c

Unpredictable and uninsured: The challenging labor market experiences of nontraditional workers

As a result of the COVID-19 pandemic, the U.S. labor market has deteriorated from a position of relative strength into an extraordinarily weak condition in just a matter of weeks. Yet even in times of relative strength, millions of Americans struggle in the labor market, and although it is still early in the current downturn,…

       




c

Hutchins Roundup: Stimulus checks, team players, and more.

Studies in this week’s Hutchins Roundup find that households with low liquidity are more likely to spend their stimulus checks, social skills predict group performance as well as IQ, and more. Want to receive the Hutchins Roundup as an email? Sign up here to get it in your inbox every Thursday. Households with low liquidity…

       




c

Supporting students and promoting economic recovery in the time of COVID-19

COVID-19 has upended, along with everything else, the balance sheets of the nation’s elementary and secondary schools. As soon as school buildings closed, districts faced new costs associated with distance learning, ranging from physically distributing instructional packets and up to three meals a day, to supplying instructional programming for television and distributing Chromebooks and internet…

       




c

Class Notes: Harvard Discrimination, California’s Shelter-in-Place Order, and More

This week in Class Notes: California's shelter-in-place order was effective at mitigating the spread of COVID-19. Asian Americans experience significant discrimination in the Harvard admissions process. The U.S. tax system is biased against labor in favor of capital, which has resulted in inefficiently high levels of automation. Our top chart shows that poor workers are much more likely to keep commuting in…

       




c

A conversation with the CIA’s privacy and civil liberties officer: Balancing transparency and secrecy in a digital age

The modern age poses many questions about the nature of privacy and civil liberties. Data flows across borders and through the hands of private companies, governments, and non-state actors. For the U.S. intelligence community, what do civil liberties protections look like in this digital age? These kinds of questions are on top of longstanding ones…

       




c

20190618 Axios Chris Meserole

       




c

Women and the war on terror: An insider account

I am often asked what it is like to work for the Central Intelligence Agency. I spent 30 years there, both as an analyst and an operator abroad. A new book by Nada Bakos—“The Targeter: My Life in the CIA, Hunting Terrorists and Challenging the White House” (with Davin Coburn, published by Little, Brown and…

       




c

Secrets and Spies

Exploring how intelligence professionals view accountability in the context of twenty-first century politics How can democratic governments hold intelligence and security agencies accountable when what they do is largely secret? Using the UK as a case study, this book addresses this question by providing the first systematic exploration of how accountability is understood inside the…

       




c

Webinar: Becoming Kim Jong Un — A former CIA officer’s insights into North Korea’s enigmatic young dictator

When it became clear in 2009 that Kim Jong Un was being groomed to be the leader of North Korea, Jung Pak was a new analyst at the Central Intelligence Agency. Her job was to analyze this then little-known young man who would take over a nuclear-armed country and keep the highest levels of the…

       




c

Trump’s politicization of US intelligence agencies could end in disaster

       




c

The State of Drug Safety Surveillance in the U.S.: Much Improved, More to Come


When a new drug is approved in the United States, it is virtually impossible to know all of the risks that a population may encounter when using that product. Even though the U.S. Food and Drug Administration (FDA) requires drug manufacturers to meet rigorous standards demonstrating the drug’s safety and effectiveness for its intended use, once approved, drugs can be used by many more patients than were studied in clinical trials. This may include patients with unique clinical conditions, differing health status, ethnicity, age, or other characteristics which were not well-represented before the drug’s approval. Further, the drugs themselves can be used in different ways and in different settings than were studied. Until recently, FDA did not have the necessary tools and data access to rapidly and consistently track the risks of serious side effects of regulated drugs after approval. Recognizing this challenge, FDA has developed a pilot system to make the best use of available electronic health data using a new data and research network capable of evaluating the safety of medical products in the U.S. 

Authorized by the Food and Drug Administration Amendments Act (FDAAA) of 2007, this pilot is known as Mini-Sentinel, and is part of FDA’s larger Sentinel Initiative. Sentinel was envisioned as a national electronic system to track the safety of regulated medical products, through the use of existing health insurance claims and electronic clinical data that are generated as part of routine care. In the four years since its inception, Mini-Sentinel has made tremendous progress toward developing this system. Mini-Sentinel is comprised of insurance claims and clinical data from 18 participating data-partners, including some of the largest private health plans in the United States. In order to best protect patient privacy, the data from each partner is maintained behind each individual health plan fire-wall. This “distributed data” approach allows a single coordinating center to distribute FDA safety questions in the form of “queries,” to each of the participating data partners to be run against their own data. Aggregated summary results are then sent back to the coordinating center for final analysis. This process allows FDA to access data that can help in addressing safety questions in near real-time.  

Through Mini-Sentinel, FDA has the capability to better understand the safety outcomes using electronic health care data of approximately 169 million covered lives. This accumulation of data represents the capture of 382 million person-years of observation time and billions of prescription dispensings.[1] Examples of the types of safety questions that have already been addressed by Mini-Sentinel include the following:

  • Safety concerns with drugs used to treat high blood pressure and the incidence of angioedema;
  • Safety concerns with a new diabetes treatment and the incidence of heart attacks; and
  • Impact of FDA regulatory actions (i.e. drug label changes) intended to mitigate serious risks of drugs.

The Mini-Sentinel pilot has demonstrated substantial progress and has proven to be a very useful tool for FDA, largely due to the strong partnerships developed between FDA, collaborating academic institutions, and private health plans. However, in order to ensure continued progress and long-term sustainability, it will be critical for progress to continue in several key areas. 

First, continued methods development and data understanding will be necessary to ensure FDA has access to the most innovative tools. The field of pharmacoepidemiology and drug safety surveillance is still young and the continued development of better study designs and analytic tools to quantify risks of serious adverse events, while accounting for many confounding factors that are inherent on observational data, will be critical. Further, as health reforms impact that way health care is delivered and financed (e.g., development of accountable care organizations and increased use of bundled payments), the electronic health data will change. It will be important to focus efforts on understanding how these changes will impact data used for safety evaluations. 

Second, it is clear that Sentinel’s contributions may extend well beyond FDA’s medical product assessments. The tools and infrastructure that have been developed by FDA over the last four years could be used as a platform to establish a national resource for a more evidence-based learning health care system. This system will enable a better understanding of not only the risks, but also benefits and best uses, of drugs in the post-market settings. 

FDA has initiated steps to ensure the long-term sustainability and impact of Sentinel infrastructure and tools. Within the next few years, FDA has proposed that Sentinel be transitioned into three main components: the Sentinel Operations Center, the Nation Resource Data Infrastructure, and the Methodological Resource for Medical Product Surveillance using Electronic Healthcare Databases. FDA has indicated that while the Sentinel Operations Center will continue to serve as FDA’s portal to the distributed database, the Nation Resource Data Infrastructure could potentially be used by other groups to support broader evidence generation. Potential groups with interest in improving our understanding of the impact of medical products and who could benefit from this framework include the National Institutes of Health, the Regan-Udall Foundation, the Patient Centered Outcomes Research Institute, and other possible stakeholder groups, such as the private industry. 

Collectively, these components will ensure that FDA continues to have the tools to engage in medical product surveillance, while ensuring the long-term sustainability of the system. In just four years, the Sentinel Initiative has laid the groundwork to transform how FDA, and the nation, benefits from electronic health care data. This network continues to foster a community of stakeholders committed the evidence generation, which will ultimately contribute to a learning health care system.

New Advances in Medical Records Reflects the Realities of the U.S. Healthcare System

For more information on these issues, including discussion by leaders from Sentinel stakeholders, please visit the Sentinel Initiative Public Workshop event page. There you will find archived video, presentations, and further reading.



[1] http://mini-sentinel.org/about_us/MSDD_At-a-Glance.aspx

Video

Authors

      
 
 




c

What past oil crashes say about today’s slump

The oil industry is going through its third crash in prices since the formation of the OPEC cartel. Many are wondering when the market will recover and what oil prices will be when it finally does. The first price crash came in the mid-1980’s, a decade after OPEC’s formation. The second crash came at the onset…

       




c

Stocks and the economy

The stock market started 2016 with its worst first two weeks ever, renewing a decline in stocks that began around mid-2015. In mid-December, the Fed indicated its confidence in the economy's expansion by finally raising the policy interest rate above zero. Does the falling stock market reflect signs of economic trouble that the Fed missed?…

       




c

Is there any ammo left for recession fighting?

A government’s arsenal for moderating business cycles consists of fiscal and monetary policy. But the U.S. has little scope for using either if a new recession should now emerge. The Fed has only limited options left for stimulating the economy. And political gridlock may prevent any timely injection of fiscal stimulus. How big are the…

       




c

Yawn, another OPEC meeting

On Thursday, the 13-nation Organization of the Petroleum Exporting Countries ended its meeting without reaching an agreement on oil production. Some had hoped OPEC would freeze and lower oil supplies to stabilize prices, but Saudi Arabia’s new oil minister and de factor OPEC leader left supplies unchanged. The gathering in Vienna received plenty of attention…

       




c

Should the Fed’s discretion be constrained by rules?

The Federal Reserve is the most second-guessed agency in the government. Congress regularly calls on the Fed Chairperson to explain its actions and part of Wall Street is always blaming the Fed for something it did or did not do. But suffering such scrutiny comes with being responsible for important policy making. A deeper issue,…

       




c

Donald Trump’s fiscal package promises to promote expansion

One month after the election, a huge market rally shows stock-market investors like the changes Donald Trump will bring to the business world. At the same time, great uncertainty remains about the new Administration's policies toward the Middle East, Russia, trade relations, and other matters of state and defense. But on the core issues of…

       




c

Will President Trump derail the U.S. economy?

Is the great surge in the stock market since Trump’s election a promise of better economic times ahead? It is easy to see why Trump's core economic proposals sharply raised stock prices and why they could help the expansion in the near term. The rest of the Trump program--the attacks on immigrants and trading partners--promise…

       




c

There’s no recession, but a market correction could cause one

Before last Friday’s employment release, some pessimistic observers feared a recession was near. The latest GDP release from the BEA showed real output growth slowed to a crawl in the first quarter, rising at an annual rate of only 0.7 percent. And that followed the report on March employment that had shown an abrupt slowdown…

       




c

The new oil market: Chaos or order?

The CEO of Royal Dutch Shell recently projected oil prices will remain “lower forever.” This comes after a decade of the most chaotic gyrations of oil markets since the 1970s. But unlike that earlier period, when production cuts by the new OPEC cartel led to a quadrupling of world oil prices, this one has included…

       




c

Oil prices are tumbling. Volatility aside, expect them to stay low over the next 20 years.

Crude oil prices have dropped over 20 percent the past two weeks, reminding observers of just how uncertain the oil market has become. That uncertainty started in 1973 when the OPEC cartel first drove prices sharply higher by constraining production. During the 1980s and 90s, new offshore oil fields kept non-OPEC supplies growing and moderated…

       




c

Iran’s corona-diplomacy

While President Trump’s campaign of “maximum pressure” against Iran has been building for three years now, the COVID-19 pandemic is making its impact much more acute. The administration of Iranian President Hassan Rouhani has been pressing the U.S. to ease or lift sanctions in light of the public health and economic crises affecting a huge…

       




c

How Gulf states can lead the global COVID-19 response

As the coronavirus pandemic intensifies, it is becoming clear that no unified international response is in the works. Indeed, international organizations have been undermined by national actions, such as U.S. President Donald Trump’s shortsighted decision to suspend funding to the World Health Organization (WHO). In lieu of global coordination, the buck has been passed down…

       




c

GCC News Roundup: Saudi Arabia, UAE, Qatar, Kuwait implement new economic measures (April 1-30)

Gulf economies struggle as crude futures collapse Gulf debt and equity markets fell on April 21 and the Saudi currency dropped in the forward market, after U.S. crude oil futures collapsed below $0 on a coronavirus-induced supply glut. Saudi Arabia’s central bank foreign reserves fell in March at their fastest rate in at least 20…

       




c

Webinar: Public health and COVID-19 in MENA: Impact, response and outlook

The coronavirus pandemic has exacted a devastating human toll on the Middle East and North Africa (MENA) region, with over 300,000 confirmed cases and 11,000 deaths to date. It has also pushed the region’s public healthcare systems to their limits, though countries differ greatly in their capacities to test, trace, quarantine, and treat affected individuals. MENA governments…

       




c

Pandemic politics: Does the coronavirus pandemic signal China’s ascendency to global leadership?

The absence of global leadership and cooperation has hampered the global response to the coronavirus pandemic. This stands in stark contrast to the leadership and cooperation that mitigated the financial crisis of 2008 and that contained the Ebola outbreak of 2014. At a time when the United States has abandoned its leadership role, China is…

       




c

It’s George Wallace’s World Now

       




c

Too Much Democracy Is Bad for Democracy

       




c

Black Americans are not a monolithic group so stop treating us like one

       




c

The killing of Ahmaud Arbery highlights the danger of jogging while black

       




c

The CARES Act Risks Becoming a Caste Act. Here’s How We Change That.

       




c

Artificial Intelligence Won’t Save Us From Coronavirus

       




c

Why AI systems should disclose that they’re not human

       




c

In the Republican Party establishment, Trump finds tepid support

For the past three years the Republican Party leadership have stood by the president through thick and thin. Previous harsh critics and opponents in the race for the Republican nomination like Senator Lindsey Graham and Senator Ted Cruz fell in line, declining to say anything negative about the president even while, at times, taking action…

       




c

Ahmaud Arbery and the dangers of running while black

       




c

Record-setting White House staff turnover continues with news of Counsel’s departure

With the recent departure of White House Counsel, Don McGahn (and premature announcement of his successor, Pat Cipollone), turnover within the most senior level of White House staff members bumped up to 83 percent. Ten of the twelve Tier One staff members have departed, leaving only Cabinet Secretary, Bill McGinley, and Chairman of the Council…

       




c

In search of a third chief of staff, Trump sets a record

When President Trump appoints a replacement to Chief of Staff John Kelly, whose resignation (or firing) he announced on December 8th, he will once again have set a record. This time it is the record for most chiefs of staff within the first 24 months of an administration. Since President Trump’s inauguration, the most influential…

       




c

Tracking turnover in the Trump administration

The rate of turnover among senior level advisers to President Trump has generated a great deal of attention. Below, we offer four resources to help measure and contextualize this turnover. The first set of resources tracks turnover among senior-ranking advisers in the executive office of the president (which does not include Cabinet secretaries), whereas the second…

       




c

Kirstjen Nielsen, secretary of Homeland Security, out amidst national emergency

Kirstjen Nielsen, the secretary of Homeland Security, submitted her resignation letter on Sunday, April 7, 2019, marking the 15th Cabinet-level departure in the Trump administration since January 2017. By contrast, President Obama had seven departures after three full years in office, and President George W. Bush had four departures after three full years. Cabinet turnover…

       




c

Who is in the president’s Cabinet?

Last month, Kirstjen Nielsen, the former secretary of the Department of Homeland Security, became the 15th Cabinet member to leave the Trump administration. By contrast, after three full years in office, President Obama had lost seven Cabinet members and President W. Bush had lost only four. Just as with the rate of White House staff turnover, President…

       




c

With Acosta’s resignation, how is high turnover affecting the administration?

Following Labor Secretary Alex Acosta's resignation, Kathryn Dunn Tenpas updates her count of the Trump administration's unprecedented levels of senior staff turnover and examines the effect leadership turmoil has on the ability of departments and agencies to govern. http://directory.libsyn.com/episode/index/id/10499969 Related material:  Tracking turnover in the Trump administration Why is Trump’s staff turnover higher than the…

       




c

Crippling the capacity of the National Security Council

The Trump administration’s first three years saw record-setting turnover at the most senior level of the White House staff and the Cabinet. There are also numerous vacancies in Senate-confirmed positions across the executive branch. As of September 22, 2019, the turnover rate among senior White House aides had reached 80 percent, a rate that exceeded…

       




c

And then there were ten: With 85% turnover across President Trump’s A Team, who remains?

Having tracked turnover for five presidents and closely following the churn in the Trump White House, it is clear that what is currently going on is far from normal. Less than a month after President Trump’s inauguration, National Security Advisor Michael Flynn was forced to resign, and this high-level departure marked the beginning of an…

       




c

Webinar: How federal job vacancies hinder the government’s response to COVID-19

Vacant positions and high turnover across the federal bureaucracy have been a perpetual problem since President Trump was sworn into office. Upper-level Trump administration officials (“the A Team”) have experienced a turnover rate of 85 percent — much higher than any other administration in the past 40 years. The struggle to recruit and retain qualified…

       




c

How instability and high turnover on the Trump staff hindered the response to COVID-19

On Jan. 14, 2017, the Obama White House hosted 30 incoming staff members of the Trump team for a role-playing scenario. A readout of the event said, “The exercise provided a high-level perspective on a series of challenges that the next administration may face and introduced the key authorities, policies, capabilities, and structures that are…

       




c

How might COVID-19 affect the global economy?

As COVID-19 continues to spread around the world, Warwick J. McKibbin joined us from his home in Australia to discuss how the novel coronavirus may disrupt the global economy. McKibbin, a nonresident senior fellow at Brookings, authored a recent report outlining seven different scenarios of how COVID-19 might evolve and the implications each scenario would…

       




c

Around-the-halls: What the coronavirus crisis means for key countries and sectors

The global outbreak of a novel strain of coronavirus, which causes the disease now called COVID-19, is posing significant challenges to public health, the international economy, oil markets, and national politics in many countries. Brookings Foreign Policy experts weigh in on the impacts and implications. Giovanna DeMaio (@giovDM), Visiting Fellow in the Center on the…

       




c

How will the Chinese economy rebound from COVID-19?

What effect has COVID-19 had on the Chinese economy and phase one of the U.S.-China deal? Could the United States or other nations draw lessons from China’s response to the virus? David Dollar is joined in this episode of Dollar & Sense by Dexter Roberts, former China Bureau Chief for Bloomberg Businessweek, to discuss these…

       




c

How will COVID-19 reshape America’s logistics workforce?

What effect will the COVID-19 pandemic have on the 9.2 million Americans working in logistics? Adie Tomer joins David Dollar to discuss the geographic distribution of logistics workers, their role in supply chains, the lack of protection for essential workers, and the necessity to create a more equitable social contract for America’s labor force. http://directory.libsyn.com/episode/index/id/13855505…

       




c

The politics of Congress’s COVID-19 response

In the face of economic and health challenges posed by COVID-19, Congress, an institution often hamstrung by partisanship, quickly passed a series of bills allocating trillions of dollars for economic stimulus and relief. In this episode, Sarah Binder joins David Dollar to discuss the politics behind passing that legislation and lingering uncertainties about its oversight…