io Trump’s India trip, Delhi riots, and India in American domestic politics By webfeeds.brookings.edu Published On :: Tue, 03 Mar 2020 19:19:20 +0000 Full Article
io On April 8, 2020, Tanvi Madan discussed the implications of the coronavirus pandemic for the Sino-Indo bilateral relations with ORF By webfeeds.brookings.edu Published On :: Wed, 08 Apr 2020 19:36:56 +0000 On April 8, 2020, Tanvi Madan discussed the implications of the coronavirus pandemic for the Sino-Indo bilateral relations via teleconference with Observer Research Foundation. Full Article
io On April 16, 2020, Tanvi Madan unpacked how India’s relation with China changed under Narendra Modi and Xi Jinping via teleconference with the Asia Society Switzerland By webfeeds.brookings.edu Published On :: Thu, 16 Apr 2020 20:02:19 +0000 On April 16, 2020, Tanvi Madan unpacked how India's relation with China changed under Narendra Modi and Xi Jinping via teleconference with the Asia Society Switzerland. Full Article
io India’s coronavirus response, anti-China sentiment, and the communalization of Covid-19 By webfeeds.brookings.edu Published On :: Tue, 21 Apr 2020 19:46:59 +0000 Full Article
io The mudslinging campaign and Barkha Dutt on the “fear” election of 2019 By webfeeds.brookings.edu Published On :: Fri, 24 Apr 2020 19:41:39 +0000 Full Article
io How is the coronavirus outbreak affecting China’s relations with India? By webfeeds.brookings.edu Published On :: Thu, 30 Apr 2020 12:02:00 +0000 China’s handling of the coronavirus pandemic has reinforced the skeptical perception of the country that prevails in many quarters in India. The Indian state’s rhetoric has been quite measured, reflecting its need to procure medical supplies from China and its desire to keep the relationship stable. Nonetheless, Beijing’s approach has fueled Delhi’s existing strategic and economic concerns. These… Full Article
io U.S.–Japan alliance conference: Regional perspectives on the Quadrilateral Dialogue and the Free and Open Indo-Pacific By webfeeds.brookings.edu Published On :: Mon, 04 May 2020 20:13:34 +0000 Full Article
io ISIS is pushing Turkey in the wrong direction By webfeeds.brookings.edu Published On :: Fri, 01 Jul 2016 09:00:00 -0400 Editor’s Note: Turkey's terrorism troubles are bad and getting worse. At least 41 people died Tuesday when authorities say that ISIS attackers opened fire on crowds at Istanbul's airport and then detonated suicide vests, wreaking havoc. Dan Byman writes that Turkey's ISIS problems are bound up in its Syria policy and that the biggest danger of the attacks is that they push Turkey further toward authoritarianism and away from Europe and the United States. This piece was originally published by Slate. Turkey’s terrorism troubles are bad and getting worse. At least 41 people died Tuesday in a terrorist attack on Istanbul’s airport. Authorities say that ISIS attackers opened fire on crowds at the airport and then detonated suicide vests, wreaking havoc. For Turks, such an attack is not a surprise: The country has seen as spate of attacks throughout the country in recent years. ISIS has not formally taken credit for the attack as of Wednesday morning, but it has struck Turkey repeatedly and with growing frequency: ISIS has previously hit Istanbul twice in 2016, including a January suicide bomber attack on Sultanahmet Square that killed 12 in the heart of Turkey’s tourist district. In 2015, Turkey suffered its most deadly terrorist attack ever when more than 100 people were killed after bombs went off near Ankara’s railway station, targeting a rally opposing Turkey’s conflict with its own Kurdish population. In 2013, more than 50 people were killed when car bombs went off in Reyhanli near the Syrian border. Although ISIS is usually blamed for these attacks, Turkey’s Kurds, the Syrian regime, and Syria’s al-Qaida affiliate Jabhat al-Nusra have all been named as suspects. The sheer number of possibilities and the politicized finger-pointing reveals how daunting a challenge Turkey faces on the counterterrorism front. The government of President Recep Tayyip Erdogan is trying to fight ISIS, but this is only one of its problems and, so far, not its No. 1 priority. Erdogan’s government also seeks to topple the Syrian regime of Bashar al-Assad, and manage its own and the regional Kurdish problem—tough enough tasks without having to also shore up the government’s declining legitimacy. When the Arab Spring broke out in 2011, Turkey seemed a model for aspiring democracies in the Middle East. Here, after all, was a democratic government that embraced political Islam but did so in a seemingly moderate way, was a member of NATO, a booming economic power, and a force for stability in the region. The Middle East, however, has come to Turkey rather than the other way around. Although Turkey’s economy continues to do well, Turkey has far fewer admirers in the West and is often considered part of the problem, even drawing public criticism from President Obama. For many Turks, the Istanbul attack is part of this changing landscape. Asli Aydintasbas, a Turkish analyst, described a “world turned upside down” to the New York Times: Istanbul “was a happening town, cutting edge in arts and culture. It’s the kind of place that Condé Nast would write about. Now this is a Middle Eastern country where these things happen.” Turkey’s ISIS problems are bound up in its Syria policy. Turkey’s ISIS problems are bound up in its Syria policy. Erdogan had cultivated Assad and then was outraged when the Syrian dictator proved to be, well, a dictator. Instead of making reforms to placate protesters, as Erdogan had urged, Assad reached out to Iran and commenced a brutal crackdown that would lead to a civil war in which more than 400,000 Syrians have died so far—most at the hands of the regime, not ISIS. Although the United States prioritizes fighting ISIS, Turkey sees ousting Assad as more important. Ankara has armed and trained opposition fighters and hosted Syrian dissidents. Turkey has backed more radical groups like Ahrar al-Sham, which works with the Islamic State’s affiliate Jabhat al-Nusra. The country’s policy toward ISIS should be seen in this context: Anyone opposing Assad seemed to be on the right side. Although ISIS relies heavily on foreign volunteers for manpower, Turkey dragged its feet and allowed volunteers to transit Turkey unimpeded so as to make their way to fight Assad. European governments reacted with growing concern and anger, fearing that these volunteers would come back and conduct terrorist attacks on the West. In the last year, Turkey has become far tougher on foreign fighters, but it is difficult to uproot the now-extensive radical infrastructure. ISIS attacks on Turkey have grown in response to this crackdown. In addition to public attacks, ISIS has shot and beheaded activists linked to “Raqqa Is Being Silently Slaughtered,” a non-government organization providing information and video footage of the brutal life in ISIS-controlled areas. Such acts and Western pressure have also led to more Turkish military involvement, and this too probably led to an escalation of ISIS attacks. Turkey used tanks and artillery to strike ISIS after the January bombing in Istanbul’s Sultanahmet Square and has shelled ISIS positions in response to ISIS cross-border shelling. Perhaps more importantly, Turkey allows the United States and other coalition countries to base aircraft out of the Incirlik and Diyabakir air bases in southern Turkey for strikes on ISIS. Making things even more complex, Turkey’s own Kurdish problem put it at odds with Washington in the fight against ISIS. From Ankara’s point of view, there are good Kurds and bad Kurds. The good ones include Iraq’s main Kurdish organizations which have good relations and economic ties with Turkey. On the other hand, the Erdogan government sees the Kurdish Workers Party (PKK) as an enemy. The group claims to represent the aspiration of Turkey’s own Kurds, which make up perhaps 20 percent of the population, and past regimes had fought civil wars with the group, leading to 40,000 deaths since the conflict began in 1984. In 1999, the PKK’s leader was captured and the conflict declined in ferocity. Peace seemed at hand as negotiations commenced secretly in 2009, and at the end of 2012 Erdogan publicly embraced the talks. The ceasefire broke down in 2015, however, when Turkey bombed the PKK’s bases in Iraq, and Kurdish violence and terrorism in Turkey returned: Many observers believe Erdogan renewed operations because his electoral fortunes were waning and he sought to stir up nationalist sentiment. With this dynamic in mind, Syria’s small Kurdish group the Democratic Union Party (PYD) has come to play an important role for Turkish policy, ISIS, and Syria. Although the group has historically been minor, its ties to the PKK made Turkey see it as an enemy. This mattered little until central government authority in Syria’s Kurdish areas collapsed. The PYD and other Kurdish groups carved out their own autonomous areas, leading to Turkish fears that the PYD would inspire Turkey’s Kurds to seek independence and would provide the PKK a base for attacks. Washington took a different view: As U.S. military training programs against ISIS proved ineffective, the PYD also emerged as a valuable military ally, perhaps the most effective foe of ISIS within Syria. Even as the United States works with Syria’s Kurds, Turkey has embargoed Kurdish areas in Syria (at a time when humanitarian conditions are desperate) and even threatened to intervene if the Syrian Kurds expand their territory near the Turkish border too much. And to make this more complex, the PYD itself doesn’t work well with other anti-Assad groups, which oppose Kurdish autonomy and are angered by the PYD’s willingness to ignore Assad, making it difficult to square with broader U.S. goals in Syria. All this would be easier for Turkey if the Erdogan government had broad support at home and abroad, but it doesn’t. Recent years have seen massive anti-government protests with the Turkish government responding by stepping up repression. Erdogan changed jobs from prime minister to the more ceremonial role of president, but he remains the power behind—or even in front of —the throne. Turkey has used anti-terrorism as an excuse to crack down on legitimate political dissent at home, straining ties with Europe and the United States. The government is increasingly authoritarian, with crackdowns on press freedom being particularly acute. (And whatever you do, don’t compare Erdogan to Gollum.) The good news is that Turkey is trying to break out of its growing isolation; the bad news is that it is doing so by mending fences with another authoritarian strongman, Russian President Vladimir Putin. [T]he biggest danger of the ISIS attacks is that they push Turkey further toward authoritarianism and away from Europe and the United States. In addition to the horrific loss of lives, the biggest danger of the ISIS attacks is that they push Turkey further toward authoritarianism and away from Europe and the United States. Dictators throughout the Middle East use legitimate security and terrorism dangers to justify delaying reforms, repressing any form of opposition, and labeling all foes as terrorists. The Turkish model, unfortunately, is a Middle Eastern one now. Authors Daniel L. Byman Publication: Slate Image Source: © Murad Sezer / Reuters Full Article
io The vicious cycle of French terrorism By webfeeds.brookings.edu Published On :: Fri, 15 Jul 2016 13:50:00 -0400 Editors’ Note: The attack in Nice will inevitably, and appropriately, lead to more aggressive intelligence efforts against suspected ISIS networks and tighter security in general, writes Dan Byman. Unfortunately, they are also likely to bolster anti-Muslim voices in France and throughout Europe, and ISIS may in turn exploit Muslims’ resulting shame and anger. This post originally appeared on Slate. At least 84 people are dead in Nice, France, after a truck deliberately plowed for over a mile through packed crowds celebrating Bastille Day; ISIS or one of its supporters is believed to be linked to the attack. As we reel in horror from yet another instance of terrorist carnage, news reports are trickling in, giving us a sense of the attack, its victims, and those behind the killings. We’ll learn more in the days to come, but we already knew Europe—and France in particular—has a terrorism problem and that it may go from bad to worse in the near future. Ironically, one of the reasons for the increased attacks is the military successes the United States, France, and other countries and local fighters are scoring against ISIS’s core in Iraq and Syria and the setbacks suffered by ISIS’s key provinces such as that in Libya. ISIS, which had long trumpeted its success in establishing the now-shrinking caliphate, needs victories to compensate for these major losses. Earlier this month, CIA Director John Brennan warned, “As the pressure mounts on ISIL, we judge that it will intensify its global terror campaign to maintain its dominance of the global terrorism agenda.” Running down people with a truck is a new form of violence for ISIS, though ISIS propaganda has called for supporters to kill by “ramming” people, al-Qaida’s Yemen branch recommended it in the past to “mow down the enemies of Allah,” and in 2008 a Palestinian used a bulldozer to kill three Israelis. But this is the fourth major terror attack in Europe in the past eight months: ISIS-directed terrorists killed 130 people in November in Paris; in March suicide bombers killed 32 people in Brussels, and just two weeks ago three men believed to be tied to ISIS killed more than 40 at the Istanbul airport. The attacks will inevitably, and appropriately, lead to more aggressive intelligence efforts against suspected ISIS networks and tighter security in general. Unfortunately, they are also likely to bolster anti-Muslim voices in France and throughout Europe, fostering daily humiliations and furthering Muslim communities’ sense that they are suspect and under siege. ISIS will exploit the resulting shame and anger, increasing the risk of future attacks. European nations face several types of terror threats from ISIS. The first is the unprecedented number of fighters—more than 5,000—that Europe has exported to Iraq and Syria to fight under the banners of ISIS and other jihadi groups. More than 900 of them (including 200 women) have come from France. More than 130 are dead, and almost 250 have returned; the rest are believed to still be in Iraq and Syria. The Paris attacks, which were coordinated and practiced, illustrate the danger such fighters can pose: Time in the battle zone allows them to gain fighting skills, become indoctrinated, and develop a network to exploit for future attacks. In addition, ISIS leaders can direct their operations to achieve maximal effect. As the so-called caliphate shrinks, more of these fighters may try to return. More than 1,000 other Frenchmen are believed to be radicalized but have not gone to Iraq and Syria, and this represents another overlapping danger. In the past many might have tried to go to Syria, but now, perhaps acting on directions from ISIS leaders with whom they are communicating or perhaps mixing with returned foreign fighters, these individuals might strike directly at France or other countries. The last category are true “lone wolves”—those inspired by ISIS or other jihadi ideologies but with no direct operational connection to a group (the attacks in San Bernardino and Orlando appear to fall into this category). Two years ago ISIS propaganda emphasized coming to the “caliphate” to help it consolidate and expand. Earlier this year, however, its spokesman and external operations leader Muhammad al-Adnani declared, “The smallest action you do in the heart of their land is dearer to us than the largest action by us and more effective and more damaging to them.” France, as we’ve seen, is particularly vulnerable. As my Brookings colleagues Will McCants and Chris Meserole have recently argued, French political culture is a counterterrorism problem. They found that “four of the five countries with the highest rates of radicalization in the world are Francophone, including the top two in Europe (France and Belgium).” Part of the problem are the large numbers of unemployed urban youth, a fertile field for radical recruiting. But part of it is also France’s aggressive secularization programs, which prohibit girls from wearing the veil in school and are considered by many Muslims to be a deliberate attack on their religion. Muslims’ trust in the government and security services is low. Add such a sense of humiliation to a surging far-right political movement that constantly blasts Muslim immigrants and citizens, and the conditions for radicalization are strong. The United States is less vulnerable by comparison. Fewer than 300 Americans have gone to fight in Iraq and Syria. Part of this is because of an aggressive and effective law enforcement and intelligence effort to disrupt volunteers. But part of it is because the American Muslim community is far better integrated than its French counterpart and regularly cooperates with law enforcement. U.S. politics are becoming more poisonous toward Muslims, but—we can hope—that anti-Muslim sentiment in America may have peaked, and recent polls suggest positive attitudes toward Muslims are increasing. Continued military and intelligence operations against the ISIS core by U.S.-led coalition forces and their local partners are necessary, but they will take time to bear fruit and in the end still don’t solve the terrorism problem. Stopping an attack like the one in Nice is exceptionally difficult. The attacker chose a “soft” (undefended) target and showed that one sick person can kill many with the right combination of determination and luck. Unfortunately, the most likely reaction after the Nice attack is also the worst one: more vitriol and hostility toward French and European Muslims, furthering a cycle that makes it harder for European security services to gain the cooperation of local communities and easier for ISIS to gain recruits and score victories. Authors Daniel L. Byman Publication: Slate Full Article
io The legal foundations of the Islamic State By webfeeds.brookings.edu Published On :: Mon, 18 Jul 2016 00:00:00 -0400 Media coverage of the Islamic State frequently refers to the group’s violent and seemingly archaic justice system without considering the institutional structures that enable this violence, or the broader function that it serves in the group’s ambitious state-building project. Legal institutions make it easier for the group to capture and retain territory by legitimizing its claim to sovereignty, justifying the expropriation of the property and land of enemies, and building goodwill with civilians by ensuring accountability. The Islamic State’s legal system purports to strictly apply the divinely revealed body of Islamic law known as Sharia, which it regards as the only legitimate basis for governance. Although its legal system is frequently characterized as medieval, it has instrumentally supplemented the original text of the Quran with the modern rules and regulations that are needed to govern a 21st century state and punish modern day offenses—for example, traffic violations. It has the same three features that are present in any modern legal system: police, courts, and prisons. In a region that has long been plagued by corruption, the Islamic State has attempted to ingratiate itself with civilians by claiming that its legal system is comparatively more legitimate and effective than the available alternatives. However, two emerging vulnerabilities—the system’s susceptibility to corruption and propensity for extra-legal violence—are increasingly undermining the Islamic State’s ability to obtain the trust and cooperation of civilians. Counterinsurgency efforts should be designed to undermine the legitimacy of its institutions. Long-term solutions in the region must involve a fundamental reorganization of political and legal institutions in ways that promote legitimacy and rule of law. Downloads The legal foundations of the Islamic State Authors Mara Revkin Image Source: © Stringer . / Reuters Full Article
io Realist or neocon? Mixed messages in Trump advisor’s foreign policy vision By webfeeds.brookings.edu Published On :: Tue, 19 Jul 2016 08:00:00 -0400 Last night, retired lieutenant general Michael Flynn addressed the Republican convention as a headline speaker on the subject of national security. One of Donald Trump’s closest advisors—so much so that he was considered for vice president—Flynn repeated many of the themes found in his new book, The Field of Fight, How We Can Win the Global War Against Radical Islam and Its Allies, which he coauthored with Michael Ledeen. (The book is published by St. Martin’s, which also published mine.) Written in Flynn’s voice, the book advances two related arguments: First, the U.S. government does not know enough about its enemies because it does not collect enough intelligence, and it refuses to take ideological motivations seriously. Second, our enemies are collaborating in an “international alliance of evil countries and movements that is working to destroy” the United States despite their ideological differences. Readers will immediately notice a tension between the two ideas. “On the surface,” Flynn admits, “it seems incoherent.” He asks: “How can a Communist regime like North Korea embrace a radical Islamist regime like Iran? What about Russia’s Vladimir Putin? He is certainly no jihadi; indeed, Russia has a good deal to fear from radical Islamist groups.” Flynn spends much of the book resolving the contradiction and proving that America’s enemies—North Korea, China, Russia, Iran, Syria, Cuba, Bolivia, Venezuela, Nicaragua, al-Qaida, Hezbollah, and ISIS—are in fact working in concert. No one who has read classified intelligence or studied international relations will balk at the idea that unlikely friendships are formed against a common enemy. As Flynn observes, the revolutionary Shiite government in Tehran cooperates with nationalist Russia and communist North Korea; it has also turned a blind eye (at the very least) to al-Qaida’s Sunni operatives in Iran and used them bargaining chips when negotiating with Osama bin Laden and the United States. Flynn argues that this is more than “an alliance of convenience.” Rather, the United States’ enemies share “a contempt for democracy and an agreement—by all the members of the enemy alliance—that dictatorship is a superior way to run a country, an empire, or a caliphate.” Their shared goals of maximizing dictatorship and minimizing U.S. interference override their substantial ideological differences. Consequently, the U.S. government must work to destroy the alliance by “removing the sickening chokehold of tyranny, dictatorships, and Radical Islamist regimes.” Its failure to do so over the past decades gravely imperils the United States, he contends. The book thus offers two very different views of how to exercise American power abroad: spread democracies or stand with friendly strongmen...[P]erhaps it mirrors the confusion in the Republican establishment over the direction of conservative foreign policy. Some of Flynn’s evidence for the alliance diverts into the conspiratorial—I’ve seen nothing credible to back up his assertion that the Iranians were behind the 1979 takeover of the Grand Mosque in Mecca by Sunni apocalypticists. And there’s an important difference between the territorially-bounded ambitions of Iran, Russia, and North Korea, on the one hand, and ISIS’s desire to conquer the world on the other; the former makes alliances of convenience easier than the latter. Still, Flynn would basically be a neocon if he stuck with his core argument: tyrannies of all stripes are arrayed against the United States so the United States should destroy them. But some tyrannies are less worthy of destruction than others. In fact, Flynn argues there’s a category of despot that should be excluded from his principle, the “friendly tyrants” like President Abdel-Fatah el-Sissi in Egypt and former president Zine Ben Ali in Tunisia. Saddam Hussein should not have been toppled, Flynn argues, and even Russia could become an “ideal partner for fighting Radical Islam” if only it would come to its senses about the threat of “Radical Islam.” Taken alone, these arguments would make Flynn realist, not a neocon. The book thus offers two very different views of how to exercise American power abroad: spread democracies or stand with friendly strongmen. Neither is a sure path to security. Spreading democracy through the wrong means can bring to power regimes that are even more hostile and authoritarian; standing with strongmen risks the same. Absent some principle higher than just democracy or security for their own sakes, the reader is unable to decide between Flynn’s contradictory perspectives and judge when their benefits are worth the risks. It’s strange to find a book about strategy so at odds with itself. Perhaps the dissonance is due to the co-authors’ divergent views (Ledeen is a neocon and Flynn is comfortable dining with Putin.) Or perhaps it mirrors the confusion in the Republican establishment over the direction of conservative foreign policy. Whatever the case, the muddled argument offered in The Field of Fight demonstrates how hard it is to overcome ideological differences to ally against a common foe, regardless of whether that alliance is one of convenience or conviction. Authors William McCants Full Article
io What are the legal foundations of the Islamic State? By webfeeds.brookings.edu Published On :: Tue, 26 Jul 2016 10:00:00 -0400 Media coverage of the Islamic State has focused on the group’s grotesque use of violence and archaic governance style. Less attention has been paid, however, to the institutions that make those practices possible—institutions that lend the group legitimacy, at least in the eyes of supporters, as a sovereign state. In her new Brookings Analysis Paper, “The legal foundations of the Islamic State,” Mara Revkin argues that legal institutions play a critical role in the Islamic State’s state-building project. Those structures help the group take and keep territory, as well as provide a measure of accountability to the people living under its rule. Lesser evil? Revkin writes that “the Islamic State has attempted to ingratiate itself with civilians by claiming that its legal system is comparatively more legitimate and effective than the available alternatives.” The Syrian and Iraqi governments, Revkin explains, are often perceived as being highly corrupt and ineffective. The Islamic State is able to gain civilians’ favor by arguing that its political and legal institutions are more legitimate than those of the Syrian and Iraqi governments or rival armed groups. She adds: “some Syrians and Iraqis seem to prefer the legal system of the Islamic State to the available alternatives not because they agree with its ideology, but simply because they regard it as the lesser evil.” The Syrian and Iraqi governments...are often perceived as being highly corrupt and ineffective. Revkin writes that for the Islamic State, shariah law is “the only legitimate basis for governance.” In cases where shariah fails to address modern-day problems, she explains, religiously legitimate authorities appointed by the Islamic State—such as military commanders, police officers, and the caliph himself—can issue legal decisions as long as they do not conflict with the divine rules of shariah or harm the welfare of the greater Muslim community. Alongside this is a system of rules and regulations to “govern civilians, discipline its own officials and combatants, and control territory” in areas of rights and duties, behavior, property, trade, and warfare. Making the state possible Legal institutions help the Islamic State advance three main state-building objectives, in Revkin’s view: First, they support the Islamic State’s territorial expansion by “legitimizing [its] claims to sovereignty, justifying the expropriation of the property and land of enemies, and building goodwill with civilians.” Legal institutions also allow the Islamic State to enforce compliance and accountability of its own members and maintain internal control and discipline. Revkin describes various types of punishments the Islamic State uses to discipline its own members—these punishments are important, she writes, because “no government can establish itself as legitimate and sovereign without policing the behavior of the people who are responsible for implementing its policies.” Finally, Revkin explores the legal institutions surrounding the Islamic State’s tax policies, which are “critical to financing the Islamic State’s governance and military operations.” Courts and judges, she explains, are crucial to “administering and legitimizing” taxation and justifying “economic activities that might otherwise resemble theft.” Weaknesses in the system Although the Islamic State claims to have legitimate governing authority, based on a defined legal system, that system faces vulnerabilities. Revkin writes, for instance, that reports of corruption and extra-legal violence are “threatening the organization’s long-term sustainability and undermining its ability to win the trust and cooperation of civilians.” Amid recent signs that the group is losing strength, Revkin argues that it’s struggling to maintain its own moral standards. To further weaken the Islamic State, she recommends working to undermine those institutions. The trouble is, as Revkin points out: “the Islamic State came to power largely by exploiting the weakness and illegitimacy of existing institutions” in Iraq and Syria. Thus, a sustainable plan for ultimately destroying the organization must also involve strengthening political and legal institutions in those countries. Authors Dana Hadra Full Article
io On May 4, 2020, Jung H. Pak discussed her recent publication, Becoming Kim Jong Un, with Politics and Prose By webfeeds.brookings.edu Published On :: Mon, 04 May 2020 18:31:51 +0000 On May 4, 2020, Jung H. Pak discussed her recent publication, “Becoming Kim Jong Un,” with Politics and Prose. Full Article
io U.S.–Japan alliance conference: Regional perspectives on the Quadrilateral Dialogue and the Free and Open Indo-Pacific By webfeeds.brookings.edu Published On :: Mon, 04 May 2020 20:13:34 +0000 Full Article
io The fundamental connection between education and Boko Haram in Nigeria By webfeeds.brookings.edu Published On :: Thu, 07 May 2020 20:51:38 +0000 On April 2, as Nigeria’s megacity Lagos and its capital Abuja locked down to control the spread of the coronavirus, the country’s military announced a massive operation — joining forces with neighboring Chad and Niger — against the terrorist group Boko Haram and its offshoot, the Islamic State’s West Africa Province. This spring offensive was… Full Article
io The Political Economy of Poverty Reduction By webfeeds.brookings.edu Published On :: Fri, 30 Nov 2007 12:00:00 -0500 Executive Summary Large-scale antipoverty programs have achieved significant and positive results in many developing countries around the world in the past decade. This paper explores the challenges of “scaling up” small-scale antipoverty programs—taken here to mean the processes by which successful efforts to raise the incomes of the poorest citizens in developing counties are expanded in coverage over time and across geography. In particular, I advocate supplementing approaches that highlight resource and program constraints with an expanded focus on the political dynamics involved in expanding pro-poor policies. Thus, greater emphasis should be placed on understanding the political factors that limit the expansion and survivability of antipoverty programs. A broader view along these lines highlights the bargaining strength of beneficiaries, the need to secure public support, the potential for political misuse of antipoverty programs, and how institutional fragilities affect their sustainability. Antipoverty programs can be effectively scaled up if attention is paid to addressing these political and institutional challenges. An agenda for future research is also identified. Downloads Download Authors Raj M. Desai Full Article
io Scaling Up Development Interventions: A Review of UNDP's Country Program in Tajikistan By webfeeds.brookings.edu Published On :: Tue, 21 Feb 2012 12:12:00 -0500 A key objective of the United Nations Development Programme (UNDP) is to assist its member countries in meeting the Millennium Development Goals (MDGs). UNDP pursues this objective in various ways, including through analysis and advice to governments on the progress towards the MDGs (such as support for the preparation and monitoring Poverty Reduction Strategies, or PRSs, in poor countries), assistance for capacity building, and financial and technical support for the preparation and implementation of development programs. The challenge of achieving the MDGs remains daunting in many countries, including Tajikistan. To do so will require that all development partners, i.e., the government, civil society, private business and donors, make every effort to scale up successful development interventions. Scaling up refers to “expanding, adapting and sustaining successful policies, programs and projects on different places and over time to reach a greater number of people.” Interventions that are successful as pilots but are not scaled up will create localized benefits for a small number of beneficiaries, but they will fail to contribute significantly to close the MDG gap. This paper aims to assess whether and how well UNDP is supporting scaling up in its development programs in Tajikistan. While the principal purpose of this assessment was to assist the UNDP country program director and his team in Tajikistan in their scaling up efforts, it also contributes to the overall growing body of evidence on the scaling up of development interventions worldwide. Downloads Download Full Paper Authors Johannes F. Linn Full Article
io Evaluating the Evaluators: Some Lessons from a Recent World Bank Self-Evaluation By webfeeds.brookings.edu Published On :: Tue, 21 Feb 2012 14:15:00 -0500 Editor's Note: The World Bank’s Independent Evaluation Group (IEG) recently published a self-evaluation of its activities. Besides representing current thinking among evaluation experts at the World Bank, it also more broadly reflects some of the strengths and gaps in the approaches that evaluators use to assess and learn from the performance of the international institutions with which they work. The old question “Quis custodet ipsos custodes?” – loosely translated as “Who evaluates the evaluators?” – remains as relevant as ever. Johannes Linn served as an external peer reviewer of the self-evaluation and provides a bird’s-eye view on the lessons learned. An Overview of the World Bank’s IEG Self-Evaluation Report In 2011 the World Bank’s Independent Evaluation Group (IEG) carried out and published a self-evaluation of its activities. The self-evaluation team was led by an internal manager, but involved a respected external evaluation expert as the principal author and also an external peer reviewer. The IEG self-evaluation follows best professional practices as codified by the Evaluation Cooperation Group (ECG). This group brings together the evaluation offices of seven major multilateral financial institutions in joint efforts designed to enhance evaluation performance and cooperation among their evaluators. One can therefore infer that the approach and focus of the IEG self-evaluation is representative of a broader set of practices that are currently used by the evaluation community of international financial organizations. At the outset the IEG report states that “IEG is the largest evaluation department among Evaluation Capacity Group (ECG) members and is held in high regard by the international evaluation community. Independent assessments of IEG’s role as an independent evaluation function for the Bank and IFC rated it above the evaluation functions in most other ECG members, international nongovernmental organizations, and transnational corporations and found that IEG follows good practice evaluation principles.” The self-evaluation report generally confirms this positive assessment. For four out of six areas of its mandate IEG gives itself the second highest rating (“good”) out of six possible rating categories. This includes (a) the professional quality of its evaluations, (b) its reports on how the World Bank’s management follows up on IEG recommendations, (c) cooperation with other evaluation offices, and (d) assistance to borrowing countries in improving their own evaluation capacity. In the area of appraising the World Bank’s self-evaluation and risk management practices, the report offers the third highest rating (“satisfactory”), while it gives the third lowest rating (“modest”) for IEG’s impact on the Bank’s policies, strategies and operations. In addition the self-evaluation concludes that overall the performance of IEG has been “good” and that it operates independently, effectively and efficiently. The report makes a number of recommendations for improvement, which are likely to be helpful, but have limited impact on its activities. They cover measures to further enhance the independence of IEG and the consistency of evaluation practices as applied across the World Bank Group’s branches – the World Bank, the International Finance Corporation (IFC), and the Multilateral Investment Guarantee Agency (MIGA) –; to improve the design of evaluations and the engagement with Bank management upstream for greater impact; and monitoring the impact of recent organizational changes in IEG in terms of results achieved. The report also recommends that more be done to evaluate the Bank’s analytical work and that evaluations draw on comparative evidence. Assessment In terms of the parameters of self-evaluation set by the prevailing practice among the evaluators on international financial agencies, the IEG self-evaluation is accurate and helpful. From my own experience as an operational manager in the Bank whose activities were evaluated by IEG in years past, and as a user of IEG evaluations (and of evaluations of other international aid organizations) for my research on aid effectiveness, I concur that IEG is independent and effective in meeting its mandate as defined. Moreover, the self-evaluation produces useful quantitative evidence (including survey results, budget analysis, etc.) to corroborate qualitative judgments. However, the self-evaluation suffers from a number of limitations in approach and gaps in focus, which are broadly representative of the practices prevalent among many of the evaluation offices of international aid agencies. Approach of the IEG self-evaluation The core of the self-evaluation report is about the evaluation process followed by IEG, with very little said about the substance of IEG’s evaluations. The following questions could have usefully been raised, but were not: do evaluations cover the right issues with the right intensity, such as growth and poverty; environmental, governance, and gender impacts; regional dimensions versus exclusive country or project focus; effectiveness in addressing the problems of fragile and conflict states; effectiveness in dealing with global public goods; sustainability and scaling up; etc. Therefore the report does not deal with the question of whether IEG effectively responds in its evaluations to the many important strategic debates and issues with which the development community is grappling. Related to this limitation is the fact that the report assessed the quality of IEG’s mostly in terms of (a) whether its approach and processes meet certain standards established by the Evaluation Cooperation Group; and (b) how it is judged by stakeholders in response to a survey commissioned for this evaluation. Both these approaches are useful, but they do not have any basis in professional assessments of the quality of individual products. This is equivalent to IEG evaluating the World Bank’s projects on the quality of its processes (e.g., appraisal and supervision processes) and on the basis of stakeholder surveys, without evaluating individual products and their impacts. Gaps in the Self-Evaluation and in Evaluation Practice Careful reading of the report reveals six important gaps in the IEG self-evaluation, in the prevailing evaluation practice in the World Bank, and more generally in the way international financial organizations evaluate their own performance. The first three gaps relate to aspects of the evaluation approach used and the second three gaps relate to lack of focus in the self-evaluation on key internal organizational issues: 1. Impact Evaluations: The report notes that IEG carries out two to three impact evaluations per year, but it sidesteps the debate in the current evaluation literature and practice as to what extent the “gold standard” of randomized impact evaluation should occupy a much more central role. Given the importance of this debate and divergence of views, it would have been appropriate for the self-evaluation to assess IEG’s current practice of very limited use of randomized evaluations. 2. Evaluation of Scaling Up: The report does not address the question of to what extent current IEG practice not only assesses the performance of individual projects in terms of their outcomes and sustainability, but also in terms of whether the Bank has systematically built on its experience in specific projects to help scale up their impact through support for expansion or replication in follow-up operations or through effective hand-off to the government or other partners. In fact, currently IEG does not explicitly and systematically consider scaling up in its project and program evaluations. For example, in a recent IEG evaluation of World Bank funded municipal development projects (MDPs) , IEG found that the Bank has supported multiple MDPs in many countries over the years, but the evaluation did not address the obvious question whether the Bank systematically planned for the project sequence or built on its experience from prior projects in subsequent operations. While most other evaluation offices like IEG do not consider scaling up, some (in particular those of the International Fund for Agricultural Development and the United Nations Development Program) have started doing so in recent years. 3. Drawing on the Experience of and Benchmarking Against Other Institutions: The self-evaluation report does a good job in benchmarking IEG performance in a number of respects against that of other multilateral institutions. In the main text of the report it states that “IEG plans to develop guidelines for approach papers to ensure greater quality, in particular in drawing on comparative information from other sources and benchmarking against other institutions.” This is a welcome intention, but it is inadequately motivated in the rest of the report and not reflected in the Executive Summary. The reality is that IEG, like most multilateral evaluation offices, so far has not systematically drawn on the evaluations and relevant experience of other aid agencies in its evaluations of World Bank performance. This has severely limited the learning impact of the evaluations. 4. Bank Internal Policies, Management Processes and Incentives: IEG evaluations traditionally do not focus on how the Bank’s internal policies, management and incentives affect the quality of Bank engagement in countries. Therefore evaluations cannot offer any insights into whether and how Bank-internal operating modalities contribute to results. Two recent exceptions are notable exceptions. First, the IEG evaluation of the Bank’s approach to harmonization with other donors and alignment with country priorities assesses the incentives for staff to support harmonization and alignment. The evaluation concludes that there are insufficient incentives, a finding disputed by management. Second, is the evaluation of the Bank’s internal matrix management arrangements, which is currently under way. The self-evaluation notes that Bank management tried to quash the matrix evaluation on the grounds that it did not fall under the mandate of IEG. This is an unfortunate argument, since an assessment of the institutional reasons for the Bank’s performance is an essential component of any meaningful evaluation of Bank-supported programs. While making a good case for the specific instance of the matrix evaluation, the self-evaluation report shies away from a more general statement in support of engaging IEG on issues of Bank-internal policies, management processes and incentives. It is notable that IFAD’s Independent Office of Evaluation appears to be more aggressive in this regard: It currently is carrying out a full evaluation of IFAD’s internal efficiency and previous evaluations (e.g., an evaluation of innovation and scaling up) did not shy away from assessing internal institutional dimensions. 5. World Bank Governance: The IEG self-evaluation is even more restrictive in how it interprets its mandate regarding the evaluation of the World Bank’s governance structures and processes (including its approach to members’ voice and vote, the functioning of its board of directors, the selection of its senior management, etc.). It considers these topics beyond IEG’s mandate. This is unfortunate, since the way the Bank’s governance evolves will substantially affect its long-term legitimacy, effectiveness and viability as an international financial institution. Since IEG reports to the Bank’s board of directors, and many of the governance issues involve questions of the board’s composition, role and functioning, there is a valid question of how effectively IEG could carry out such an evaluation. However, it is notable that the IMF’s Independent Evaluation Office, which similarly reports to the IMF board of directors, published a full evaluation of the IMF’s governance in 2008, which effectively addressed many of the right questions. 6. Synergies between World Bank, IFC and MIGA: The self-evaluation report points out that the recent internal reorganization of IEG aimed to assure more effective and consistent evaluations across the three member branches of the World Bank Group. This is welcome, but the report does not assess how past evaluations addressed the question of whether the World Bank, IFC and MIGA effectively capitalized on the potential synergies among the three organizations. The recent evaluation of the World Bank Group’s response to the global economic crisis of 2008/9 provided parallel assessments of each agency’s performance, but did not address whether they work together effectively in maximizing their synergies. The reality is that the three organizations have deeply engrained institutional cultures and generally go their own ways rather than closely coordinating their activities on the ground. Future evaluations should explicitly consider whether the three effectively cooperate or not. While the World Bank is unique in the way it has organizationally separated its private sector and guarantee operations, other aid organizations also have problems of a lack of cooperation, coordination and synergy among different units within the agency. Therefore, the same comment also applies to their evaluation approaches. Conclusions Self-evaluations are valuable tools for performance assessment and IEG is to be congratulated for carrying out and publishing such an evaluation of its own activities. As for all self-evaluations, it should be seen as an input to an independent external evaluation, a decision that, for now, has apparently been postponed by the Bank’s board of directors. IEG’s self-evaluation has many strengths and provides an overall positive assessment of IEG’s work. However, it does reflect some important limitations of analysis and of certain gaps in approach and coverage, which an independent external review should consider explicitly, and which IEG’s management should address. Since many of these issues also likely apply to most of the other evaluation approaches by other evaluation offices, the lessons have relevance beyond IEG and the World Bank. Key lessons include: An evaluation of evaluations should focus not only on process, but also on the substantive issues that the institution is grappling with. An evaluation of the effectiveness of evaluations should include a professional assessment of the quality of evaluation products. An evaluation of evaluations should assess: o How effectively impact evaluations are used; o How scaling up of successful interventions is treated; o How the experience of other comparable institutions is utilized; o Whether and how the internal policies, management practices and incentives of the institution are effectively assessed; o Whether and how the governance of the institution is evaluated; and o Whether and how internal coordination, cooperation and synergy among units within the organizations are assessed. Evaluations play an essential role in the accountability and learning of international aid organizations. Hence it is critical that evaluations address the right issues and use appropriate techniques. If the lessons above were reflected in the evaluation practices of the aid institutions, this would represent a significant step forward in the quality, relevance and likely impact of evaluations. Authors Johannes F. Linn Image Source: © Christian Hartmann / Reuters Full Article
io The Taiwan issue and the normalization of US-China relations By webfeeds.brookings.edu Published On :: Executive Summary Taiwan was the key issue that the United States and China had to address before the diplomatic relations in 1979. After intense negotiations, the Carter administration recognized the People’s Republic of China as the sole legal government of China, confirming Beijing’s role in international organizations. Washington also pledged to conduct relations with Taiwan… Full Article
io Danger ahead? Taiwan’s politics, China’s ambitions, and US policy By webfeeds.brookings.edu Published On :: It is a great honor for me to speak today at the Hamilton Lugar School, not only because I worked for Congressman Lee Hamilton for two and a half years, but also because he and Senator Lugar have represented something very important about the politics of U.S. foreign policy. They were in their time two… Full Article
io The Trump administration’s policies toward Taiwan By webfeeds.brookings.edu Published On :: It is a great pleasure to speak to you today, at this event sponsored by Taipei Forum.1 I’m deeply grateful to my Columbia tongxue Su Chi for inviting me. It’s wonderful to see so many long-time friends. Thank you for coming today. I just arrived in Taipei yesterday evening. I am pretty confident that I… Full Article
io Taiwan’s January 2020 elections: Prospects and implications for China and the United States By webfeeds.brookings.edu Published On :: EXECutive Summary Taiwan will hold its presidential and legislative elections on January 11, 2020. The incumbent president, Tsai Ing-wen of the Democratic Progressive Party (DPP), appears increasingly likely to prevail over her main challenger, Han Kuo-yu of the Kuomintang (KMT). In the legislative campaign, the DPP now has better than even odds to retain its… Full Article
io Donald Trump and the authoritarian temptation By webfeeds.brookings.edu Published On :: Mon, 09 May 2016 08:00:00 -0400 Editors’ Note: Donald Trump has exposed the tension between democracy and liberal values—similar to the Arab Spring, writes Shadi Hamid. This piece originally appeared on The Atlantic. When I was living in the Middle East, politics always felt existential, in a way that I suppose I could never fully understand. After all, I could always leave (as my relatives in Egypt were fond of reminding me). But it was easy enough to sense it. Here, in the era of Arab revolt, elections really had consequences. Politics wasn’t about policy; it was about a battle over the very meaning and purpose of the nation-state. These were the things that mattered more than anything else, in part because they were impossible to measure or quantify. The primary divide in most Arab countries was between Islamists and non-Islamists. The latter, especially those of a more secular bent, feared that Islamist rule, however “democratic” it might be, would alter the nature of their countries beyond recognition. It wouldn’t just affect their governments or their laws, but how they lived, what they wore, and how they raised their sons and daughters. Perhaps more than at any other time, millions of Americans are getting a sense, however mild in comparison, of what it might feel like to lose your country—or at least think about losing your country—because of what people decide to do in the privacy of the voting booth. It still remains (somewhat) unlikely that Donald Trump, the now presumptive Republican nominee, can win a general election. Regardless of the final outcome, however, the billionaire’s rise offers up a powerful—and frightening—reminder that liberal democracy, even where it’s most entrenched, is a fragile thing. * * * When I hear my friends debating how, exactly, so many of their fellow citizens could support someone like Trump, it reminds me a bit of Egypt. In my forthcoming book, I relay a telling conversation I had four years ago, which has stayed with me since. A few days after the country’s first post-revolutionary elections concluded in January 2012, I visited my great aunt in her extravagant flat in the posh Cairo suburb of Heliopolis. She was in a state of shock, but worse than that was the confusion. It was one thing for the Muslim Brotherhood, long Egypt’s largest opposition group, to win close to 40 percent of the vote, but how could 28 percent of Egyptians vote for ultraconservative Salafi parties, which believed in the strict implementation of Islamic law? Like most Egyptians, she personally knew Brotherhood members even if she didn’t quite like them, but she hadn’t had much experience with Salafis and seemed totally unaware that they had extended their reach deep into Egyptian society. She realized, perhaps for the first time, that the country she had thought was hers for the better part of 70 years would never quite be the same. It hadn’t really even been hers to begin with. What if voters don’t want to be liberal and vote accordingly? What my aunt feared was that Egypt would become an “illiberal democracy,” a term popularized by Fareed Zakaria in his 2003 book The Future of Freedom, but one that’s still difficult for Americans to fundamentally relate to. In the American experience, democracy and liberalism seemed to go hand in hand, to such an extent that democracy really just became shorthand for “liberal democracy.” As Richard Youngs writes in his excellent study of non-Western democracy, liberalism and democracy have historically been “rival notions and not bedfellows.” Liberalism is about non-negotiable personal rights and freedoms. Democracy, while requiring some basic protection of rights to allow for meaningful competition, is more about popular sovereignty, popular will, and accountability and responsiveness to the voting public. Which, of course, raises the question: What if voters don’t want to be liberal and vote accordingly? * * * When the stakes are high, there is more to lose, and if there is more to lose, those on the losing end of a ballot box have powerful incentives to play “spoiler.” Fortunately, in the post-Civil War United States, the stakes have never reached what political scientist Barry Weingast calls the “threshold” at which citizens decide to defend themselves through extra-constitutional means, including by appealing for the military to take sides. This, in part, is why (good) constitutions are so important: They lower the stakes, reassuring citizens that even if their preferred party loses the election, it’s still just that—an election. Donald Trump, or more specifically what he represents, calls some of these assumptions into question. Trump himself isn’t quite an Islamist, but he is a proponent of a kind of “illiberal democracy,” even if he himself may not be familiar with the term. Drawing on a wellspring of white nativism and machismo, candidate Trump has regularly made demeaning statements about entire groups of people, including African-Americans, Mexicans, and women. His commitment to the protections enshrined in U.S. constitution are questionable, at best, and if we assume the worst, downright frightening (the difficulty with Trump is that he’s not precise with words, so it’s sometimes hard to make sense of what he’s saying). He has expressed support for registering Muslims in a database, elaborating that they could “sign up at different places.” When a reporter asked how this was different from requiring Jews to register in Nazi Germany, Trump said “you tell me,” prompting The Atlantic’s David Graham to note that “it’s hard to remember a time when a supposedly mainstream candidate had no interest in differentiating ideas he’s endorsed from those of the Nazis.” Trump, for good measure, has also refused to disavow President Franklin D. Roosevelt’s internment of Japanese-Americans. The U.S. Constitution includes robust civil-liberties protections, enshrined in the Bill of Rights. But these protections are not unlimited. Contrary to popular belief, majorities—if they’re large enough—can, in fact, do nearly anything they want, even in established democracies. It’s only really a question of how high the majoritarian bar is. In the United States, two-thirds of Congress and 75 percent of the states can amend or repeal articles of the Constitution. They could theoretically pass a constitutional amendment banning abortion. In countries like Egypt, Tunisia, and Turkey, where alcohol is currently legal and relatively easy to find, the issue of alcohol consumption is a touchstone for endless “what if” hypothesizing. Yet, Prohibition happened not in any of those countries but in America, with large majorities in the Senate and House of Representatives as well as 46 of 48 states backing the 18th Amendment (of course, banning alcohol in the U.S. wasn’t justified on primarily scriptural grounds, while in Muslim-majority countries, prohibition is seen as fulfilling an explicitly Quranic directive). In other words, built-in constraints and constitutional “guarantees” aren’t enough on their own to preclude illiberal outcomes. What Americans really depend on, then, is a shared political culture and the ideas and ideals that undergird it. As James Fallows notes, “Liberal democracies like ours depend on rules but also on norms—on the assumption that you’ll go so far, but no further, to advance your political ends.” But all it apparently takes is one man with charisma and an unusually perceptive understanding of the human psyche to change that. There are norms against politicians suggesting that minorities should have special identification cards. There are norms against saying you want to kill the families of terrorists. There are norms against encouraging your supporters to use violence against their political opponents. It’s not entirely clear why you don’t do or say these things (because Trump clearly has), but you just don’t. The very fact that Trump has made such frightening comments on national television—without any corresponding “disqualification” or decline in popular support—has already undermined these longstanding norms. The United States has had demagogues before, but they rarely make for viable presidential candidates. This is democracy’s blessing as well as its curse: that people you really don’t like—people who you think might threaten the Republic—can actually win. In the specific context of the Republican nomination, Trump opponents basically called for prioritizing good outcomes over democratic ones. They continued to search for possible paths to denying Trump the nomination, despite the fact that, barring acts of God, he was certain to win the popular vote and a plurality of delegates in the primaries. Even if Trump reached the magic number of 1,237 delegates, which would normally settle the matter, there were those who still seemed intent on scouring the rulebooks, parliamentary procedure, and delegate details in the hope of averting disaster. Democratic norms, the thinking goes, are great in normal contexts, but sometimes the stakes are simply too high to let democratic outcomes stand. As the columnist Walter Shapiro wrote, “[W]ith the threat of the first takeover of a modern political party by an authoritarian who traffics in racism and exudes contempt for the First Amendment ... [t]here would be nothing anti-democratic about GOP leaders using every mechanism in their power to stop Trump.” Nate Silver pointed out that “technically [Republicans would] be able to deny Trump the nomination even if he had a delegate majority by changing the rules at the last minute.” They could still theoretically do something like this, even after Trump’s decisive victory in Indiana. The Republican Party is not a country, and the party can disregard the preferences of primary voters if it so chooses, but elite pacts and back-room negotiations would seem decidedly antiquated during an unusually populist moment in American politics. [T]here will no doubt be a temptation to defy or otherwise undermine a democratically elected Trump. This particular debate in some ways mirrors arguments over the tensions between democracy and liberalism, a debate that will only intensify if Trump gains ground on Hillary Clinton in the coming months. It is probably time to err on the side of imagination, since party elites and pundits failed to imagine the unthinkable once already. What if Trump actually wins the presidency? How would we as Americans deal with an outcome that at least some of us see as a potential danger to our Constitution as well as our livelihoods? If Donald Trump wins, he would have, whether we liked it or not, a democratic mandate. Once in power, he might moderate his rhetoric and policies (yet another data point in the debate over the “inclusion-moderation hypothesis”), rendering at least some of this discussion moot. Yet it’s also possible that, facing a growing terrorist threat and a sputtering economy, more and more Americans might, like their newly elected president, dispense with the norms of reasonable conduct and support extreme measures. Still, a President Trump would be a legitimate president, having been freely and fairly elected by enough Americans. He would be, as much as it pains me to say it, our president. Still, there will no doubt be a temptation to defy or otherwise undermine a democratically elected Trump. For those of us who study the Middle East, the idea of not respecting democratic outcomes is business as usual, but I never thought it would be up for debate in the United States. * * * “Deep state” is a phrase that’s used to describe the constellation of autonomous and self-perpetuating institutions, namely the judiciary, military, and security services, which operate outside the glare of the public and are immune to the electorate’s whims. This deep state, acting as the guardian of national identity, puts limits on what elected politicians can hope to accomplish. The deep state was responsible for four coups in Turkey, the most recent of which deposed the country’s first-ever democratically elected Islamist prime minister in 1997. It would be difficult for Americans to think about their own government—or “regime”—in such terms. The U.S. military is subject to civilian control, while Supreme Court justices, though unelected and appointed to life terms, are nominated by the president and confirmed by the Senate. It is possible, however, to imagine a president so reckless as to activate state institutions against him or her, in a way that makes the notion of an American deep state more meaningful and relevant. Former CIA Director Michael Hayden ignited some speculative debate when he said that the military “would refuse to act” if ordered by a President Trump to take actions that were clearly illegal, such as killing the families of terrorists. Moreover, he said, military commanders are “required not to follow an unlawful order.” Even short of flagrant illegality, the military can still do what it’s done, at times, with nearly every sitting president. Peter Feaver, a leading expert on civil-military relations, notes that “the historical record is replete with cases of the military shirking—withholding information and options, slow-rolling, end-runs to Congress and the media, inflating cost estimates, etc.—to thwart civilian policies they deem to be unwise.” Considering, however, that Trump would likely be more “unwise” than most past presidents, such tensions could intensify well beyond what America’s political system is accustomed to. "[C]oup”...is not a word that Americans should ever get used to hearing in everyday political discourse. One can also easily imagine left-of-center (and right-of-center) civil servants in the Departments of State and Defense working against the president from within to mitigate his effectiveness and even his authority. This would be good, insofar as Americans wouldn’t want their president doing things that were crazy, illegal, or both. But it would still raise difficult questions about democratic legitimacy and how far an elected president can pursue his preferred policies, especially when it comes to issues that aren’t clear-cut. If the military refused to obey orders, however justified their refusal, then it could very well erode norms against military intervention in domestic politics. In response to Hayden’s comments, host Bill Maher joked that the former CIA director was floating “a coup.” This is not a word that Americans should ever get used to hearing in everyday political discourse. The norm against “coups” is a powerful one, which explains why American analysts (if not the U.S. government) are generally uncomfortable with military coups in foreign countries. No one teaches us that military coups are bad. Rather, it’s something we absorb in the process of being American. It goes without saying, so it’s rarely said. Recently, a few friends (who work on Middle East issues) and I had an interesting although ultimately frightening conversation, as Trump extended his delegate lead over Ted Cruz. Sometimes it’s useful to game out worst-case scenarios, however unlikely they might seem. We tried imagining a dystopian future and came up with internment camps, (threats of) military coups, and pro-Trump militias. Soon enough, the last didn’t seem nearly so farfetched, with volunteers offering to provide security at Trump rallies (for Trump supporters). * * * It is hard to imagine such things because, despite a long, low-intensity war on terrorism, America hasn’t faced a large-scale terrorist attack on the homeland since September 11, 2001. Democratic systems produce self-perpetuating norms, because they are accountable to a voting public. It’s this very responsiveness, though, that can be a source of vulnerability, if enough citizens, in the grip of fear, decide to prioritize “security” over liberty. As the legal scholar Christopher Kutz writes in the suggestively titled article “How Norms Die,” democracy can be “at the same time both fertile and toxic: fertile as a source of humanitarian values and institutions, but toxic to the very institutions it cultivates.” This is something we can measure. As Daniel Bush observed, after analyzing Pew survey data from 2002 to 2014: “During each campaign season, respondents reported having a higher negative impression of Muslim Americans than in non-election years.” This is a bit more mild than the link between elections and religious riots in India. As the historian of religions Michael Cook notes, “There is no doubt that Hindu nationalist politicians believe that communal riots can get out the Hindu vote for them. ... Under the right conditions the communal riot is a winning [electoral] strategy.” Norm shifting of an even more dangerous kind than India’s can happen rather quickly in countries where democracy is not yet consolidated. For example, millions of Egyptians who demanded freedom and democracy in 2011 turned seemingly against it in less than two and half years, supporting not just a return to authoritarian rule but the August 14, 2013 massacre of more than 800 protesters—what Human Rights Watch calls the “worst mass killing in [Egypt’s] modern history.” The kinds of shifts that occur in established democracies are less nefarious, but they can happen just the same. Torture is a good example. Kutz calls the spread of global norms against torture “one of the most impressive successes of the post-war period.” Yet, in the United States, these norms began to erode after the attacks of September 11th. Soon enough, torture—or what some were now euphemistically calling “enhanced interrogation”—came to enjoy broad support among the American public. The lesson again is clear. However strong they may first appear, norms, particularly those relating to national security, are more fragile than we might like to think. Once their sanctity is undermined by authority figures (whether presidents or presidential candidates), others can judge that what was once considered shameful is now not just socially tolerated but also necessary, good, and just. This is why “political correctness”—even if it seems irritating and is sometimes abused to restrict reasonable debate—still represents a public good: It makes us think twice about saying things that might contribute to the erosion of liberal and democratic norms. [N]orms, particularly those relating to national security, are more fragile than we might like to think. We have now reached a point where current or former presidential candidates from both parties have flirted with the idea of internment camps (former Democratic candidate Wesley Clark has called for “segregating” radicalized Muslims who are “disloyal to the United States”). In a series of incidents that have received less attention, a Tennessee State Representative called for using state institutions, in this case the National Guard, to “round up” Syrian refugees. Meanwhile, the mayor of Roanoke, Virginia, called for suspending assistance to refugees, but went further in an official statement on government letterhead. “I’m reminded,” he wrote, “that President Franklin D. Roosevelt felt compelled to sequester Japanese foreign nationals after the bombing of Pearl Harbor, and it appears that the threat of harm to America from ISIS now is just as real and serious as that from our enemies then.” No less than Supreme Court justice Antonin Scalia believed that it could happen here. On this, he is on strong ground, since it has, of course, already happened. In 1944, the Supreme Court upheld Roosevelt’s internment of Japanese-Americans in Korematsu v. United States. While Scalia said that the decision was “wrong,” he also issued a warning in his blunt style: “You are kidding yourself if you think the same thing will not happen again.” The norm against internment has been undermined, even though Americans do not face anything close to the threat presented by the Nazis and Japan during World War II. Which raises the question of what a plurality, or even a majority, of Americans might be willing to support if they had to confront a threat that was truly existential. We Americans are not, today, at war, at least not in the normal sense. I hope to God that we never will be again. But we might be. And this is where Scalia’s words that day were perhaps most chilling, in part because he was right. Evoking the Latin expression inter arma enim silent leges, he reminded the audience that “in times of war, the laws fall silent.” All we will have then are the things we still believe in—our norms. But, by then, they might not be enough. Authors Shadi Hamid Publication: The Atlantic Full Article
io A Congressional Oversight Office: A proposed early warning system for the United States Congress By webfeeds.brookings.edu Published On :: Fri, 03 Jun 2016 00:00:00 -0400 A central function of the United States Congress is oversight of the executive branch. Congressional oversight, as exercised from the beginning of the nation, is an essential tool in making the separation of powers real by empowering Congress to check the executive. In recent years, however, as polarization has reached paralyzing levels, Congress has largely gotten out of the business of routine and prospective “police-patrol” oversight. In the absence of the will and the capacity to do prospective oversight, Congress is at risk of losing its power to the executive branch and thus failing one of its most important constitutional roles. This paper assesses whether or not anything can be done to get Congress back into the oversight business. Specifically, author Elaine Kamarck examines the following question: Assuming that future Congresses develop the political will to conduct oversight, do they have the capacity to do oversight of a large, modern, and complex executive branch? As Kamarck illustrates, mismatched resources may make it difficult for Congress to resume its oversight function. The modern federal government is a complex and enormous enterprise. But as the executive branch has grown considerably over the past decades, Congress has adopted budget cuts that make the legislative branch less and less capable of undertaking the kinds of systemic oversight that can solve or prevent problems. Congress employs a mere 17,272 professional staff to oversee an executive branch consisting of 4.2 million civil servants and uniformed military. “The existing infrastructure that is supposed to help Congress be on top of the executive branch has fallen prey to a mindless dumbing down of Congress,” Kamarck states. She details the five entities that are meant to support Congress in its oversight role: committee staff, the Congressional Research Service, the Government Accountability Office, the Congressional Budget Office, and the Inspectors General, all of which are understaffed and under-budgeted. Kamarck recommends the first thing Congress should do to fix its oversight problem is to properly staff the agencies it already has and to stop nickel and diming and degrading its own capacity. Furthermore, Kamarck calls for a “Congressional Oversight Office,” a body charged with evaluating governmental performance before a crisis arises. This office should be staffed by implementation professionals who can gather the signals from all the other oversight organizations annually and in sync with the budget cycle. “Congress needs to get back into the business of productive executive branch oversight,” concludes Kamarck. A Congressional Oversight Office is certainly a step in that direction. Downloads Download the paper Authors Elaine Kamarck Image Source: © Kevin Lamarque / Reuters Full Article
io Too much or too little democracy? Some reflections on Democracy for Realists By webfeeds.brookings.edu Published On :: Mon, 13 Jun 2016 00:00:00 -0400 Recent political movements within the United States have raised concerns about the health of American democracy. With hyper-partisanship dividing the country and Donald Trump—the most unlikely, unsuitable, and unpopular presidential nominee of a major party in American history—securing the Republican nomination, the question emerges of whether democracy in America has gone awry. And if so, is it too much or too little democracy that’s to blame? To help address those questions, in this paper, Thomas E. Mann summarizes and discusses the findings of Christopher Achen and Larry Bartels’ ambitious treatise on American democracy: “Democracy for Realists.” Achen and Bartels contend that the traditional conception of voters as rational, attentive decision-makers does not hold against empirical evidence. Instead, voters are best understood as members of partisan groups, which influence their perception of candidates, issues, and even simple facts. According to Achen and Bartels, perceived social identities drive voting decisions, rather than rationality. Mann notes that most scholars would agree that voters do not follow the expectations of idealistic models, but draws attention to competing theories that are far less damning to voters’ rationality. In particular, the research of Paul Sniderman and Arthur Lupia suggests that voters are far more capable than Achen and Bartels would assert. In their view, voters have enough rationality and information to ensure a well-functioning democracy. As Mann summarizes the arguments: Achen and Bartels believe that citizens and elections are held to impossible, idealistic standards in the folk theory of democracy, which perpetuates myths and works against government responsiveness. Sniderman and Lupia, on the other hand, are offended by those who dismiss citizens as ignorant and incompetent; they seek to defend voters’ dignity and demonstrate the rationality and efficacy of their behavior in American democracy. What does this scholarship tell us about the coming presidential election, and the future of American democracy? Ultimately, Mann concludes that Achen and Bartel’s perspective is not anti-democratic, even if it is built on a belief that too much importance is placed on the often random and myopic outcomes of elections. Instead, Mann believes that “Democracy for Realists” reveals the real democratic deficit facing America is one stemming not from too much democracy, but from “asymmetry in political resources and representation of different segments of American society.” Truly understanding this problem and its root cause is a step toward strengthening American democracy. Downloads Download the paper Authors Thomas E. Mann Full Article
io Local elections could help unlock Palestinian political paralysis By webfeeds.brookings.edu Published On :: Tue, 26 Jul 2016 08:00:00 -0400 Last month’s decision by the Palestinian Authority to schedule municipal elections in early October hardly registered in the West Bank and Gaza Strip, much less here in Washington. In light of Hamas’ recent decision to take part in the process, however, those elections have suddenly taken on new meaning. While the election of some 414 village, town, and city councils across the West Bank and Gaza Strip will not change the face of the Palestinian leadership or alter the diplomatic impasse with Israel, local elections have the potential to unlock the current paralysis within Palestinian politics. Although Palestinian law calls for local elections to take place every four years, they have only been held twice since the creation of the Palestinian Authority (PA) in 1993, only one of which could be deemed genuinely competitive. The first and only local elections to take place in both the West Bank and Gaza Strip were held in 2004-05, in which Hamas—in its first foray into electoral politics—made major gains. Local elections were again held in 2012, although this time Hamas boycotted the process, preventing the vote from taking place in Gaza and allowing Fatah to declare a sweeping, if somewhat hollow, victory. Hamas’ decision to take part in this year’s local elections was therefore something of a surprise. Indeed, Hamas initially expressed dismay at the announcement, accusing the leadership in Ramallah of acting without consulting the other parties. Moreover, should the elections proceed as planned on October 8, they would be the first competitive electoral contest in the occupied territories since Hamas defeated Mahmoud Abbas’s ruling Fatah faction in the 2006 legislative election. Those elections triggered an international boycott of the PA which eventually led to the split between Fatah and Hamas and the current political paralysis. If nothing else, Hamas’ entry into the elections averts another needless internal crisis in Palestinian politics. A boycott by Hamas would likely have further entrenched the political and geographic division between the Fatah-dominated West Bank and Hamas-ruled Gaza Strip, while dealing yet another blow to the beleaguered National Consensus Government, which despite being accepted by both factions in April 2014 has yet to physically return to Gaza. Movement on the reconciliation track could also help push the long-stalled reconstruction of Gaza, which has yet to recover from the devastating war of 2014. Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other...[and Fatah] has little to gain from “winning” another electoral process that is largely uncontested. What explains Hamas’ apparent change of heart? For one, Hamas may believe it has an advantage over Fatah, which continues to suffer from widespread perceptions of corruption and incompetence—a perception reinforced by the collapse of the peace process as well as the unprecedented unpopularity of President Abbas. Hamas may also view the upcoming vote as a way to gauge its current standing and future prospects in anticipation of long-awaited legislative and presidential elections. Either way, Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other. Hamas’ decision to participate in the elections is welcome news for Palestinian voters eager to see the return of competitive elections and a revival of political life after years of stagnation. It even helps Fatah, which has little to gain from “winning” another electoral process that is largely uncontested. More important, as the party that lost both parliamentary elections and a civil war in 2006-07 and that remains the chief proponent of a failed process, Fatah desperately needs a political victory of some kind as well as a basis on which to stake its claim to legitimacy and continued grip on power. That said, it is important not to overstate the significance of local elections, which in the end will do nothing to address the deeper problems facing Palestinians in the occupied territories, whether from Israel’s continued occupation and its ever-expanding settlement enterprise or the ongoing political dysfunction within their own ranks. On the other hand, the prospect of the first competitive Palestinian elections in a decade represents a small but significant ripple in the otherwise stagnant waters of Palestinian politics. Authors Khaled Elgindy Full Article
io Multinational corporations in a changing global economy: Opportunities and challenges for workers, firms, communities and governments By webfeeds.brookings.edu Published On :: Mon, 02 Dec 2019 15:42:12 +0000 As policymakers in the United States consider strategies to stimulate economic growth, bolster employment and wages, reduce inequality, and stabilize federal government finances, many express concerns about the role of US multinational corporations and globalization more generally. Despite a significant body of work, the research community cannot yet fully explain and coherently articulate the roles… Full Article
io Regional leaders need to join together to stay competitive in the global market By webfeeds.brookings.edu Published On :: Thu, 13 Feb 2020 15:37:41 +0000 In 2014, St. Petersburg, Fla. mayor Rick Kriseman and Tampa mayor Bob Buckhorn went on a trade mission to Chile. But, in recognizing that scale matters in such attempts at global competitiveness, the two mayors made their trip not as representatives of two separate cities, but as dual ambassadors of the Tampa Bay region. Prior… Full Article
io 20200609 Daring to Lead: Organizational Alignment By webfeeds.brookings.edu Published On :: Mon, 22 Apr 2019 17:21:42 +0000 Full Article
io Beyond Arithmetic: How Medicare Data Can Drive Innovation By webfeeds.brookings.edu Published On :: Fri, 06 Jun 2014 00:00:00 -0400 Five years ago, my mother needed an orthopedic surgeon for a knee replacement. Unable to find any data, we went with an academic doctor that was recommended to us (she suffered surgical complications). Last month, we were again looking for an orthopedic surgeon- this time hoping that a steroid injection in her spine might allay the need for invasive back surgery. This time, thanks to a recent data dump from CMS, I was able to analyze some information about Medicare providers in her area and determine the most experienced doctor for the job. Of 453 orthopedic surgeons in Maryland, only a handful had been paid by Medicare for the procedure more than 10 times. The leading surgeon had done 263- as many as the next 10 combined. We figured he might be the best person to go to, and we were right- the procedure went like clockwork. Had it been a month prior to the CMS data release, I wouldn’t have had the data at my fingertips. And I certainly wouldn’t have found the most experienced hand in less than 10 minutes. It’s been a couple of month since the release of Medicare data by the Centers for Medicare and Medicaid (CMS) on the volume and cost of services billed by healthcare providers, and despite the whiff of scandal surrounding the highest paid providers (including the now-famous Florida ophthalmologist that received $21 million) the analyses so far have been somewhat unsurprising. This week, coinciding with the fifth Health DataPalooza, is a good time to take stock of the utility of this data, its limitations, and what the future may hold. The millions of lines of data was exactly as advertised: charges and paid services under traditional Medicare “fee-for-service,” including the billing provider’s ID and the costs to Medicare. The initial headlines touting “Medicare Millionaires” relied on some basic arithmetic and some sorting. And the cautions piled up: the data could reflect multiple providers billing under a single ID; payments are not the same as a provider’s actual take home income; it’s not complete information as it doesn’t contain information about other insurers, or even Medicare Advantage, and so on. But perhaps most damning was how little insight the data seemed to provide on the quality or value of care provided, as opposed to volume of services. As Lisa Rosenbaum wrote in the New Yorker, “So much of that good isn’t captured by these numbers. You don’t bill for talking to a patient about how he wants to die. There’s no code for providing reassurance rather than ordering a test.” Where is the value in the data? Data bear witness to the fundamental flaw of the payment system that generates them. The absence of information on quality, safety, appropriateness, or outcomes appears to have been a genuine revelation to many, but it is in fact exactly the type of output that we should expect from this volume-based system that we have built. This is not a critique of the data release. It is an indictment of our payment system. Data is revealing important trends in how we pay doctors differently. Not all physician payments are created equal, and the data certainly shows the disparities across specialties, primary care, and others. For example, the average total annual Medicare payment to geriatricians was less than $100,000, while dermatologists and radiation oncologists (who presumably also see non-elderly patients) received on average $200,000 and $360,000 respectively. The important question will be why and should it continue? Figure 1: Distribution of Total Medicare Pay by Provider Type, 2012 Source: Author's calculations based on Medicare data released in April 2014 Data is revealing important indicators of cost and pricing – a major contributor to rising health care costs. Why is it that a brief visit with a geriatrician is worth $13; a 45-minute visit with a geriatrician sorting through medications, educating family members, and developing a quality of life plan with a terminal cancer patient is worth $79; and a dermatologist treating suspected skin cancer can earn upwards of $600 for a procedure that takes them minutes? Data sheds light on practice patterns. The data is also revealing important variances in utilization of drugs and treatments. For example, a block apart on Park Avenue, two ophalmologists differ significantly in their use of treatments for macular degeneration. One uses expensive injectable drugs and gets paid over $10,000 per injection, while the other receives less than $500 for the lower-cost equivalent. A CBS News report looked at spinal fusion surgeries—a procedure where there is almost no evidence demonstrating a net benefit to patients compared to other conservative therapies. They observed that “while the average spine surgeon performed them on 7 percent of patients they saw, some did so on 35 percent.” At the extremes, outlier “practice pattern” begins to raise questions of potential improper billing or outright fraud and abuse. For example, simply looking at the frequency and volume of services provided to individual beneficiaries can identify concerning outliers. This laboratory company billed for 28,954 blood glucose reagent strips in 2012- for 88 patients. And yes, that’s highly unusual. Figure 2: "Outlier" Medicare Billing for Blood Glucose Reagent Strips, 2012 Source: Author's calculations based on Medicare data released in April 2014 One clinical social worker billed for 1,697 separate days of service on 28 patients (the size of the bubble is proportional to the total amount of reimbursement by Medicare in 2012). Figure 3: "Outlier" Medicare Billing for Days of Service, 2012 Source: Author's calculations based on Medicare data released in April 2014 The most extreme outlier, Dr. Gary Ordog, was named by NPR and ProPublica in their examination of providers who are outliers on their pattern of coding for the highest intensity office. Ordog had previously lost the right to bill California’s state Medicaid program, and yet continued to charge Medicare for over $500,000 in billing in 2012. It’s important to caution however, that even in these extreme outliers, statistics alone cannot provide definitive evidence of abuse. There is a need for formal investigation. Medicare and law enforcement officials will need to create new processes for dealing with a potential flood of outlier reports from amateur sleuths like me. What's Next for Medicare Data? Data can be trended. Updates of data releases can begin to show us not just snapshots, but moving pictures of our healthcare system as it undergoes rapid changes. The New York Times reported on the increase in charges for certain frequent causes of hospitalization between 2011 and 2012. It will be interesting to see whether the data release itself, and the Steven Brill landmark Time article on hospital charges, have an impact on reversing these trends. Data can be “mashed up”. The value of open data is hugely greater than the sum of its parts. As more and more data becomes available, the files can be cross-linked and “mashed up” to be able to answer questions no one database could have. ProPublica linked together cobbled together data on state actions and sanctions on physicians with the Medicare data release to ask why these physicians are still being paid by Medicare. What does the future hold? Correlations with drug prescribing data, meaningful use, and referral patterns are possible today, Sunshine Act disclosures and quality reporting, and much more is soon to come. As we get comfortable with the data, analysts can move past the basics of arithmetic and sorting, we have an opportunity to make more ‘meaningful use’ of this data. We can begin to identify practice patterns, overuse, variations in geography or demographics, and potentially even fraud and abuse. As more and more data becomes available, the files can be cross-linked and “mashed up” to be able to answer questions no one database could have addressed. What will determine the value of the Medicare data release will be the creativity of those data scientists, epidemiologists, and health services researchers (amateur as well as professional) who can ask the challenging questions that must be answered. Authors Farzad Mostashari Full Article
io Health Policy Issue Brief: How to Improve the Medicare Accountable Care Organization (ACO) Program By webfeeds.brookings.edu Published On :: Tue, 17 Jun 2014 00:00:00 -0400 Contributors: Alice M. Rivlin and Christine Dang-Vu Recent data suggest that Accountable Care Organizations (ACOs) are improving important aspects of care and some are achieving early cost savings, but there is a long way to go. Not all ACOs will be successful at meeting the quality and cost aims of accountable care. The private sector has to date allowed more flexibility in terms of varying risk arrangements—there are now over 250 accountable care arrangements with private payers in all parts of the country—with notable success in some cases, particularly in ACOs that have been able to move farther away from fee-for-service payments. Future growth of the Medicare ACO program will depend on providers having the incentives to become an ACO and the flexibility to assume different levels of risk, ranging from exclusively upside arrangements to partial or fully capitated payment models. Given that the first three year cycle of Medicare ACOs ends in 2015 and more providers will be entering accountable care in the coming years, the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) affecting the Medicare ACO program. In anticipation of these coming changes, the Engelberg Center for Health Care Reform has identified the "Top Eight ACO Challenges" that warrant further discussion and considerations for ensuring the continued success of ACOs across the country. To support that discussion, we also present some potential alternatives to current Medicare policies that address these concerns. These findings build on the experiences of the Engelberg Center’s ACO Learning Network members and other stakeholders implementing accountable care across the country. In some cases, the alternatives might have short-term costs, but could also improve the predictability and feasibility of Medicare ACOs, potentially leading to bigger impacts on improving care and reducing costs over time. In other cases, the alternatives could lead to more savings even in the short term. In every case, thoughtful discussion and debate about these issues will help lead to a more effective Medicare ACO program. Top Eight ACO Challenges 1. Make technical adjustments to benchmarks and payments 2. Transition to more person-based payments 3. Increase beneficiary engagement 4. Enhance and improve alignment of performance measures 5. Enable better and more consistent supporting data 6. Link to additional value-based payment reforms 7. Develop bonus payments and other incentives to participate 8. Support clinical transformation Downloads Issue Brief: Improving the Medicare ACO Program Authors Mark B. McClellanRoss WhiteFarzad MostashariS. Lawrence Kocot Full Article
io Patient Medication Information: Keep It Simple, Stakeholders By webfeeds.brookings.edu Published On :: Tue, 24 Jun 2014 16:00:00 -0400 Erica has a history of cardiac issues. She visits her doctor for a regular checkup and her doctor writes a new prescription to better control her heart disease. Unfortunately, her doctor didn't mention any instructions, except to take it once a day. Erica thanks her doctor and heads to the pharmacy. At the check-out counter, the clerk hands Erica her new prescription drug, in addition to three documents stapled to the bag that he says "will explain everything you need to know about your medication." Later on, while reviewing the materials at home, Erica is overwhelmed by the information, which is in fine print and difficult to understand. She is frustrated and confused, and tosses the documents in the trash. This scenario is not uncommon. Research suggests that about 50 percent of Americans find it difficult to read health information.[i] Consumers who cannot find the information they need, or who do not understand the information because it is presented in a convoluted manner, are less likely to use it to prevent unnecessary medical errors. In Erica’s case, she could have ended up in the emergency room because she missed some basic warnings about her prescription. For example, one warning might have been that she should not chew the medication because it was an extended release capsule. Chewing the capsule could release the entire day’s dose at once, resulting in an unintended overdose. We know that consumers are receiving information – sometimes too much information. Not only are consumers receiving pages of medication information, the information they receive is uncoordinated and sometimes conflicting. Some documents are written by the drug manufacturer, and others are written by pharmacies or another third party. Some medication information documents are FDA-approved and others are not. The real question is – could medication information be presented in such a way that it would be more useful for consumers? The answer is a resounding “yes.” One study found that just 75 percent of consumer medication information met the minimum criteria for usefulness.[ii] That number might be impressive as a field goal percentage in the NBA, but for consumers it represents an unmet need for high quality medication information. The U.S. Food and Drug Administration (FDA) has spent the past several years working with stakeholders to determine the most effective methods for conveying medication information. One overarching principle that has emerged from FDA’s engagement with the health care community is the need for a single, standardized document to replace the numerous existing documents. This document is identified as Patient Medication Information (PMI). PMI creates an easier way for consumers to access and understand their medication information. By presenting the most salient pieces of information – including drug uses, warnings, side effects, and directions – on a single page that is easy to navigate, PMI can be a useful tool for enhancing treatments and preventing avoidable medication errors or side effects. PMI holds promise both for consumers and the broader health care system. For consumers, PMI could contribute to better outcomes and an overall improvement in patient experience. For health systems, PMI’s positive impact on medication adherence could improve performance on quality measures, such as hospital readmissions, that could lead to shared savings or other rewards. Through a cooperative agreement, the Engelberg Center for Health Care Reform at the Brookings Institution has worked in collaboration with FDA over the past few years to convene a series of workshops focused on identifying best PMI practices – for example, how to make PMI both more usable and accessible. Workshop participants identified several guiding principles for improving the content, format, and distribution of PMI. PMI Guiding Principles PMI content should be consumer-friendly. Expert stakeholders identified a lack of consumer-friendly information as one of the most important barriers to effectively communicating critical medication information. To fix this problem, the language used in PMI will need to be simplified, patient-centric, and understandable across the entire spectrum of health literacy levels. The types of information that should be included in PMI must be essential for taking a medication properly. Extraneous information, such as a discussion of previous treatments a consumer must have previously tried and failed before receiving the new prescription, may be more confusing than helpful. The best PMI formats are simple and easy to navigate. Consumers don’t want to be given a technical-looking instruction manual when they pick up their prescriptions. Participants at the workshops generally agreed that it would be ideal to keep PMI to a single page. They also agreed that actionable headers that help consumers locate the information they are looking for are preferable to the question and answer format (e.g., “Uses” and “Directions” are more effective than “What does the drug treat?” and “How do I use the drug?”). There was consensus on the point that consumers will ultimately decide the best format. Access to PMI will be bolstered by multiple channels of distribution. Paper is still the primary source of medication information, and is preferred by certain demographics. However, technology is revolutionizing the way consumers receive information. This is generally good for society, but it introduces some challenges, including the fact that consumers now have more access to information of questionable quality. One method for ensuring access to consistent and high quality PMI would be to have a central repository for all PMI documents. This approach could support distribution of both printed and electronic PMI. Access to PMI could be further enhanced by making it available on smartphones and via email. On July 1, the Center will convene a public meeting that will provide an opportunity for the health care community to discuss the issues mentioned above. Researchers will give an update on progress made since the previous meetings and share the lessons they learned from recent studies. Diverse stakeholders – including patient advocacy groups, providers, pharmacies, and drug manufacturers – will provide their perspectives on the future of PMI and assess their role in making high quality PMI a reality. There are many issues that need to be addressed in exploring the promise of PMI. However, one thing that participants at the July 1 meeting should remember is this: Keep it simple, stakeholders. [i] Shrank, William, and Jerry Avorn. "Educating Patients About Their Medications: The Potential And Limitations of Written Drug Information." Health Affairs26.3 (2007): 731-40. Healthaffairs.org. Health Affairs, May 2007. [ii] Kimberlin, Carole, and Almut Winterstein. Expert and Consumer Evaluation of Consumer Medication Information‐2008. Rep. University of Florida College of Pharmacy, 4 Nov. 2008. Web. 8 June 2014. Authors Gregory W. DanielAhimsa GovenderDerek Griffing Image Source: © Lucas Jackson / Reuters Full Article
io Health Policy Issue Brief: Four A's of Expanding Access to Life-Saving Treatments and Regulatory Implications By webfeeds.brookings.edu Published On :: Thu, 31 Jul 2014 15:27:00 -0400 Please note that this Engelberg Center for Health Care Reform Health Policy Issue Brief first appeared in the Health Affairs Blog on July 31, 2014. Click here for the Health Affairs Blog version. Abstract Individual patient expanded access is a process by which patients can obtain investigational drugs that have not been approved by the Food and Drug Administration (FDA) outside of a clinical trial setting from biopharmaceutical companies when no other alternative therapy is available. Currently, no industry-wide structural principles exist to help companies navigate this process while balancing the needs of getting a drug to the market as quickly as possible with providing potentially life-saving treatment to individual patients. The Engelberg Center convened a stakeholder group to identify common themes and identify common principles related to expanded access, as none currently exist. The result was 4 A’s - Anticipation, Accessibility, Accountability, and Analysis – to help assist patients, providers, and companies with expanded access. Process and capacity building recommendations for the FDA also were proposed to assist companies with sustaining expanded access programs. Call to Action: The Importance of Expanded Access Programs Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer. Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome. The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage. Such cases included 7-year-old Josh Hardy (brincidofovir from Chimerix for disseminated adenovirus infection), 45-year-old Andrea Sloan (BMN673 from BioMarin for ovarian cancer), 41-year-old Nick Auden (pembrolizumab from Merck for melanoma), and 6-year-old Jack Fowler (intrathecal idursulfase from Shire for Hunter Syndrome). Expanded access requests to the FDA for new patients are increasing, from 1,000 patients nationwide in 2010 to more than 1,200 in 2012.[i] (This is likely an underestimate, since it does not include appeals made directly to companies.) In the wake of these events, it became clear that many biopharmaceutical companies had varying experiences and policies related to such access. From the domestic regulatory standpoint, the FDA revised its expanded access regulations in 2009, which define criteria that must be met to authorize expanded access, list requirements for expanded access submissions, describe safeguards that will protect patients, and preserve the ability to develop meaningful data about the use of the drug. Biopharmaceutical companies typically face a complex global environment in which legal and regulatory frameworks can differ substantially. At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. Still, the public belief persists that the FDA is the main bottleneck that restricts access. In April 2014, Representative Morgan Griffith (R-VA) proposed H.R. 4475, The Compassionate Freedom of Choice Act of 2014, designed to restrict the FDA’s ability to prevent the use of investigational drugs in terminally ill patients. Similarly, some states have passed “Right to Try” legislation to reduce FDA oversight, but contains no requirement that companies must make drugs available.[ii] The goal of our meeting was to identify common themes and possibly broad outlines to suggest industry-wide policies related to expanded access, as none currently exist. The group first discussed background issues related to expanded access and agreed on definitions. The meeting then focused on three topics. First, the group participants who play key roles in evaluating expanded access requests were invited to share narrative experiences in specific clinical cases, in an effort to lay the groundwork for trust and open discussion. Second, the group was asked to identify internal industry-specific structural barriers, such as the existence of clear procedures or tracking mechanisms within companies to handle requests. Finally, the participants reflected on situations in which expanded access may not be appropriate, or where regulatory barriers or liability concerns may hinder expanded access. This paper reflects the authors’ observations and assessment of the internal and external landscape, based upon information provided by the meeting participants. Laying the Groundwork with Shared Experiences The FDA allows companies to provide drugs and charge individual patients that do not meet the enrollment criteria for clinical trials geared towards regulatory approval through expanded access programs.[iii] These programs are meant to provide the drug directly to treat the patient’s condition, rather than having the primary goal of collecting efficacy or detailed safety data in support of approval. Before 1987, the FDA lacked formal recognition of expanded access, although investigational drugs were provided informally.[iv] Since then, the FDA has instituted novel classes of individual INDs so that a company sponsor or licensed physician can legally obtain treatment access from the FDA to provide a drug while it is still in the approval process.[v] Essentially, this provides companies a legal exception from the law to ship unapproved drugs across state lines, and if they desire, to charge for them. These INDs are designed solely for the potential benefit of desperate patients and not intended to formally collect safety or efficacy data that could potentially inform a regulatory decision, but can have regulatory impact, nonetheless. At the outset, several participants objected to the term “compassionate use,” since it introduces inherent value decisions, can emotionally charge discussions, and does not recognize that there may be valid and ethically appropriate reasons for denial. The generally agreed upon term “expanded access,” is used throughout this paper. (One participant suggested the term “early access.”) Ideally, the term would make it obvious that this is access to an unapproved drug, in order to temper expectations of favorable results. Somewhat confusingly, the FDA uses the terms “expanded access,” “access,” and “treatment use” interchangeably to refer to the use of a drug, and of which none clearly identify the stage of development.[vi] Participants shared numerous examples of requests for expanded access and explained that their companies handle anywhere from a handful to several hundred requests per year. The following selected stories illustrate the wide range of experiences and situations that companies encounter when navigating the complex decisions involved in administering an expanded access program. Several other examples were discussed and the specific participants expressed that they would be willing to share these particular examples publicly. Chimerix, a 54-employee company based in Durham, North Carolina, is developing the drug brincidofovir and previously had created an intermediate expanded access protocol for the drug (CMX001-350) as encouraged by the FDA following over 200 emergency INDs granted for access to brincidofovir.[vii] One such case was for an armed services member with previously undiagnosed acute myelogenous leukemia who developed life-threatening vaccinia infection following smallpox vaccination in 2009.[viii] The patient received the drug from Chimerix through an emergency IND. After two years, the company had not secured FDA approval for the drug and eliminated expanded access in February 2012 in order to focus on studies which would inform a regulatory decision. In March 2014, Chimerix originally rejected an emergency IND request for 7-year old, Josh Hardy, who was critically ill from disseminated adenovirus infection after bone marrow transplantation. A highly public social media campaign targeted the company in the wake of this decision, and the experience was traumatizing for many of the employees. Following discussion with the FDA, Chimerix initiated a new clinical trial for the treatment of adenovirus infection in order to collect safety and efficacy data to support an NDA submission. Hardy was the first patient enrolled in the clinical trial, and his family reported through several media outlets that he recovered from the adenovirus infection and was discharged home. One biopharmaceutical company representative described receiving a middle-of-the-night telephone call directly at home, with an emergent, time-sensitive request for an experimental therapy for a critically ill child with a rare acute disease in a foreign pediatric intensive care unit, where regulatory standards were different from those in the U.S. The ideal pediatric dosage was unknown, and only limited safety data and clinical details were available. Urgent efforts were made to gather more information and the request was approved, but despite these efforts the patient did not survive. Bristol-Myers Squibb began a clinical trial for a cancer drug several years ago.[ix] A woman with pancreatic cancer enrolled in the trial and saw that her tumor was no longer growing. After the 3.5 year trial, the study closed because the drug was deemed ineffective for all other patients and was not approved for further development. However, the company continued to provide the drug for the one woman for whom the drug was effective through a single patient IND for an additional 9 years. To demonstrate the volume of expanded access requests, one participant showed several messages on his mobile device during the half-day discussion, directly from patients who had located his email addresses through on-line searches, to plead for expanded access to an anticancer therapy. Development of Structural Principles: The Four A's Broadly, no specific industry-wide consensus on expanded access procedures exists. As a result, there is significant variation in company policies and procedures. During this phase of discussion, participants shared their own company strategies and suggested possible areas of consensus that might form the basis for shared principles and industry-wide practices. These suggestions fell into four categories, which we termed the 4 “A’s”: Anticipation, Accessibility, Accountability, and Analysis (see Figure 1). First, the group agreed that large and small companies should anticipate the need for and creation of expanded access programs when developing drugs expected to generate expanded access requests and as part of the drug development plan. This is particularly important for drugs that might be considered for priority or breakthrough designation during FDA approval. In these cases, companies should strongly consider developing a written expanded use policy with clear guidelines for inclusion and exclusion, which would also feature a defined review process, clear decision making criteria, and a defined time frame for response to requests. This also allows companies to plan for the demands that may be placed on their supply chain and staff resources to ensure sufficient supply for investigational and expanded use purposes. Identifying a decision maker within each company and for each disease area/product will also help patients or physicians reach the appropriate contact when requesting a drug, as well as assist the company in gaining expertise in responding to these requests. For example, one large company identifies one point of contact for all expanded access requests regarding each product and posts that individual’s contact information on the website. In the early stages of drug development, supplies of investigational drugs are extremely limited. This is often because the technically-challenging process of optimizing drug product manufacture takes a considerable amount of time. Low yielding manufacture batches are not uncommon at the early phases of research. Some companies do not approve expanded access requests because they do not have enough of the drug in stock to supply these external requests and meet the needs of investigational study patients and individuals participating in clinical trials, an issue which may be particularly acute for biologics. Smaller companies may have more resource constraints, such as inadequate staff to manage requests or supply chain and logistics issues. One representative suggested that if a company had early transparency from regulators about the final numbers of subjects they would be willing to accept to achieve drug development milestones, it would make it much easier for the company to feel less reservation about its drug supply. (It may be beneficial for companies to analyze their financial ability to provide drugs potentially at no cost or when there is not a large enough supply, ideally in a transparent manner.) Once an expanded access policy is anticipated and developed, the second key principle the group identified was making the policy accessible to all individuals who may qualify. First, for patients, with guidance from their treating physician, the company making the drug should always steer the patient to enter a clinical trial (if they meet eligibility criteria). If the contacted company cannot accommodate the patient, they should steer them to other open trials if possible, even if sponsored by another company. Many of our participants noted that this already occurs. The group was particularly cognizant of the disparity in access to drug companies and their expanded access programs: patients with savvy social media strategies are more likely to succeed in navigating across organizational constraints than without similar sophistication. The group believes that increased accessibility would assist in making opportunities for expanded access more equitable. In addition, these policies could help educate patients and physicians about submitting legitimate expanded access requests and help decrease the costs of reviewing inappropriate requests on the company (for example, if there are other proven therapies or the situation is not life threatening). If the patient is ineligible for a trial, the patient should be able to easily access the written expanded access policy online. For example, both large and small companies like Pfizer, Bristol-Myers Squibb, Shire, and Merck post their expanded access policies on their websites, though the terminology may in some cases be complex. In addition, Janssen has developed a video explaining their policies in non-technical terms. Ideally, such policies should be available in some web based or public facing platform to both patients and physicians and written in a clear manner that is jargon free and accessible to individuals at various education levels. Most participants felt strongly that requests for expanded access should originate from a medical provider, not from a patient, since expertise is needed to first screen appropriate candidates. This is consistent with current FDA regulations for an IND, in which a physician or qualified medical expert must sponsor an IND or serve as an investigator under an existing IND for expanded access. Third, companies should have accountability to the requesting party for expanded use requests that they receive and review them within a specified, transparent amount of time. If the request could not be approved, the company should consider clear communication and provide an explanation of why the request was turned down. In these cases, some participants suggested that the company might also consider instituting an appeals process by which a patient can receive an additional review if not approved, potentially from a non-binding third party such as an independent, multidisciplinary body or a regulatory agency like the FDA. (Two participants, however, were uncomfortable with any third party review.) Companies can track expanded access requests in order to guarantee that the patient has received follow-up and that the communication loop has been closed. One large pharmaceutical company conducted an internal audit of its expanded access procedures and found that the largest problem was that employees did not know where to find information. Another representative noted that it is important to maintain consistency across patients and the process of requesting a drug. The final principle would encourage companies to release timely analysis of data from expanded access patients. In addition to tracking communication, companies should keep a database of the number of requests and outcomes, in a manner that doesn’t slow getting drugs to needy patients rapidly. One company refined its internal tracking tools to determine who was requesting drugs, for what conditions, and where they lived. Where possible, companies might be encouraged to share anecdotal or preliminary safety or efficacy data from expanded access in peer-reviewed or other refereed venues in a prudent time frame following collections, if this is available or known. This is not always possible, because emergency INDs do not require provision of safety or outcome data to the company. There are several challenges associated with operationalizing this in the current model, namely the appropriateness of anecdotal data, the level of detailed safety and efficacy data currently available through expanded access, suitability for publication, and funding for these activities in the current budget climate. One potential approach to address this is funding from federal or state regulatory agencies or payers for the reasonable costs of follow-up and reporting outcomes. Regulatory Considerations The participants then discussed the types of risks, including regulatory and financial, that may affect companies’ expanded access policies. When a company is considering expanded access requests, they consider the risks-benefits of providing the drug outside of a clinical trial as well as the potential for any regulatory issues in an era of litigation and an increased threshold for demonstration of safety. While a company’s provision of a drug for expanded access is voluntary, the FDA does require the company to collect and report safety data. Notably, none of the representatives felt that the FDA is a major regulatory barrier to processing and approving expanded access requests once the sponsor has reviewed the request, assessed the benefit-risk, and determined the request meets FDA requirements and evidentiary standards. In addition, the attendees felt that adverse effects and related liability risk were not of particular concern given that the drugs are assessed on a risk-benefit analysis. However, companies that make drugs in particularly limited markets with small numbers of patients (for example, for unusual diseases with less than 200,000 patients nationwide which may justify a special designation called “orphan status”) may be more concerned about restrictive labeling if an unusual adverse event occurred even in one or two patients during expanded access of an orphan or small market therapy. However, there is no data of which participants were aware and no public reports that an adverse event during expanded access has harmed regulatory approval.[x] The group opinion was that that safety data would be available eventually in any event and an FDA “safe harbor” provision would not necessarily affect companies’ willingness to accept more requests for expanded access. A final concern was that there is no regulatory mechanism to consider data from expanded access in the evidence generation process for approval. An Expanded Role for the FDA While the FDA may not serve as a strong barrier to expanded access, the group considered strategies to promote equitable and fair access. For example, some argued that the breakthrough or priority review categories for FDA review might identify products that could have high potential for expanded access requests. This designation expedites “the development and review of drugs for serious or life-threatening conditions.”[xi] As of mid-April 2014, the FDA had received nearly 180 requests for breakthrough designation, with 44 requests granted.[xii] By hastening the drug development process, the FDA has already begun to bring drugs that have a reasonable expectation of benefit to the market faster. In order to receive breakthrough therapy designation, current legislation might be amended so companies could be asked to provide evidence that the 4 A’s are being followed in some capacity. The FDA might also assist companies in establishing expanded access programs during open clinical trials in two main areas: process and capacity building. First, in terms of process, the FDA could be asked to create a defined path for regulatory approval with provisions that would encourage companies, both large and small, to include plans for expanded access programs when developing a drug. While FDA’s draft guidance related to INDs notes that larger expanded access programs could threaten enrollment in clinical trials,[xiii] and some participants agreed that this was a significant issue, not all companies have had difficulties enrolling patients in both clinical trials and expanded access programs. For example, one large pharmaceutical company left a Phase 1 clinical trial open for a promising therapy while concurrently enrolling individuals who didn’t qualify for open clinical trials into an expanded access program, without appreciable leakage of enrollees in their advanced phase trials that might affect the key development pathway. Second, the FDA could support convening around capacity building and sharing best practices with companies. With the understanding that there are many small biotechnology or pharmaceutical companies with limited budgets and staff, the FDA could foster a partnership of large and small companies. This partnership could be achieved by convening meetings where companies share their experiences in creating and sustaining expanded access programs. This could be supported by creating a database for these shared ideas, as well as any expanded access data that can be made legally available, such as how many requests are granted or patient outcomes. To ensure equitable, consistent, and transparent review of requests, some companies suggested the use of an impartial external advisory board. Similar to an unbiased review from an institutional review board (IRB), this committee could have an advisory or decision making function. Companies with supply constraints may feel that if they cannot give the drug to everyone who requests it, then they should give it to no one. This committee could help the company triage the patients who would benefit the most, and would be protected from liability. Next Steps The most efficient and equitable way to make new effective treatments to the largest number of needy patients is regulatory approval, accelerated or otherwise, following successful demonstration of efficacy and safety for a given indication in a specific population. Until that process is complete, access to an experimental therapy is by definition an additional risk, as the agreed necessary safety and efficacy have not yet been demonstrated. True informed consent in this setting is difficult to obtain (i.e. studies have shown that severely ill patients, such as those with life-threating circumstances requesting expanded access, had less retention of information discussed in the informed-consent process and less-clear understanding of the risks of therapy compared to healthier patients[xiv]). One position companies and regulators can consider is that the default answer to expanded access requests should be affirmative, unless there are compelling reasons for not approving requests to patients with life-threatening illnesses. (Such reasons, for example, might include limited treatment supply or lack of reasonable expectation of benefits versus risks.) Such a position would require, however, that there be broader industry, clinician, regulatory, and patient advocacy agreement of shared principles. This paper outlines the experiences, structural principles, and regulatory considerations of a small group, but further meetings may convene a broader group of stakeholders to build upon these concepts. Such consensus-based approaches might lead to durable systems that meet the needs of desperate patients who have run out of options—while allowing innovation to continue to benefit those who may come afterwards. Acknowledgements: We are grateful for the participation of the following representatives in the roundtable: Jeff Allen (Friends of Cancer Research), Michelle Berrey (Chimerix), Renzo Canetta (Bristol-Myers Squibb), Anne Cropp (Pfizer), Joseph Eid (Merck), Aaron Kesselheim (Harvard Medical School), Howard Mayer (Shire), Jeffrey Murray (FDA), Lilli Petruzzelli (Novartis), Amrit Ray (Janssen), and Robert Truog (Harvard Medical School). We thank Mark McClellan (Brookings Institution) for helpful discussions of this topic and comments on the manuscript, and to the Richard Merkin Foundation for support. The views and opinions expressed in this article were interpreted and organized by the staff of the Brookings Institution. They do not necessarily reflect the official policy or position of any individual roundtable representative, their companies, or their employers. References [i] Gaffney, A. Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program. Regulatory Focus. 2014. Available from: Regulatory Affairs Professionals Society. Washington, DC. Accessed May 7, 2014. [ii] U.S. House of Representatives. 113th Congress, 2nd Session. H.R. 4475, Compassionate Freedom of Choice Act of 2014. Washington, Government Printing Office, 2014. [iii] FAQ: ClinicalTrials.gov- What is “Expanded Access”? U.S. National Library of Medicine Web site. https://www.nlm.nih.gov/services/ctexpaccess.html. Published October 24, 2009. Accessed May 19, 2014. [iv]Food and Drug Administration. Expanded Access to Investigational Drugs for Treatment Use. Fed Register. 2009;74;40900-40945. Codified at 21 CFR §312 and §316. [v]Investigational New Drug Application. U.S. Food and Drug Administration Web site. Published October 18, 2013. Accessed May 19, 2014. [vi] Draft Guidance for Industry: Expanded Access to Investigational Drugs for Treatment Use—Qs & As. U.S. Food and Drug Administration Web site. Accessed May 19, 2014. [vii] A Multicenter, Open-label study of CMX001 treatment of serious diseases or conditions caused by dsDNA viruses. ClinicalTrials.gov Web site. http://clinicaltrials.gov/ct2/show/NCT01143181 Accessed May 19, 2014. [viii] Lane, JM. Progressive Vaccinia in a Military Smallpox Vaccinee—United States, 2009. Morbidity and Mortality Weekly Report. 2009. Centers for Disease Control and Prevention, Atlanta, Geo. Accessed May 7, 2014. [ix] Ryan, DP et al. Phase I clinical trial of the farnesyltransferase inhibitor BMS-214662 given as a 1-hour intravenous infusion in patients with advanced solid tumors. Clin Cancer Res 2004: 10; 2222. [x] Usdin, S. Viral Crossroads. BioCentury. March 31, 2014. Accessed June 10, 2014. [xi] Frequently Asked Questions: Breakthrough Therapies. U.S. Food and Drug Administration Web site. Accessed May 19, 2014. [xii] Breakthrough Therapies. Friends of Cancer Research Web site. http://www.focr.org/breakthrough-therapies. Accessed May 19, 2014. [xiii]Draft Guidance for Industry: Expanded Access to Investigational Drugs for Treatment Use—Qs & As. U.S. Food and Drug Administration Web site. Published May 2013. Accessed May 19, 2014. [xiv] Schaeffer MH, Krantz DS, Wichman A, et al. The impact of disease severity on the informed consent process in clinical research. Am J Med 1996;100:261-268. Downloads The Four A's of Expanded Patient Access Authors Darshak SanghaviMeaghan GeorgeSara Bencic Full Article
io A More Complete Picture of Pioneer ACO Results By webfeeds.brookings.edu Published On :: Mon, 13 Oct 2014 10:08:00 -0400 The Centers for Medicare and Medicaid Services (CMS) recently released more detailed ACO-level data for participants in first two years of the Pioneer ACO Model. The program, which is designed for health systems with more experience assuming financial risk for patient populations, has generated savings and improvements in quality measures, but has also struggled to retain participants. The program began with 32 provider organizations; following a series of recent announcements there are now 19 total participants. Last month, CMS announced that the Pioneer Program was able to yield total program savings of $96 million in its second year and resulted in ACOs sharing in savings of $68 million. CMS also reported that the Pioneers were able to improve mean quality scores by 19 percent and increased performance on 28 of 33 measures between performance year one and performance year two. Financial Results The latest financial results provide more participant-level data and allow for a new level of analysis of performance across all these ACOs. In year one of the program, financial performance for individual Pioneers ranged from a gross loss of $9.31 million to a gross savings of $23.34 million. Thirteen Pioneers reduced costs enough to qualify for shared savings, with an average of $5.85 million returned to the ACOs, ranging from $1.00 million to $14.00 million. One ACO owed shared losses of $2.55 million. The remaining eighteen ACOs were within the minimum savings or loss rate and did not earn shared savings or owe money to Medicare due to losses. Following year one, nine Pioneer ACOs either left the Medicare ACO program entirely, or moved to the lower risk Medicare Shared Savings Program (MSSP). Eight of the nine Pioneers that left the program failed to reduce spending in their first year. Out of the remaining 23 participants in the second performance year, three of these ACOs opted to defer reconciliation until the end of Performance Year 3. The 20 Pioneers with final Performance Year 2 data had financial performance ranging from a gross savings of $24.59 million to gross losses of $6.26 million. Fourteen ACOs reduced spending in Performance Year 2, eleven of which reduced enough to qualify for shared savings. The average shared savings for these ACOs was $6.55 million, ranging from $1.22 million to $13.41 million. Three Pioneers shared losses, averaging $2.33 million back to the Medicare program. The table below shows the breakdown of ACOs according to whether they reduced spending, increased spending, shared in savings, or owed money back to Medicare due to losses. More than half of the Pioneers were able to reduce spending in year one (18/32) and year two (14/23), with more than one-third of total ACOs earning shared savings in each year as well. The data also suggest that those ACOs that were most successful in reducing spending in the first year were also more likely to reduce spending in their second year. As the chart below shows, three ACOs that earned shared savings in year one owed money back to Medicare due to losses in year two, while no ACO that had shared losses in year one was able to attain shared savings in year two. Quality Results CMS also released ACO-level performance on all 33 measures for Pioneer participants in year one and year two. The 23 ACOs that remain in the Pioneer Program showed overall improvement in average quality scores from the first to second performance year. The ACOs also improved overall on 28 of 33 measures, as the chart below shows. The quality domain with the greatest improvement in year two was Domain 4 (At Risk-Populations) which saw an overall improvement from 67.5% to 83%. The marked improvement in this domain suggests that ACOs are making progress at better coordinating and delivery care for high-risk patients, many of whom have multiple chronic conditions. Chronic care management for conditions such as diabetes, coronary artery disease, and hypertension is critical for the continued success of accountable care efforts. All other domains saw average quality improvement as well, summarized below. Likewise, almost all of the individual Pioneer ACOs improved their performance on quality measures from year one to year two. Of the ACOs that remained in the program for year two, all but one ACO was able to improve its overall quality score in its second year. Additionally, the percentage of Pioneer ACOs performing in the 80th or 90th percentile in quality scores also increased from year one to year two, as shown in the chart below. Putting Together Financial and Quality Results In year one of the Pioneer Program there appeared to be no direct correlation between average quality scores and gross savings or losses for individual ACOs. This may not be unexpected, especially since Pioneer ACOs in their first year are eligible for shared savings simply by reporting their quality. In subsequent years, however, the ACO’s quality score impacts the level of shared savings that the Pioneers are eligible to receive, so we might expect a bit more alignment between quality and financial performance. Average quality scores and level of savings or losses for each of the 32 first year Pioneer ACOs is below. After year two, there still does not appear to be a direct relationship between higher quality scores and level of savings or losses in the Pioneer Program. Further examination of results begs additional questions about why certain ACOs clustered in different parts of the grid relative to others. Of those ACOs in the red circle above— higher total savings and relatively average quality scores—two of the ACOs are from the Boston area and the remaining ones from other large metropolitan areas (New York City; Orange County, CA; Phoenix, AZ; and Detroit, MI). The average per capita Medicare spending for the counties corresponding to these ACOs is $11,544, compared to an average of $10,384 for counties corresponding to all 23 of the Pioneer participants. Meanwhile those ACOs within the yellow circle had the highest quality scores, but also experience financial losses or slight savings. Many of these ACOs are from less densely populated areas, such as Maine, Wisconsin, and Illinois. There are a number of factors that could be contributing to their quality success, but little financial savings—healthier patient populations, a smaller or more engaged patient population, financial baselines impacted by lower per capita spending in these areas, or other factors driven by their region. Further analysis of these ACOs and the other public and private ACO programs, including both their characteristics and regional market characteristics, will provide needed further insights on the factors most likely to drive success. Next Steps These ACO-level data reflect the range of experiences across Pioneer participants. Some ACOs have sustained positive performance to date, while others have seen diminishing rates of return. Those organizations more committed to clinical transformation, patient outreach, and organizational change may be more likely to do better, but further analysis of differences in performance could enable the Pioneer Program and ACOs to achieve bigger impacts over time. It is hard to know what the third performance year of the Pioneer program will show, but as noted earlier, the Pioneer Program has already lost over a third of its original 32 participants. Despite the decline in participation and mixed results so far, CMS remains optimistic and committed to the program, and the overall number of Medicare, Medicaid, and privately-insured individuals in ACO arrangements continues to rise. We can anticipate a proposed rule impacting the MSSP, likely later this Fall, which will impact elements of the Pioneer ACO program. Regulatory changes that may help increase the ability of the Medicare ACO programs to support better care while ensuring sustainability include: adjustments to attribution methods, benchmark calculations, collection and sharing of data with ACOs, updating performance measures, linking to other ongoing payment and delivery reforms, and creating more financial sustainability for program participants. The current Pioneer program can be a key step toward effective payment reform, but further steps are needed to assure long-term success. Authors S. Lawrence KocotRoss WhitePratyusha KatikaneniMark B. McClellan Full Article
io A plausible solution to the Syrian refugee crisis By webfeeds.brookings.edu Published On :: Wed, 12 Feb 2020 18:09:12 +0000 The Syrian crisis is approaching its ninth year. In that span, the conflict has taken the lives of over five hundred thousand people and forced over seven million more to flee the country. Of those displaced, more than 3.6 million have sought refuge in Turkey, which now hosts more refugees than any other country in the world.… Full Article
io COVID-19, Africans’ hardships in China, and the future of Africa-China relations By webfeeds.brookings.edu Published On :: Fri, 17 Apr 2020 13:54:45 +0000 In the midst of the global scramble to deal with the COVID-19 crisis, relations have ruptured at a most unexpected front—between China and Africa. Since April 8, reports and social media discussions about the eviction and maltreatment of Africans in the Chinese city of Guangzhou have gone viral, leading to a series of formal and… Full Article
io Suspending immigration would only hurt America’s post-coronavirus recovery By webfeeds.brookings.edu Published On :: Tue, 21 Apr 2020 20:24:44 +0000 Full Article
io What are the legal foundations of the Islamic State? By webfeeds.brookings.edu Published On :: Mon, 30 Nov -0001 00:00:00 +0000 Media coverage of the Islamic State has focused on the group’s grotesque use of violence and archaic governance style. Less attention has been paid, however, to the institutions that make those practices possible—institutions that lend the group legitimacy, at least in the eyes of supporters, as a sovereign state. Full Article Uncategorized
io The polarizing effect of Islamic State aggression on the global jihadi movement By webfeeds.brookings.edu Published On :: Wed, 27 Jul 2016 17:26:41 +0000 Full Article
io A better way to counter violent extremism By webfeeds.brookings.edu Published On :: Tue, 02 Aug 2016 21:34:29 +0000 Full Article
io The U.S. needs a national prevention network to defeat ISIS By webfeeds.brookings.edu Published On :: Wed, 03 Aug 2016 15:40:11 +0000 The recent release of a Congressional report highlighting that the United States is the “top target” of the Islamic State coincided with yet another gathering of members of the global coalition to counter ISIL to take stock of the effort. There, Defense Secretary Carter echoed the sentiments of an increasing number of political and military leaders when he said that military […] Full Article
io Minding the gap: A multi-layered approach to tackling violent extremism By webfeeds.brookings.edu Published On :: Wed, 03 Aug 2016 16:20:33 +0000 Full Article
io Tackling the Mortgage Crisis: 10 Action Steps for State Government By webfeeds.brookings.edu Published On :: Thu, 29 May 2008 12:00:00 -0400 Introduction During 2006, the United States saw a considerable upswing in the number of new mortgage defaults and foreclosure filings. By 2007, that upswing had become a tidal wave. Today, national homeownership rates are falling, while more than a million American families have already lost their homes to foreclosure. Across the country, boarded houses are appearing on once stable blocks. Some of the hardest hit communities are in older industrial cities, particularly Midwestern cities such as Cleveland, Detroit, and Indianapolis.Although most media attention has focused on the role of the federal government in stemming this crisis, states have the legal powers, financial resources, and political will to mitigate its impact. Some state governments have taken action, negotiating compacts with mortgage lenders, enacting state laws regulating mortgage lending, and creating so-called “rescue funds.” Governors such as Schwarzenegger in California, Strickland in Ohio, and Patrick in Massachusetts have taken the lead on this issue. State action so far, however, has just begun to address a still unfolding, multidimensional crisis. If the issue is to be addressed successfully and at least some of its damage mitigated, better designed, comprehensive strategies are needed. This paper describes how state government can tackle both the immediate problems caused by the wave of mortgage foreclosures and prevent the same thing from happening again. After a short overview of the crisis and its effect on America’s towns and cities, the paper outlines options available to state government, and offers ten specific action steps, representing the most appropriate and potentially effective strategies available for coping with the varying dimensions of the problem. Downloads Download Authors Alan Mallach Full Article
io A Restoring Prosperity Case Study: Akron Ohio By webfeeds.brookings.edu Published On :: Wed, 17 Sep 2008 12:00:00 -0400 Part of the larger Northeast Ohio regional economy, the Akron metropolitan area is composed of two counties (Summit and Portage) with a population of just over 700,000, and is surrounded by three other metropolitan areas. Akron is located approximately 40 miles south of Cleveland, 50 miles west of Youngstown, and 23 miles north of Canton. The Cleveland metro area is a five-county region with a population of 2.1 million. The Youngstown metro area includes three counties, extending into Pennsylvania, and has a population of 587,000. Canton is part of a two-county metropolitan area with a population of 410,000.The adjacency of the Akron and Cleveland Metropolitan Statistical Areas (MSAs) is an important factor in the economic performance of the Akron region. The interdependence of economies of the two MSAs is evidenced by the strong economic growth of the northern part of Summit County adjacent to the core county of the Cleveland metropolitan area. This part of Summit County beyond the city of Akron provides available land, access to the labor pools of the two metropolitan areas, and proximity to the region’s extensive transportation network. Although affected by economic activity in the larger region, the fate and future of Akron and its wider region are not solely determined by events in these adjacent areas. While sharing broad economic trends with its neighbors, the Akron metro area has been impacted by a different set of events and has shown different patterns of growth from other areas in Northeast Ohio. This study provides an in-depth look at Akron’s economy over the past century. It begins by tracing the industrial history of the Akron region, describing the growth of the rubber industry from the late 1800s through much of following century, to its precipitous decline beginning in the 1970s. It then discusses how the “bottoming out” of this dominant industry gave rise to the industrial restructuring of the area. The paper explores the nature of this restructuring, and the steps and activities the city’s business, civic, and government leaders have undertaken to help spur its recovery and redevelopment. In doing so, it provides a series of lessons to other older industrial regions working to find their own economic niche in a changing global economy. Download Case Study » (PDF) Downloads Download Authors Larry LedeburJill Taylor Full Article
io Addressing Ohio's Foreclosure Crisis: Taking the Next Steps By webfeeds.brookings.edu Published On :: Fri, 05 Jun 2009 16:34:06 -0400 Introduction Ohio has already taken important steps to address the state’s ongoing foreclosure crisis, yet the crisis continues, causing distress for thousands of families and individuals, and destabilizing cities, towns and neighborhoods across the state. Therefore, the state, its local governments and private stakeholders need to do still more to deal more effectively with the crisis and its impacts on the state’s housing stock, cities and neighborhoods.What is often termed the “foreclosure crisis” is actually a multi-dimensional crisis, in which the collapse of the housing bubble, the devastation caused by the lax and often irresponsible credit practices that accompanied and perpetuated that bubble, the resulting freeze on commercial and consumer credit, and the worldwide recession are interwoven, and can only with great difficulty be untangled. In Ohio, those forces are further exacerbated by profound changes to the state’s historical economic underpinnings. Ohio cannot solve the crisis by itself, but it can significantly mitigate its impact on people, neighborhoods, and towns and cities. These mitigating efforts will also help preserve the value of homes and neighborhoods in the state, and place Ohio in a stronger position to benefit from the future economic recovery. The paper begins with a short summary of current conditions and the actions the state has already taken to address the wave of foreclosures, followed by a discussion of areas for future action. This discussion will address mitigating both the individual and community impacts of foreclosure, but will give particular emphasis to the critical issue of softening the blow of foreclosure on communities, which up to now has been less of a focus for state action. Downloads Download Authors Alan Mallach Full Article
io Transforming Ohio's Communities for the Next Economy By webfeeds.brookings.edu Published On :: Mon, 22 Feb 2010 00:00:00 -0500 Ohio, like most other states in the country and particularly its neighbors in the Great Lakes region, is still reeling from the “Great Recession.” This economic crisis, the worst in a half century, has devastated economies across the globe. While economists have declared that the recession has abated, it will be a long time before the businesses, households, and government treasuries across the country, and specifically in the state of Ohio, shake off the effects. And when the recession’s grip finally breaks, what will Ohio’s economy and landscape look like?The choices that Ohio’s people and its leaders make—starting now and continuing over the next few years—will determine that answer. Ohioans can decide whether to shy away from manufacturing after the loss of so many jobs, or to transform the state’s old manufacturing strengths, derived from its role in the auto supply chain, into new products, markets, and opportunities. They can decide to opt out of the national shift to a lower-carbon economy, or to be at the forefront of developing clean coal and renewable energy industries and jobs. They can choose a workforce system that is aligned to the true metropolitan scale of the economy and oriented to the needs of workers and employers. They can choose transformative transportation networks over more roads; smaller, greener, stronger cities; collaboration and regional cooperation to save money, reduce duplication, and bolster regional competitiveness. And instead of trying to go it alone in the 21st century global marketplace, they can maximize the federal resources on offer to support Ohio’s economic transformation and choose to compete effectively for new federal investments. This report, Restoring Prosperity: Transforming Ohio’s Communities for the Next Economy, lays out some of the specific policy options that will help Ohioans restore the prosperity that the state enjoyed for much of the 19th and 20th centuries, but that it has been struggling to regain for at least a decade, if not longer.Full Report » Downloads Full ReportExecutive SummaryBruce Katz's Speech in Ohio Publication: The Brookings Institution and the Greater Ohio Policy Center Full Article
io Ohio's Cities at a Turning Point: Finding the Way Forward By webfeeds.brookings.edu Published On :: Tue, 18 May 2010 00:00:00 -0400 For over 100 years, the driving force of Ohio’s economy has been the state’s so-called Big Eight cities—Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Canton, and Youngstown. Today, though, the driving reality of these cities is sustained, long-term population loss. The central issue confronting these cities—and the state and surrounding metropolitan area—is not whether these cities will have different physical footprints and more green space than they do now, but how it will happen.The state must adopt a different way of thinking and a different vision of its cities’ future—and so must the myriad local, civic, philanthropic, and business leaders who will also play a role in reshaping Ohio’s cities. The following seven basic premises should inform any vision for a smaller, stronger future and subsequent strategies for change in these places: These cities contain significant assets for future rebuilding These cities will not regain their peak population These cities have a surplus of housing These cities have far more vacant land than can be absorbed by redevelopment Impoverishment threatens the viability of these cities more than population loss as such Local resources are severely limited The fate of cities and their metropolitan areas are inextricably inter-connected These premises have significant implications for the strategies that state and local governments should pursue to address the issues of shrinking cities.Full Paper on Ohio's Cities » (PDF)Paper on Shrinking Cities Across the United States » Downloads Full Paper Authors Lavea BrachmanAlan Mallach Full Article
io Brazil and the international order: Getting back on track By webfeeds.brookings.edu Published On :: Wed, 29 Jun 2016 18:00:00 +0000 Crisis seems to be the byword for Brazil today: political crisis, economic crisis, corruption crisis. Yet despite the steady drum beat of grim news, Brazil is more than likely to resume its upward trajectory within a few years. Full Article Uncategorized
io The 2016 Rio Olympics: Will Brazil’s emergence get a second wind? By webfeeds.brookings.edu Published On :: Mon, 01 Aug 2016 15:00:57 +0000 In these days when Brazil’s politics are in turmoil and its economy is in the doldrums, it is all too easy for Brazilians to dismiss their country’s decision to host the Summer 2016 Olympics as part and parcel of the same package of bad policy decisions that landed them in their present predicament. The steady […] Full Article
io The fundamental connection between education and Boko Haram in Nigeria By webfeeds.brookings.edu Published On :: Thu, 07 May 2020 20:51:38 +0000 On April 2, as Nigeria’s megacity Lagos and its capital Abuja locked down to control the spread of the coronavirus, the country’s military announced a massive operation — joining forces with neighboring Chad and Niger — against the terrorist group Boko Haram and its offshoot, the Islamic State’s West Africa Province. This spring offensive was… Full Article