by Member States for the specific prevention and treatment of drug dependence and substance use disorders among women, who often do not have access to any assistance and suffer in silence,” the report pointed out.
In this context and to learn more about the work of the INCB, as well as the challenges before the international drug control regime, UN News spoke to Mr. Sumyai, a national of Thailand, during his recent visit to UN Headquarters.

Health on the National level

CDC invests more than $200 million to help states respond to infectious disease threats
PRESS RELEASE ISSUED 8/ 4/ 17

The Centers for Disease Control and Prevention (CDC) has awarded more than $200 million through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement to help states, cities, counties, and territories prevent, detect, respond to, and control the growing threats posed by emerging and re-emerging infectious diseases. State programs are the foundation of the U.S. public health system and are integral to the nation’s efforts to combat infectious disease threats. CDC and states work together to improve local surveillance, laboratory diagnostic capabilities, and outbreak response. The Centers for Disease Control and Prevention (CDC) has awarded more than $200 million through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement to help states, cities, counties, and territories prevent, detect, respond to, and control the growing threats posed by emerging and re-emerging infectious diseases. State programs are the foundation of the U.S. public health system and are integral to the nation’s efforts to combat infectious disease threats. CDC and states work together to improve local surveillance, laboratory diagnostic capabilities, and outbreak response.

The CDC funds include $77 million to help state health departments fight local antibiotic resistance threats. CDC is investing in every state to combat antibiotic-resistant foodborne infections and infections in healthcare facilities and communities.

“More than 23,000 people in the United States die each year from infections caused by antibiotic resistance,” said CDC Director Brenda Fitzgerald, M.D. “CDC is committed to helping states and cities strengthen their ability to combat antibiotic resistance, and these funds will help state efforts to keep people safe.”

In addition, CDC is enhancing the Antibiotic Resistance Laboratory Network (AR Lab Network) to sound the alarm when known and emerging antibiotic resistance threats are detected. Data generated by the AR Lab Network can help improve infection control in healthcare facilities and enable more rapid and effective responses to outbreaks.

New activities to combat antibiotic resistance in the U.S.
The 2017 funding enhances current AR Lab Network activities by:

Increasing testing nationwide for the fungal threat Candida, including emerging drug-resistant Candida auris fungi. The AR Lab Network Regional Labs are ramping up techniques nationwide to more rapidly identify and understand this new threat to stop further spread. C. auris can cause invasive and often deadly infections that are resistant to multiple antifungal drugs. Without action, it may spread further in the U.S.
Strengthening national tuberculosis (TB) surveillance and infrastructure by adding a new national laboratory. The National TB Molecular Surveillance Center is equipped to perform DNA sequencing of Mycobacterium tuberculosis gathered from newly diagnosed patients in the United States. This technology – whole genome sequencing, or WGS – can help target public health interventions and identify new antibiotic-resistant TB strains as they emerge. TB is the world’s leading infectious disease killer, with an estimated 1.8 million deaths each year. Drug-resistant TB makes it even more difficult to treat and control TB in the United States.
Enhancing detection of drug-resistant gonorrhea threats using WGS. Enhanced gonorrhea surveillance will identify when and how drug-resistant strains emerge and spread. This information could lead to more rapid outbreak response, and help stop antibiotic-resistant gonorrhea from spreading further into the community. It will also help clinicians make more accurate treatment decisions for their patients. About 820,000 new gonorrhea infections occur each year in the U.S. More than a quarter of reported cases are resistant to at least one antibiotic.
The $77 million to combat antibiotic resistance will also be used to build on the successes of PulseNet, the national laboratory network that connects foodborne illness cases to detect outbreaks. Every state public health lab will work toward performing WGS on food and waterborne bacteria, including Salmonella, Shigella and Campylobacter.

All 50 states, six large cities and Puerto Rico will also continue to test for carbapenem-resistant Enterobacteriaceae (CRE)—the deadly germ resistant to nearly all antibiotics.

ELC funding also includes support for other infectious disease control activities
In addition to combatting antibiotic resistance, the ELC also provides resources for other infectious disease control activities, including supporting states’ continued vigilance against Zika, which can cause microcephaly and other serious birth defects. In fiscal year 2017, CDC provided more than $300 million to state, local, and territorial health departments through the ELC program. Of these awards, $100.8 million were provided earlier in the fiscal year as part of a supplemental, one-time investment to fight Zika.

The remaining 2017 funding, a total of $124 million, goes to more than 40 projects, including:

Enhance influenza surveillance and diagnostic testing, parasitic diseases, tickborne diseases, West Nile virus and other mosquito-borne diseases, foodborne diseases, waterborne disease detection
Establish and maintain local, state, and territorial health coordinators to track vaccine-preventable diseases like measles and pertussis.
Help states build their capacity for Advanced Molecular Detection, an emerging field that combines next-generation genomic sequencing with bioinformatics to more quickly identify and respond to disease outbreaks
Protect the public health and safety of the American people by strengthening cross-cutting national surveillance, boosting laboratory infrastructure with the latest diagnostic technologies, and enhancing health information systems to efficiently transmit, receive, and analyze infectious disease-related data electronically.
Support states’ continued vigilance against Zika virus outbreaks and associated adverse health outcomes, including microcephaly and other serious birth defects.
The ELC program distributes resources to all 50 state health departments, six local health departments (Chicago, the District of Columbia, Houston, Los Angeles County, New York City, and Philadelphia), and eight territories or U.S. affiliates, including U.S. Virgin Islands, Puerto Rico and Guam.

For more information on the ELC Cooperative Agreement and a breakdown of state-specific funding: https://www.cdc.gov/elc.

For more information on CDC’s Antibiotic Resistance Solutions Initiative: https://www.cdc.gov/drugresistance/index.html.


FDA: Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions
PRESS RELEASE ISSUED 8/ 4/ 17

U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown.
The consent decree prohibits Isomeric, its owners and chief operating officer from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements.

According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. The complaint also alleges that Isomeric manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.

“Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We will continue taking strong enforcement actions against compounders who violate the Drug Quality and Security Act and put patients at risk by failing to produce sterile drugs in compliance with the law.”

The FDA most recently inspected Isomeric from Feb. 22 to March 24, 2017. Following the FDA inspection, because of a lack of sterility assurance for its purportedly sterile drug products, Isomeric agreed to a voluntary nationwide recall of all lots of unexpired drug products produced for sterile use and distributed to patients, providers, hospitals, or clinics nationwide between Oct. 4, 2016 and Feb. 7, 2017.

Previously, the FDA inspected Isomeric in August 2015 and observed similar poor conditions and practices for sterile drug production. Despite assurances that Isomeric was correcting its violations, a follow-up inspection in June 2016 revealed that the company had not implemented adequate corrective actions. Following this inspection, the FDA issued a warning letter to Isomeric.

Isomeric initially registered as an outsourcing facility in July 2015, re-registered in December 2015 and January 2017.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.



FDA approves Mavyret for Hepatitis C
PRESS RELEASE ISSUED 8/ 3/ 17

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, an estimated 2.7 to 3.9 million people in the United States have chronic HCV. Some patients who suffer from chronic HCV infection over many years may have jaundice (yellowish eyes or skin) and complications, such as bleeding, fluid accumulation in the abdomen, infections, liver cancer and death.

There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the strain of the virus can help inform treatment recommendations. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small number of patients are infected with genotypes 4, 5 or 6.

The safety and efficacy of Mavyret were evaluated during clinical trials enrolling approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 92-100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.

Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status.

The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.

Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.

Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.

The FDA granted this application Priority Review and Breakthrough Therapy designations.
The FDA granted approval of Mavyret to AbbVie Inc.




FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia
PRESS RELEASE ISSUED 8/ 3/ 17

The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.

“This is the first approved treatment specifically for patients with certain types of high-risk AML,” 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. “Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately.”

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 at the National Institutes of Health estimates that approximately 21,380 people will be diagnosed with AML this year; approximately 10,590 patients with AML will die of the disease in 2017. T-AML occurs as a complication of chemotherapy or radiation in approximately 8 to10 percent of all patients treated for cancer within an average of five years after treatment. AML-MRC is characterized by a history of certain blood disorders and other significant mutations within cancer cells. Patients with t-AML or AML-MRC have very low life expectancies.

The safety and efficacy of Vyxeos were studied in 309 patients with newly diagnosed t-AML or AML-MRC who were randomized to receive Vyxeos or separately administered treatments of daunorubicin and cytarabine. The trial measured how long patients lived from the date they started the trial (overall survival). Patients who received Vyxeos lived longer than patients who received separate treatments of daunorubicin and cytarabine (median overall survival 9.56 months vs. 5.95 months).

Common side effects of Vyxeos include bleeding events (hemorrhage), fever with low white blood cell count (febrile neutropenia), rash, swelling of the tissues (edema), nausea, inflammation of the mucous membranes (mucositis), diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, shortness of breath (dyspnea), headache, cough, decreased appetite, abnormal heart rhythm (arrhythmia), lung infection (pneumonia), blood infection (bacteremia), chills, sleep disorders and vomiting.

Patients who have a history of serious hypersensitivity to daunorubicin, cytarabine or any component of the formulation should not use Vyxeos. Patients taking Vyxeos should be monitored for hypersensitivity reactions and decreased cardiac function. Vyxeos has been associated with serious or fatal bleeding events. Daunorubicin has been associated with severe damage (necrosis) where the drug leaks into the skin and subcutaneous tissue from the intravenous infusion (extravasation). Women who are pregnant or breastfeeding should not take Vyxeos, because it may cause harm to a developing fetus or a newborn baby.

The prescribing information for Vyxeos includes a boxed warning not to interchange Vyxeos with other daunorubicin- and/or cytarabine-containing products.

The FDA granted this application Priority Review and Breakthrough Therapy designations. Vyxeos 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 Vyxeos to Jazz Pharmaceuticals.


HHS: HHS Secretary Statement on FDA Reauthorization Act of 2017
PRESS RELEASE ISSUED 8/ 3/ 17

Health and Human Services Secretary Tom Price, M.D. issued the following statement on the FDA Reauthorization Act of 2017:

“Congress is to be commended for passing the FDA Reauthorization Act of 2017. This bill is a vital first step to accomplishing our goal of expanding access to affordable, life-saving drugs and medical devices in a thoughtful manner that protects taxpayer resources, promotes competition, improves healthcare outcomes, and stimulates scientific innovation and medical advances. We welcome this progress.  To accomplish this goal more fully for the American people, more work remains to be done. Together with FDA Commissioner, Dr. Scott Gottlieb, we will continue to work with Congress to ensure that FDA remains the gold standard in advancing medical breakthroughs that will improve the health and well-being of the American people.”


HHS Secretary Price Statement on Lower Drug Costs for Seniors
PRESS RELEASE ISSUED 8/ 2/ 17
Health and Human Services Secretary Tom Price, M.D., released the following statement after the Centers for Medicare & Medicaid Services announced that Medicare Part D premiums are projected to decline for our nation’s seniors in 2018:
“For the first time in five years, the average premium for a Medicare Part D prescription drug plan is projected to decline in 2018. This is encouraging news for the nearly 43 million seniors who are enrolled in the program. Lowering drug costs is a key principle of President Trump’s efforts to address the challenges in our healthcare system, and HHS is committed to doing all we can to increase the affordability and accessibility of care.
“Reflecting President Trump’s commitment to this issue, HHS has begun a broad effort to make drugs more affordable – particularly for America’s seniors. This announcement by CMS comes on the heels of a proposal released last month that would allow seniors to share in the discounted drug prices hospitals are already getting under Medicare.”

HHS Awards $3.2 Million for a Registry of Residents Affected by Lead Exposure in Flint, Michigan
PRESS RELEASE ISSUED 8/ 1/ 17

The U.S. Department of Health and Human Services announced today that Michigan State University (MSU) will receive approximately $3.2 million to establish a registry of Flint residents who were exposed to lead-contaminated water from the Flint Water System during 2014-2015. The funds are the first installment of a 4-year, $14.4 million grant.

MSU will use the funds in partnership with the City of Flint leadership and other community organizations, clinical partners and educators, and stakeholders that serve Flint residents. They will address community health concerns related to lead exposures, monitor health outcomes among registrants, and expand efforts to reduce and eliminate lead in the community.

“This funding is a continuation of the Trump Administration’s commitment to support the affected or at-risk residents of Flint, Michigan, who have been exposed to lead-contaminated drinking water,” said Health and Human Services Secretary Tom Price, M.D. “Flint residents will benefit from having their health monitored over time and from being readily connected to services that will help reduce the health effects of lead exposure. Information collected by the registry will guide important health decisions and recommendations for the City of Flint and the State of Michigan for years to come.”

Lead exposures are a well-known hazard for adults. In children, lead exposure can result in serious effects on IQ, ability to pay attention, and academic achievement. The Flint registry will link registrants’ data on exposure, health, and key childhood developmental milestones with their participation in services through a voluntary referral network.

“CDC is committed to supporting the Flint Lead Exposure Registry as part of our ongoing efforts across the country to reduce and prevent exposure to lead,” said Brenda Fitzgerald, M.D., CDC director and administrator of the Agency for Toxic Substances and Disease Registry. “Using our experience with the Childhood Lead Poisoning Prevention program, we will work hard to make sure that the Registry meets the needs of Flint residents affected by this crisis.”
Tracking both children and adults will be extremely valuable in providing important health impacts from exposure and the impact of community services on recovery. This joint effort will evaluate the effectiveness of available health, educational, environmental, and community services on improving the health of participants.
“The registry will be a powerful tool to understand, measure, and improve the lives of those exposed to the contaminated water,” said Mona Hanna-Attisha, M.D., M.P.H., director of the MSU-Hurley Children’s Hospital Pediatric Public Health Initiative, who will lead the registry effort. “The more people who participate in the registry, the more powerful this tool will be for Flint and for communities everywhere that continue to suffer from preventable lead exposure.”
In January 2017, the Michigan Department of Environmental Quality stated that the lead levels in city water tested below federal limits, but recommends that residents use filtered or bottled water for drinking or cooking while pipe replacements continue.

GLOBAL POVERTY
UN NEWS CENTER: UN, Government join forces to boost Somalia's drought response capacity
4 August 2017 – In the wake of a severe drought in Somalia that has displaced more than 800,000 people, the United Nations migration and development entities are helping the Horn of Africa country enhance its national drought response capacity.








WORLD & NATIONAL BRIEFS

UN NEWS CENTER: UN notified of US intention to withdraw from Paris climate pact
Posted on 8/ 4/ 17 (source link)
4 August 2017 – United Nations Secretary-General António Guterres today received a notification from the delegation of the United States expressing the country's intention to withdraw from the Paris Agreement on climate change as soon as it is eligible to do so, his spokesman has confirmed.

The notification came two months after President Donald Trump announced his intention to leave the accord.
“As the Secretary-General said in a statement on 1 June 2017, the decision by the United States to withdraw from the Paris Agreement is a major disappointment for global efforts to reduce greenhouse gas emissions and promote global security,” said UN Spokesman Stéphane Dujarric in a note sent tonight to correspondents.
Under article 28 of the Paris Agreement, a Party may withdraw at any time after three years from the date on which the Agreement has entered into force for that Party, and such withdrawal takes effect upon expiry of one year from the date of receipt by the Depositary of the notification of withdrawal. The United States accepted the Paris Agreement on 3 September 2016 and the Agreement entered into force for the United States on 4 November 2016.This means that the US must stay in the pact until at least 2019.
The communication says the US intends to exercise its right to withdraw, unless it identifies suitable terms for re engagement.

The Secretary General welcomes any effort to reengage in the Paris Agreement by the United States, Mr. Dujarric said.
“It is crucial that the United States remains a leader on climate and sustainable development. Climate change is impacting now. He looks forward to engaging with the American government and all other actors in the United States and around the world to build the sustainable future for our children and future generations,” he added.
The Spokesman said that the Secretary-General is the depositary of the Agreement, and will circulate the text of this communication as a notification, in English and French, early next week.

US STATE DEPT: Communication Regarding Intent To Withdraw From Paris Agreement
PRESS RELEASE ISSUED 8/ 4/ 17 (link Source)

Today, the United States submitted a communication to the United Nations, in its capacity as depositary for the Paris Agreement, regarding the U.S. intent to withdraw from the Paris Agreement as soon as it is eligible to do so, consistent with the terms of the Agreement. As the President indicated in his June 1 announcement and subsequently, he is open to re-engaging in the Paris Agreement if the United States can identify terms that are more favorable to it, its businesses, its workers, its people, and its taxpayers.

The United States supports a balanced approach to climate policy that lowers emissions while promoting economic growth and ensuring energy security. We will continue to reduce our greenhouse gas emissions through innovation and technology breakthroughs, and work with other countries to help them access and use fossil fuels more cleanly and efficiently and deploy renewable and other clean energy sources, given the importance of energy access and security in many nationally determined contributions.

The United States will continue to participate in international climate change negotiations and meetings, including the 23rd Conference of the Parties (COP-23) of the UN Framework Convention on Climate Change, to protect U.S. interests and ensure all future policy options remain open to the administration. Such participation will include ongoing negotiations related to guidance for implementing the Paris Agreement.

UN NEWS CENTER: UN Security Council toughens sanctions on DPR Korea over ballistic missile launches
5 August 2017 – In response to the launches of ballistic missiles of possible intercontinental range by the Democratic People's Republic of Korea (DPRK), the United Nations Security Council today moved to strengthen sanctions on the Northeast Asian country's exports.

NATIONAL

WP: She’s an American. Her parents are undocumented. Together, they’re speaking out on behalf of immigrants.
Heather Piña and her parents have been anxious since Donald Trump became president. Unlike most immigrants in the United States illegally, they remain defiant about their rights and and hopeful for the future. “We as children have lots of power, and we have to support and protect our parents,” Heather says.

WP: Trump promised the GOP would tire of winning. Instead the party thinks it’s losing.
With full control of the capital, barely more Republicans think they are winning vs. Democrats who said the same when they had only the president and four-plus years of Washington gridlock.



NEWS REPORT COMMENTARY

Local primary results, under a blanket of a smoked filled air.
By, Peter Ripley

Surprising election results were under a wildfire blanket of smoke this week. If you blinked because of the smoke irritation in your eyes because of the smoke, you might have missed newspaper reports over some surprising primary election results.
Lets take a look at some news stories about wildfires, and the election results first off:
Peninsula Daily News article: Smoke from British Columbia wildfires that is blanketing the North Olympic Peninsula is expected to stick around a bit longer, according to the National Weather Service.

SEATTLE TIMES: Is the air as unhealthy as it looks?
One study predicts a 35 percent spike in hospital asthma admissions in this state due to this week’s wildfire smoke. So far, nothing close to that has been reported. We seem to be coping OK with the unhealthy air and unsightly skies.

LOCAL PRIMARY COVERAGE
Peninsula Daily News: Incumbent concedes election; Whetham says ‘voters have spoken’
http://www.peninsuladailynews.com/politics/incumbent-concedes-election-whetham-says-voters-have-spoken/
One-term Position 2 Councilman Lee Whetham, with 804 votes and 26.25 percent of the total cast after the tally, said the gap was too great to overtake Mike French (1,207 votes, 39.41 percent) and Jacob Oppelt (1,052 votes, 34.35 percent)
Editorial Comment: What was surprising about the election is that Whetham lost his re-election bid. Thought for sure he'd win, because he seemed more sure about his stand on Fluoridation, which is a hot boiler issue. I do have to question how much are the ties to Port Angeles these new guys have here? Are they looking out for the community, or more concern getting their names up in lights? So, looks like Oppelt managed to survive those news stories about committing traffic violations years ago after all. The voters seemed to over look those. So much for those smear campaign news stories from both the Port O Call, and PDN huh!? And, talk about other smear campaigns why wasn't there any follow up from the local media outlets on stories about Port Commissioner Candidat Cobb (resident story), or City Council Candidate Artur Wojnowsk with his face book postings. Could it be those stories were a result of drive by journalism?
Then low and behold this headline in the PDN today, just before I was to publish this commentary: Port hopeful says  he  lied  about address to protect partner---PDN

Apparently readers someone from the local media establishment must have been reading my mind about doing follow up stories!


THIS WEEK'S BIBLE LESSON
GOSPEL WAY:  Bible Principles about Marriage and Sexual Relationships
Our society has become increasingly confused about the meaning of marriage. This confusion reflects itself in rampant violation of principles of sexual purity, which principles are based on the meaning of true marriage. In fact, it appears that efforts to confuse the meaning of marriage are often motivated by a desire to lower the standard of sexual conduct.
In order to emphasize the divine standard for marriage, let us summarize some basic teachings regarding marriage and the principles of sexual conduct that are based on marriage. But it must be emphasized that these teachings are revealed by the Creator and Ruler of the universe. All people are required to obey them and will be judged by them.
https://www.gospelway.com/topics/family/marriage-definition.php

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