FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids
Source: U.S. Food and Drug Administration
In a safety communication notice issued today, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.
Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.
Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
The Employment Situation — March 2014
Source: Bureau of Labor Statistics
Total nonfarm payroll employment rose by 192,000 in March, and the unemployment rate was unchanged at 6.7 percent, the U.S. Bureau of Labor Statistics reported today. Employment grew in professional and business services, in health care, and in mining and logging.
FDA approves new hand-held auto-injector to reverse opioid overdose
Source: U.S Food and Drug Administration
The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.
It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.
Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.
IPCC Report: A changing climate creates pervasive risks but opportunities exist for effective responses; Responses will face challenges with high warming of the climate
IPCC Report: A changing climate creates pervasive risks but opportunities exist for effective responses; Responses will face challenges with high warming of the climate (PDF)
Source: Intergovernmental Panel on Climate Change
The Intergovernmental Panel on Climate Change (IPCC) issued a report today that says the effects of climate change are already occurring on all continents and across the oceans. The world, in many cases, is ill-prepared for risks from a changing climate. The report also concludes that there are opportunities to respond to such risks, though the risks will be difficult to manage with high levels of warming.
The report, titled Climate Change 2014: Impacts, Adaptation, and Vulnerability, from Working Group II of the IPCC, details the impacts of climate change to date, the future risks from a changing climate, and the opportunities for effective action to reduce risks. A total of 309 coordinating lead authors, lead authors, and review editors, drawn from 70 countries, were selected to produce the report. They enlisted the help of 436 contributing authors, and a total of 1,729 expert and government reviewers.
The report concludes that responding to climate change involves making choices about risks in a changing world. The nature of the risks of climate change is increasingly clear, though climate change will also continue to produce surprises. The report identifies vulnerable people, industries, and ecosystems around the world. It finds that risk from a changing climate comes from vulnerability (lack of preparedness) and exposure (people or assets in harm’s way) overlapping with hazards (triggering climate events or trends). Each of these three components can be a target for smart actions to decrease risk.
NLRB Director for Region 13 issues Decision in Northwestern University Athletes Case</strong>
Source: National Labor Relations Board
Regional Director, Peter Sung Ohr, has issued a Decision in 13-RC-121359 finding the Grant-in-aid scholarship football players are employees under the NLRA and has directed an election to take place.
The parties have until April 9, 2014 to file with the Board in Washington, D.C. a Request for Review of the Decision.
IRS Notice 2014-21 (PDF)
Source: Internal Revenue Service
For federal tax purposes, virtual currency is treated as property. General tax principles applicable to property transactions apply to transactions using virtual currency.
The Employment Situation — February 2014
Source: Bureau of Labor Statistics
Total nonfarm payroll employment increased by 175,000 in February, and the unemployment rate was little changed at 6.7 percent, the U.S. Bureau of Labor Statistics reported today. Employment increased in professional and business services and in wholesale trade but declined in information.
Delivering Opportunity and the Redesigned SAT
Source: College Board
When students open their SAT test books in spring 2016, they’ll encounter an SAT that is more focused and useful than ever before. The full specifications of the exam along with extensive sample items for each section will be available on April 16, 2014. Major changes are described below.
- The redesigned SAT will first be given in spring 2016.
- The SAT will be offered in print and, at selected locations, on computer.
- There will be three sections: Evidence-Based Reading and Writing, Math, and the Essay.
- The length of the SAT will be about three hours, with an added 50 minutes for the essay. Precise timing will be finalized after further research.
- The exam will once again be scored on a 400- to 1600-point scale. The Evidence-Based Reading and Writing section and the Math section will each be scored on a 200- to 800-point scale. Scores for the Essay will be reported separately.
FDA proposes updates to Nutrition Facts label on food packages
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.
FY15 Budget Preview — As Delivered by Secretary of Defense Chuck Hagel, Pentagon Press Briefing Room, Monday, February 24, 2014
FY15 Budget Preview — As Delivered by Secretary of Defense Chuck Hagel, Pentagon Press Briefing Room, Monday, February 24, 2014
Source: U.S. Department of Defense
Today I am announcing the key decisions I have recommended to the President for the Defense Department’s Fiscal Year 2015 budget and beyond.
These recommendations will adapt and reshape our defense enterprise so that we can continue protecting this nation’s security in an era of unprecedented uncertainty and change. As we end our combat mission in Afghanistan, this will be the first budget to fully reflect the transition DoD is making for after 13 years of war – the longest conflict in our nation’s history.
We are repositioning to focus on the strategic challenges and opportunities that will define our future: new technologies, new centers of power, and a world that is growing more volatile, more unpredictable, and in some instances more threatening to the United States.
The choices ahead will define our defense institutions for the years to come. Chairman Dempsey and I worked in a pragmatic and collaborative way to build the balanced force our nation must have for the future. I worked closely with the Chairman, Vice Chairman, Service Secretaries, and Service Chiefs in developing these recommendations, in a process that began with last summer’s Strategic Choices and Management Review. I also want to recognize today the senior enlisted leaders in each of the services for their contributions and their involvement and their leadership and what they continue to do every day for our country, but in particular their help and input in crafting this budget.Our recommendations were guided by an updated defense strategy that builds on the President’s 2012 Defense Strategic Guidance. As described in the upcoming Quadrennial Defense Review report, this defense strategy is focused on:
- Defending the homeland against all strategic threats;
- Building security globally by projecting U.S. influence and deterring aggression; and;
- Remaining prepared to win decisively against any adversary should deterrence fail.
The Effects of a Minimum-Wage Increase on Employment and Family Income
Source: Congressional Budget Office
Increasing the minimum wage would have two principal effects on low-wage workers. Most of them would receive higher pay that would increase their family’s income, and some of those families would see their income rise above the federal poverty threshold. But some jobs for low-wage workers would probably be eliminated, the income of most workers who became jobless would fall substantially, and the share of low-wage workers who were employed would probably fall slightly.
Report of the Commission of Inquiry on Human Rights in the Democratic People’s Republic of Korea
Source: United Nations Office of the High Commissioner for Human Rights
From press release:
A wide array of crimes against humanity, arising from “policies established at the highest level of State,” have been committed and continue to take place in the Democratic People’s Republic of Korea, according to a UN report released Monday, which also calls for urgent action by the international community to address the human rights situation in the country, including referral to the International Criminal Court.
In a 400-page set of linked reports and supporting documents, based on first-hand testimony from victims and witnesses, the UN Commission of Inquiry on human rights in the DPRK has documented in great detail the “unspeakable atrocities” committed in the country.
“The gravity, scale and nature of these violations reveal a State that does not have any parallel in the contemporary world,” the Commission — established by the Human Rights Council in March 2013 — says in a report that is unprecedented in scope.
“These crimes against humanity entail extermination, murder, enslavement, torture, imprisonment, rape, forced abortions and other sexual violence, persecution on political, religious, racial and gender grounds, the forcible transfer of populations, the enforced disappearance of persons and the inhumane act of knowingly causing prolonged starvation,” the report says, adding that “Crimes against humanity are ongoing in the Democratic People’s Republic of Korea because the policies, institutions and patterns of impunity that lie at their heart remain in place.”
The second more detailed section of the report cites evidence provided by individual victims and witnesses, including the harrowing treatment meted out to political prisoners, some of whom said they would catch snakes and mice to feed malnourished babies. Others told of watching family members being murdered in prison camps, and of defenceless inmates being used for martial arts practice.
FinCEN Issues Guidance to Financial Institutions on Marijuana Businesses
Source: Financial Crimes Enforcement Network
The Financial Crimes Enforcement Network (FinCEN), in coordination with the U.S. Department of Justice (DOJ), today issued guidance that clarifies customer due diligence expectations and reporting requirements for financial institutions seeking to provide services to marijuana businesses. The guidance provides that financial institutions can provide services to marijuana-related businesses in a manner consistent with their obligations to know their customers and to report possible criminal activity.
Providing clarity in this context should enhance the availability of financial services for marijuana businesses. This would promote greater financial transparency in the marijuana industry and mitigate the dangers associated with conducting an all-cash business. The guidance also helps financial institutions file reports that contain information important to law enforcement. Law enforcement will now have greater insight into marijuana business activity generally, and will be able to focus on activity that presents high-priority concerns.
AHA/ASA Guidelines for the Prevention of Stroke in Women
The aim of this statement is to summarize data on stroke risk factors that are unique to and more common in women than men and to expand on the data provided in prior stroke guidelines and cardiovascular prevention guidelines for women. This guideline focuses on the risk factors unique to women, such as reproductive factors, and those that are more common in women, including migraine with aura, obesity, metabolic syndrome, and atrial fibrillation.
Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association (AHA) Stroke Council’s Scientific Statement Oversight Committee and the AHA’s Manuscript Oversight Committee. The panel reviewed relevant articles on adults using computerized searches of the medical literature through May 15, 2013. The evidence is organized within the context of the AHA framework and is classified according to the joint AHA/American College of Cardiology and supplementary AHA Stroke Council methods of classifying the level of certainty and the class and level of evidence. The document underwent extensive AHA internal peer review, Stroke Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the AHA Science Advisory and Coordinating Committee.
We provide current evidence, research gaps, and recommendations on risk of stroke related to preeclampsia, oral contraceptives, menopause, and hormone replacement, as well as those risk factors more common in women, such as obesity/metabolic syndrome, atrial fibrillation, and migraine with aura.
To more accurately reflect the risk of stroke in women across the lifespan, as well as the clear gaps in current risk scores, we believe a female-specific stroke risk score is warranted.
United Nations Convention on the Rights of the Child — Concluding observations on the report submitted by the Holy See
Concluding observations on the report submitted by the Holy See (PDF)
Source: United Nations
The Committee is concerned that in dealing with cases of child pornography committed by members of the clergy, the Holy See has failed to ensure children’s right to express their views and have them given due weight, and that the Holy See has given preceden ce to the preservation of the reputation of the church over children’s rights to have their best interests taken as a primary consideration. The Committee is concerned that in doing so, the Holy See has undermined the prevention of offences under the Optional Protocol and the capacity of child victims to report them and therefore contributed to the impunity of the perpetrators and created further trauma for child victims of offences.
U.S. abortion rates hit lowest level since 1973
Source: Guttmacher Institute
The U.S. abortion rate declined to 16.9 abortions per 1,000 women aged 15–44 in 2011, well below the 1981 peak of 29.3 per 1,000 and the lowest since 1973 (16.3 per 1,000), according to “Abortion Incidence and Service Availability in the United States, 2011,” by Rachel Jones and Jenna Jerman. Between 2008 and 2011, the abortion rate fell 13%, resuming the long-term downward trend that had stalled between 2005 and 2008. The number of abortions (1.1 million in 2011) also declined by 13% in this time period.
While the study did not specifically investigate reasons for the decline, the authors note that the study period (2008–2011) predates the major surge in state-level abortion restrictions that started during the 2011 legislative session, and that many provisions did not go into effect until late 2011 or even later. The study also found that the total number of abortion providers declined by only 4% between 2008 and 2011, and the number of clinics (which provide the large majority of abortion services) declined by just 1%.
Fact Sheet: Keystone XL Pipeline
Source: U.S. Department of State
On January 31, 2014, the U.S. Department of State (“the Department”) released the Final Supplemental Environmental Impact Statement (Final Supplemental EIS). The analysis in the Final Supplemental EIS was done consistent with the National Environmental Policy Act and is in response to TransCanada’s application (May 4, 2012) for a Presidential Permit to construct and operate the Keystone XL Pipeline.
The President’s authority to approve or deny a cross-border pipeline permit is delegated to the Secretary of State or his designees in Executive Order 13337.
The analysis in the Final Supplemental EIS builds on the Draft Supplemental Environmental Impact Statement released on March 1, 2013 as well as the documents released in 2011 as part of the previous Keystone XL Pipeline application.
The proposed Keystone XL project consists of a 875-mile long pipeline and related facilities to transport up to 830,000 barrels per day of crude oil from Alberta, Canada and the Bakken Shale Formation in Montana. The pipeline would cross the U.S. border near Morgan, Montana and continue through Montana, South Dakota, and Nebraska where it would connect to existing pipeline facilities near Steele City, Nebraska for onward delivery to Cushing, Oklahoma and the Gulf Coast area.
The Final Supplemental EIS is not a decisional document on whether to approve or deny the proposed project. The Final Supplemental EIS is a technical assessment of the potential environmental impacts related to the proposed pipeline. It responds to over 1.9 million comments received since June 2012 (from both the scoping and Draft Supplemental Environmental Impact Statement comment periods). The Final Supplemental EIS reflects the most current information on the proposed Project as well as discussions the Department has had with both state and federal agencies. Notable changes since the Draft Supplemental Environmental Impact Statement released in March 2013, include: an expanded analysis of potential oil releases; an expanded climate change analysis; an updated oil market analysis incorporating new economic modeling; and an expanded analysis of rail transport.
Federal Reserve issues FOMC statement
Source: Federal Reserve Board
Information received since the Federal Open Market Committee met in December indicates that growth in economic activity picked up in recent quarters. Labor market indicators were mixed but on balance showed further improvement. The unemployment rate declined but remains elevated. Household spending and business fixed investment advanced more quickly in recent months, while the recovery in the housing sector slowed somewhat. Fiscal policy is restraining economic growth, although the extent of restraint is diminishing. Inflation has been running below the Committee’s longer-run objective, but longer-term inflation expectations have remained stable.
Consistent with its statutory mandate, the Committee seeks to foster maximum employment and price stability. The Committee expects that, with appropriate policy accommodation, economic activity will expand at a moderate pace and the unemployment rate will gradually decline toward levels the Committee judges consistent with its dual mandate. The Committee sees the risks to the outlook for the economy and the labor market as having become more nearly balanced. The Committee recognizes that inflation persistently below its 2 percent objective could pose risks to economic performance, and it is monitoring inflation developments carefully for evidence that inflation will move back toward its objective over the medium term.
Taking into account the extent of federal fiscal retrenchment since the inception of its current asset purchase program, the Committee continues to see the improvement in economic activity and labor market conditions over that period as consistent with growing underlying strength in the broader economy. In light of the cumulative progress toward maximum employment and the improvement in the outlook for labor market conditions, the Committee decided to make a further measured reduction in the pace of its asset purchases. Beginning in February, the Committee will add to its holdings of agency mortgage-backed securities at a pace of $30 billion per month rather than $35 billion per month, and will add to its holdings of longer-term Treasury securities at a pace of $35 billion per month rather than $40 billion per month. The Committee is maintaining its existing policy of reinvesting principal payments from its holdings of agency debt and agency mortgage-backed securities in agency mortgage-backed securities and of rolling over maturing Treasury securities at auction. The Committee’s sizable and still-increasing holdings of longer-term securities should maintain downward pressure on longer-term interest rates, support mortgage markets, and help to make broader financial conditions more accommodative, which in turn should promote a stronger economic recovery and help to ensure that inflation, over time, is at the rate most consistent with the Committee’s dual mandate.
Report on the Telephone Records Program Conducted under Section 215 of the USA PATRIOT Act and on the Operations of the Foreign Intelligence Surveillance Court
Report on the Telephone Records Program Conducted under Section 215 of the USA PATRIOT Act and on the Operations of the Foreign Intelligence Surveillance Court (PDF)
Source: Privacy and Civil Liberties Oversight Board (U.S. Congress)
The body of this Report consists of seven sections, five of which address the Section 215 telephone records program. After this introduction and the executive summary, Part 3 describes in detail how the telephone records program works. To put the present-day operation of the program in context, Part 4 reviews its history, including its evolution from predecessor intelligence activities. An analysis of whether the telephone records program meets applicable statutory requirements follows in Part 5. Part 6 addresses the constitutional issues raised by the telephone records program under both the First and Fourth Amendments. The final section discussing the Section 215 program, Part 7, examines the potential benefits of the program, its efficacy in achieving its purposes, the impact of the program on privacy and civil liberties, and the Board’s conclusions that reforms are needed.
After considering the 215 program, the Report addresses the operations of the Foreign Intelligence Surveillance Court. That section, Part 8, concludes by proposing an approach that, in appropriate cases, would allow the FISC judges to hear from a Special Advocate. Part 9, the final section of the Report, addresses the issue of transparency, which has been a priority of this Board since it began operations.