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Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for drugs or biologics that carry serious potential or known risks. Since that time, the REMS program has become an important tool in ensuring that riskier drugs are used safely, and it has allowed FDA to facilitate access to a host of drugs that may not otherwise have been approved. However, concerns have arisen regarding the effects of REMS programs on patient access to products, as well as the undue burden that the requirements place on the health care system. In response to these concerns, FDA has initiated reform efforts aimed at improving the standardization, assessment, and integration of REMS within the health care system. As part of this broader initiative, the agency is pursuing four priority projects, one of which focuses on improving provider-patient benefit-risk counseling for drugs that have a REMS attached.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held an expert workshop on July 24 titled, “Risk Evaluation and Mitigation Strategies (REMS): Building a Framework for Effective Patient Counseling on Medication Risks and Benefits”. This workshop was the first in a series of convening activities that will seek input from stakeholders across academia, industry, health systems, and patient advocacy groups, among others. Through these activities, Brookings and FDA will further develop and refine an evidence-based framework of best practices and principles that can be used to inform the development and effective use of REMS tools and processes.

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Introduction

The global community has set itself the challenge of meeting the Millennium Development Goals (MDGs) by 2015 as a way to combat world poverty and hunger. In 2007, the halfway point, it is clear that many countries will not be able to meet the MDGs without undertaking significantly greater efforts. One constraint that needs to be overcome is that development interventions—projects, programs, policies—are all too often like small pebbles thrown into a big pond: they are limited in scale, short-lived, and therefore have little lasting impact. This may explain why so many studies have found that external aid has had weak or no development impact in the aggregate, even though many individual interventions have been successful in terms of their project- or program-specific goals.

Confronted with the challenge of meeting the MDGs, the development community has recently begun to focus on the need to scale up interventions. Scaling up means taking successful projects, programs, or policies and expanding, adapting, and sustaining them in different ways over time for greater development impact. This emphasis on scaling up has emerged from concern over how to deploy and absorb the substantially increased levels of official development assistance that were promised by the wealthy countries at recent G8 summits. A fragmented aid architecture complicates this task; multilateral, bilateral, and private aid entities have multiplied, leading to many more—but smaller— aid projects and programs and increasing transaction costs for recipient countries. In response, some aid donors have started to move from project to program support, and in the Paris Declaration, official donors committed themselves to work together for better coordinated aid delivery.

The current focus on scaling up is not entirely new, however. During the 1980s, as nongovernmental organizations (NGOs) increasingly began to engage in development activities, scaling up emerged as a challenge. NGO interventions were (and are) typically small in scale and often apply new approaches. Therefore, the question of how to replicate and scale up successful models gained prominence even then, especially in connection with participatory and community development approaches. Indeed, the current interest among philanthropic foundations and NGOs in how to scale up their interventions is an echo of these earlier concerns.

In response to this increased focus on scaling up—and its increased urgency—this policy brief takes a comprehensive look at what the literature and experience have to say about whether and how to scale up development interventions.

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Abstract

Scaling up of development interventions is much debated today as a way to improve their impact and effectiveness. Based on a review of scaling up literature and practice, this paper develops a framework for the key dynamics that allow the scaling up process to happen. The authors explore the possible approaches and paths to scaling up, the drivers of expansion and of replication, the space that has to be created for interventions to grow, and the role of evaluation and of careful planning and implementation. They draw a number of lessons for the development analyst and practitioner. More than anything else, scaling up is about political and organizational leadership, about vision, values and mindset, and about incentives and accountability—all oriented to make scaling up a central element of individual, institutional, national and international development efforts. The paper concludes by highlighting some implications for aid and aid donors.

An annotated bibliography of the literature on scaling up and development aid effectiveness was created by Oksana Pidufala to supplement this working paper. Read more »

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The workplace is changing rapidly, and more and more leaders in government and private industry are required to lead those who are geographically separated. Globalization, economic shifts from manufacturing to information, the need to be closer to customers, and improved technological capabilities have increased the geographic dispersion of many organizations. While these organizations offer many exciting opportunities, they also bring new leadership challenges that are amplified because of the separation between leaders and followers. Although much has been researched and written on leadership in general, relatively little has been focused on the unique leadership challenges and opportunities presented in geographically separated environments. Furthermore, most leaders are not given the right tools and training to overcome the challenges or take advantage of the opportunities when leading in these unique settings.

A survey of leaders within a geographically dispersed military organization confirmed there are distinct differences in how remote and local leaders operate, and most leadership tasks related to leading those who are remote are more difficult than with those who are co-located. The tasks most difficult for remote leaders are related to communicating, mentoring and building personal relationships, fostering teamwork and group identity, and measuring performance. To be effective, leaders must be aware of the challenges they face when leading from afar and be deliberate in their engagement.

Although there are unique leadership challenges in geographically dispersed environments, most current leadership literature and training is developed on work in face-to-face settings. Leading geographically dispersed organizations is not a new concept, but technological advances over the last decade have provided leaders with greater ability to be more influential and involved with distant teams than ever before. This advancement has given leaders not only the opportunity to be successful in a moment of time but ensures continued success by enhancing the way they build dispersed organizations and grow future leaders from afar.

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Terrorist attacks with high casualties usually create a sense of national solidarity and patriotic reaction in societies that fall victim to such heinous acts. Not in Turkey, however. Despite a growing number of terrorist attacks by the so-called Islamic State on Turkish soil in the last 12 months, the country remains as polarized as ever under strongman President Recep Tayyip Erdogan.

In fact, for two reasons, jihadist terrorism is exacerbating the division. First, Turkey's domestic polarization already has an Islamist-versus-secularist dimension. Most secularists hold Erdogan responsible for having created domestic political conditions that turn a blind eye to jihadist activities within Turkey.

It must also be said that polarization between secularists and Islamists in Turkey often fails to capture the complexity of Turkish politics, where not all secularists are democrats and not all Islamists are autocrats. In fact, there was a time when Erdogan was hailed as the great democratic reformer against the old secularist establishment under the guardianship of the military.

Yet, in the last five years, the religiosity and conservatism of the ruling Justice and Development Party, also known by its Turkish acronym AKP, on issues ranging from gender equality to public education has fueled the perception of rapid Islamization. Erdogan's anti-Western foreign policy discourse -- and the fact that Ankara has been strongly supportive of the Muslim Brotherhood in the wake of the Arab Spring -- exacerbates the secular-versus-Islamist divide in Turkish society.

Erdogan doesn't fully support the eradication of jihadist groups in Syria.

The days Erdogan represented the great hope of a Turkish model where Islam, secularism, democracy and pro-Western orientation came together are long gone. Despite all this, it is sociologically more accurate to analyze the polarization in Turkey as one between democracy and autocracy rather than one of Islam versus secularism.

The second reason why ISIS terrorism is exacerbating Turkey's polarization is related to foreign policy. A significant segment of Turkish society believes Erdogan's Syria policy has ended up strengthening ISIS. In an attempt to facilitate Syrian President Bashar Assad's overthrow, the AKP turned a blind eye to the flow of foreign volunteers transiting Turkey to join extremist groups in Syria. Until last year, Ankara often allowed Islamists to openly organize and procure equipment and supplies on the Turkish side of the Syria border.

Making things worse is the widely held belief that Turkey's National Intelligence Organization, or MİT, facilitated the supply of weapons to extremist Islamist elements amongst the Syrian rebels. Most of the links were with organizations such as Jabhat al-Nusra, Ahrar al-Sham and Islamist extremists from Syria's Turkish-speaking Turkmen minority.

He is trying to present the PKK as enemy number one.

Turkey's support for Islamist groups in Syria had another rationale in addition to facilitating the downfall of the Assad regime: the emerging Kurdish threat in the north of the country. Syria's Kurds are closely linked with Turkey's Kurdish nemesis, the Kurdistan Workers' Party, or PKK, which has been conducting an insurgency for greater rights for Turkey's Kurds since 1984.

On the one hand, Ankara has hardened its stance against ISIS by opening the airbase at Incirlik in southern Turkey for use by the U.S-led coalition targeting the organization with air strikes. However, Erdogan doesn't fully support the eradication of jihadist groups in Syria. The reason is simple: the Arab and Turkmen Islamist groups are the main bulwark against the expansion of the de facto autonomous Kurdish enclave in northern Syria. The AKP is concerned that the expansion and consolidation of a Kurdish state in Syria would both strengthen the PKK and further fuel similar aspirations amongst Turkey's own Kurds.

Will the most recent ISIS terrorist attack in Istanbul change anything in Turkey's main threat perception? When will the Turkish government finally realize that the jihadist threat in the country needs to be prioritized? If you listen to Erdogan's remarks, you will quickly realize that the real enemy he wants to fight is still the PKK. He tries hard after each ISIS attack to create a "generic" threat of terrorism in which all groups are bundled up together without any clear references to ISIS. He is trying to present the PKK as enemy number one.

Only after a peace process with Kurds will Turkey be able to understand that ISIS is an existential threat to national security.

Under such circumstances, Turkish society will remain deeply polarized between Islamists, secularists, Turkish nationalists and Kurdish rebels. Terrorist attacks, such as the one in Istanbul this week and the one in Ankara in July that killed more than 100 people, will only exacerbate these divisions.

Finally, it is important to note that the Turkish obsession with the Kurdish threat has also created a major impasse in Turkish-American relations in Syria. Unlike Ankara, Washington's top priority in Syria is to defeat ISIS. The fact that U.S. strategy consists of using proxy forces such as Syrian Kurds against ISIS further complicates the situation.

There will be no real progress in Turkey's fight against ISIS unless there is a much more serious strategy to get Ankara to focus on peace with the PKK. Only after a peace process with Kurds will Turkey be able to understand that ISIS is an existential threat to national security.

This piece was originally posted by The Huffington Post.

Part II of the 2015 Brown Center Report on American Education

Over the next several years, policy analysts will evaluate the impact of the Common Core State Standards (CCSS) on U.S. education.  The task promises to be challenging.  The question most analysts will focus on is whether the CCSS is good or bad policy.  This section of the Brown Center Report (BCR) tackles a set of seemingly innocuous questions compared to the hot-button question of whether Common Core is wise or foolish.  The questions all have to do with when Common Core actually started, or more precisely, when the Common Core started having an effect on student learning.  And if it hasn’t yet had an effect, how will we know that CCSS has started to influence student achievement? 

The analysis below probes this issue empirically, hopefully persuading readers that deciding when a policy begins is elemental to evaluating its effects.  The question of a policy’s starting point is not always easy to answer.  Yet the answer has consequences.  You can’t figure out whether a policy worked or not unless you know when it began.^[i] 

The analysis uses surveys of state implementation to model different CCSS starting points for states and produces a second early report card on how CCSS is doing.  The first report card, focusing on math, was presented in last year’s BCR.  The current study updates state implementation ratings that were presented in that report and extends the analysis to achievement in reading.  The goal is not only to estimate CCSS’s early impact, but also to lay out a fair approach for establishing when the Common Core’s impact began—and to do it now before data are generated that either critics or supporters can use to bolster their arguments.  The experience of No Child Left Behind (NCLB) illustrates this necessity.

After the 2008 National Assessment of Educational Progress (NAEP) scores were released, former Secretary of Education Margaret Spellings claimed that the new scores showed “we are on the right track.”^[ii] She pointed out that NAEP gains in the previous decade, 1999-2009, were much larger than in prior decades.  Mark Schneider of the American Institutes of Research (and a former Commissioner of the National Center for Education Statistics [NCES]) reached a different conclusion. He compared NAEP gains from 1996-2003 to 2003-2009 and declared NCLB’s impact disappointing.  “The pre-NCLB gains were greater than the post-NCLB gains.”^[iii]  It is important to highlight that Schneider used the 2003 NAEP scores as the starting point for assessing NCLB.  A report from FairTest on the tenth anniversary of NCLB used the same demarcation for pre- and post-NCLB time frames.^[iv]  FairTest is an advocacy group critical of high stakes testing—and harshly critical of NCLB—but if the 2003 starting point for NAEP is accepted, its conclusion is indisputable, “NAEP score improvement slowed or stopped in both reading and math after NCLB was implemented.” 

Choosing 2003 as NCLB’s starting date is intuitively appealing.  The law was introduced, debated, and passed by Congress in 2001.  President Bush signed NCLB into law on January 8, 2002.  It takes time to implement any law.  The 2003 NAEP is arguably the first chance that the assessment had to register NCLB’s effects. 

Selecting 2003 is consequential, however.  Some of the largest gains in NAEP’s history were registered between 2000 and 2003.  Once 2003 is established as a starting point (or baseline), pre-2003 gains become “pre-NCLB.”  But what if the 2003 NAEP scores were influenced by NCLB? Experiments evaluating the effects of new drugs collect baseline data from subjects before treatment, not after the treatment has begun.   Similarly, evaluating the effects of public policies require that baseline data are not influenced by the policies under evaluation.   

Avoiding such problems is particularly difficult when state or local policies are adopted nationally.  The federal effort to establish a speed limit of 55 miles per hour in the 1970s is a good example.  Several states already had speed limits of 55 mph or lower prior to the federal law’s enactment.  Moreover, a few states lowered speed limits in anticipation of the federal limit while the bill was debated in Congress.  On the day President Nixon signed the bill into law—January 2, 1974—the Associated Press reported that only 29 states would be required to lower speed limits.  Evaluating the effects of the 1974 law with national data but neglecting to adjust for what states were already doing would obviously yield tainted baseline data.

There are comparable reasons for questioning 2003 as a good baseline for evaluating NCLB’s effects.  The key components of NCLB’s accountability provisions—testing students, publicizing the results, and holding schools accountable for results—were already in place in nearly half the states.  In some states they had been in place for several years.  The 1999 iteration of Quality Counts, Education Week’s annual report on state-level efforts to improve public education, entitled Rewarding Results, Punishing Failure, was devoted to state accountability systems and the assessments underpinning them. Testing and accountability are especially important because they have drawn fire from critics of NCLB, a law that wasn’t passed until years later.

The Congressional debate of NCLB legislation took all of 2001, allowing states to pass anticipatory policies.  Derek Neal and Diane Whitmore Schanzenbach reported that “with the passage of NCLB lurking on the horizon,” Illinois placed hundreds of schools on a watch list and declared that future state testing would be high stakes.^[v] In the summer and fall of 2002, with NCLB now the law of the land, state after state released lists of schools falling short of NCLB’s requirements.  Then the 2002-2003 school year began, during which the 2003 NAEP was administered.  Using 2003 as a NAEP baseline assumes that none of these activities—previous accountability systems, public lists of schools in need of improvement, anticipatory policy shifts—influenced achievement.  That is unlikely.^[vi]

Unlike NCLB, there was no “pre-CCSS” state version of Common Core.  States vary in how quickly and aggressively they have implemented CCSS.  For the BCR analyses, two indexes were constructed to model CCSS implementation.  They are based on surveys of state education agencies and named for the two years that the surveys were conducted.  The 2011 survey reported the number of programs (e.g., professional development, new materials) on which states reported spending federal funds to implement CCSS.  Strong implementers spent money on more activities.  The 2011 index was used to investigate eighth grade math achievement in the 2014 BCR.  A new implementation index was created for this year’s study of reading achievement.  The 2013 index is based on a survey asking states when they planned to complete full implementation of CCSS in classrooms.  Strong states aimed for full implementation by 2012-2013 or earlier.      

Fourth grade NAEP reading scores serve as the achievement measure.  Why fourth grade and not eighth?  Reading instruction is a key activity of elementary classrooms but by eighth grade has all but disappeared.  What remains of “reading” as an independent subject, which has typically morphed into the study of literature, is subsumed under the English-Language Arts curriculum, a catchall term that also includes writing, vocabulary, listening, and public speaking.  Most students in fourth grade are in self-contained classes; they receive instruction in all subjects from one teacher.  The impact of CCSS on reading instruction—the recommendation that non-fiction take a larger role in reading materials is a good example—will be concentrated in the activities of a single teacher in elementary schools. The burden for meeting CCSS’s press for non-fiction, on the other hand, is expected to be shared by all middle and high school teachers.^[vii] 

Table 2-1 displays NAEP gains using the 2011 implementation index.  The four year period between 2009 and 2013 is broken down into two parts: 2009-2011 and 2011-2013.  Nineteen states are categorized as “strong” implementers of CCSS on the 2011 index, and from 2009-2013, they outscored the four states that did not adopt CCSS by a little more than one scale score point (0.87 vs. -0.24 for a 1.11 difference).  The non-adopters are the logical control group for CCSS, but with only four states in that category—Alaska, Nebraska, Texas, and Virginia—it is sensitive to big changes in one or two states.  Alaska and Texas both experienced a decline in fourth grade reading scores from 2009-2013.

The 1.11 point advantage in reading gains for strong CCSS implementers is similar to the 1.27 point advantage reported last year for eighth grade math.  Both are small.  The reading difference in favor of CCSS is equal to approximately 0.03 standard deviations of the 2009 baseline reading score.  Also note that the differences were greater in 2009-2011 than in 2011-2013 and that the “medium” implementers performed as well as or better than the strong implementers over the entire four year period (gain of 0.99).

Table 2-2 displays calculations using the 2013 implementation index.  Twelve states are rated as strong CCSS implementers, seven fewer than on the 2011 index.^[viii]  Data for the non-adopters are the same as in the previous table.  In 2009-2013, the strong implementers gained 1.27 NAEP points compared to -0.24 among the non-adopters, a difference of 1.51 points.  The thirty-four states rated as medium implementers gained 0.82.  The strong implementers on this index are states that reported full implementation of CCSS-ELA by 2013.  Their larger gain in 2011-2013 (1.08 points) distinguishes them from the strong implementers in the previous table.  The overall advantage of 1.51 points over non-adopters represents about 0.04 standard deviations of the 2009 NAEP reading score, not a difference with real world significance.  Taken together, the 2011 and 2013 indexes estimate that NAEP reading gains from 2009-2013 were one to one and one-half scale score points larger in the strong CCSS implementation states compared to the states that did not adopt CCSS.

As noted above, the 2013 implementation index is based on when states scheduled full implementation of CCSS in classrooms.  Other than reading achievement, does the index seem to reflect changes in any other classroom variable believed to be related to CCSS implementation?  If the answer is “yes,” that would bolster confidence that the index is measuring changes related to CCSS implementation. 

Let’s examine the types of literature that students encounter during instruction.  Perhaps the most controversial recommendation in the CCSS-ELA standards is the call for teachers to shift the content of reading materials away from stories and other fictional forms of literature in favor of more non-fiction.  NAEP asks fourth grade teachers the extent to which they teach fiction and non-fiction over the course of the school year (see Figure 2-1). 

Historically, fiction dominates fourth grade reading instruction.  It still does.  The percentage of teachers reporting that they teach fiction to a “large extent” exceeded the percentage answering “large extent” for non-fiction by 23 points in 2009 and 25 points in 2011.  In 2013, the difference narrowed to only 15 percentage points, primarily because of non-fiction’s increased use.  Fiction still dominated in 2013, but not by as much as in 2009.

The differences reported in Table 2-3 are national indicators of fiction’s declining prominence in fourth grade reading instruction.  What about the states?  We know that they were involved to varying degrees with the implementation of Common Core from 2009-2013.  Is there evidence that fiction’s prominence was more likely to weaken in states most aggressively pursuing CCSS implementation? 

Table 2-3 displays the data tackling that question.  Fourth grade teachers in strong implementation states decisively favored the use of fiction over non-fiction in 2009 and 2011.  But the prominence of fiction in those states experienced a large decline in 2013 (-12.4 percentage points).  The decline for the entire four year period, 2009-2013, was larger in the strong implementation states (-10.8) than in the medium implementation (-7.5) or non-adoption states (-9.8).  

This section of the Brown Center Report analyzed NAEP data and two indexes of CCSS implementation, one based on data collected in 2011, the second from data collected in 2013.  NAEP scores for 2009-2013 were examined.  Fourth grade reading scores improved by 1.11 scale score points in states with strong implementation of CCSS compared to states that did not adopt CCSS.  A similar comparison in last year’s BCR found a 1.27 point difference on NAEP’s eighth grade math test, also in favor of states with strong implementation of CCSS.  These differences, although certainly encouraging to CCSS supporters, are quite small, amounting to (at most) 0.04 standard deviations (SD) on the NAEP scale.  A threshold of 0.20 SD—five times larger—is often invoked as the minimum size for a test score change to be regarded as noticeable.  The current study’s findings are also merely statistical associations and cannot be used to make causal claims.  Perhaps other factors are driving test score changes, unmeasured by NAEP or the other sources of data analyzed here. 

The analysis also found that fourth grade teachers in strong implementation states are more likely to be shifting reading instruction from fiction to non-fiction texts.  That trend should be monitored closely to see if it continues.  Other events to keep an eye on as the Common Core unfolds include the following:

1.  The 2015 NAEP scores, typically released in the late fall, will be important for the Common Core.  In most states, the first CCSS-aligned state tests will be given in the spring of 2015.  Based on the earlier experiences of Kentucky and New York, results are expected to be disappointing.  Common Core supporters can respond by explaining that assessments given for the first time often produce disappointing results.  They will also claim that the tests are more rigorous than previous state assessments.  But it will be difficult to explain stagnant or falling NAEP scores in an era when implementing CCSS commands so much attention.   

2.  Assessment will become an important implementation variable in 2015 and subsequent years.  For analysts, the strategy employed here, modeling different indicators based on information collected at different stages of implementation, should become even more useful.  Some states are planning to use Smarter Balanced Assessments, others are using the Partnership for Assessment of Readiness for College and Careers (PARCC), and still others are using their own homegrown tests.   To capture variation among the states on this important dimension of implementation, analysts will need to use indicators that are up-to-date.

3.  The politics of Common Core injects a dynamic element into implementation.  The status of implementation is constantly changing.  States may choose to suspend, to delay, or to abandon CCSS.  That will require analysts to regularly re-configure which states are considered “in” Common Core and which states are “out.”  To further complicate matters, states may be “in” some years and “out” in others.

A final word.  When the 2014 BCR was released, many CCSS supporters commented that it is too early to tell the effects of Common Core.  The point that states may need more time operating under CCSS to realize its full effects certainly has merit.  But that does not discount everything states have done so far—including professional development, purchasing new textbooks and other instructional materials, designing new assessments, buying and installing computer systems, and conducting hearings and public outreach—as part of implementing the standards.  Some states are in their fifth year of implementation.  It could be that states need more time, but innovations can also produce their biggest “pop” earlier in implementation rather than later.  Kentucky was one of the earliest states to adopt and implement CCSS.  That state’s NAEP fourth grade reading score declined in both 2009-2011 and 2011-2013.  The optimism of CCSS supporters is understandable, but a one and a half point NAEP gain might be as good as it gets for CCSS.

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The eurozone has three problems: national debt obligations that cannot be met, medium-term imbalances in trade competitiveness, and long-term structural flaws.

The short-run problem requires more of the monetary easing that Germany has, with appalling shortsightedness, been resisting, and less of the near-term fiscal restraint that Germany has, with equally appalling shortsightedness, been seeking. To insist that Greece meet all of its near-term current debt service obligations makes about as much sense as did French and British insistence that Germany honor its reparations obligations after World War I. The latter could not be and were not honored. The former cannot and will not be honored either.

The medium-term problem is that, given a single currency, labor costs are too high in Greece and too low in Germany and some other northern European countries. Because adjustments in currency values cannot correct these imbalances, differences in growth of wages must do the job—either wage deflation and continued depression in Greece and other peripheral countries, wage inflation in Germany, or both. The former is a recipe for intense and sustained misery. The latter, however politically improbable it may now seem, is the better alternative.

The long-term problem is that the eurozone lacks the fiscal transfer mechanisms necessary to soften the effects of competitiveness imbalances while other forms of adjustment take effect. This lack places extraordinary demands on the willingness of individual nations to undertake internal policies to reduce such imbalances. Until such fiscal transfer mechanisms are created, crises such as the current one are bound to recur.

Present circumstances call for a combination of short-term expansionary policies that have to be led or accepted by the surplus nations, notably Germany, who will also have to recognize and accept that not all Greek debts will be paid or that debt service payments will not be made on time and at originally negotiated interest rates. The price for those concessions will be a current and credible commitment eventually to restore and maintain fiscal balance by the peripheral countries, notably Greece.