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.

      

The Roosevelt House Public Policy Institute hosted a forum with Ted Piccone and Ambassadors Hardeep Singh Puri and Antonio de Aguiar Patriota as they discussed his new book, Five Rising Democracies and the Fate of the International Liberal Order.

While the spread of democracy over the last three decades has inspired hope for an international liberal order, recent shifting power balances and democratic backsliding are shaking this foundation. In his new book, Brookings Institution Senior Fellow Ted Piccone discusses how five pivotal countries—India, Brazil, South Africa, Turkey, and Indonesia—could play a critical role as examples and supporters of liberal ideas and practices. 

Mr. Piccone, Hardeep Singh Puri, former Ambassador of India to the U.N. and Secretary General of the Independent Commission on Multilateralism, and Antonio de Aguiar Patriota, Ambassador of Brazil to the U.N. and former Minister of External Relations, discuss the ways in which these countries stand out for their embrace of globalization and liberal norms on their own terms—and how, in a multipolar world, they may impact our shared future.

      

Editors’ Note: The phenomenon Donald Trump has created has become something larger than him, and something far more dangerous, writes Bob Kagan. This phenomenon has arisen in other democratic and quasi-democratic countries over the past century, and it has generally been called “fascism.” This piece originally appeared in The Washington Post.

The Republican Party’s attempt to treat Donald Trump as a normal political candidate would be laughable were it not so perilous to the republic. If only he would mouth the party’s “conservative” principles, all would be well.

But of course the entire Trump phenomenon has nothing to do with policy or ideology. It has nothing to do with the Republican Party, either, except in its historic role as incubator of this singular threat to our democracy. Trump has transcended the party that produced him. His growing army of supporters no longer cares about the party. Because it did not immediately and fully embrace Trump, because a dwindling number of its political and intellectual leaders still resist him, the party is regarded with suspicion and even hostility by his followers. Their allegiance is to him and him alone.

And the source of allegiance? We’re supposed to believe that Trump’s support stems from economic stagnation or dislocation. Maybe some of it does. But what Trump offers his followers are not economic remedies—his proposals change daily. What he offers is an attitude, an aura of crude strength and machismo, a boasting disrespect for the niceties of the democratic culture that he claims, and his followers believe, has produced national weakness and incompetence. His incoherent and contradictory utterances have one thing in common: They provoke and play on feelings of resentment and disdain, intermingled with bits of fear, hatred and anger. His public discourse consists of attacking or ridiculing a wide range of “others”—Muslims, Hispanics, women, Chinese, Mexicans, Europeans, Arabs, immigrants, refugees—whom he depicts either as threats or as objects of derision. His program, such as it is, consists chiefly of promises to get tough with foreigners and people of nonwhite complexion. He will deport them, bar them, get them to knuckle under, make them pay up or make them shut up.

That this tough-guy, get-mad-and-get-even approach has gained him an increasingly large and enthusiastic following has probably surprised Trump as much as it has everyone else. Trump himself is simply and quite literally an egomaniac. But the phenomenon he has created and now leads has become something larger than him, and something far more dangerous.

[T]he phenomenon he has created and now leads has become something larger than him, and something far more dangerous.

Republican politicians marvel at how he has “tapped into” a hitherto unknown swath of the voting public. But what he has tapped into is what the founders most feared when they established the democratic republic: the popular passions unleashed, the “mobocracy.” Conservatives have been warning for decades about government suffocating liberty. But here is the other threat to liberty that Alexis de Tocqueville and the ancient philosophers warned about: that the people in a democracy, excited, angry and unconstrained, might run roughshod over even the institutions created to preserve their freedoms. As Alexander Hamilton watched the French Revolution unfold, he feared in America what he saw play out in France—that the unleashing of popular passions would lead not to greater democracy but to the arrival of a tyrant, riding to power on the shoulders of the people.

This phenomenon has arisen in other democratic and quasi-democratic countries over the past century, and it has generally been called “fascism.” Fascist movements, too, had no coherent ideology, no clear set of prescriptions for what ailed society. “National socialism” was a bundle of contradictions, united chiefly by what, and who, it opposed; fascism in Italy was anti-liberal, anti-democratic, anti-Marxist, anti-capitalist and anti-clerical. Successful fascism was not about policies but about the strongman, the leader (Il Duce, Der Fuhrer), in whom could be entrusted the fate of the nation. Whatever the problem, he could fix it. Whatever the threat, internal or external, he could vanquish it, and it was unnecessary for him to explain how. Today, there is Putinism, which also has nothing to do with belief or policy but is about the tough man who singlehandedly defends his people against all threats, foreign and domestic.

Successful fascism was not about policies but about the strongman, the leader (Il Duce, Der Fuhrer), in whom could be entrusted the fate of the nation.

To understand how such movements take over a democracy, one only has to watch the Republican Party today. These movements play on all the fears, vanities, ambitions and insecurities that make up the human psyche. In democracies, at least for politicians, the only thing that matters is what the voters say they want—vox populi vox dei. A mass political movement is thus a powerful and, to those who would oppose it, frightening weapon. When controlled and directed by a single leader, it can be aimed at whomever the leader chooses. If someone criticizes or opposes the leader, it doesn’t matter how popular or admired that person has been. He might be a famous war hero, but if the leader derides and ridicules his heroism, the followers laugh and jeer. He might be the highest-ranking elected guardian of the party’s most cherished principles. But if he hesitates to support the leader, he faces political death.

In such an environment, every political figure confronts a stark choice: Get right with the leader and his mass following or get run over. The human race in such circumstances breaks down into predictable categories—and democratic politicians are the most predictable. There are those whose ambition leads them to jump on the bandwagon. They praise the leader’s incoherent speeches as the beginning of wisdom, hoping he will reward them with a plum post in the new order. There are those who merely hope to survive. Their consciences won’t let them curry favor so shamelessly, so they mumble their pledges of support, like the victims in Stalin’s show trials, perhaps not realizing that the leader and his followers will get them in the end anyway.

A great number will simply kid themselves, refusing to admit that something very different from the usual politics is afoot.

A great number will simply kid themselves, refusing to admit that something very different from the usual politics is afoot. Let the storm pass, they insist, and then we can pick up the pieces, rebuild and get back to normal. Meanwhile, don’t alienate the leader’s mass following. After all, they are voters and will need to brought back into the fold. As for Trump himself, let’s shape him, advise him, steer him in the right direction and, not incidentally, save our political skins.

What these people do not or will not see is that, once in power, Trump will owe them and their party nothing. He will have ridden to power despite the party, catapulted into the White House by a mass following devoted only to him. By then that following will have grown dramatically. Today, less than 5 percent of eligible voters have voted for Trump. But if he wins the election, his legions will comprise a majority of the nation. Imagine the power he would wield then. In addition to all that comes from being the leader of a mass following, he would also have the immense powers of the American presidency at his command: the Justice Department, the FBI, the intelligence services, the military. Who would dare to oppose him then? Certainly not a Republican Party that laid down before him even when he was comparatively weak. And is a man like Trump, with infinitely greater power in his hands, likely to become more humble, more judicious, more generous, less vengeful than he is today, than he has been his whole life? Does vast power un-corrupt?

This is how fascism comes to America, not with jackboots and salutes (although there have been salutes, and a whiff of violence) but with a television huckster, a phony billionaire, a textbook egomaniac “tapping into” popular resentments and insecurities, and with an entire national political party—out of ambition or blind party loyalty, or simply out of fear—falling into line behind him.

      

Data shows that white, poor, elderly, uneducated men from rural England pulled the United Kingdom outside the European Union. Great Britain will be on its own as it will have to navigate an increasingly complex and globalized world. Europeans must wish all the very best to their British friends. At the same time, they must explore what opportunities are there to be seized. Britain’s departure presents Europeans with many exciting political prospects.

Scotland

Unlike England, Scotland voted massively in favor of remaining within the European Union. Scots now risk being dragged out of it at the hands of the English. Because of this, Scottish First Minister Nicola Sturgeon has been clear: The possibility of a new referendum for Scottish independence is on the table. Should Scotland break free of England, it would immediately be welcome back into the European Union as a sovereign and independent country. Scots would have the best of both worlds: free of English dictates and welcome in the common European family. Their economic liberalism and progressive social policies meanwhile being a boon to the rest of Europe. 

Ireland

Although far less likely than those of a Scottish scenario, major changes could be afoot in Ireland as well. Ireland is presented with a fantastic opportunity to solidify its position as an outpost of Anglo-Saxon economic dynamism within the European Union. A global language, a flexible labour market and low corporate taxation (as well as great beer) are the ingredients the Irish bring to Europe. In the coming years, they could leapfrog what will be left of Britain as America’s springboard into Europe. Meanwhile, Dublin has a fantastic opportunity to punch above its weight in international affairs (as it could and should) by acting as an honest broker between Brussels and London.

International affairs

Calls for the establishment of a common European military, of shared European representation in international institutions, and of a truly European diplomatic service have for the last 40 years regularly and to varying degrees been frustrated by the United Kingdom. Now that Britain is out, Berlin, Paris, and all other like-minded member states should seize this historical opportunity in order to tremendously boost their cooperation in all these policy areas. By doing so, Europe could achieve economies of scale, save money and resources on possible duplications, boost its global standing, and become the strong and reliable partner that the United States desperately wants it to be.

The economy

The welfare state, public services, and healthcare that most continental and northern Europeans enjoy have long been far superior to anything most Brits can even dream of. Additionally, Germany and most northern European member states boost far more competitive economies and standards of living than the United Kingdom. The historical challenge for Europeans is now to improve the performance of the southern and eastern member states of the European Union. Free from British fears of Brussels’ red tape and with the crucial contribution of small yet economically dynamic countries such as the Netherlands or Sweden, Europeans should further integrate toward a dynamic yet inclusive social-market economic model.

Democracy

Westminster gave parliamentary democracy to the rest of the world. After having made a joke out of it through a referendum marred by enormous lies regurgitated onto an ill-informed population, Britain might have given a new impetus to democratic ideals across Europe. Two elements conspire positively in this respect. On the one hand, the country that historically more than any other opposed reforms aimed at further democratizing the European Union is out of the way: Britain will no more be able to veto reforms in this direction. On the other hand, both European elites and common citizens alike might now be spurred into further democratizing the EU as a means to rescuing it.

A rather homogenous socio-demographic group of white, poor, uneducated, elderly, and rural Englishmen have pulled the rest of Britain outside the European Union. The United Kingdom might now enter a new phase in its history characterized by a further deterioration of its international standing. Europeans, meanwhile, have to catch up on the time they spent dealing with 40 years of British foot-dragging. Great opportunities are out there to be seized.

       

       

       

       

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.

      

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

      

ACOs have to assess both the opportunities and the challenges in pursuing risk based payment arrangements. However, there are key strategies ACOs can adopt to help with the transition to greater financial accountability, and higher levels of performance. On July 16^th, our ACO Learning Network hosted a webinar that explored critical success factors and barriers, as well as potential lessons for ACOs to increase their risk-bearing capacity.

Different Payment Models Pose Unique Challenges

Drawing upon an issue brief authored with colleagues from the American Academy of Actuaries, Greger Vigen highlighted some of the actuarial concerns inherent in various risk-based payment models. For example, when organizations undertake one-sided or “bonus only” shared savings arrangements, the arrangement should create incentives that are adequately aligned across the system to reward physicians that are providing not just cost-efficient, but also high-value, care. They must also find ways to create additional non-financial support when the size of provider shared savings is minimal. Both one-sided and two-sided shared savings models can lead to complex calculations in determining the true amount of savings resulting from the arrangement. Organizations undertaking bundled or episode-based payments must clearly determine what is included in specific bundles in order to justify assuming risk for those services.  Although partial capitation lends itself to an increased level of risk by creating strong incentives to reduce inefficiencies in certain parts of the system, such arrangements create effects on areas not covered by the partial capitation arrangement. Finally, by virtue of the increased risk level, global payment arrangements raise solvency considerations for organizations and require significant investment in infrastructure (or use resources from aligned partners) to manage utilization and facilitate appropriate organizational culture change. As programs move forward, there may be a combination of approaches used, including broad risk sharing or partial capitation arrangements between buyer and provider organizations. At the same time, more focused initiative may be used between the provider organization and the provider partners, such as bundled payments or partial capitation to certain providers. 

Critical Elements of High Performing Systems

Regardless of which risk-type arrangements ACOs choose to pursue, there are some critical elements that most high-performing systems share. According to Vigen, high-performing systems typically use a highly analytic process to understand their performance over time, rely on financial committees that are clear and “blunt” about the organization’s financial state, have in place multiple targeted financial initiatives, use payment reform to show how expenses could reduce revenue across multiple specific cases, have advanced clinical reporting systems, develop strong partnerships within and outside the organization to transform care, and use “next generation” analytic tools from outside organizations. Vigen contends that, in order to succeed at true transformation, organizations must develop initiatives aimed specifically at financial results, to supplement other initiatives designed to simply improve quality.  Building around these initiatives provides targeted results that can effectively engage and utilize actuaries. Actuaries and other external partners can help ACOs to more fully address financial issues and develop a framework for the prioritization and allocation of resources that identifies which existing processes to discontinue and which new processes to initiate.

Jim Whisler, a Principal at Deloitte Consulting, added that there are a number of opportunities to realize savings, many of which can be achieved through reducing variation. He emphasized that ACOs should take advantage of “low hanging fruit” that decrease utilization and optimize costs, such as ensuring appropriate use of generic and specialty pharmaceuticals, reducing inpatient stays, increasing use of ambulatory surgery center (ASC), and understanding appropriate use of lab, radiation, MRI, and CT scans. Savings and gain sharing can also vary between the different providers—primary care, specialists, and hospitals.  Ultimately, actuaries and clinical staff alike must be able to analyze data and pinpoint the true drivers of variation.

Effective Strategies Can Yield Significant Cost and Quality Improvements

In order to shed more light on how these strategies can be deployed in health systems, Bart Wald, Chief Executive for Physicians Services at Providence Health and Services, discussed the approaches that he undertook as President and CEO of Physician Associates of the Greater San Gabriel Valley, an IPA in California. Unlike compensation in most IPAs, which often relies either on fee-for-service (FFS) or capitation, Physician Associates, developed a system that uses a combination of both payment models. While capitation has traditionally been used more for primary care physicians (PCPs) than specialists, Dr. Wald emphasized that developing financial incentives for specialists was critical to effectively engaging them.  In his mind, specialists must be integrated and engaged in order to create a truly effective model. The IPA also created a “peer satisfaction” bonus program, in which PCPs and specialists rate each other and those attaining the highest ratings are given an additional bonus payment. The ratings are also posted on the web to increase transparency, and impact physician behaviors. In addition to engaging specialists, Physician Associates made sure to integrate hospitalists into the care team and incorporate social services and mental health staff.

The IPA was able to further transform care by building a population health infrastructure that directed funds towards ambulatory care management, patient-centered medical home (PCMH) development, complex care centers and disease management programs for vulnerable patients. They have also focused on improving the collection and sharing of patient data to better manage generic drug utilization, prescribing and adherence; track and attempt to minimize care received by patients outside of the physician network; and ensure effective continuity of care across the system. In summary, Dr. Wald stressed a number of factors for succeeding at risk-sharing—engaged practice members, adequate physician incentives to improve care performed in the outpatient setting, hospitalists and outpatient coordination on referrals, more advanced pharmacy management, extended disease registries, and integration between physicians and hospitals that includes joint expense management and other synergies. These interventions have resulted in a noticeable improvement in quality of care and led Physician Associates to run at a price and expense advantage below IPAs using a purely FFS payment model.

Dr. Wald also discussed an example of how hospitals are attempting to improve performance through creative partnerships with medical staff using a joint venture limited liability corporation between Providence Health Systems California and local physicians to reduce the occurrences of specific clinical conditions, such as hospital acquired complications, readmissions, and sepsis mortality. These physicians participate in a shared savings model.

Successful Risk-Sharing Arrangements Take Time

While the interventions described above may work and possibly work very well, truly effective risk-sharing design is an iterative process. Organizations must be nimble and able to adapt and modify tactics as necessary. As Greger Vigen emphasized, payment reform can be used as a tactic at the provider level in additional to a broad strategy or vision between provider and buyer.

Downloads

• Issue Brief: Improving the Medicare ACO Program

       

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

Downloads

• The Four A's of Expanded Patient Access

       

Event Information

Register for the Event

Many clinicians have terrific ideas for improving the quality and cost of health care, but often don’t know how to navigate the frequently baffling landscape of payment and delivery reform options. To address this need in clear, practical terms, we are pleased to announce the third MEDTalk event in the “Merkin Series on Innovations in Care Delivery.” The series is designed to support clinicians and policymakers who’ve always wondered how delivery reform occurs, but didn’t know where to begin.

Our third case drew on the experiences of the Community Asthma Initiative, an enhanced pediatric asthma intervention, and their efforts in sustainability. The event featured seven brief “TED-style” talks that consider the challenges of delivering pediatric care, while tackling non-medical factors that drive suboptimal care, improving patient and family quality of life, and reducing costs. The agenda included firsthand experiences from patients, payers, policymakers, and clinical leadership from Massachusetts and Arkansas. Sustainable improvement strategies and the financial mechanisms available to encourage innovations in asthma were explored.

Video

• MEDTalk: Pediatric Asthma and Transforming Care for the Most Vulnerable
• A Day in the Life: The Patient Experience
• Challenge Accepted: Delivery of Asthma Care in a Triple Aim World
• The Community Asthma Initiative: A Case Study in Clinical Innovation
• Paying for Asthma Care: Options for Tackling Challenges
• State Medicaid Innovation: Opportunities and Barriers
• A Tale of Success: How to Get the Payer on Board
• Lessons Learned and the Path Forward
• Question and Answer Session

       

       

       

       

       

       

       

       

       

       

With over 16 million people and nearly 8.6 million jobs, America's older industrial cities remain a vital-if undervalued-part of the economy, particularly in states where they are heavily concentrated, such as Ohio and Pennsylvania. They also have a range of other physical, economic, and cultural assets that, if fully leveraged, can serve as a platform for their renewal.

Read the Executive Summary  »

Across the country, cities today are becoming more attractive to certain segments of society. Meanwhile, economic trends-globalization, the demand for educated workers, the increasing role of universities-are providing cities with an unprecedented chance to capitalize upon their economic advantages and regain their competitive edge.

Many cities have exploited these assets to their advantage; the moment is ripe for older industrial cities to follow suit. But to do so, these cities need thoughtful and broad-based approaches to foster prosperity.

"Restoring Prosperity" aims to mobilize governors and legislative leaders, as well as local constituencies, behind an asset-oriented agenda for reinvigorating the market in the nation's older industrial cities. The report begins with identifications and descriptions of these cities-and the economic, demographic, and policy "drivers" behind their current condition-then makes a case for why the moment is ripe for advancing urban reform, and offers a five-part agenda and organizing plan to achieve it.

Publications & Presentations
Connecticut State Profile
Connecticut State Presentation 

Michigan State Profile
Michigan State Presentation 

New Jersey State Profile
New Jersey State Presentation 

New York State Profile
New York State Presentation 

Ohio State Profile
Ohio State Presentation
Ohio Revitalization Speech

Pennsylvania State Profile 

Downloads

• Download

       

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

       

Louisville/Jefferson County is the principal city of America’s 42nd largest metropolitan area, a 13-county, bi-state region with a 2006 population estimated at 1.2 million. It is the largest city by far in Kentucky, but it is neither Kentucky’s capital nor its center of political power.

The consolidated city, authorized by voter referendum in 2000 and implemented in 2003, is home to 701,500 residents within its 399 square miles, with a population density of 4,124.8 per square mile.² It is either the nation’s 16th or its 26th largest incorporated place, depending on whether the residents of smaller municipalities within its borders, who are eligible to vote in its elections, are counted (as local officials desire and U.S. Census Bureau officials resist). The remainder of the metropolitan statistical area (MSA) population is split between four Indiana counties (241,193) and eight Kentucky counties (279,523). Although several of those counties are growing rapidly, the new Louisville metro area remains the MSA's central hub, with 57 percent of the population and almost 70 percent of the job base.

Centrally located on the southern banks of the Ohio River, amid an agriculturally productive, mineral rich, and energy producing region, Louisville is commonly described as the northernmost city of the American South. Closer to Toronto than to New Orleans, and even slightly closer to Chicago than to Atlanta, it remains within a day’s drive of two-thirds of the American population living east of the Rocky Mountains.

This location has been the dominant influence on Louisville’s history as a regional center of trade, commerce and manufacture. The city, now the all-points international hub of United Parcel Service (UPS), consistently ranks among the nation’s top logistics centers. Its manufacturing sector, though much diminished, still ranks among the strongest in the Southeast. The many cultural assets developed during the city’s reign as a regional economic center rank it highly in various measures of quality of life and “best places.”

Despite these strengths, Louisville’s competitiveness and regional prominence declined during much of the last half of the 20th Century, and precipitously so during the economic upheavals of the 1970s and ‘80s. Not only did it lose tens of thousands of manufacturing jobs and many of its historic businesses to deindustrialization and corporate consolidation, it also confronted significant barriers to entry into the growing knowledge-based economy because of its poorly-educated workforce, lack of R&D capacity, and risk-averse business culture.

In response, Louisville began a turbulent, two-decade process of civic and economic renewal, during which it succeeded both in restoring growth in its traditional areas of strength, most notably from the large impact of the UPS hub, and in laying groundwork for 21st century competitiveness, most notably by substantially ramping up university-based research and entrepreneurship supports. Doing so required it to overhaul nearly every aspect of its outmoded economic development strategies, civic relationships, and habits of mind, creating a new culture of collaboration.

Each of the three major partners in economic development radically transformed themselves and their relationships with one another. The often-paralyzing city-suburban divide of local governance yielded to consolidation. The business community reconstituted itself as a credible champion of broad-based regional progress, and it joined with the public sector to create a new chamber of commerce that is the region’s full-service, public-private economic development agency recognized as among the best in the nation. The Commonwealth of Kentucky embraced sweeping education reforms, including major support for expanded research at the University of Louisville, and a “New Economy” agenda emphasizing the commercialization of research-generated knowledge. Creative public-private partnerships have become the norm, propelling, for instance, the dramatic resurgence of downtown.

The initial successes of all these efforts have been encouraging, but not yet sufficient for the transformation to innovation-based prosperity that is the goal. This report details those successes, and the leadership, partnerships, and strategies that helped create them. It begins by describing Louisville’s history and development and the factors that made its economy grow and thrive. It then explains why the city faltered during the latter part of the 20th century and how it has begun to reverse course. In doing so, the study offers important lessons for other cities that are striving to compete in a very new economic era. 

Download Case Study » (PDF)

Downloads

• Download

       

Chattanooga a few years ago faced what many smaller cities are struggling with today—a sudden decline after years of prosperity in the "old" economy. This case study offers a roadmap for these cities by chronicling Chattanooga's demise and rebirth.

Chattanooga is located in the southern end of the Tennessee Valley where the Tennessee River cuts through the Smoky Mountains and the Cumberland Plateau. The city’s location, particularly its proximity to the Tennessee River, has been one of its greatest assets. Today, several major interstates (I-24, I-59, and I-75) run through Chattanooga, making it a hub of transportation business. The city borders North Georgia and is less than an hour away from both Alabama and North Carolina. Atlanta, Nashville, and Birmingham are all within two hours travel time by car.

Chattanooga is Tennessee’s fourth largest city, with a population in 2000 of 155,554, and it covers an area of 143.2 square miles. Among the 200 most populous cities in the United States, Chattanooga—with 1,086.5 persons per square mile—ranks 190th in population density.2 It is the most populous of 10 municipalities in Hamilton County, which has a population of 307,896, covers an area of 575.7 square miles, and has a population density of 534.8 persons per square mile.

With its extensive railroads and river access, Chattanooga was at one time the “Dynamo of Dixie”—a bustling, midsized, industrial city in the heart of the South. By 1940, Chattanooga’s population was centered around a vibrant downtown and it was one of the largest cities in the United States. Just 50 years later, however, it was in deep decline. Manufacturing jobs continued to leave. The city’s white population had fled to the suburbs and downtown was a place to be avoided, rather than the economic center of the region. The city lost almost 10 percent of its population during the 1960s, and another 10 percent between 1980 and 1990. It would have lost more residents had it not been for annexation of outlying suburban areas.

The tide began to turn in the 1990s, with strategic investments by developing public-private partnerships—dubbed the “Chattanooga way.” These investments spurred a dramatic turnaround. The city’s population has since stabilized and begun to grow, downtown has been transformed, and it is once again poised to prosper in the new economy as it had in the old.

This report describes how Chattanooga has turned its economy around. It begins with a summary of how the city grew and developed during its first 150 years before describing the factors driving its decline. The report concludes by examining the partnerships and planning that helped spur Chattanooga’s current revitalization and providing valuable lessons to other older industrial cities trying to ignite their own economic recovery. 

Download Case Study » (PDF)

Downloads

• Download

       

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

       

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

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

Event Information

Register for the Event

While the future impact of rising powers such as Brazil, Russia, India and China is uncertain and the shifting political landscape in the Arab world is still playing out, the influence of these emerging nations is a central fact of geopolitics.

Already the global financial crisis, the Copenhagen climate negotiations, and the debate over Iran sanctions have illustrated the potential, the pitfalls, and above all the centrality of the relationship between American power and the influence of these rising actors and developing democracies.

In a new paper, Senior Fellow Bruce Jones, director of the Managing Global Order Project at Brookings, argues the greatest risk lies not in a single peer competitor but in the erosion of cooperation on issues vital to U.S. interests and a stable world order. U.S. power is indispensible for that purpose but not sufficient. No longer the CEO of Free World Inc., the United States is now the largest minority shareholder in Global Order LLC.

On March 15, the Brookings Institution and Foreign Policy magazine hosted the launch of Bruce Jones’s paper "Largest Minority Shareholder in Global Order LLC: The Changing Balance of Influence and U.S. Strategy." Panelists explored the prospects for cooperation on global finance and transnational threats; the need for new investments in global economic and energy diplomacy; and the case for new crisis management tools to help de-escalate inevitable tensions with emerging powers.

Susan Glasser, editor in chief of Foreign Policy, moderated the discussion. After the presentations, panelists took audience questions.

Video

• Relative Shift in U.S. Balance of Power
• Shifting Coalitions of Consensus
• Paradox of Power for U.S.
• U.S. Needs To Get Serious about Development and Energy

Audio

• Shifting Balance of Power: Has the U.S. Become the Largest Minority Shareholder in the Global Order?

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20110315_global_order

      

      

Leaders from the world’s largest economies are gathering in Cannes, France for the second round of G-20 talks this year. The most pressing issue on the agenda is the ongoing sovereign debt crisis that is still looming despite a plan to help stabilize the fiscal free fall in Greece. The call from all quarters is for leaders to hammer out an action plan that spurs global growth, promotes investment and facilitates trade. Nonresident Senior Fellow Colin Bradford says dealing with the eurozone debt crisis presents an opportunity for leaders to make a serious commitment to a serious problem.

Video

• 01 bradford g20

      

Editor's Note: The National Perspectives on Global Leadership (NPGL) project reports on public perceptions of national leaders’ performance at important international events. The sixth series of commentary focuses on the Cannes G-20 Summit and discusses the ongoing euro crisis, the rising G20 profile, and the growing social mobilization around concerns with the global crisis. Read the other commentary »

OVERVIEW: COMPARATIVE PERSPECTIVE ON THE CANNES G20 SUMMIT

Despite the euro zone crisis, the profile of the G20 was raised in many member-state capitals, and G20 leaders and media did focus on other agenda items and domestic issues.

Reporting from 13 G20 countries reveals that, through the eyes of the national media, the euro crisis “overwhelmed,” “dominated,” “totally sidetracked” or “hijacked” the Cannes G20 Summit on Thursday night through Friday afternoon, November 4-5, 2011. Only Argentina seems to have been captivated by the bilateral meeting between US President Barack Obama and their leader, President Cristina Kirschner, to such a degree that it overshadowed the global preoccupation with the Greek debt crisis and its implications for the euro zone and the global economy. As she did at other G20 summits, Cristina Kirschner found a way to project her own priorities and portray them to the Argentine public through deliberate preparation with her cabinet beforehand and in regional consultations, and this also held true at her appearance at the B20 (G20 business summit) held just before the G20.

Other Issues

G20 leaders and the national media in G20 capitals were, nonetheless, able to focus on several other G20 issues of vital interest to their publics.

Kirschner and other leaders were indeed able to project to the national media in their capitals other issues and priorities, despite the euro crisis capturing public attention around the world. The two most frequently profiled international issues in the G20 capitals surveyed here, were the financial transactions tax proposal and the G20’s work on tax havens that began in London in 2009. Among the other issues discussed was the strong focus on development by Chinese President Hu Jintao and on least-developed countries by South African President Jacob Zuma. The Financial Stability Board (FSB) action on “too big to fail” banks was highlighted by The Washington Post on Saturday morning, as well as by the Canadian media, in part because Canada’s central bank governor, Mark Carney, was named head of the FSB, replacing Mario Draghi. Japanese Prime Minister Yoshihiko Noda was able to keep his country’s media focused on his priorities.

What was also of interest to NPGL country observers was the extent to which some G20 leaders were able to profile their domestic concerns, linking the Cannes G20 deliberations on either Europe or the on-going G20 agenda to jobs and growth at home. Canadian Prime Minister Stephen Harper highlighted the fact that the G20 Action Plan on Growth and Jobs, which was endorsed in Cannes, corresponded exactly to the title of his government’s 2011 budget. Brazilian President Dilma Rouseff highlighted the International Labour Organization’s social initiative on the G20 agenda, likening it to her government’s domestic program of social inclusion.

South Africa’s Jacob Zuma emphasized jobs as crucial to South Africa’s future, which coincided strongly with the Congress of South African Trade Unions labour leader’s meeting with Nicolas Sarkozy in Cannes. U.S. President Barack Obama’s major thrust in Cannes was to support the Europeans’ efforts to resolve the euro crisis themselves as being critical to jobs and growth in the United States against a background of a U.S. job report the same day. In her appearance at the B20 meeting, Cristina Kirschner declared herself against the “anarchic financial capitalism” that had dramatically impacted people in the real economy, not just bankers and banks.
 
Despite the overwhelming force of events in Greece, Italy and global financial markets on the same days that the Cannes summit took place, events which riveted the world’s attention, G20 leaders and the national media in their capitals were, nonetheless, able to focus on several other G20 issues of vital interest to their publics.

Communications

The global crisis managed to create a higher profile for the G20 in many G20 capitals.

The combination of the euro crisis drama and the growing social mobilization around peoples’ concerns with the global crisis, managed to create a higher profile for the G20 in many of its capitals.
 
Our NPGL colleagues from China begin their commentary by saying: “the first thing that should be reported from Beijing is that China’s media have begun to pay more attention to the G20 than in the past.”

From Germany, we learn that “the Cannes event generated a higher volume of media coverage than previous G20 summits.”
 
“This summit had a great deal of relevance for the Argentine public,” we are told by our NPGL colleague in Buenos Aires. “After London, the summit in Cannes has received the greatest attention by the media,” she adds. “The Cannes summit was seen to have a large impact on the Argentine public.”
 
And in South Africa, “surprisingly, media coverage was not cynical, such as ridiculing G20’s role, which we have witnessed in the recent past. Again this probably was due to the magnitude of the issues at stake, and in that sense, probably more closely resembles the political dynamics around the London summit.”

From Tokyo, “Japanese public and media attention to the G20 meeting in Cannes was higher this time.”

But, interestingly, in contrast to massive attention to the G20 summit held in Seoul a year ago, “very little attention” was paid to the Cannes G20 Summit by the Korean media and public.

Other Leaders, Leading

In this intense context, two sets of leaders stood out visibly in most G20 capitals as the euro crisis–G20 drama unfolded: Nicolas Sarkozy and Angela Merkel battling for the core of Europe against George Papandreou and Silvio Berlosconi on the periphery. Barack Obama was given lots of space in the media in France, the United States, Mexico, Australia and South Africa, but he was seen as “marginal” in Germany, “detached” in the United Kingdom, and “not given special attention” in Canada, for example. Christine Lagarde, the new head of the International Monetary Fund (IMF), seemed to be given more play in the G20 emerging market economies media, than in the G20 industrial economies of the West. Leaders were varied in the intensity of their participation in the summit and their interactions with the global and national media.

Concluding Remarks

In the end, the euro crisis took centre stage at the Cannes summit in the eyes of most of the world, but as observed through the media in G20 capitals, other issues managed to surface for public attention, and national leaders from G20 countries were able, in several cases, to project their own priorities amid the welter of events in Athens and Rome, as well as Cannes, during those two turbulent days in early November 2011. The profile of the G20 was strikingly more visible in many capitals, but serious questions were raised in Mexico and Korea, especially about the future of G20 summits.

Our NPGL colleague in Mexico noted that “the fact that no specific goals, financial commitments or timelines were set for the principal agenda items included in the communiqué was highlighted in commentaries [in Mexico] that focused on why the leaders’ level G20 is not really the ‘premier’ forum its founders proclaimed it to be and why its very existence as a global steering committee is at stake.” From Korea, we heard that “the image of the G20 leaders that prevailed in Korea was one of a confused and ineffective bunch.” The sense in Australia, however, was that the G20 is “the best option on offer.”

As Mexico prepares to take up the presidency next year, and as we look ahead to Russia and Australia’s presidency in the years ahead, it is clear that many challenges remain.

UNITED STATES

As surely was the case in other countries, the Greek debt drama, with the proposed referendum, withdrawn referendum and the vote of confidence, overshadowed and seemed to stymie action by G20 leaders in Cannes. But the competing headlines in Washington focused on the jobs report for October, which showed mixed results with public sector jobs falling significantly while private sector employment grew steadily again, and the debate in Congress between Republican and Democratic versions of a jobs bill. CNN’s John King was called upon to comment on the G20 summit from his perch in Iowa, reminding viewers that there was a seamless connection between the president’s efforts to push Europeans to deal with their debt and financial fragility, and his reelection prospects.

There is no doubt that in Washington, Athens was more visible than Cannes, and that the G20 summit took a back seat to the euro crisis. The Financial Times opined that the “forum’s high ambitions delivered meager results” as a headline. This certainly is borne out by the communiqué, which indeed did not push forward the specifics of the G20 agenda.

President Obama made his position extremely clear in his actions and words at Cannes, that he regarded the euro crisis as a European problem and the solutions were within Europe’s grasp and did not require outside support for the moment — a geopolitical strategy, which revealed his conviction that Europe is pivotal for the United States economically and strategically, keeping China and Asia more in the background. The fact that the Cannes summit put out an Action Plan on Growth and Jobs and the interdependence of the United States and Europe is the centerpiece for global growth, linked well to his domestic agenda of recovery and employment.

Other Issues

Importantly, the G20 summit approved an FSB report, making public for the first time a list of 29 “too big to fail” banks that would be subject to more vigorous FSB oversight and higher capital requirements, in order to protect taxpayers from bailing out failed banks. This is a highly significant G20 accomplishment, following directly from the seminal London G20 Summit in April 2009, at which the expanded FSB was established, incorporating all G20 countries into what was a highly euro-centric predecessor, and carrying forward the London G20 priority on strengthening national andglobal mechanisms for financial oversight, supervision and regulation. Interestingly, only The Washington Post carried this story as part of its G20 coverage — no articles on this G20 action appeared in The New York Times or the Financial Times.

Communications

President Obama’s press conference at the conclusion of the Cannes G20 Summit was carried live on CNN late on the morning of November 4, with wide CNN commentary afterward, linking Obama’s thrust in Europe with his domestic economic and political agenda. The Washington Post on November 5 grasped the strategic point of the president in an editorial: “Cannes heat: President Obama delivers the right message to Europe.” The Post argued, based on Obama’s remarks in Cannes, that “even if we [the United States] had the money to rescue the euro, it’s not clear that we should make such an investment, unless and until Europe itself had exhausted its resources, which it has not yet done… if the Europeans mean it when they say that the fate of their union itself depends on saving the euro, they will find a way.”

So, whereas the G20 profile receded in the face of the euro avalanche, US global interests were projected clearly and forcefully by the American president to European leaders and to the US public, from his participation in the Cannes G20 Summit. The link between US domestic political imperatives and a global strategic thrust was forged and made visible by Obama’s presence in Cannes.

Other Leaders, Leading

The image of the G20 leaders that prevailed in the US media from the Cannes G20 Summit was predominantly Obama with European leaders, not with Asian leaders or leaders from other parts of the world represented in the G20 grouping. Even The Washington Post editorial contained a photo nested into the editorial itself of Obama, Merkel, Sarkozy and Cameron talking in an animated fashion with the G20 France imprimatur in the background. This was clearly consistent with the dominance of the euro crisis in the meeting itself, and with Obama’s strategic focus and message. In other G20 summits, Obama with Hu Jintao in London, or Berlusconi thrusting himself between Obama and Medvedev in Pittsburgh, were memorable images. In Washington, the West was shown at Cannes as being front and centre stage, with The New York Times carrying an amusing and insightful portrait of the relationship between Barack Obama and Nicolas Sarkozy.

      

The biggest news at the end of the Brisbane G-20 on Sunday will be to confirm for the first time in an official G-20 communique that China will indeed chair the G-20 Summit in 2016. 

Coming on the heals of a momentous week of great power realignments and breakthroughs at the APEC Summit in Beijing and other one-on-one meetings of heads of state, the timing of China’s presidency of the G-20 Summit in 2016 could not be a better follow-up to this week’s accomplishments. It puts China in play as a global leader at a critical moment in geopolitical relations and in terms of several global agendas that will culminate in the next two years. It also provides an unusual opportunity for the U.S. and China to collaborate on a broader set of societal issues affecting everyone everywhere building on their agreements this week.

One of the reasons why the G-20 Summits have yet to realize their full potential is that the leaders-level summits have been captured by the finance ministers’ agendas and discourse. Leaders at G-20 Summits have individually and collectively failed to connect with their publics; ordinary citizens do not see their urgent issues being dealt with. Exchange rates, current account balances, reserve ratios for banks, and the role of the IMF do not resonate with public anxieties over their lives and livelihoods.

Three streams of global issues will culminate in 2015:  the forging of a “post-2015 agenda” on sustainable development with a new set of global goals to succeed the Millennium Development Goals (MDGs); the agreement on  “financing for development” (FFD) arrangements and mechanisms to support the new post-2015 Sustainable Development Goals (SDGs) to be realized in 2030; and the achievement of a United Nations Framework Convention on Climate Change (UNFCCC) by the end of 2015, which looks more promising now than it did a week ago.

What has been learned from previous global goal setting processes is that building on the momentum for the goal-setting process in 2015 and carrying it directly into the mobilization of national political commitment, resources and policies for implementation is vital. China as a member of the G-20 troika in 2015 through 2017 will be in crucial position of bridging the goal-setting and implementation phases of the new SDGs for 2030 to be adopted at the United Nations in September of next year.

China, as one of the five permanent members of the U.N. Security Council, will be in a pivotal position to create complementarities between the G-20 forum for the major economies and the U.N. as a forum for all countries for this critical period of setting the global sustainability agenda for the next fifteen years.  

The post-2015 agenda for social, economic and environmental sustainability is of high interest to the United States, and the new China-U.S. climate change agreement in Beijing this week augurs well for collaboration between the two countries on the broader agenda. White House Chief of Staff John Podesta was on the high-level panel for the post-2015 development agenda last year, which signals high U.S. policy involvement. The Shanghai Institute for International Studies has argued in a recent paper for the U.N. Development Program that “the G-20 and the U.N. could have certain complementary roles. The development issue could become the one linking the major work of both the U.N. and the G-20.”  

The world should welcome the unique role that China can now play in bringing the international community and the global system of international institutions together in charting a common path forward building on the progress made in the various summits this week. 

       

Event Information

Register for the Event

In an era of fluid geopolitics and geoeconomics, challenges to the global order abound: from ever-changing terrorism, to massive refugee flows, a stubbornly sluggish world economy, and the specter of global pandemics. Against this backdrop, the question of whether leader summitry—either the G-7 or G-20 incarnations—can supply needed international governance is all the more relevant. This question is particularly significant for East Asia this year as Japan and China, two economic giants that are sometimes perceived as political rivals, respectively host the G-7 and G-20 summits. 

On April 18, the Center for East Asia Policy Studies and the Project on International Order and Strategy co-hosted a discussion on the continued relevancy and efficacy of the leader summit framework, Japan’s and China’s priorities as summit hosts, and whether these East Asian neighbors will hold parallel but completely separate summits or utilize these summits as an opportunity to cooperate on issues of mutual, and global, interest.

Join the conversation on Twitter using #G7G20Asia

Audio

• Japan’s G-7 and China’s G-20 chairmanships: Bridges or stovepipes in leader summitry?

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20160418_g7g20_transcript