[TRANSCRIPT] Sens. Coons, Hassan reinforce importance of U.S.-Japan alliance in Tokyo

by: Senator Christopher A .Coons (D-DE)

Washington, D.C. - April 23, 2019 - (The Ponder News) -- U.S. Senators Chris Coons (D-Del.) and Maggie Hassan (D-N.H.) held a press availability in Tokyo, where they met with senior officials this week to reinforce the U.S.-Japan alliance and discuss ways to advance our shared interests and values.

The Senators met with U.S. Ambassador to Japan Bill Hagerty and members of the Diet, Japan’s parliament, to discuss ways to strengthen and deepen the partnership between the U.S. and Japan. They were briefed by Lieutenant General Kevin Schneider, Commander, U.S. Forces Japan, about the role of U.S. troops in Japan and U.S. military strategy in the Indo-Pacific. They also met with senior Japanese government officials including National Security Advisor Shotaro Yachi, Defense Minister Takeshi Iwaya, Foreign Minister Taro Kono, and Minister of Finance Taro Aso. The two Senators also met with senior Japanese business officials from Keidanren, a top Japanese business association.

“I do think that the relationship between the United States and Japan is rooted not just in shared economic and security interests, but is rooted in core shared values. We value a free press, we value elections, which just happened here…We value human rights, we value the rule of law. These are defining characteristics of our political systems, and those are not common values that we share with the People's Republic of China. And so, if Japan is in a bridge relationship, a positive relationship with China, that may well help the United States and China also reach a more positive relationship,” said Senator Coons.

“We have come here not only to learn, but to reinforce that our relationship and alliance with Japan is the bedrock of our alliance in this region -- it is the bedrock of stability in this region, and we just want to make sure that we are poised to partner with Japan as we move forward to continue not only the alliance, but to meet the challenges in this region, always recognizing that as allies, we can be much more effective together,” said Senator Hassan.

Excerpts from the press availability are below:

Senator Coons Opening Remarks: Thank you. Thanks for a chance to join press today. Senator Hassan and I have had a remarkably busy and productive day. Last night, we had dinner with Ambassador Hagerty, four members of the Diet from three different parties. Given that it was an important election day, we were particularly grateful for their attendance. Today we began, in a briefing with General Schneider, who is the Commander for American Forces in Japan, and then a broader conversation about regional security concerns. And we had a series of meetings with National Security Advisor Yachi, with Foreign Minister Kono, with Minister of Finance Aso, and Defense Minister Iwaya. And, across those four conversations with senior administration leaders, we expressed our deep appreciation for the significance of the U.S.-Japan alliance and partnership. Our hopes for a prompt and positive resolution to trade negotiations, our interests in their opinions and views about the regional challenges that we face, and that we address specific issues with each particular industry. We've just come from a meeting with a number of business leaders from Keidanren, and across all of these conversations, we talked about some of the demographic, and budgetary, and innovation challenges that came from both of our countries, and we had an opportunity to express our appreciation for the ways in which our seven-decade long alliance with Japan continues to promote security and prosperity for all Americans.

Senator Hassan Opening Remarks: Thank you all for being here. It has been a very productive trip so far, and we've appreciated the hospitality, but also the time and energy the participants in our meetings have provided to all of us. We have come here not only to learn, but to reinforce that our relationship and alliance with Japan is the bedrock of our alliance in this region -- it is the bedrock of stability in this region, and we just want to make sure that we are poised to partner with Japan as we move forward to continue not only the alliance, but to meet the challenges in this region, always recognizing that as allies, we can be much more effective together. We have talked about everything from the various geopolitical challenges to economic issues like trade and, again, had the great opportunity to reinforce the values that make us the allies that we are, the respect for rule of law, for free speech, for democracy, and the importance of those values to the continuation and strength of this partnership.

Senator Coons on CODEL: We travel from here to South Korea and China, and think it's particularly important that we begin this regional engagement here in Japan, because of the importance of this foundational relationship. So, thank you for your questions.

Senator Coons on North Korea: I think what's important is that there is a consistent message from the United States and Japan, which is that we expect Kim Jong-Un to keep the commitment that he made, both privately and publicly, to full, irreversible, and verifiable denuclearization. And we need to see real progress on defining the terms: What is the process? How will there be an accounting for the nuclear enrichment and weapons manufacturing, and the missile program that is not known with any specificity? And then, what will the progress be towards it? The Hanoi summit was, I think, a great disappointment in that Kim Jong-Un, the DPRK delegation, did not come forward with any new proposals that were significant. They somehow expected the relationship between President Trump and Leader Kim to produce a dramatic result, when it was exactly the same proposal that's been made by previous leaders to North Korea, to a positive effect. So, I think -- I don't mean to speak for you, but I think we supported President Trump's decision to walk away from the negotiating table, and we discussed this in several of our meetings today. I think the United States and Japan are closely aligned on saying that sanctions relief will come only after significant movement, dramatic movement, that moves us toward denuclearization on the peninsula. I will say that I hope to raise this issue both in South Korea and in China, and given the significance of the relationship between DPRK and China, I would welcome seeing more active engagement in terms of the imposition of sanctions on North Korea. I think they will only take significant steps toward denuclearization if they feel they have no alternative.

Senator Coons on North and South Korea: I think the Moon administration has made encouraging positive progress. There have been a number of visits, leader-to-leader visits, between North and South Korea. There have been some positive steps in terms of reducing tension in the DMZ, and beginning to discuss exchange of families and contacts, and so forth. But, speaking for myself, I tend to be much closer to the Japanese view that we should not be making significant concessions, in terms of sanctions, until there have been demonstrable, irreversible steps by North Korea. And if you look over the previous two administrations in North Korea, they have followed exactly this path before -- making grand promises of full denuclearization, and then failing to make any significant steps at all in that direction. I do think, just to be fair, I do think it was a positive step that President Trump, in his Singapore summit with Kim Jong-Un, secured the remains of 55 Americans killed in the Korean War. But there are thousands more unaccounted for. I know that that is important to those families, but there are many other issues, such as accountability for Japanese citizens abducted by North Korea. There are many issues that are sources of enduring tension in the relationship between North Korea and the United States, and North Korea and Japan, North Korea and South Korea. My hope is that with more regular consultation between the three parties -- Japan, South Korea, and the United States -- we can avoid any surprises at the negotiating table. We can have more aligned priorities. But, for myself, I am much closer to the Japanese position which is -- the burden is on North Korea now. They've made encouraging pronouncements, but have taken no significant actions that are irreversible or verifiable.

Senator Coons on China and Japan: I will say that I think it is a good thing for China and Japan to have improved relations. I think having tense relations is not constructive. My impression is that Japan has had to deal with significant incursions into its airspace by Russia, particularly over Habomai, northern territories, related territories. And, in previous years, there were significant potential conflicts in the territorial wars of Japan. And that some of that contact tension with China has reduced, and some of the public posture has become more positive. I think that's a good thing. I do think that the relationship between the United States and Japan is rooted not just in shared economic and security interests, but is rooted in core shared values. We value a free press, we value elections, which just happened here yesterday. We value human rights, we value the rule of law. These are defining characteristics of our political systems, and those are not common values that we share with the People's Republic of China. And so, if Japan is in a bridge relationship, a positive relationship with China, that may well help the United States and China also reach a more positive relationship. one of the big unanswered questions for this century is: In what areas will the United States and China cooperate? Can we find areas of genuine cooperation? In what areas will we compete? And, how can we prepare for, but avoid, conflict? There are many in our country now who are speaking of the inevitability of conflict with China. I do not think conflict with China is inevitable. But, I think we will have to manage our competition in a way that gives room for both countries to be successful, and I think we need to try harder to find areas of cooperation.

Senator Hassan on Japan and China: I agree that improved relationships are a good thing. Again, it is our values that make us the allies we are, Japan and the United States. And, there are, even with improved relationships there are -- obviously, between Japan and China -- there are obviously some concerns and challenges that any democracy would have when it thinks about its relationship with China, and China's influences and actions in the world. So, I think we will continue to be united to stand up for our values when that is necessary to confront and counter China's behavior.

Senator Coons on North Korea: If I understood your question, it's not just "what are the issues we'll bring up in conversations in China," but, what are the issues specific to North Korea?" The United States is grateful that our fellow permanent member of the U.N. Security Council has been implementing sanctions against North Korea. But, we will look for closer cooperation on fully implementing the whole range of sanctions, both U.N. and bilateral sanctions that may be required to provide the incentives for Kim Jong-Un to take the decision to fully and finally verifiably denuclearize. I think our interest areas aligned here. I think China has a great deal to lose if the Kim Jong-Un regime were to collapse. I think the impact on China would be very negative. I think the risks to the world, to China, the United States, Japan, and the whole world, of nuclear proliferation from North Korea is particularly great. We have seen a history of North Korea sharing technology with other regimes that are outside the international order. And, I think, as countries that have confronted terrorism, the United States and China have a shared interest in preventing proliferation of missile technology, nuclear technology, to non-state actors and to countries who do not participate in the rule of law and of order. China was a good partner with United States in crafting the Joint Comprehensive Protocol -- the JCPOA -- with regards to Iran's illicit nuclear weapons program. My purpose in conversations in China about North Korea is to both express thanks for the work we've done together, but also concern that they not relieve sanctions to early, because the public position of China and the United States is that we support full denuclearization of the peninsula, that will only be achieved if China reinforces the view that Japan has and the United States has, which is that the Kim regime can and should have security guarantees. The United States does not seek regime change. We do not seek to continue or extend the conflict, so the time is at hand for us to reach peace in the Korean peninsula, and having a closer, tighter, better alliance with China in this is, I think, the only way for us to resolve it.

Cassidy Criticizes Academic Integrity of NCIL Dyslexia Report Created with Department of Education Funds

by: Senator Bill Cassidy (R-LA)

Washington, D.C. - April 23, 2019 - (The Ponder News) -- U.S. Senator Bill Cassidy, M.D. (R-LA), member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, today expressed serious concerns to the U.S. Department of Education regarding the academic integrity of the National Center on Improving Literacy’s (NCIL) report, “Screening for Dyslexia.” The NCIL’s report was a product of a $1.5 million grant funded through the Department of Education.

Cassidy worked in the Senate HELP Committee to establish the National Center on Improving Literacy (NCIL) in the 2015 passage of the Every Student Succeeds Act (ESSA). One of the primary charges of NCIL was to conduct a thorough review of the literature available and provide assistance on how to improve identification of dyslexia at an early age. However, the NCIL report relies heavily on outdated or inaccurate references and fails to provide evidence-based recommendations for schools screening young children for dyslexia.

“If one were to look past the significant issue of inaccurately referencing key ‘facts’ to support NCIL’s argument, which on its own presents serious questions regarding the legitimacy of the paper’s scholarship, one would find that NCIL’s suggestions and recommendations to improve efforts to effectively screen for dyslexia are sloppy and misguided, at best,” Dr. Cassidy said in the letter. “At worst, the paper’s scholarship is ideologically skewed in an effort to advance a specific agenda to help struggling readers read, rather than the stated purpose of the paper, which is to provide evidence-based recommendations when screening young children for dyslexia.”

Dr. Cassidy is an active advocate on behalf of Americans with dyslexia, describing how his family has overcome dyslexia and how others can too. He also passed legislation included in the First Step Act providing dyslexia screening in prisons to reduce recidivism by helping more inmates learn to read.

The full text of the letter is below:

Dear Secretary DeVos:

The ability to read, comprehend what is read, and write well are crucial learning abilities for educational achievement and lifelong success. Young students, who are unable to read in the same manner as their peers, struggle to catch up to their peers later on in school and must exert extra focus and attention to read at the same level as their peers.[1] This unexpected difficulty to read can present adverse long term effects in many forms, including career outcomes[2] and the potential for legal trouble later on in life.[3] Of the students who are unable to read in the same manner as their peers, it is understood that a significant percentage have dyslexia, which is known to affect 1-in-5 Americans (20 percent).[4]

Understanding that 1-in-5 Americans are affected by dyslexia, I worked with my colleagues on the Senate Health, Education, Labor, and Pensions (HELP) Committee to establish the National Center on Improving Literacy (NCIL) in the 2015 passage of the Every Student Succeeds Act (ESSA).[5]One of the primary charges of NCIL was to conduct a thorough review of the literature available and provide assistance on how to improve identification of dyslexia at an early age. In doing so, NCIL was to identify or develop professional development recommendations for schools to better understand dyslexia, identify evidence-based screeners, implement evidence-based instruction, and disseminate the findings to States and local school districts.[6]

Unfortunately, as the primary author of the provision that authorizes funding for the center and as the father of a child with dyslexia, I find the most recent evidence of NCIL’s work deeply troubling. NCIL’s recent paper “Screening for Dyslexia,”[7] published on March 2, 2019, painted a picture of dyslexia that is foreign to my family’s lived experience. Furthermore, it lacks the serious scholarship that a $1.5 million center[8] should produce on behalf of taxpayers and the millions of families in the United States with loved ones who struggle to read because of dyslexia.

Perhaps the most objectionable aspect of the paper is the number of outdated references, references that are omitted in the reference list, and references entirely missing from the paper. If one were to look past the significant issue of inaccurately referencing key ‘facts’ to support NCIL’s argument, which on its own presents serious questions regarding the legitimacy of the paper’s scholarship, one would find that NCIL’s suggestions and recommendations to improve efforts to effectively screen for dyslexia are sloppy and misguided, at best. At worst, the paper’s scholarship is ideologically skewed in an effort to advance a specific agenda to help struggling readers read, rather than the stated purpose of the paper, which is to provide evidence-based recommendations when screening young children for dyslexia.

In an academic setting, the existence of just one or two improper citations or references is enough to invalidate and cripple an entire argument or study. The reason for this is clear: the ability to hold the argument or study up to rigorous testing depends on the validity and application of the information presented in the paper, assuming that the information presented is traceable, reliable, and presented in good faith. If one is unable to trace down the underlying point cited or referenced, the reader will have no way of knowing if the statement in the paper is based on fact, whether it is an opinion expressed by a reputable author, or if it is entirely fabricated and falsely attributed for the purpose of advancing a special interest.

In the case of NCIL’s “Screening for Dyslexia” paper, it takes the reader only a handful of pages to find examples of egregious errors. In discussing the prevalence of dyslexia, it references an outdated statistic by Sally Shaywitz, M.D., claiming that 5-17 percent of children have dyslexia.[9]The paper failed to use the most up-to-date statistic from the same Dr. Shaywitz, which shows that 1 in 5 children, or 20 percent, have dyslexia.[10] While there are varying degrees of dyslexia found in children and adults, it is widely understood that far more than 5-17 percent of children have dyslexia.

Another example on the same page of the paper (6) that demonstrates the failure of NCIL to use up-to-date information is the International Dyslexia Association’s (IDA) definition of dyslexia, which is more than 15 years old. While some states do use the IDA definition, the First Step Act, which was signed into law in December 2018, includes a federal definition for dyslexia and an evidence-based way to screen for dyslexia. The First Step Act definition for dyslexia and the required approach to screening are as follows:

Dyslexia Definition:

Dyslexia means an unexpected difficulty in reading for an individual who has the intelligence to be a much better reader, most commonly caused by a difficulty in the phonological processing (the appreciation of the individual sounds of spoken language), which affects the ability of an individual to speak, read, and spell.[11]

Dyslexia Screening Program:

Dyslexia Screening Program is a screening program for dyslexia that is:

(A) evidence-based (as defined in section 8101(21) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801(21))) with proven psychometrics for validity;

(B) efficient and low-cost; and

(C) readily available.”[12]

Understanding the unexpected nature of dyslexia and the absence of an effect dyslexia has on an individual’s intelligence is critical to understanding what dyslexia is and is not. Additionally, employing an evidence-based, cost-effective, and readily-available screening mechanism is critical to ensure a screener’s large-scale effectiveness and feasibility.

The IDA definition for dyslexia states that

“difficulties [with dyslexia] typically result from a deficit in the phonological component of language that is often unexpected in relation to other cognitive abilities and the provision of effective classroom instruction.”

While the IDA definition recognizes the phonologic and unexpected nature of dyslexia (underlined), it implicitly blames teachers and classroom instruction as the reason why some individuals are dyslexic (bolded). Defining dyslexia in this way is harmful and neglects the fact that individuals with dyslexia are born with the difficulty. Dyslexic individuals have an inherently harder time than their non-dyslexic peers when learning to read and write well, and speak foreign languages.

If using outdated statistics, definitions, and neglecting to mention existing federal definitions and screening requirements for dyslexia is not enough to convince one of the lack of serious scholarship on the authors’ part, then page 7 of the paper makes it abundantly clear that the authors did not put in the effort necessary to publish a reputable document. On page 7, six separate references are listed that do not appear on the paper’s reference list. Those sentences and the corresponding references are listed below:

Students may be at risk for not attaining full literacy skills for a variety of reasons. For example, students may be at risk because they are English learners who are struggling to learn literacy skills in two languages simultaneously (Gersten, 1996).

Of course, single-cause explanations rarely capture the complexity behind a student’s struggle to develop strong literacy skills (Maughan & Carroll, 2006; Snowling, 2012).[13]

Multiple risk factors may be interacting with each other to make literacy problems more pronounced than they might be if only one risk factor was present (Muter & Snowling, 2009).

This includes providing intervention to students with (yet) undiagnosed literacy-related disabilities, including dyslexia, as well as those students who are experiencing literacy-related difficulties for other underlying reasons (Shaywitz, 2014).

Whether the literacy-related difficulty is caused by dyslexia or a disability other than dyslexia, another factor (e.g. low oral language skills), or a combination of factors, early and intense intervention to address the difficulties is the best way to prevent early problems from becoming more severe over time (Connor, et al., 2014).

If one did not read the rest of the paper, they might look at these clear omissions and think that the authors accidently left references for page 7 off the reference list. That would be a mistake. The trend of omitting references continues throughout the paper. My tabulation shows that the following references and the corresponding pages were omitted from NCIL’s reference list.

As a gastroenterologist, if I published an academic paper that was funded by the Department of Health and Human Services on the best ways to screen for colon cancer but failed to properly reference 31 of my sources, would you feel comfortable distributing that document to physicians nationwide as a guide to “better screening?” I certainly hope not.

Thus is the problem with NCIL’s “Screening for Dyslexia.” It is abundantly clear that the authors of the paper never sought any form of peer review. If it was reviewed by their peers, any of the 31 missing references would have been flagged. A proper peer review not only would have revealed the absence of listed references, it would have invoked significant scrutiny on NCIL’s numerous assertions without any form of citation or reference.

For example, on page 8, one page after which six references were cited but not listed in the reference list, not a single assertion is cited and listed in the reference list. This is despite the fact that the authors went on a 479-word tangent on the neuroscience behind early screening for dyslexia. Early screening and intervention is critical for dyslexic students and there is good research available regarding the neuroscience of dyslexia;[14] however, the lack of any such reference to the research available raises the question of whether the information is presented as fact or simply the opinion of a few individuals.

Instead of focusing on screening for dyslexia as the title implied, the paper is about screening for struggling readers and multi-tiered systems of support (MTSS), which is most often implemented in schools through Response to Intervention (RtI). The paper paints a very favorable review of MTSS—and RtI by extension—despite the 2015 study by the National Center for Education Evaluation and Regional Assistance titled “Evaluation of Response to Intervention Practices for Elementary School Reading.” The study, which was commissioned through the Department of Education, demonstrated the weaknesses and shortcomings of RtI, going as far as to say, “for those students just below the school-determined eligibility cut point in Grade 1, assignment to receive reading interventions did not improve reading outcomes; it produced negative impacts.”[15]

Finally, pages 17 and 18 of the paper discuss how dyslexia screening assessments should be implemented from kindergarten through the beginning of high school. The entire paragraph, starting with “Dyslexia screening assessments” and ending with the five bullet points on page 18, is opinion masquerading as fact. There is no evidence to support the assertions made by the authors. To the degree that sources are cited in the section, they are nowhere to be found in the reference list. If screening is conducted with an evidence-based screener, a student only needs to be screened for dyslexia once because dyslexic students are born with dyslexia—it is not acquired over time. The paper also neglects to mention the availability of affordable, evidence-based screeners that schools can use to help identify dyslexic students. If schools were to use a screener to help better identify students, they would save significant resources that are currently spent on RtI and other offerings of MTSS. Not only will the use of an effective screener save school districts precious time and resources as they try to identify students with dyslexia, an effectively employed screener and the necessary follow up testing can then ensure dyslexic students get the evidence-based instruction they deserve and need at an earlier date than would otherwise be provided.

It is clear to me that NCIL does not have the expertise or interest in properly identifying or screening for dyslexia, as is demonstrated by the significant lack of quality, peer-reviewed scholarship. Should the current grant recipients at the University of Oregon apply for another grant through the Comprehensive Centers Program, I strongly recommend that the Department of Education go in a different direction.

Thank you for considering the many concerns I laid out for you with NCIL’s “Screening for Dyslexia” paper. If I can be of further assistance to you or your staff, please do not hesitate to let me know.

Volunteer Responder Incentive Protection Act (VRIPA) Introduced

by: Sendator Benjamin L.Cardin (D - MD

Washington, D.C. - April 23, 2019 - (The Ponder News) -- U.S. Senators Ben Cardin (D-Md.), a member of the Senate Finance Committee, and Susan Collins (R-Maine), the Chair of the Congressional Fire Services Caucus, introduced the Volunteer Responder Incentive Protection Act (VRIPA), bipartisan legislation to enhance communities’ ability to recruit and retain volunteer firefighters and Emergency Medical Services (EMS) personnel.

“Local communities depend on the public service of volunteer firefighters to stay safe and secure. These modest changes will make it easier for communities across Maryland and nationwide to recruit and retain the bravest men and women who are ready to defend against whatever might come next,” said Senator Cardin. “Protecting our communities from harm is one of the most basic functions of government.”

“Across our nation, volunteer firefighters play a critical role in helping to ensure the safety of our communities and the well-being of our neighbors. Maine is largely a rural state, and more than 90 percent of firefighters are volunteers. Without these public-spirited citizens, many smaller communities would be unable to provide firefighting and other emergency services at all,” said Senator Collins. “This bipartisan bill would protect cost-effective incentives that support the brave men and women who volunteer to protect their communities, and I urge our colleagues to join us in supporting the Volunteer Responder Incentive Protection Act.”

“I’d like to thank Senator Cardin for introducing this bill exempting volunteer benefits from being taxed by the federal government,” said Eric Bernard, a volunteer firefighter in Rockville who also serves as the Executive Director of the Montgomery County Volunteer Fire-Rescue Association. “Recruitment and retention of volunteers is a major challenge for fire and EMS agencies in Maryland and across the nation. Passage of the Volunteer Responder Incentive Protection Act will make it easier for communities to offer incentives to their volunteers.”

“Call and volunteer emergency responders are absolutely critical in a predominantly rural state like Maine,” said Ken Desmond, President of the Maine State Federation of Firefighters. “We thank Senator Collins for introducing this important legislation, which will support our efforts to maintain uniform and effective emergency response services throughout the State of Maine.”

In order to bolster recruitment and retention, many fire and EMS agencies now provide benefits, including non-monetary gifts, reductions in property taxes, per-call payments, stipends, or retirement benefits. The Volunteer Responder Incentive Protection Act would allow communities to provide volunteer firefighters and EMS workers with up to $600 per year of property tax reductions or other incentives, without those benefits being subject to federal income tax and withholding. This would ease the administrative burden that local departments sometimes face when they reward their volunteers with minor benefits.

The U.S. Senate Finance Committee has introduced the Retirement Enhancement and Savings Act, which incorporates VRIPA authored by Senators Cardin and Collins.

Click HERE to read the full-text of the bill.

Brown Bill to Crack Down on Drug Company Greed, Protect Taxpayer Dollars Signed into Law

by: Senator Sherrod Brown (D-OH)

Washington, D.C. - April 23, 2019 - (The Ponder News) -- President Trump signed U.S. Senator Sherrod Brown’s (D-OH) bipartisan measure into law that would prevent drug companies from misclassifying their medications as generic drugs to charge Medicaid, and therefore taxpayers, more money. Brown’s measure follows Mylan’s $465 million settlement with the U.S. Department of Justice (DOJ) for overcharging Medicaid by millions of dollars by misclassifying their EpiPen as a generic medication. Brown’s bill would give the U.S. Department of Health and Human Services (HHS) the ability to correctly reclassify a medication and recoup any rebates given to the drug companies when they misclassify a drug. Brown’s measure is part of a bipartisan bill that now heads to the President’s desk to be signed into law.

“Taxpayers should not be on the hook for the drug companies’ corporate greed,” said Brown. “By going after bad actors who try to rig the game in their favor by misclassifying their products, we can cut down on costs and protect Ohio taxpayers who rely on these medications for their health and the health of their families.”

Brown has led the charge when it comes to lowering the cost of prescription drugs for Ohio patients.

Brown recently re-introduced his Stop Price Gouging Act, which would require drug companies to report and justify increases in drug prices, and penalize drug companies that engage in unjustified price increases with financial penalties proportionate to the price spike.

The Stop Price Gouging Act would:

Require drug companies to report increases in drug prices, and justify the increase.

Penalize drug companies that engage in unjustified price increases with financial penalties proportionate to the price spike.

In addition to the Stop Price Gouging Act, Brown also introduced legislation with Rep. Doggett (D-TX) to put people over big Pharma profits. Their Medicare Negotiation and Competitive Licensing Act would authorize the Secretary of Health and Human Services (HHS) to negotiate drug prices and, if drug companies refuse to negotiate in good faith, it would enable the Secretary to issue a competitive, compulsory license to another company that is willing and able to produce the medication as a generic.

Last year, Brown and a group of Senators introduced a package of proposals to help bring down the cost of prescription drugs. The package included provisions to stop price spikes by penalizing pharmaceutical companies that engage in price gouging, and would allow Medicare to negotiate drug prices – which the President promised to do throughout his campaign. Brown’s bill, which will be reintroduced later this year, has been described as “just about every policy idea drug lobbyists hate.”

20th Anniversary of Colombine High School Shooting

by: Senator Michael F. Bennet (D-CO)
April 22, 2019
“Twenty years ago, tragedy struck Columbine High School. Today we remember the 13 innocent victims, their families, and a community determined not to be defined by this senseless act of violence.

“This tragedy opened a troubling new era for our country. Unlike the America I was raised in, we have an entire generation growing up with the fear that they could be a victim of a mass shooting at their school. We cannot accept this as our new normal. As we pay tribute to the lives taken at Columbine we also rededicate ourselves to freeing every American child from the shadow of gun violence.”

Read more...

by: Senator Cory Gardner (R-CO)
April 22, 2019
“On the 20th anniversary of the heart wrenching tragedy at Columbine High School we must all remember the friends and loved ones whose lives were taken far too soon,” said Senator Gardner. “As a Coloradan and a father of three I will never forget April 20th, 1999, the day the sanctity of our schools was taken away as parents waited in anguish wondering if their child would make it home. Today is a solemn reminder of the terror unleashed at Columbine High School, and while the years continue to pass since this dreadful day, our state and our country will never forget.”

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Electronic Health Records

by: Senator Lamar Alexander (R-TN)
April 20, 2019
“This proposed rule is an important step toward making it as easy for patients to get their medical records as it is to book an airline flight — and to reduce administrative burdens that are driving doctors away from the practice of medicine. The proposal implements reforms in the 21st Century Cures Act, which Majority Leader Mitch McConnell called the most important new law of the 114th Congress.”

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Senators Blackburn, Tester Ramp Up Oversight of VA’s $16 Billion Electronic Health Record Modernization
by: Senator Marsha Blackburn (R-TN
April 16, 2019
Senators Marsha Blackburn (R-Tenn.) and Jon Tester (D-Mont.) are fighting to keep the VA on target and transparent on its roll-out of the new $16 billion commercial electronic health record system for nine million veterans. The VA is currently undertaking a decade-long transition to bring veterans’ health records into the 21st century by ensuring that veterans can have access to a seamless electronic health record across the VA and Department of Defense health systems. Blackburn and Tester introduced the VA Electronic Health Record Advisory Committee Act to establish a third-party oversight committee to help monitor the implementation of the new electronic health record system.

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UnidosUS: HUD’s Latest Rule Could Impact Millions of U.S. Citizen Children

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by: UnidosUS

Washington, D.C. - April 22, 2019 - (The Ponder News) -- UnidosUS (formerly the National Council of La Raza) issued the following statement in response to the U.S. Department of Housing and Urban Development’s (HUD) proposed rule, which would bar individuals from mixed-status families access to public housing assistance:

“This is really a broader story about how the long-term cost of president’s whimsical immigration policies—here masked under a proposed HUD regulation—will be borne largely by the nearly six million U.S. citizen children that live in a mixed status household. Make no mistake, this is part of an intentionally cruel, misguided and wasteful immigration enforcement strategy hatched by Stephen Miller and his allies. And, it is an effort that is also desperately tone deaf. Our leaders at the highest levels of government should not be engaging in dog whistle politics at a time when there is a real and actionable humanitarian crisis along our southern border that needs to be addressed,” said Carlos Guevara, Senior Policy Advisor at UnidosUS.

UnidosUS, previously known as NCLR (National Council of La Raza), is the nation’s largest Hispanic civil rights and advocacy organization. Through its unique combination of expert research, advocacy, programs, and an Affiliate Network of nearly 300 community-based organizations across the United States and Puerto Rico, UnidosUS simultaneously challenges the social, economic, and political barriers that affect Latinos at the national and local levels. For more than 50 years, UnidosUS has united communities and different groups seeking common ground through collaboration, and that share a desire to make our country stronger.

Decision on Imports of Iranian Oil

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by: U.S. Secretary of State

Washington, D.C. - April 22, 2019 - (The Ponder News) -- Today we are announcing the United States will not issue any additional Significant Reduction Exceptions to existing importers of Iranian oil. The Trump Administration has taken Iran’s oil exports to historic lows, and we are dramatically accelerating our pressure campaign in a calibrated way that meets our national security objectives while maintaining well supplied global oil markets. We stand by our allies and partners as they transition away from Iranian crude to other alternatives. We have had extensive and productive discussions with Saudi Arabia, the United Arab Emirates, and other major producers to ease this transition and ensure sufficient supply. This, in addition to increasing U.S. production, underscores our confidence that energy markets will remain well supplied.

Today’s announcement builds on the already significant successes of our pressure campaign. We will continue to apply maximum pressure on the Iranian regime until its leaders change their destructive behavior, respect the rights of the Iranian people, and return to the negotiating table.

Cotton Statement on U.S. Efforts to End Iranian Oil Exports
by: Senator Tom Cotton (R-AR)
April 22, 2019
"The world pays a steep price for Iranian oil, which funds Iran's military aggression and terrorist proxies. Pressure on the Iranian regime was a necessary decision and I commend the leadership of Secretary Pompeo in the efforts to shift oil reliance from Iran."

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Sen. Cruz: I Applaud President Trump and His Administration for Announcing End of Oil Waivers for Iran
by: Senator Ted Cruz (R - TX)
April 22, 2019
"I applaud President Trump and Secretary of State Pompeo for announcing this morning that the Trump administration will finally end oil waivers for Iran. This decision will deprive the Ayatollahs of billions of dollars that they would have spent undermining the security of the United States and our allies, building up Iran's nuclear and ballistic missile programs, and financing global terrorism. Ending these waivers is another important step in finally ending all American implementation of the Obama Iran nuclear deal, and one that I have longed called for. The administration should also take the long overdue step of ending civil-nuclear waivers, which allow the Iranians to continue nuclear-related work in places like the Fordow centrifuge bunker, which they secretly dug under a mountain so they could build nuclear weapons with additional protection from an aerial attack."

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Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

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by: U.S. Food and Drug Administration

Washington, D.C. - April 22, 2019 - (The Ponder News) -- The FDA is a public health agency that always strives to use the best available scientific evidence to promote and protect the well being of individuals. It deeply concerns us when we see preventable diseases such as measles or mumps reemerging in the United States and threatening our communities. The World Health Organization recently named vaccine hesitancy one of the top 10 threats to global health. In this time of multiple measles outbreaks, and as we approach National Infant Immunization Week, we want to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases.

The MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. However we’re seeing an increasing number of outbreaks of measles in communities across the country, including those in New York, New Jersey, Washington, California, and Michigan.

Considered eradicated within the U.S. since 2000, measles has persisted in other areas of the world where the vaccine is not as readily available, including countries in Europe, Asia, the Pacific Islands, and Africa. Unvaccinated U.S. residents may be exposed to measles while they are abroad and bring the disease back into the U.S. and spread it to others. Worldwide, about 20 million people get measles each year. According to the Centers for Disease Control and Prevention (CDC), there have also been outbreaks of mumps reported. It’s an urgent public health priority to monitor these diseases and raise awareness of the importance of timely immunizations, especially as outbreaks are taking hold among unvaccinated populations in this country.

These diseases start with symptoms that may mirror the common cold, but they can cause serious illness and in some cases, even death. Measles – a respiratory disease that causes a skin rash, fever, cough and runny nose – can be dangerous, especially for babies and young children. It is one of the most contagious diseases and can cause severe complications, including pneumonia, swelling of the brain and death. In fact, one to two children out of every 1,000 who contract measles dies from complications of the disease and one in four people who get measles need to be hospitalized. Mumps causes fever, headache, loss of appetite and the well-known sign of swollen cheeks and jaw from the swelling of the salivary glands. Complications, though rare, can include deafness and meningitis (an infection of the lining that surrounds the brain and spinal cord). Rubella, once a common disease that occurred primarily among young children, causes fever, rash, and -- mainly in women -- arthritis. Rubella infection during pregnancy can also lead to birth defects.

We cannot state strongly enough – the overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health.

Vaccinating against measles, mumps and rubella not only protects us and our children, it protects people who can’t be vaccinated, including children with compromised immune systems due to illness and its treatment, such as cancer.

We do not take lightly our responsibility to ensure the safety and effectiveness of vaccines, and work diligently to assess safety and effectiveness of all licensed vaccines for their intended uses. The MMR vaccine is very effective at protecting people against measles, mumps, and rubella. It also prevents complications caused by these diseases. And we have nearly 50 years of experience and evidence supporting that fact. In fact, according to the CDC, two doses of the MMR vaccine beginning at 12 months of age (the recommended dosing schedule) are 97% effective against measles, 88% effective against mumps, and 97% effective for rubella.

Like many medical products, the MMR vaccine has known potential side effects that are generally mild and short-lived, such as rash and fever. If parents have concerns about these side effects, we recommend that they speak with their health care providers about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases.

The FDA will continue to closely monitor these outbreaks of vaccine-preventable diseases alongside our federal partners at CDC and the Department of Health and Human Services, and will provide any new information about vaccine safety or effectiveness to the public. But just to be clear, the FDA has determined that the MMR vaccine is both safe and effective in preventing these diseases. We join our colleagues at HHS, CDC, National Institutes of Health and state and local health departments across the country in the continued effort to encourage vaccinations against these preventable diseases.

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.

FDA permits marketing of first medical device for treatment of ADHD

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by: U.S. Food and Drug Administration

Washington, D.C. - April 22, 2019 - (The Ponder News) -- The U.S. Food and Drug Administration has permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorization by the FDA.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”

ADHD is a common disorder that begins in childhood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. The diagnosis of ADHD requires a comprehensive evaluation by a health care professional. For a person to receive a diagnosis of ADHD, the symptoms of inattention and/or hyperactivity-impulsivity must be chronic or long-lasting, impair the person’s functioning and cause the person to fall behind normal development for his or her age.

The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

The stimulation should feel like a tingling sensation on the skin, and the device should be used in the home under the supervision of a caregiver during periods of sleep. Clinical trials suggest that a response to eTNS may take up to 4 weeks to become evident. Patients should consult with their health care professional after four weeks of use to assess treatment effects.

The Monarch eTNS System’s efficacy in treating ADHD was shown in a clinical trial that compared eTNS as the sole treatment, or monotherapy, to a placebo device. A total of 62 children with moderate to severe ADHD were enrolled in the trial and used either the eTNS therapy each night or a placebo device at home for four weeks. The trial's primary endpoint was improvement on a clinician-administered ADHD Rating Scale, ADHD-RS. ADHD-RS scales are used to monitor severity and frequency of ADHD symptoms. A higher score is indicative of worsening symptoms. The ADHD-RS uses questions about the patient’s behavior, such as whether they have difficulty paying attention or regularly interrupt others. The trial showed that subjects using the eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

The most common side effects observed with eTNS use are: drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue. No serious adverse events were associated with use of the device.

The Monarch eTNS System should not be used in children under seven years of age. It should not be used in patients with an active implantable pacemaker or with active implantable neurostimulators. Patients with body-worn devices such as insulin pumps should not use this device. The eTNS System should not be used in the presence of radio frequency energy such as magnetic resonance imaging (MRI), because it has not been tested in an MRI machine, or cell phones, because the phone’s low levels of electromagnetic energy may interrupt the therapy.

The FDA reviewed the Monarch eTNS System through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Monarch eTNS System to NeuroSigma.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.