Let’s take a moment for a thought experiment. I do this days after more Palestinian attacks on Israelis, including the horrific murder of a mother of six children; soon after Israel announced the expropriation of another 370 acres of land near Jericho; and after Majed Faraj, the Palestinian security chief, announced that Palestinian security forces had intercepted 200 potential terrorist attacks against Israel. The thought experiment focuses on whether the “Plan B” for the Israel-Palestine dispute should be Israel’s annexation of the territories it occupied in 1967 and the extension of full citizenship rights to the Palestinians in those areas.

To be sure, I still count myself among the dying breed of those who believe fervently in the two-state solution—two states living side by side in peace and security, each enjoying sovereignty and political independence in part of the land that both claim as their exclusive national homes. This is still the best, by far, of all possible outcomes of the dispute. This is not to say that the two-state solution is without faults. Thus far, the two sides have not been able to agree on critical details, and there is no guarantee that achieving two states would assure peaceful relations. But the two-state solution, based on partition of the land, appears to offer the best chance for long term peace. I would dump all Plan B’s and C’s in a heartbeat if leadership emerged in Israel and Palestine—and in the United States—that proved willing to move toward a two-state outcome. 

I still count myself among the dying breed of those who believe fervently in the two-state solution.

But hoping for better, stronger, more farsighted leadership is not a substitute for policy. The fact is that both Israel and the Palestine Liberation Organization (PLO) are further today from bringing forth such leaders than at any time before. Even if Benjamin Netanyahu yields the prime minister’s office to another contender, no one in Israel is proposing the kind of far-reaching accommodation toward which Ehud Olmert was heading in 2008. None of Mahmoud Abbas’s likely successors has even articulated a reasonable peace plan. And none of the candidates for U.S. president is likely to be as committed to the search for peace as Barack Obama has been, and even his commitment has fallen far short of what is needed to move the recalcitrant parties toward peace. The sad reality is that politics—not policy, per se—is what blocks progress toward a two-state solution.

The sad reality is that politics—not policy, per se—is what blocks progress toward a two-state solution.

Regional solution?

In the absence of progress toward two states, are there better alternatives than throwing in the towel and looking at annexation as Plan B? The search for alternative Plan B’s is a fool’s errand. Some of those ideas are creative, but none of them will be accepted by both sides. For example, one Plan B variant du jour rests on the premise of a “regional solution”—that is, having Israel and the Arab world reach a comprehensive peace agreement that includes a resolution of the Palestinian issue. Sounds good, except it makes no sense. 

First, Israel has not accepted the Arab Peace Initiative (API) of 2002, the closest the Arab world has come to accepting Israel within the borders of the 1949 armistice line and agreeing to normalize relations with Israel once peace has been achieved. But no Israeli government has liked its terms, especially the paragraph on Palestinian refugees, the notion of a Palestinian capital in Jerusalem, and the API’s insistence on full Israeli withdrawal. Thus, the question to those who propose a regional solution today is whether there is a coalition in Israel ready to use the API as the basis for negotiating a comprehensive peace. I think not.

Second, the Arab world is in no position to deliver on what the API promises. The Arabs have never followed up the API by engaging Israel. And the premise of the API has been that the Arabs will recognize Israel and agree to normalize only after peace is concluded with the Palestinians (and the Syrians and Lebanese)– not a very attractive incentive for Israelis to enter a risky peace process.

[T]he Arab world of 2002, however dysfunctional, was far more stable than the Arab world of 2016.

And third, the Arab world of 2002, however dysfunctional, was far more stable than the Arab world of 2016. The opponents of the two-state solution in Israel point to this when describing the security dangers that Israel would face were it to concede anything now to the Palestinians. Even if a comprehensive solution were to rest on the shoulders of Egypt and Jordan, Israel’s peace treaty partners, would Israeli skeptics truly be assuaged that these countries could assure Israel’s security in the face of continued instability (Egypt) or the impact of refugees and economic distress (Jordan)? Indeed, the idea of a regional or comprehensive solution based on Arab stability today is chimerical. 

Status quo?

The alternatives to the regional idea are equally unrealistic. The idea of confederation rests on the agreement of Jordan (and potentially Egypt) to join a political entity with the Palestinians. However, neither state has indicated any interest in doing so. 

“Maintaining the status quo” is a non-starter, because status quos are never static—as the events of recent years prove, they tend to get worse. How many Intifadas or stabbings will it take for the people of Israel to believe their own security chiefs, who recognize that these actions are born of frustration over the occupation and related grievances? Why should Israelis believe that the majority of Palestinians are interested in peace when Hamas—opposed to Israel’s very existence—still rules Gaza and commands significant popular support, and while the Palestinian Authority is crumbling and hardly represents anyone anymore? And how long will it take Palestinian supporters of armed and violent resistance to recognize that their abortive efforts to destroy Israel and indiscriminate attacks on Israeli civilians are repugnant: targeting civilians is a morally unacceptable tactic for any resistance movement. 

Thus, the idea of “conflict management” or even “conflict mitigation”—staple products of those who support maintaining the status quo until somehow things change—is pernicious, for it rests on an assumption that the rest of us simply don’t understand the conflict.

[T]he idea of a regional or comprehensive solution based on Arab stability today is chimerical.

A futile search for alternatives

And so it is for all other Plan B’s. Several years ago, my Princeton graduate students embarked on an effort to find a viable alternative to the two-state solution; and they told me at the outset that they intended to prove that such an alternative existed. In the end, they failed and returned to the idea that the only viable solution was to partition the land into two states. Others, too, have tried to find alternatives, and some retain the hope that their policy proposal might win the day. I wish them well—for I really do believe in peace, whether it’s via two states or otherwise. But I have no confidence they will succeed.

[T]he idea of “conflict management” or even “conflict mitigation”—staple products of those who support maintaining the status quo until somehow things change—is pernicious, for it rests on an assumption that the rest of us simply don’t understand the conflict.

And so we are back to the thought experiment. This would take as a starting point what Israeli Minister Uri Ariel told my students several years ago: we (Israel) have won, and the land of Israel is ours. Under this scenario, Israel would:

• Formally annex the territories it occupied in 1967, basing its legal argument on its belief that these are “disputed” rather than “occupied” territories. 
• In connection with this act of annexation, Israel would offer full citizenship rights to all the Palestinians living in the territories. While Israel would probably want to include only the West Bank in this arrangement, excluding Gaza would make it impossible to secure any support internationally, in that Gaza is as much a part of Resolution 242 as is the West Bank.
• Those Palestinians who accept citizenship would then enjoy equal rights with all other Israelis; those Palestinians who reject citizenship would be offered permanent residency, a status that would include certain rights and privileges but not full citizenship rights (for example, voting in national elections). 
• Israel would then approach the United Nations Security Council to argue that these measures constituted an act of self-determination, and that the outcome represented an end of the conflict in accordance with Resolution 242. I am not a lawyer and I assume that many—including Palestinians and Arabs—would dispute this Israeli argument. But the process would change the status quo fundamentally and offer a real alternative to the two-state solution.

Could this work, and is it a real Plan B for the conflict? This is but a thought experiment. I suppose most Israelis will hate this idea for it exposes the most significant weakness of the Israeli right wing and the settlements movement, namely that it undercuts fundamentally the idea of a permanent Jewish majority state. Similarly, most Palestinians will also hate this idea because it forecloses the possibility of a real act of self-determination culminating in an independent state and forces Palestinians to confront the emptiness of the slogans that their leaders have employed over the years in the context of the Arab-Israeli dispute. 

The thought experiment is thus not very sound. Perhaps, then, it will scare everyone enough for leaders to get serious about peace.

Indian and Israeli relations are getting even friendlier: Indian Foreign Minister Sushma Swaraj visited Israel in January, and the trip is widely thought to precede higher level visits, including by Prime Minister Narendra Modi (he’d be the first Indian head of government to visit Israel). Israeli President Reuven Rivlin and Prime Minister Benjamin Netanyahu have both also indicated that they plan to travel to India “soon.”

The foreign minister’s visit was part of the ongoing Indian effort not just to broaden and deepen India’s relationship with Israel, but also to make it more public. But the trip—not just to Israel, but to what the Indian government now routinely calls the state of Palestine—also highlighted the Modi government’s attempt to de-hyphenate India’s relations with the Israelis and Palestinians. 

What is the state of India’s relationship with Israel, the Modi government’s approach toward it, and this de-hyphenated approach? 

A blossoming friendship

Since India normalized relations with Israel in 1992, the partnership has developed steadily. The countries have a close defense, homeland security, and intelligence relationship—one that the two governments do not talk much about publicly. Shared concerns about terrorism have proven to be a key driver; so have commercial interests (including Israel’s quest for additional markets and India’s desire to diversify its defense suppliers, get access to better technology, and co-develop and co-produce equipment). India has become Israeli defense companies’ largest customer. Israel, in turn, has shot up on India’s list of suppliers. 

In the early 1990s, Israel—like the United States—did not really figure on India’s list of defense suppliers. However, between 2005 and 2014, it accounted for 7 percent (in dollar terms) of military equipment deliveries—the third highest after Russia and the United States. As Indian President Pranab Mukherjee recently noted, Israel has crucially come through for India at times “when India needed them the most” (i.e. during crises or when other sources have not been available, for example, due to sanctions). The president referred to the assistance given during the Kargil crisis in 1999 in particular, but there has also been less publicly-acknowledged help in the past, including during India’s 1965 and 1971 wars with Pakistan. 

Beyond the defense and security relationship, cooperation in the agricultural sector—water management, research and development, sharing of best practices—might have the most on-the-ground impact, including in terms of building constituencies for Israel at the state level in India. Israeli ambassadors have indeed been nurturing this constituency and reaching out to the chief ministers of Indian states for a number of years. (Incidentally, India, for its part, has felt that the closer relationship with Israel has created a constituency for it in the United States.)

Economic ties have also grown: The two countries are negotiating a free trade agreement, and have been trying to encourage greater investments from the other. The success of Indian and Israeli information technology companies has particularly led to interest in collaboration in that sector. 

The governments have also been trying to increase people-to-people interaction through educational exchanges and tourism, with some success. Israeli tourism officials have highlighted the 13 percent increase in arrivals from India over the last year. And tourist arrivals to India from Israel have doubled over the last 15 years, including thousands of Israelis visiting after their compulsory military service. 

Let’s go public

The India-Israel relationship has developed under Indian governments of different stripes. It was normalized by a Congress party-led government and progressed considerably during the United Progressive Alliance coalition government led by the party between 2004 and 2014. However, while some ministers and senior military officials exchanged visits during that decade, there were not that many high-visibility visits—especially from India to Israel, with the foreign minister only visiting once. A planned 2006 trip by then Defense Minister Mukherjee was reportedly cancelled because of Israeli military operations in Gaza and then the Lebanon war. The last Israeli prime minister to visit India was Ariel Sharon in 2003, and no defense minister had ever visited despite those ties. 

The Israeli ambassador has talked about the relationship being “held under the carpet.” More bluntly, in private, Israeli officials and commentators have said that India has treated Israel like a “mistress”—happy to engage intimately in private, but hesitant to acknowledge the relationship in public. The explanations for this have ranged from Indian domestic political sensitivities to its relations with the Arab countries.

[I]n private, Israeli officials and commentators have said that India has treated Israel like a “mistress”—happy to engage intimately in private, but hesitant to acknowledge the relationship in public.

When the Bharatiya Janata Party (BJP)-led government took office in May 2014 with Modi at its helm, there was a belief that the partnership with Israel would be a priority and more visible. Relations under the BJP-led coalition government between 1998 and 2004 had been more conspicuous. When in opposition, BJP leaders had visited Israel, and also been supportive of that country in election manifestos and speeches. 

As chief minister of the state of Gujarat, Modi himself had expressed admiration for Israel’s achievements, including “how it has overcome various adversities to make the desert bloom.” Traveling there in 2006 with the central agricultural minister, he also helped facilitate trips for politicians, business leaders, and farmers from his state to Israel. His government welcomed Israeli investment and technological assistance in the agricultural, dairy, and irrigation sectors. And, at a time when Modi was not welcome in many Western capitals, Israelis reciprocated: Businesses and government engaged with him, with Israeli ambassadors and consul generals from Mumbai meeting with him long before European and American officials did so. Thus, Modi’s elevation to prime minister was welcomed in Israel, as was the appointment as foreign minister of Swaraj, a former head of the India-Israel Parliamentary Friendship Group.

However, the Modi government’s response to the Gaza crisis in summer 2014 left many perplexed and some of its supporters disappointed. The Indian government initially sought to avoid a debate on the crisis in the Indian parliament, on the grounds that it did not want “discourteous references” to a friend (Israel). After opposition complaints, there was a debate but the government nixed a resolution. In its official statements, the Modi government consistently expressed concern about the violence in general—and, in particular, both the loss of civilian life in Gaza and the provocations against Israel—and called for both sides to exercise restraint and deescalate. Yet, it then voted in support of the U.N. Human Rights Council (UNHRC) resolution that condemned Israel, a move that left observers—including many in the BJP base—wondering why the government didn’t instead abstain. 

Since then, however, the Modi government has moved toward the expected approach. The first sign of this was Modi’s decision to meet with Netanyahu on the sidelines of the opening of the U.N. General Assembly in 2014—despite reported hesitation on the part of some in the foreign ministry. Since then, there have been a number of high-level visits and interactions (and Twitter exchanges), including a few “firsts.” This past October, Pranab Mukherjee, for example, became the first Indian president to travel to Israel, where he declared the state of the relationship to be “excellent.” 

The Israeli ambassador to India has observed the “high visibility” the relationship now enjoys. Also noticed more widely was India abstaining in a July 2015 UNHRC vote on a report criticizing Israeli actions in the 2014 Gaza crisis. Indian diplomats explained the vote as due to the mention of the International Criminal Court (ICC) in the resolution, but observers pointed out that India has voted for other resolutions mentioning the ICC. Israeli commentators saw the abstention as “quite dramatic;” the Israeli ambassador expressed gratitude. Palestinian officials, on the other hand, expressed “shock” and criticized the vote as a “departure.” 

In the defense space, cooperation is only growing: The Indian government moved forward on (delayed) deals to purchase Spike anti-tank missiles and Barak missiles for its navy; it recently tested the jointly-developed Barak 8 missile system, along with Israel Aerospace Industries; and an Indian private sector company has reportedly formed a joint venture with an Israeli company to produce small arms. Cooperation is also continuing in the agricultural sector, with 30 centers of excellence either established or planned across 10 Indian states. More broadly, the two governments are seeking to facilitate greater economic ties, as well as science and technology collaboration. 

There have been questions about why Modi hasn’t visited Israel yet, despite the more visible bonhomie. But, in many ways, it made sense to have the Indian president take the first leadership-level visit during this government. Mukherjee’s position as head of state, as well as the fact that he was a life-long Congress party member and minister, helped convey to both Indian and Israeli audiences that this is not a one-party approach. This point was reinforced by the accompanying delegation of MPs representing different political parties and parts of the country. For similar reasons, it would not be surprising if there was a Rivlin visit to India before a Netanyahu one. 

De-hyphenation? 

The deepening—and more open—relationship with Israel, however, hasn’t been accompanied by a U-turn on the Indian government’s policy toward Palestine. What the Modi government seems to be doing is trying to de-hyphenate its ties with Israel and Palestine. Previous governments have also tried to keep the relationships on parallel tracks—but the current one has sought to make both relationships more direct and visible, less linked to the other, while also making it clear that neither will enjoy a veto on India’s relations with the other. 

The deepening—and more open—relationship with Israel, however, hasn’t been accompanied by a U-turn on the Indian government’s policy toward Palestine.

The Modi government doesn’t demure from referring to the “state of Palestine” rather than “the Palestinian Authority.” It held the first-ever Foreign Office consultations with the Palestinians last spring, and the Indian foreign ministry made it a point to release separate press releases for the president’s and the foreign minister’s trips to Israel and Palestine. The Indian president became the first foreign head of state to stay overnight in Ramallah. Modi met with Mahmoud Abbas, whom the Indian government refers to as the “president of the state of Palestine, on the sidelines of both the U.N. General Assembly meeting in New York and the climate change summit in Paris in 2015. The Indian foreign minister met with Abbas in 2014 in New York, and again in Ramallah on her visit. During their trips, both she and the Indian president also went to the mausoleum of Yasser Arafat (who the BJP in the past called “the illustrious leader of the Palestinian people”).

The government has reiterated India’s traditional position on a two-state solution, indicating its belief in an independent Palestinian state with East Jerusalem as its capital. It voted in favor of the resolution on raising the Palestinian flag at the United Nations, and has continued to sign on to BRICS declarations “oppos[ing] the continuous Israeli settlement activities in the Occupied Territories.” In Ramallah, Sushma Swaraj emphasized that India’s support for Palestinians remained “undiluted.” 

The continuity on this front is not just driven by historic and domestic political factors, but also by India’s broader balancing act in the region. Even as India’s relations with Israel have deepened, it has maintained—and even enhanced—its relations with Iran and the Gulf Cooperation Council (GCC) countries. Modi has welcomed the emir of Qatar, visited the UAE, and met with Iran’s Hassan Rouhani. The first-ever Arab-India Cooperation Forum ministerial meeting also took place in January. It would not be surprising if the Indian prime minister visited Saudi Arabia this year or there were high-level visits exchanged between Delhi and Tehran. The government has emphasized its “strategic intent and commitment to simultaneously enhance relations with the Arab world as well as Israel, without allowing it to become a zero sum game.” And, overall, the Israelis, Palestinians, and GCC countries have not pushed for Delhi to make a choice. 

The de-hyphenated approach, in turn, potentially gives Indian policymakers more space to take India’s relationship with Israel further. But, as was evident during the Indian president’s visit to the region, it hasn’t been problem-free and it has not been feasible to keep the two relationships entirely insulated. An upsurge in violence reportedly caused Israel to nix a proposal for Mukherjee to visit the Al-Aqsa mosque in Jerusalem. There was also some heartburn about the Israeli delay in clearing 30 Indians' computers destined for an India-Palestine Centre for Excellence in Information and Communication Technology at Al-Quds University in Ramallah, as well as its refusal to allow communications equipment to be transferred. In the Israeli press, there was criticism of the president’s lack of mention of Palestinian violence. The Indian president and the foreign ministry also found themselves having to explain the president’s remark in Israel that “religion cannot be the basis of a state.”

There have been other differences between India and Israel as well, notably on Iran (something officials have tended not to discuss publicly). There might be other difficulties in the future, stemming, for example, from: negative public and media reaction in India if there’s another Israel-Palestine crisis; the stalled free trade agreement negotiations; potential Israeli defense sales to China; renewed questions about defense acquisitions from Israel; or the behavior of Israeli tourists in India. But the relationship is likely to continue to move forward, and increase in visibility, including with visits by Rivlin, Netanyahu, and Modi—potentially before the 25th anniversary of the two countries establishing full diplomatic relations on January 29, 2017.

2016 ushered in the revamped UN Sustainable Development Goals (SDGs), which built on the Millennium Development Goals (MDGs), adopted in 2000. Poverty eradication is the number one developmental goal of both the MDGs and SDGs.

Over the past two decades, global efforts have been successful as the number of people living in poverty declined by more than half, from more than 1.9 billion in 1990 to 836 million in 2015. Despite such progress, the Arab world continues to lag in its efforts to combat poverty.

In fact, according to the UNDP, between 2010 and 2012, the percentage of the population in the region making less than $1.25 a day increased (PDF) from 4.1 percent to 7.4 percent. Previously, countries in the region had made progress in reducing poverty, but high levels of political unrest had reversed many of these improvements.

Poverty and conflict: A direct correlation

The persistence of conflict in Syria, Iraq, and Yemen remains one of the main drivers of poverty regionally. In Syria, after five years of civil war it is estimated that 80 percent of the population lives in poverty, and life expectancy has been cut by 20 years.

Almost a decade after the US-led invasion in 2003, poverty rates are on the rise in Iraq with statistics from the World Bank showing that 28 percent of Iraqi families live under the poverty line. The mass displacement from the Islamic State of Iraq and the Levant (ISIL) controlled areas, the decline in global oil prices and higher unemployment rates has meant that despite its oil wealth, the Iraqi government has failed miserably in addressing the poverty rate in the country.

Yemen's poverty rate has increased from 42 percent of the population in 2009, to an even more alarming 54.5 percent in 2012.

Despite an initial wave of optimism after the 2011 Arab uprisings, countries in North Africa continue to face economic challenges that have seen poverty rates increase in many areas.

In Egypt, the Arab world's most populous country, five years of political upheaval have taken a toll on the economy. Increased unemployment, lower tourist arrivals, dwindling foreign currency reserves, and a weaker Egyptian pound has meant that 26 percent of Egypt's 90 million people live under the poverty line.

Despite a relatively successful and ongoing political transition in Tunisia, one in every six Tunisians lives below the poverty line as well. Tunisia is one of the highest contributors of ISIL fighters per capita, and Tunisian leaders continue to make a direct correlation between poverty and terrorism.

In the Palestinian territories, a lack of employment opportunities due to restrictions imposed by the Israeli occupation continues to drive rising levels of poverty (PDF). Nearly two years after the war in Gaza, reconstruction efforts have slowed to a crawl. Such efforts promised employment for thousands of Palestinians; however, the slow trickle of foreign donations and a deficiency of construction materials indicate that the situation will not improve any time soon.

Although the outlook for the West Bank appears less grim than in Gaza, high levels of poverty persist as many Palestinians hold jobs that pay a meager wage. This shortage of suitable employment forces many Palestinians to seek employment from companies operating in settlements on occupied Palestinian territory.

Even with some Palestinians performing these jobs out of necessity, per capita income in the West Bank continues to decline. In Gaza, the situation is even worse with per capita income 31 percent lower than in 1994.

One step forward, two steps back

The SDGs provide an ambitious blue print for global development that includes a focus on education, the environment, women's rights, sustainable water, and many other critical areas. While all of these issues are of importance to the region, it will become increasingly problematic to progress these goals without a renewed emphasis on poverty eradication.

Countries currently in conflict pose the greatest challenge to poverty eradication efforts, as participants in these conflicts have pushed aside humanitarian concerns in the quest for victory. The international community should make preparations for post-war reconstruction in Syria and Yemen, while also remaining wary of incomplete political settlements that raise the prospect for the resumption of hostilities in the future.

Even though in Palestine it is unlikely that the Israeli occupation will end anytime soon, however Fatah and Hamas should work toward a reconciliation to improve the system of governance in the territories. This will provide Palestinians with a united front to tackle the challenges posed by the occupation and ease the suffering felt in both Gaza and the West Bank.

Arab countries must recognise that absolute poverty is only one dimension of the problem and that redistributive policies can only go as far to address the issue. The uprisings have shown that Arab youth not only protested against economic inequality, but also against marginalisation and political disenfranchisement. Any renewed push for more economic opportunities must also provide Arab youth with a chance to shape their future.

Lower oil prices will likely affect the level of aid wealthier Gulf Cooperation Council countries give to poorer countries in the region. Nonetheless, such aid should not simply dry up. The Saudi-led coalition has destroyed a large portion of the Yemeni infrastructure, so the Kingdom and members of its coalition should bear a large part of the reconstruction effort.

Arab governments should understand that poverty also has a security and stability dimension. The 2011 uprisings have shown that Arab societies have the ability to challenge incompetent governance and corruption.

Food security remains a huge challenge for a region that imports much of its key food staples. Should poverty and food security issues not be addressed, any future protest wave may constitute a "revolution of the hungry", that is likely to be more violent than the protest wave of 2011.

This article originally appeared in Al Jazeera English.

While Israeli and Palestinian interests are best served by a negotiated two-state state solution, the peace plan that Sam Bahour proposed in his February post disregards Israel's demographic and security concerns and is tantamount to a Palestinian veto on a negotiated solution. His insistence on the right of return for Palestinian refugees and rejection of security limitations on Palestinian sovereignty in effect asks Israel to become a binational state while creating a militarized Palestinian state alongside it. Bahour rejects the notion of unilateral action, but his case only reinforces my belief that Israel may need to act independently to protect its interests.

The logic behind the Clinton parameters and President Obama’s peace plan was that in return for the creation of a Palestinian state, Palestinian refugees would relinquish their claim to Israel; the hope was that this would allow for the "two states for two peoples" to exist side-by-side. Yet Bahour rejects compromise on the refugee issue as the forfeiture of “basic components of statehood and basic principles of Israeli-Palestinian peace that are enshrined in international law.” Any peace agreement that both establishes a Palestinian state and recognizes the rights of millions of Palestinians to enter Israel would hasten the end of Israel's Jewish identity.

Israel's interest in the creation of a Palestinian state is also built upon the assumption that a sound agreement would improve its security rather than threaten it. To this end, Israel has called for a demilitarized Palestinian state, and this has been echoed by the United States, France, the Czech Republic, the European Union, and Australia’s Labor Party. Even Mahmoud Abbas accepted the premise of demilitarization, saying, “We don’t need planes or missiles. All we need is a strong police force.” Nevertheless, Bahour’s piece declares any limitations on the sovereignty of Palestine unacceptable. For Israel, a peace deal that grants one’s adversaries access to more deadly weaponry would be absurd.

Bahour argues that my strategies for reaching a two-state solution are doomed because they do not meet the "mutual interests" of the parties to the conflict, but his plan does not offer incentives for Israel to make peace.

Bahour argues that my strategies for reaching a two-state solution are doomed because they do not meet the "mutual interests" of the parties to the conflict, but his plan does not offer incentives for Israel to make peace. His proposal not only fails to improve Israel's situation in any tangible sense, but further endangers it. Rejectionist Palestinian positions like Bahour's (and Abbas's recent dismissal of Biden's initiative) would veto the two-state solution as a means to move towards a single binational state. That is precisely why Israel may need to act independently to keep a two-state solution viable.

While much of the outside world has focused on the current wave of violence in Israel and the West Bank, far less attention is paid to the causes behind it and the context in which it is occurring. In meetings last month in Ramallah and Jerusalem with a range of Palestinian politicians, journalists, and analysts, as well as with senior U.S. officials, it was clear that the attacks reflect the deepening anger and despondency among Palestinians.

The current violence is largely despair-driven, but remains individualistic and politically directionless. Palestinians use different terms to describe the current violence. Popularly, and in most local media, it is known as the “Jerusalem Intifada.” But unlike previous Palestinian uprisings, this latest wave of violence lacks both political organization and clear political demands. 

The fact that so many young Palestinians are willing to risk almost certain death in order to carry out otherwise ineffective stabbing attacks on Israelis points to a deep sense of hopelessness and despair. It’s not only that Israeli settlement expansion, home demolitions, land confiscations, and movement restrictions continue to rob Palestinians of their land, livelihoods, and dignity; it’s that Palestinians now must endure Israel’s seemingly endless occupation without any of the “safety nets” they traditionally have fallen back on: the peace process is dead, Arab regional support and solidarity has evaporated, and their political leaders (both secular and Islamist) are ineffective and increasingly discredited. 

In short, Palestinians feel a deep sense of abandonment by the international community, their fellow Arabs, and even their own leaders. Although domestic political considerations as well as Abbas’ own waning credibility have constrained the leadership’s ability to disavow the violence outright, the Palestinian Authority (PA) continues to work quietly with the Israelis to keep the situation under control. The main question now, particularly for U.S. officials, is how long this PA security coordination with Israel can continue given mounting public opposition and the precipitous decline in international aid, which according to the World Bank is down by roughly 60 percent.

As confidence in Abbas’ leadership declines, Palestinian political stagnation and dysfunction is likely to continue. Since a public opinion poll published last September found that an unprecedented two-thirds of Palestinians wanted Abbas to resign, popular frustration with the Palestinian leader seems only to have grown. Many Palestinians lament what they see as the transformation of their national movement from groups and leaders dedicated to national liberation to a ruling class with special privileges (VIP status, travel, etc.) and a stake in the status quo. Even American officials seemed alarmed by the extent to which the PA is now perceived as a “collaborationist” government by ordinary Palestinians. 

At the same time, Abbas’ leadership style and decision-making are also alienating much of the political elite, including within his own Fatah movement. Several Palestinian officials were privately critical of Abbas. Others have been more open in their criticism, including former West Bank security chief Jibril Rajoub, who recently railed against Abbas and his inner clique in a lengthy interview on Palestinian TV. 

Much of the internal frustration with Abbas has to do with recent leadership appointments as well as what many see as his growing paranoia and personal vendettas against perceived rivals like Salam Fayyad, Yasser Abed-Rabbo, and his arch-nemesis, Mohamed Dahlan, the now-exiled former Gaza security chief. Both of these underscore the growing anxiety over the lack of clarity regarding a future succession process (on which I will have more to say in a subsequent post). Many also voiced skepticism about Abbas’ current diplomatic strategy, which is focused on building support for an international peace conference. While most Palestinians support internationalization, and virtually no one supports a return to U.S.-led peace negotiations, there are doubts as to whether Abbas’ international efforts are rooted in a broader strategy. 

The lack of strategic thinking is also fueling frustration over the ongoing stalemate with Hamas in Gaza. Indeed, many view Abbas as the primary obstacle to Gaza reconstruction and progress toward reconciliation with Hamas. Despite Hamas’ clear weakness since 2013, Abbas has been loath to give Hamas anything it could claim as a political concession and is equally reluctant to inherit responsibility for Gaza’s myriad social, economic, and security problems, for which he currently has no solutions. 

[T]here is a growing feeling, both within Fatah and beyond, that things are unlikely to change internally (and perhaps even diplomatically) until Abbas has left the scene.

Consequently, there is a growing feeling, both within Fatah and beyond, that things are unlikely to change internally (and perhaps even diplomatically) until Abbas has left the scene. At the same time, despite the growing frustration with Abbas, most are not eager to accelerate his departure. As I have written elsewhere, the absence of credible alternatives has given Abbas a sort of “legitimacy by default.” This may explain Abbas’ otherwise inexplicable complacency and his sense, as I was repeatedly told, that time is on his side.

Gaza’s Hamas rulers face their own set of equally daunting political, economic, and security challenges. Although I did not visit Gaza or meet with any Hamas representatives, both figured prominently in most of my discussions. Hamas continues to face serious financial problems as a result of the virtual elimination of its tunnels network and the closure of the Rafah border crossing. The scarcity of resources, a major factor in Hamas’ decision to pursue reconciliation with the PA in 2014, is also fueling tensions within the movement. Whereas Hamas’ military wing, the al-Qassam Brigades, seeks to rebuild its military capabilities and restore its ties with Iran, its political leadership is equally keen to avoid another military confrontation with Israel and hopes to capitalize on diplomatic openings with Turkey and Saudi Arabia. 

The main security threat to Hamas rule comes from jihadi groups, most notably Jaysh al-Islam in the Gaza Strip and the Sinai-based Ansar Beit al-Maqdis, both of which have pledged allegiance to ISIS and regard Hamas (as well as its parent, the Muslim Brotherhood) as apostates. Despite occasional tit-for-tat attacks, at the moment neither Hamas nor the jihadis appear eager for a major fight. The potential for escalation remains, however, particularly if jihadi groups decide to exploit internal discontent within Hamas or force its hand militarily by launching rocket attacks on Israel. Such internal instability, along with the slow pace of reconstruction and already abysmal economic and humanitarian conditions in Gaza, highlights the ever-present danger of yet another devastating war between Israel and Hamas. 

In the end, while the outside world’s preoccupation with the current wave of violence is understandable, merely condemning ad hoc violence by Palestinians while failing to address the deeper, institutionalized violence of the Israeli occupation is both morally dishonest and politically untenable.

Editors’ Note: To salvage his Middle East legacy, advance American interests in the Arab world, and align with the position of the international community on this conflict, Ibrahim Fraihat argues, President Obama must make the long overdue decision of recognizing a sovereign and independent Palestinian state before leaving office. This post originally appeared on Middle East Eye.

Driven by the search for his legacy in the Middle East, it seems President Barack Obama has decided to spend additional political capital on reviving Israeli-Palestinian talks before the end of his second term in office.

Last month, the Wall Street Journal reported that the White House is working on a renewed peace push, including a possible Security Council resolution or other initiatives such as “a presidential speech and a joint statement from the Middle East Quartet.”

While it is still unclear where President Obama is going with this renewed effort, he must understand that using the same old techniques of U.S. mediation will only exacerbate the crisis, consequently tarnishing his legacy in the Middle East. To salvage his Middle East legacy, advance American interests in the Arab world, and align with the position of the international community on this conflict, he must make the long overdue decision of recognizing a sovereign and independent Palestinian state before leaving office.

[U]sing the same old techniques of U.S. mediation will only exacerbate the crisis, consequently tarnishing [Obama's] legacy in the Middle East.

First, Obama should learn from the mistakes of his predecessors, George W. Bush and Bill Clinton, who also tried to reach a mutually acceptable agreement between the Palestinian and Israelis with only a few months left in office.

Reaching an agreement between the two parties under severe time pressure will not work. A party that is not interested in a peace agreement can easily maneuver by using delaying tactics until Obama’s term ends. Israeli Prime Minister Benjamin Netanyahu already utilized this strategy when he publicly rejected an invitation from Obama to visit the White House to talk peace because he wanted to “avoid any perceived influence” in the forthcoming U.S. presidential election. These remarks came from the same person who meddled in domestic American affairs by aggressively lobbying against Obama during the last U.S. presidential election.

Obama has already put in the effort by working with the parties, but now he needs to make decisions. Unlike many American presidents, Obama made the resolution of this conflict a top priority. Despite the brutal civil wars engulfing the Middle East region in the past five years, Obama demonstrated a firm commitment and allocated the needed political capital to make a breakthrough in the Israeli-Palestinian conflict. During his time in office, Secretary of State John Kerry spent more time on Israeli-Palestinian negotiations than any other international conflict. However, the outcome of the Obama administration’s intensive diplomatic efforts has been a total failure. These negotiations ended without an accord or even a memorandum of understanding, agreements that could have built on Obama’s legacy in the Middle East.

Nonetheless, Obama knows very well who made him fail. Netanyahu repeatedly defied Obama: In Congress, he refused to engage in serious negotiations that could have led to an agreement, and he publicly lobbied against Obama’s election for a second term. Obama should not expect Netanyahu to change his position and cooperate on any renewed efforts that could save Obama’s failed legacy in the Middle East. This is the same Netanyahu whom Obama increasingly grew frustrated with throughout his presidency.

With the remaining few months in office, the time has come for Obama to shape his legacy in the Middle East the way he wants it, not the way that Netanyahu has lobbied to characterize it. Obama has an opportunity to take his place in history as the first American president to officially recognize an independent Palestinian state.

Obama has an opportunity to take his place in history as the first American president to officially recognize an independent Palestinian state.

Sooner or later, there will be a Palestinian state and the United States will recognize it. Obama knows that very well. So why should he miss this opportunity and let another president recognize it in the future? Obama should worry about his own legacy, not Netanyahu’s extremist views. Obama should never allow Netanyahu to shape his legacy in the Middle East and leave it stained with failure.

Obama’s Middle East legacy is equally bleak in other parts of the region. Syria could become Obama’s Rwanda; Benghazi and the late Ambassador Chris Stevens are witnesses to his legacy in Libya; al-Qaeda in Yemen is much stronger today than when Obama intensified his drone policy against the organization; only history will tell how the Iran nuclear deal turns out in the future. Unfortunately, Obama cannot change the facts in any of these countries with the limited time remaining for him in office. However, he can still restore his legacy in the Middle East by recognizing a Palestinian state.

By recognizing a Palestinian state now, Obama will have seized an historical opportunity to impact the future and establish a foundation for the next American administration in the Middle East. No matter who comes to the White House, they will have to deal with this new fact. Obama has the international community on his side in recognizing Palestine. France recently stated that it will recognize an independent Palestinian state if a final effort to bring about peace fails. Additionally, Sweden has officially recognized Palestine.

American diplomats have a tradition of balancing their views after they leave office as they become free from the pressure of the Israel lobby and domestic politics. President Jimmy Carter is a one example of this.

Obama should not fall into this trap. No matter how he adjusts his views after leaving office, he will never save his legacy in the Middle East and the Israeli-Palestinian conflict if he does not recognize a Palestinian state while he still has the power to do so. The time is now and he must act rather than regretting it later.

President Obama, if not for your legacy, at least recognize Palestine for the Nobel Peace Prize that you received in advance. The committee trusted you and awarded you the prize before you achieved any real peace; do not disappoint them. Make sure you earn the prize, Mr. President. If not for your legacy or the prestigious prize, then please do something for your own personal pride and be the one who laughs last, not Benjamin Netanyahu.

Mr. President, recognize Palestine now.

“We are not buildings artists; we are buildings leaders in society.” 

These stirring words of Juliano Mer Khamis, the charismatic founder of The Freedom Theatre (TFT) in Jenin refugee camp in Palestine, are coming true, despite his assassination five years ago. 

Against all odds, The Freedom Theatre, a beacon of creativity, discipline, and vision located in the heart of Jenin refugee camp, recently celebrated its tenth anniversary. Known for its fierce fighters and its conservatism, Jenin refugee camp, where over 16,000 live on one square kilometer, increasingly is known as well for its art. 

Juliano Mer Khamis returned to Jenin during the second Intifada to find his mother’s Stone Theatre (Arna’s Children tells her story) reduced - like so much of the camp—to rubble by Israeli tanks, and many of his mother’s student actors killed. In 2005 he joined forces with Jonatan Stanczak, currently Managing Director of TFT and Zakaria Zbeidi, a “Stone Theatre child” turned head of the Al-Aqsa brigades in Jenin, who later renounced militancy for cultural resistance. Together they rebuilt a theater in the camp, which evolved into The Freedom Theatre. 

Mer Khamis urged his acting students to wage a cultural intifada, warning that the occupation of the mind was more dangerous than the occupation of the body. Unlike many charismatic leaders, Mer Khamis developed an institution, not a cult of personality (even though he was adored). Following Juliano’s untimely and unsolved murder in 2011 — he was shot sitting in his car just outside the theater, with his infant son in his lap - the devastated theater soldiered on, a living testament to the powerful impact of his teaching and vision.

“When Juliano died he gave us the strength to continue and he showed us the strength we had in ourselves, so we kept going,”

Ahmad Matahen, age 24, a typical “child of The Freedom Theatre”, explained to me. Matahen joined in 2006; first as an actor, then as Juliano encouraged him to discover and exploit his individual talents, he moved into technology, engineering and stage design. He now studies stage design in Bethlehem, with the support of TFT, where he hopes eventually to work.

What a different future than Matahen might have had, if Mer Khamis had not invited in this street youth who had mocked the theater, and expressed his anger and frustration by throwing rocks at Israeli tanks. Matahen described the common attitude in Jenin:

“When you go to the camp and ask people what they want, they say they want to die. They have no jobs, no hope.”

When asked what he missed most after Juliano’s death, Matahen said “hugs”, something no one besides Juliano gave him. As a teenager, Ahmad, like so many of his contemporaries, saw his friends killed by the invading/occupying Israelis. Considered against the backdrop of trauma that pervades the camp, hugs are no small thing. They form the foundation for the self-confidence and sense of purpose that Matahen has gained from The Freedom Theatre.

High school dropout Ameer Abu Alrob defied his family and left his village to live and work at The Freedom Theatre. He traveled to India last year with a TFT group that also included two female acting students, for a ground-breaking, three-month Palestinian-Indian collaboration and tour with Janam Theater. Ameer and half of the other Palestinian student actors had never previously traveled outside Palestine, much less flown in a plane.

Through his experiences Ameer is not only broadening the horizons of his family and village, but, importantly, also introducing them to their own history through The Freedom Theatre productions such as The Siege. (One of the reasons Ameer dropped out was that school taught him nothing about his own environment and history).

Performed to date in Palestine and Great Britain, The Siege brings to life on stage the incident in 2002 during the second Intifada when armed Palestinian fighters along with some two hundred Palestinian civilians escaped the onslaught of Israeli gunfire and tanks by taking refuge in Bethlehem’s renowned Church of the Nativity. The trapped Palestinians - without food, water, or medical supplies - struggled to remain “steadfast”. After thirty-nine days, they surrendered, responding to the plea of a young mother whose baby’s life was at risk because the siege prevented her taking the infant to the hospital.

This decision, which reflected the fighters’ firm belief that the goal of their struggle was to help the Palestinian people, cost the insurgents dearly. In a European-brokered deal, they were exiled immediately upon exiting the Church — some to Europe and some to Gaza — with no hope of return (even though the European exile was supposed to last one year).

Nabil Al-Raee, The Freedom Theatre’s artistic director, explained that he wanted to re-open this important incident to present the Palestinian side, absent in the media. “This is the first time that we speak about these freedom fighters and tell their stories.” One and a half years of research, with travel to Europe and skype conversations with Gaza to interview those in exile, including personal friends of Al-Raee’s, were distilled into a visually stunning and dramatically taut production.

“The lesson of The Siege was putting weapons down,” 

according to one of the actors, Faisal Abu Alhayjaa, referring to the essential humanity of the Palestinian fighters, who would not harm a sick child for the sake of their cause.

This powerful message apparently was lost on New York’s acclaimed Public Theater which cancelled the production scheduled for this May. This alarming trend of performances cancelled/censored (take your pick) for political reasons will be examined at a conference at Georgetown University this June, where Al-Raee will speak.

Undeterred, The Freedom Theatre and its resolute supporters currently are seeking other American venues for The Siege. While some may see Palestinians on stage with machine guns, others, including sold-out audiences during The Siege‘s recent British tour, see, in the words of the Guardian review, “an unexpectedly compelling theatrical experience with a rough and ready energy, and in the very act of its telling, speaks for the voiceless and forgotten”.

In the tinderbox that is Israel-Palestine, The Freedom Theatre defies its seemingly hopeless environment, and is making a tangible difference in Jenin camp and beyond. Another child of the Theatre, an actor in The Siege and in the forthcoming feature film The Idol, Ahmed Al Rokh, described the change.

“We can feel the difference in the camp. Our audience is growing because the kids who first came now have families, and bring them. Now they understand that the theatre works for us and with us.”

In contrast to the situation in the developed world, where art is often considered discretionary, Faisal Abu Alhayjaa described art and culture in Palestine as “essential like water and bread”. Inspiring as it is, The Freedom Theatre’s story is not unique. The Palestinian Performing Arts Network (PPAN) includes many ensembles and organizations striving for dignity and agency through art.

Abu Alhayjaa sees the education and empowerment that comes through working in the arts generally, and The Freedom Theatre specifically, as vital to Palestine’s future.

“If there will be a liberation for Palestine, it will come with a generation that knows what they want, and that knows to think critically.”

That generation is being trained at The Freedom Theatre.

This piece was originally published by The Huffington Post.

On May 17, Egyptian President Abdel-Fatah el-Sissi did something Egyptian presidents have done many times before: he urged Israel and the Palestinians to renew negotiations for peace, this time by backing an international conference promoted by the French foreign minister.

But what made Sissi’s call particularly interesting is that he called on not just the leaders but also political "parties" to seize what he called “a real opportunity to find a long-awaited solution.” Sissi's call offered Israeli Prime Minister Benjamin Netanyahu an opportunity to accommodate Israel's newest best friend, Sissi, rather than the French themselves. It would not have brought peace, of course: though an international conference would offer a glimmer of hope to change some of the worst aspects of the current diplomatic deadlock, it would not solve any of the outstanding substantive issues between Israelis and Palestinians.

Sissi's reference to political parties was no coincidence: it fit perfectly with the domestic political needs of Netanyahu and of Opposition Leader Isaac Herzog, who were angling to bring the Zionist Union joint list into the government and give Netanyahu a much-needed parliamentary cushion beyond his current razor-thin coalition. 

Herzog first had to convince his own highly-reluctant party of the need to join its rival Netanyahu—and if peace was about to break out, how could they refuse? For about 48 hours it seemed like Herzog was indeed about to announce his decision to join the coalition, face the battle in his party, and become Israel's foreign minister.

Then something else happened. Rather than appointing Herzog as foreign minister, Netanyahu is now poised to bring back Avigdor Lieberman, a former foreign minister and Israel's least diplomatic politician. Lieberman won't be returning to diplomacy, however. Instead, he will get a significantly more powerful position, second only to the prime minister: minister of defense. In response, current Minister of Defense Moshe Ya’alon today resigned from the cabinet and the Knesset, refusing to take another cabinet position. He gave a scathing speech, saying that "[E]xtremist and dangerous forces have taken over Israel and the Likud movement."

In what can only be considered brilliant politicking—and reckless policy—Netanyahu jettisoned Ya’alon and Herzog in favor of his former associate and bitter personal rival, Lieberman.

In what can only be considered brilliant politicking—and reckless policy—Netanyahu jettisoned Ya’alon and Herzog in favor of his former associate and bitter personal rival, Lieberman. Herzog is left wounded and humiliated, played for a fool—the gravest sin in Israeli political culture. Netanyahu finds himself at the helm of an enlarged coalition (Lieberman brings with him five members of Knesset, after one member of his faction left the party today in protest of the move), safer from parliamentary shocks and from attacks from the right (the whole right wing is now inside the coalition. Lieberman will still likely criticize Netanyahu from within the government, but not quite as fiercely). 

A cynics’ cynic

Lieberman's pending appointment has been met with astonishment by the opposition in Israel, by many in the military which he will oversee, and indeed here in Washington—and with good reason.

Just these past few months, Lieberman has viciously attacked both Netanyahu and the military brass for what he claimed was a weak response to terrorist attacks. In but one example of many, Lieberman came to the defense of a soldier who the Israel Defense Forces (IDF) had decided to prosecute for killing a Palestinian assailant who had already been thoroughly subdued. The contrast to current Minister of Defense Moshe Ya’alon is striking: Ya’alon defended the military's decision and stressed the importance of ethical norms and of rules of engagement in the military. Ya’alon is very right wing on the Palestinian issue, but he has consistently shown an honorable stance in the face of attacks on democratic norms. 

Lieberman is ostensibly less right-wing on the Palestinian issue—sometimes. Though he is a settler himself, he has endorsed a two-state solution in very general theory, noting he would even move if peace necessitated it. His endorsement, however, has always been couched in the toughest language possible and in utter mistrust of Palestinian intentions or the chances of peace ever materializing. On the niceties of democratic norms, including military law, he is a cynics' cynic. Benny Begin, another former Likud minister and an avowed hawk, has called Lieberman's appointment “delirious.”

As minister of defense, these positions will be highly consequential. Not only will he be in charge of the military brass and its promotion, but he will have statutory authority over many affairs in the West Bank, which is under military rule. Any attempt to improve the daily lives of Palestinians (such as a project just announced to streamline checkpoints for Palestinians) will be under his purview. His open calls to bring down Hamas through a ground invasion of Gaza if there is another round of fighting with Hamas—voiced even while he was a cabinet member during the last round of fighting—will now carry the weight of the minister of defense.

What was Herzog thinking? 

For the past year, since Netanyahu formed his fourth government, Herzog had denied time and again that he was aiming to join Netanyahu rather than replace him. He bemoaned the cynicism of those who simply would not believe him. This week the masks came off. Negotiations between the sides were accelerated and Herzog began a difficult intra-party fight to justify such a move. "National unity" governments are quite common in Israel, starting with the emergency cabinet of 1967, on the eve of the Six-Day War, when a sense of imminent doom swept the country. 

These governments, however, are usually justified by either an acute crisis, like in 1967, or in order to resolve a political deadlock, such as between Shimon Peres' Labor and Yitzhak Shamir's Likud in 1984. Peres and Shamir even "rotated" the post of prime minister. Though the government was incapable of any meaningful diplomatic advances, on which it was divided, it succeeded in tackling hugely important challenges in the economy—bringing inflation down from an annual rate of over 444 percent (not a typo) in 1984, and in defense—extricating Israel from most of Lebanon, following the first Israeli Lebanon War. 

What would be the logic this time? Herzog was promising three things to his party members: a host of portfolios (jobs and titles but also influence on a range of domestic policy issues); a veto on some aspects of policy which Labor finds most damaging, including remote settlement construction and legislation seen as limiting democratic discourse in Israel; and a leading role in any negotiations with the Palestinians, staring with the French peace conference. 

The jobs for Labor would have been real. A veto on policy could have been important—Tzipi Livni, Herzog's non-Labor partner in the Zionist Union, played a crucial role in protecting democratic norms as minister of justice in Netanyahu's previous government. 

On peace, however, Herzog was offering fool's gold. Put it this way: if you think Herzog would have real autonomy to run negotiations with the Palestinians while Netanyahu is prime minister, I have two suggestions. First, ask Tzipi Livni, who had that exact task in the previous government and was accompanied to every negotiation by Netanyahu’s personal lawyer, Yitzhak Molcho. Livni, incidentally, was strongly opposed to joining Netanyahu this time around. 

Second, I have some great real-estate in a swamp in Florida I'd like to discuss with you.

Herzog had a political rationale as well. He is a natural minister and backroom politician: smart, hardworking and prone to pragmatic compromises. He is not a natural public politician. As Leader of the Opposition he has wowed no one with his charisma or ability to stand up to Netanyahu and offer a bold alternative. Better to be in the halls of power than in the open arena. With the prospects of a fierce leadership challenge in his own Labor Party, moreover, he would have bolstered his bona fides as a national leader and therefore give himself a bit more time—the most a politician in Israel can really hope for. 

If there was a political benefit to Herzog personally, the outlook for his Labor Party would have been dismal.

If there was a political benefit to Herzog personally, the outlook for his Labor Party would have been dismal. Having joined Netanyahu, it would have been very hard to present the party as an alternative to his rule. 

What now?

Netanyahu can now feel slightly more secure in his coalition, though once again at the mercy of the mercurial Lieberman. Lieberman will enjoy a powerful post that usually bestows its occupant with new popularity in Israel (the converse is true of the finance ministry). Finance Minister Moshe Kahlon will enjoy a wider coalition to pass his domestic legislation and budget; indeed he'd been pushing for enlarging the coalition since it was formed. 

In the opposition, Herzog is weaker than ever. After being led on by Netanyahu for months, breaking his own word on the negotiations and then losing his gamble, he is severely exposed to challenges within Labor. His party's image has taken a serious hit as well.

Herzog's weakness will allow others in the opposition to claim the mantle of alternative to Netanyahu. Already, Yair Lapid’s centrist Yesh Atid party is the main beneficiary, but others may emerge as well, especially from the ranks of former generals like Gabi Ashkenazi. 

Most importantly, Israel's actual policy may be affected significantly by this move. Of all the governmental posts, defense is the one that has the most effect on the crucial questions of security for Israelis (and on the daily lives of Palestinians). Instead of grand peace plans Herzog was selling, Netanyahu's political brilliance has wrought one of the most hardline governments Israel has ever had.

In a lively and wide-ranging debate that aired earlier this month on Al Jazeera English, Brookings Executive Vice President Martin Indyk sparred with Head to Head presenter Mehdi Hasan about American efforts to resolve the Israeli-Palestinian conflict and the United States’ relationship with Israel.

Indyk began by stressing that American support for Israel is what gives the United States an influential role in the peace process and the leverage to encourage Israel to move towards peace. Indyk added that this does not mean that the United States should act as “Israel’s attorney” in the negotiations, and cited a promise he made to Palestinian leaders during the 2013-2014 peace talks led by Secretary of State John Kerry that Washington would not coordinate positions with Israel in advance. 

Brookings Executive Vice President Martin Indyk in a Head to Head interview with Al Jazeera English's Mehdi Hassan.

He pointed out that the United States has traditionally relied on its close relationship with Israel to encourage its leaders to take steps for peace and make offers to the Palestinians, and that no other potential mediator has been able to produce serious offers from Israel. “[The United States is] not neutral, we don't claim to be neutral. We have an alliance with Israel,” Indyk said. “But in order to achieve another interest that we have, which is peace in the region…and a settlement that provides for the legitimate national rights of the Palestinians, we need to be able to influence Israel.”

In responding to questions from Hasan and the audience, Indyk explained that he believes that both Israelis and Palestinians had made important concessions for peace, citing Israel’s acceptance of the Clinton Parameters in 2000, and the Palestinian Liberation Organization’s historic recognition of Israel as part of the Oslo Accords. Indyk also described the dramatic shifts in the way the United States has addressed the Palestinian issue over the past few decades, “from treating it only as a refugee issue and insisting that it be dealt with through Jordan to recognizing Palestinian national rights.” 

When asked about U.S. support for Israel at the United Nations, Indyk responded that this support is definitely warranted given the history of hostility towards Israel at the UN. However, he added that he personally wouldn’t oppose a carefully-worded resolution condemning Israeli settlements “so that the settlers in Israel understand that [settlement expansion] isn’t cost free.” Indyk rejected the notion that Israel has turned from a U.S. strategic asset in the Middle East into a burden, but explained that “making progress on the Palestinian issue enhances America’s credibility in the region and failing to make progress…hurts America’s credibility in the region.” 

Indyk concluded the discussion by reiterating his commitment to achieving Israeli-Palestinian peace and emphasizing that he would “never give up on trying to resolve this conflict in a way that meets Palestinian legitimate national aspirations to an independent and viable contiguous state living alongside Israel, a Jewish state, in peace.” 

Editors’ Note: One issue that has traditionally shared bipartisan support is how the United States should approach the Israeli-Palestinian conflict, write Sarah Yerkes and Ariella Platcha. However, this year both parties have shifted their positions farther from the center and from past Democratic and Republican platforms. How will that affect Obama’s strategy? This post originally appeared on the Israel Policy Forum’s blog, Matzav.

As the Republican and Democratic parties convene in Cleveland and Philadelphia, we expect to see numerous signs of the deepening polarization that has dominated this campaign season. One issue that has traditionally shared bipartisan support is how the United States should approach the Israeli-Palestinian conflict. However, this year both parties have shifted their positions farther from the center and from past Democratic and Republican platforms. This swing impacts whether the Obama administration, which has devoted significant time and resources to the negotiations, will issue a parting statement on the conflict.

In Cleveland last week the Republican party adopted a platform entirely dropping the two-state solution to the Israeli-Palestinian conflict, a move that puts the party further to the right than either AIPAC or Israeli Prime Minister Benjamin Netanyahu. The platform states, “We reject the false notion that Israel is an occupier and specifically recognize that the Boycott, Divestment, and Sanctions Movement (BDS) is anti-Semitic in nature and seeks to destroy Israel.” This language, combined with Republican nominee Donald Trump’s apparent disinterest in the conflict, makes it unlikely a Trump administration would prioritize Israeli-Palestinian issues or make any serious attempt at negotiations.

Conversely, this year’s Democratic Party platform reaffirmed the United States government’s long-standing commitment to seeking a two-state solution in the region. But the party took a notably progressive turn, highlighting both the importance of Israel’s Jewish and democratic future and Palestinian freedom “to govern themselves in their own viable state, in peace and dignity.” The contentious fight over the Democratic Party language, combined with Democratic nominee Hillary Clinton’s (and her potential First Gentleman’s) passion for this issue reveals an intent by a future Clinton administration to reinvigorate negotiations.

As President Obama and Secretary Kerry consider their final months in office, one item on the agenda is whether to push a last-ditch effort on the issue—either by releasing some sort of Obama or Kerry Parameters based on the outcome of the failed 2013-14 negotiations or by supporting one of the international initiatives such as the French Initiative, the Quartet Report, or the regional Arab Peace Initiative, now spearheaded by Egyptian President Abdel-Fattah el-Sissi.

Likely to drive the administration’s calculus are the Democratic and Republican nominees and their political motives on the U.S. led peace process. The time to watch for a potential move, therefore, is between November and January. Given the administration’s support for its own party’s nominee, it is in Obama’s interest to keep the peace process on life support—but without resuscitating it—through January. Publicly, but somewhat unenthusiastically, supporting the various international initiatives and allowing other states and international organizations to sit in the driver’s seat sets a future Democratic administration up with the best chance of success.

Lessons from getting Israeli and Palestinian leaders to the table over the years include the wisdom to refrain from yelling about past progress in negotiations. Publicly revealing how far Netanyahu and Abbas were willing to go in 2014 would only harm the next administration’s efforts at resuming negotiations. Keeping the “Kerry Framework” in the administration’s pocket allows a Clinton administration to take ownership of the peace process should she be elected.

Alternatively, if Trump is elected, the Obama administration would have nothing to lose in revealing the fruits of its efforts in 2013-14. The administration would have little concern for derailing a possible Trump attempt (which is not likely to take place in any event) and could determine that releasing some sort of Obama or Kerry Parameters would shed a positive light on the administration’s legacy. Furthermore, should the Republican Party win the White House, neither Obama nor Kerry is likely to care about the damage that releasing such a document might do to either Netanyahu or Abbas.

The party conventions have solidified the deep divides—both between and within the parties—regarding the U.S. approach to the Israeli-Palestinian conflict this campaign season. This divide, combined with a renewed international focus on the conflict, virtually guarantees that the administration will keep the conflict on the back burner before November. The election, therefore, will not only determine our next president but also the fate of the “Obama/Kerry Parameters”.

Note: Ariella Plachta, an intern with the Center for Middle East Policy, contributed to this post.

While antibiotics are necessary and crucial for treating bacterial infections, their misuse over time has contributed to a rather alarming rate of antibiotic resistance, including the development of multidrug-resistance bacteria or “super bugs.” Misuse manifests throughout all corners of public and private life; from the doctor’s office when prescribed to treat viruses; to industrial agriculture, where they are used in abundance to prevent disease in livestock. New data from the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) confirm that rising overuse of antibiotics has already become a major public health threat worldwide.

As drug resistance increases, we will see a number of dangerous and far-reaching consequences. First, common infections like STDs, pneumonia, and “staph” infections will become increasingly difficult to treat, and in extreme cases these infections may require hospitalization or treatment with expensive and toxic second-line therapies. In fact, recent estimates suggest that every year more than 23,000 people die due to drug-resistant infections in the U.S., and many more suffer from complications caused by resistant pathogens. Further, infections will be harder to control. Health care providers are increasingly encountering highly resistant infections not only in hospitals – where such infections can easily spread between vulnerable patients – but also in outpatient care settings.

Incentivize appropriate use of antibiotics. Many patients and providers underestimate the risks of using antibiotics when they are not warranted, in part because these drugs often have rapid beneficial effects for those who truly need them.  In many parts of the world the perception that antibiotics carry few risks has been bolstered by their low costs and availability without a prescription or contact with a trained health care provider. Education efforts, stewardship programs, and the development of new clinical guidelines have shown some success in limiting antibiotic use, but these fixes are limited in scope and generally not perceived as cost-effective or sustainable. Broader efforts to incentivize appropriate use, coupled with economic incentives, may be more effective in changing the culture of antibiotic use. These options might include physician or hospital report cards that help impact patient provider selection, or bonuses based on standardized performance measures that can be used to report on success of promoting appropriate use.  While these might create additional costs, they would likely help control rates of drug resistant infections and outweigh the costs of treating them.

Reinvigorate the drug development pipeline with novel antibiotics. There has not been a new class of antibiotics discovered in almost three decades, and companies have largely left the infectious disease space for more stable and lucrative product lines, such as cancer and chronic disease. Antibiotics have historically been inexpensive and are typically used only for short periods of time, creating limited opportunities for return on investment. In addition, unlike cancer or heart disease treatments, antibiotics lose effectiveness over time, making them unattractive for investment. Once they are on the market, the push to limit use of certain antibiotics to the most severe infections can further constrict an already weak market.

Late last year, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013, was introduced and referred to the House Energy and Commerce Subcommittee on Health. If enacted, the ADAPT Act would create a streamlined development pathway to expedite the approval of antibiotics that treat limited patient populations with serious unmet medical needs. This could potentially reduce costs and development time for companies, thereby encouraging investment in this space. Regulators have indicated that they would also welcome the opportunity to evaluate benefits and risk for a more selective patient subpopulation if they could be confident the product would be used appropriately. The bill has received a great deal of support and would help address a critical public health need (I cover this topic in more detail with my colleagues Kevin Outterson, John Powers, and Mark McClellan in a recent Health Affairs paper).

Advance new economic incentives to remedy market failure. Innovative changes to pharmaceutical regulation, research and development (R&D), and reimbursement are necessary to alleviate the market failure for antibacterial drugs. A major challenge, particularly within a fee-for-service or volume-based reimbursement system, is providing economic incentives that promote investment in drug development without encouraging overuse.  A number of public and private stakeholders, including the Engelberg Center for Health Care Reform and Chatham House’s Centre on Global Health Security Working Group on Antimicrobial Resistance, are exploring alternative reimbursement mechanisms that  “de-link” revenue from the volume of antibiotics sold. Such a mechanism, combined with further measures to stimulate innovation, could create a stable incentive structure to support R&D.

Improve tracking and monitoring of resistance in the outpatient setting. There is increasing concern about much less rigorous surveillance capabilities in the outpatient setting, where drug-resistant infections are also on the rise. Policymakers should consider new incentives for providers and insurers to encourage a coordinated approach for tracking inpatient and outpatient resistance data. The ADAPT Act, mentioned above, also seeks to enhance monitoring of antibiotic utilization and resistance patterns. Health insurance companies can leverage resistance-related data linked to health care claims, while providers can capture lab results in electronic health records. Ultimately, this data could be linked to health and economic outcomes at the state, federal, and international levels, and provide a more comprehensive population-based understanding of the impact and spread of resistance. Current examples include the Food and Drug Administration’s (FDA) Sentinel Initiative and the Patient-Centered Outcomes Research Institute’s PCORnet initiative. 

Antibiotic resistance is an urgent and persistent threat. As such, patients and providers will continue to require new antibiotics as older drugs are forced into retirement by resistant pathogens. Stewardship efforts will remain critical in the absence of game-changing therapies that parry resistance mechanisms. Lastly, a coordinated surveillance approach that involves diverse stakeholder groups is needed to understand the health and economic consequences of drug resistance, and to inform antibiotic development and stewardship efforts.

Editor's note: This blog was originally posted in May 2014 on Brookings UpFront.

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As policy agendas for 2015 come into sharper focus, much of the national conversation is aimed at tackling challenges in biomedical innovation. The first two months of the year alone have seen landmark proposals from Congress and the Obama Administration, including the House’s 21^st Century Cures initiative, a bipartisan Senate working group focused on medical progress, President Obama’s Precision Medicine Initiative and a number of additional priorities being advanced by federal agencies and other stakeholders.

On March 13, the Engelberg Center for Health Care Reform hosted the State of Biomedical Innovation Conference to provide an overview of emerging policy efforts and priorities related to improving the biomedical innovation process. Senior leaders from government, academia, industry, and patient advocacy shared their thoughts on the challenges facing medical product development and promising approaches to overcome them. The discussion also examined the data and analyses that provide the basis for new policies and track their ultimate success.

 Join the conversation by following @BrookingsMed or #biomed

Video

• State of biomedical innovation conference: Panel 1
• State of biomedical innovation conference: Panel 2

Audio

• State of biomedical innovation conference

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20150313_biomed_transcript
• 313 MASTER DECK2

Breakthrough therapy designation (BTD) is the newest of four expedited programs developed by the U.S Food and Drug Administration (FDA) to accelerate the development and review of novel therapies that target serious conditions. The public response to the program has been largely positive, and dozens of drugs have successfully received the designation. However, the FDA denies many more requests than it grants. In fact, as of March 2015, less than one in three of the BTD requests submitted have been granted. By contrast, roughly 75 percent of the requests for fast track designation (another of the Agency’s expedited programs) were granted between 1998 and 2007. This discrepancy suggests ongoing uncertainty over what exactly constitutes a “breakthrough” according to the FDA’s criteria.

On April 24, the Center for Health Policy at Brookings will host an event, Breakthrough Therapy Designation: Exploring the Qualifying Criteria, that will discuss qualifying criteria for the BTD program using real and hypothetical case studies to explore how FDA weighs the evidence submitted. Below is a primer that describes the definition, value, and impact of BTD.

What is BTD?

BTD was established in 2012 under the Food and Drug Administration Safety and Innovation Act, and is intended to expedite the development and review of drugs that show signs of extraordinary benefit at early stages of the clinical development process. However, BTD is not an automatic approval. The drug still has to undergo clinical testing and review by the FDA. Rather, BTD is designed to facilitate and shorten the clinical development process, which can otherwise take many years to complete.

What criteria does FDA use to evaluate potential breakthroughs?

In order to qualify for the designation, a therapy must be intended to treat a serious or life-threatening illness, and there must be preliminary clinical evidence that it represents a substantial improvement over existing therapies on at least one clinically significant outcome (such as death or permanent impairment).

In considering a request for BTD, FDA relies on three primary considerations:

1) the quantity and quality of the clinical evidence being submitted;

2) the available therapies that the drug is being compared to; and

3) the magnitude of treatment effect shown on the outcome being studied.

In practice, however, it can be difficult to define a single threshold that a therapy must meet. The decision depends on the specific context for that drug.  In some cases, for example, the targeted disease has few or no treatments available, while in others there may be several effective alternative treatments to which the new therapy can be compared. The request may also be made at different stages of the clinical development process, which means that the amount and type of data available to FDA can vary. In some cases, early evidence of benefit may disappear when the drug is tested in larger populations, which is why FDA reserves the right to rescinded the designation if subsequent data shows that the therapy no longer meets the criteria.

How many therapies have received the designation?

As of March 2015, FDA had received a total of 293 requests for BTD. Of these, 82 received the designation, and 23 have since been approved for marketing. Ten of these approvals were new indications for already approved drugs, rather than novel therapies that had never before received FDA approval.

What are the benefits of BTD?

For drug manufacturers, it is about the intensity and frequency of their interactions with FDA. Once the designation is granted, the FDA takes an “all hands-on-deck” approach to providing the manufacturer with ongoing guidance and feedback throughout the clinical development process. Products that receive BTD are also able to submit portions of their marketing application on a rolling basis (rather than all at once at the end of clinical trials) and BTD can also be used in combination with other expedited programs in order to further reduce the product’s time to market.

For patients, the potential benefits are straightforward: earlier access to therapies that may significantly improve or extend their lives.

How does BTD relate to the other three expedited programs?

The other three expedited review and development programs—fast track designation, priority review, and accelerated approval—are also geared at facilitating the development and approval of drugs for serious conditions. These other programs have been in place for over 15 years, and have played a significant role in accelerating patient access to new therapeutics (Table 1). In 2014 alone, 66 percent of the 41 drugs approved by FDA's Center for Drug Evaluation and Research used at least one of these four pathways, and 46 percent received at least two of the designations in combination.

Table 1: Overview of FDA’s Expedited Review Programs

 Adapted from FDA's Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics

Event Information

Established by the Food and Drug Administration Safety and Innovation Act of 2012, breakthrough therapy designation (BTD) is one of several programs developed by the U.S. Food and Drug Administration (FDA) to speed up the development and review of drugs and biologics that address unmet medical needs. In order to qualify for this designation, the treatment must address a serious or life-threatening illness. In addition, the manufacturer (i.e., sponsor) must provide early clinical evidence that the treatment is a substantial improvement over currently available therapies. The FDA is working to further clarify how it applies the qualifying criteria to breakthrough designation applications.

On April 24, under a cooperative agreement with FDA, the Center for Health Policy convened a public meeting to discuss the qualifying criteria for this special designation. Using examples from oncology, neurology, psychiatry, and hematology, the workshop highlighted considerations for the BTD application process, the evaluation process, and factors for acceptance or rejection. The discussion also focused on key strategies for ensuring that the qualifying criteria are understood across a broad range of stakeholder groups.

Video

• Breakthrough therapy designation: Two and a half years in
• Applying the breakthrough therapy criteria: Oncology
• Applying the breakthrough therapy criteria: Neurology
• Applying the breakthrough therapy criteria: Anti-infective/psychiatry/hematology
• Summary and discussion of lessons learned

Event Materials

• Breakthrough Therapy Designation_final
• Breakthrough therapy slide deck

Many proposals to accelerate and improve medical product innovation and regulation focus on reforming the product development and regulatory review processes that occur before drugs and devices get to market. While important, such proposals alone do not fully recognize the broader opportunities that exist to learn more about the safety and effectiveness of drugs and devices after approval. As drugs and devices begin to be used in larger and more diverse populations and in more personalized clinical combinations, evidence from real-world use during routine patient care is increasingly important for accelerating innovation and improving regulation.

First, further evidence development from medical product use in large populations can allow providers to better target and treat individuals, precisely matching the right drug or device to the right patients. As genomic sequencing and other diagnostic technologies continue to improve, postmarket evidence development is critical to assessing the full range of genomic subtypes, comorbidities, patient characteristics and preferences, and other factors that may significantly affect the safety and effectiveness of drugs and devices. This information is often not available or population sizes are inadequate to characterize such subgroup differences in premarket randomized controlled trials.

Second, improved processes for generating postmarket data on medical products are necessary for fully realizing the intended effect of premarket reforms that expedite regulatory approval. The absence of a reliable postmarket system to follow up on potential safety or effectiveness issues means that potential signals or concerns must instead be addressed through additional premarket studies or through one-off postmarket evaluations that are more costly, slower, and likely to be less definitive than would be possible through a better-established infrastructure. As a result, the absence of better systems for generating postmarket evidence creates a barrier to more extensive use of premarket reforms to promote innovation.

These issues can be addressed through initiatives that combine targeted premarket reforms with postmarket steps to enhance innovation and improve evidence on safety and effectiveness throughout the life cycle of a drug or device. The ability to routinely capture clinically relevant electronic health data within our health care ecosystem is improving, increasingly allowing electronic health records, payer claims data, patient-reported data, and other relevant data to be leveraged for further research and innovation in care. Recent legislative proposals released by the House of Representatives’ 21st Century Cures effort acknowledge and seek to build on this progress in order to improve medical product research, development, and use. The initial Cures discussion draft included provisions for better, more systematic reporting of and access to clinical trials data; for increased access to Medicare claims data for research; and for FDA to promulgate guidance on the sources, analysis, and potential use of so-called Real World Evidence. These are potentially useful proposals that could contribute valuable data and methods to advancing the development of better treatments.

What remains a gap in the Cures proposals, however, is a more systematic approach to improving the availability of postmarket evidence. Such a systematic approach is possible now. Biomedical researchers and health care plans and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the potential for large-scale, systematic postmarket data collection. Building on these efforts could provide unprecedented evidence on how medical products perform in the real-world and on the course of underlying diseases that they are designed to treat, while still protecting patient privacy and confidentiality.

These and other postmarket data systems now hold the potential to contribute to public-private collaboration for improved population-based evidence on medical products on a wider scale. Action in the Cures initiative to unlock this potential will enable the legislation to achieve its intended effect of promoting quicker, more efficient development of effective, personalized treatments and cures.

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• Download paper

Legislative proposals to accelerate and improve the development of innovative drugs and medical devices generally focus on reforming the clinical development and regulatory review processes that occur before a product gets to market. Many of these proposals – such as boosting federal funding for basic science, streamlining the clinical trials process, improving incentives for development in areas of unmet medical need, or creating expedited FDA review pathways for promising treatments – are worthy pursuits and justifiably part of ongoing efforts to strengthen biomedical innovation in the United States, such as the 21^st Century Cures initiative in the House and a parallel effort taking shape in the Senate.

What has largely been missing from these recent policy discussions, however, is an equal and concerted focus on the role that postmarket evidence can play in creating a more robust and efficient innovation process. Data on medical product safety, efficacy, and associated patient outcomes accrued through routine medical practice and through practical research involving a broad range of medical practices could not only bolster our understanding of how well novel treatments are achieving their intended effects, but reinforce many of the premarket reforms currently under consideration. Below and in a new paper, we highlight the importance of postmarket evidence development and present a number of immediately achievable proposals that could help lay the foundation for future cures.

Why is postmarket evidence development important?

There are a number of reasons why evidence developed after a medical product’s approval should be considered an integral part of legislative efforts to improve biomedical innovation. First and foremost, learning from clinical experiences with medical products in large patient populations can allow providers to better target and treat individuals, matching the right drug or device to the right patient based on real-world evidence. Such knowledge can in turn support changes in care that lead to better outcomes and thus higher value realized by any given medical product.

Similarly, data developed on outcomes, disease progression, and associated genetic and other characteristics that suggest differences in disease course or response to treatment can form the foundation of future breakthrough medical products. As we continue to move toward an era of increasingly-targeted treatments, this important of this type of real-world data cannot be discounted.

Finally, organized efforts to improve postmarket evidence development can further establish infrastructure and robust data sources for ensuring the safety and effectiveness of FDA-approved products, protecting patient lives. This is especially important as Congress, the Administration, and others continue to seek novel policies for further expediting the pre-market regulatory review process for high-priority treatments. Without a reliable postmarket evidence development infrastructure in place, attempts to further shorten the time it takes to move a product from clinical development to FDA approval may run up against the barrier of limited capabilities to gather the postmarket data needed to refine a product’s safety and effectiveness profile. While this is particularly important for medical devices – the “life cycle” of a medical device often involves many important revisions in the device itself and in how and by whom it is used after approval – it is also important for breakthrough drugs, which may increasingly be approved based on biomarkers that predict clinical response and in particular subpopulations of patients.

What can be done now?

The last decade has seen progress in the availability of postmarket data and the production of postmarket evidence. Biomedical researchers, product developers, health care plans, and providers are doing more to collect and analyze clinical and outcomes data. Multiple independent efforts – including the U.S. Food and Drug Administration’s Sentinel Initiative for active postmarket drug safety surveillance, the Patient-Centered Outcomes Research Institute’s PCORnet for clinical effectiveness studies, the Medical Device Epidemiology Network (MDEpiNet) for developing better methods and medical device registries for medical device surveillance and a number of dedicated, product-specific outcomes registries – have demonstrated the powerful effects that rigorous, systematic postmarket data collection can have on our understanding of how medical products perform in the real-world and of the course of underlying diseases that they are designed to treat.

These and other postmarket data systems now hold the potential to contribute to data analysis and improved population-based evidence development on a wider scale. Federal support for strengthening the processes and tools through which data on important health outcomes can be leveraged to improve evidence on the safety, effectiveness, and value of care; for creating transparent and timely access to such data; and for building on current evidence development activities will help to make the use of postmarket data more robust, routine, and reliable.

Toward that end, we put forward a number of targeted proposals that current legislative efforts should consider as the 2015 policy agenda continues to take shape:

Evaluate the potential use of postmarket evidence in regulatory decision-making. The initial Cures discussion draft mandated FDA to establish a process by which pharmaceutical manufacturers could submit real-world evidence to support Agency regulatory decisions. While this is an important part of further establishing methods and mechanisms for harnessing data developed in the postmarket space, the proposed timelines (roughly 12 months to first Guidance for Industry) and wide scope of the program do not allow for a thoughtfully-, collaboratively-considered approach to utilizing real-world evidence. Future proposals should allow FDA to take a longer, multi-stakeholder approach to identify the current sources of real-world data, gaps in such collection activities, standards and methodologies for collection, and priority areas where more work is needed to understand how real-world data could be used.

Expand the Sentinel System’s data collection activities to include data on effectiveness. Established by Congress in 2007, Sentinel is a robust surveillance system geared toward monitoring the safety of drugs and biologics. In parallel to the program for evaluating the use of RWE outlined above, FDA could work with stakeholders to identify and pursue targeted extensions of the Sentinel system that begin to pilot collection of such data. Demonstration projects could enable faster and more effective RWE development to characterize treatment utilization patterns, further refine a product’s efficacy profile, or address pressing public health concerns – all by testing strategic linkages to data elements outside of Sentinel’s safety focus.

Establish an active postmarket safety surveillance system for medical devices. Congress has already acted once to establish device surveillance, mandating in 2012 that Sentinel be expanded to include safety data on medical devices. To date, however, there has been no additional support for such surveillance or even the capability of individually tracking medical devices in-use. With the recently finalized Unique Device Identifier rule going effect and the ability to perform such tracking on the horizon, the time is now to adopt recent proposals from FDA’s National Medical Device Postmarket Surveillance System Planning Board. With Congressional authorization for FDA to establish an implementation plan and adequate appropriations, the true foundation for such a system could finally be put into place.

The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness that demonstrate “substantial improvement” over existing therapies. The program has since become a widely supported mechanism for accelerating patient access to new drugs. As of March 2015, FDA has received a total of 293 requests for BTD. However, it has granted just  82 (28%), which indicates an ongoing lack of clarity over what exactly meets the criteria for the designation.

On April 24, the Center for Health Policy at Brookings convened a public meeting to explore the designation’s qualifying criteria and how FDA applies those criteria across therapeutic areas. Panelists used real-world and hypothetical case studies to frame the discussion, and highlighted major considerations for the application process, the FDA’s evaluation of the evidence, and the key factors for acceptance or rejection. The discussion also identified strategies to ensure that qualifying criteria are well understood. Here are the five big takeaways:

1.  The BTD program is viewed positively by drug companies, researchers, advocates, and others 

Across the board, participants expressed enthusiasm for the BTD program. Industry representatives noted that their experience had been extremely positive, and that the increased cooperation with and guidance from FDA were very helpful in streamlining their development programs. Receiving the designation can also raise a drug company’s profile, which can facilitate additional investment as well as clinical trial patient recruitment; this is particularly important for smaller companies with limited resources.

Patient and disease advocates were likewise supportive, and expressed hope that the early lessons learned from successful breakthrough therapy approvals (which have been mostly concentrated in the oncology and antiviral fields) could be translated to other disease areas with less success. However, while BTD is an important tool in expediting the development of new drugs, it is just one piece of broader scientific and regulatory policy landscape. Accelerating the pace of discovery and development of truly innovative new drugs will depend on a range of other factors, such as developing and validating new biomarkers that can be used to measure treatment effects at an earlier stage, as well as establishing networks that can streamline the clinical trial process. It will also be important to develop effective new approaches to collecting, analyzing, and communicating information about these treatments once they are on the market, as this information can potentially be used by FDA, providers, and patients to  further improve prescription drug policy and medical decision-making.

2.  BTD requests far outnumber those that actually meet the qualifying criteria

Since the program began, less than 30 percent of requests have received BTD designation. A substantial majority were denied at least in part due to either a lack of data or problems with the quality of the data, or some combination of the two. For example, some sponsors requested the designation before they had any clinical data, or submitted the request using clinical data that was incomplete or based on flawed study designs. Many requests also failed to meet the Agency’s bar for “substantial improvement” over existing therapies.

One reason for the high denial rate may be a lack of a clear regulatory or statutory bar that could be used as a definitive guide for sponsors to know what is needed to qualify for the designation. BTD denials are also confidential, which means that sponsors effectively have nothing to lose by submitting a request. Going forward, manufacturers may need to exercise more discretion in deciding to request the designation, as the process can be resource- and time-intensive for both sides.

3.  There is no single threshold for determining what defines a breakthrough therapy

About 53 percent of the 109 total BTD denials were due at least in part to the fact that the drug did not represent a substantial improvement over existing therapies. During the day’s discussion, FDA and sponsors both noted that this is likely because the criteria for BTD are inherently subjective. In practice, this means there is no clear threshold for determining when a new therapy represents a “substantial improvement” over existing therapies. Designation decisions are complex and highly dependent on the context, including the disease or condition being targeted, the availability of other treatments, the patient population, the outcomes being studied, and the overall reliability of the data submitted. Given the multiple factors at play, it can be difficult in some cases to determine when a new product is potentially “transformational” as opposed to “better,” especially for conditions that are poorly understood or have few or no existing treatments. In making its determinations, FDA considers the totality of the evidence submitted, rather than focusing on specific evidentiary requirements.

4.  Early communication with FDA is strongly recommended for BTD applicants

Roughly 72 percent of the BTD denials related at least in part to trial design or analysis problems, which led several people to suggest that sponsors engage with FDA prior to submitting their request. Though there are several formal mechanisms for interacting with the agency, informal consultations with the relevant review division could help sponsors to get a better  and much earlier sense of what kind of data FDA might need. This early communication could both strengthen viable BTD requests and reduce the number of frivolous requests.

5.  FDA may need more resources for implementing the BTD program

Event Information

The Sentinel System is a state of the art active surveillance system relying on a distributed data network to rapidly scale analysis of health care data collected from over 178 million patients nationwide. Sentinel is an important safety surveillance tool used by the U.S. Food and Drug Administration (FDA), and its underlying distributed data infrastructure is increasingly being recognized to have the potential to support the needs of diverse stakeholders including other public health agencies, health systems, regulated industry, and the clinical research enterprise. Despite Sentinel’s importance in safety surveillance, patients are largely unaware of Sentinel’s public health mission and commitment to protecting patient privacy. Therefore, it is both timely and critical to identify opportunities to raise awareness and build trust for Sentinel safety surveillance among patients, consumers, and the general public.

On June 23, the Center for Health Policy at Brookings, in collaboration with the FDA, hosted an expert workshop to discuss opportunities to raise awareness of the Sentinel System through improved communication to patients and consumers. Participants, including Sentinel Data Partners, patient focused organizations (e.g., consumer advocacy groups), experts in patient privacy, ethics, and health literacy, and representatives from the FDA explored possible opportunities where each stakeholder might be uniquely positioned to engage with patients, and how these communications could be designed and delivered effectively. Discussions from this workshop resulted in recommendations including a set of guiding principles, potential tools, and strategies to improve awareness of the Sentinel System, but more broadly, safety surveillance activities led by the FDA.

Event Materials

• Sentinel Engagement_Discussion Guide
• Engagement_Agenda
• Engagement_Participant List
• Engagement_Speaker BioSketches
• Engagement_Meeting Summary

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

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

Event Materials

• REMS_PBRC_Meeting_Agenda
• REMS BR Speaker Bios
• REMS BenefitRisk Meeting Summary
• REMS BenefitRisk communication white paper

If current economic growth trends persist, the “great divergence” between Western Europe and East and South Asia in per capita income that commenced 200 years ago will close sometime this century. Key to the closing will be greater accessibility to technology, higher education in East and South Asia, and the relentless diffusion of knowledge including in the biosciences. Advances in the biosciences are poised to contribute in a major way to English economist Thomas Malthus’s four necessities of human life–food, fiber, fuel, and building materials–as well as to human and animal health, biodiversity conservation, and environmental remediation and sustainability.

As my coauthor Leo Furcht and I recently wrote in “Divergence, Convergence, and Innovation: East-West Bioscience in an Anxious Age”, 21st century history will describe the great economic and technological convergence between East and West. It will also further entwine the economic and ecological storylines of the human experience as the vast populations of China and India strive to enter the middle class. Environmentally sustainable economic growth will require putting knowledge of life code, cellular processes, biosynthesis, and biological regeneration to practical use. That prospect is at hand because the biosciences are in the midst of their own convergence–with information technology, nanotechnology, microelectronics, materials, artificial intelligence, robotics, architecture, and design.

From William Hoffman and Leo Furcht, "The Biologist’s Imagination: Innovation in the Biosciences" (Oxford University Press, 2014)

Biomolecules, brainpower, and Malthusian limits

Products arising from molecular biology constitute a growing share of the global economy with each passing year as technologies evolve, production processes improve, and markets expand. In recent years industrial biotechnology has grown faster than the biologic drugs and agricultural biotech sectors in the U.S.

U.S. biotech revenue in billions of U.S. dollars.
Source: Robert Carlson, "Nature Biotechnology", In press

Industrial biotechnology employs greener and cleaner technologies to make chemicals, solvents, fuels, and materials such as biocomposites and bioplastics. Growth in this sector can weaken the link between economic growth, environmental pollution, and greenhouse gas emissions. Genomics, synthetic biology and metabolic engineering are poised to accelerate growth in the design and manufacture of industrial enzymes and renewable bio-based products. East and South Asian production and consumption of industrial enzymes are on the rise as the Asian middle class expands.

Bioscience is enabling major cereal crops such as wheat, rice, and corn to adapt to a changing climate. Cereal crop yields need to grow by an estimated 70 percent by mid-century to feed the projected nine billion people expected to then inhabit our planet. The challenge of feeding nine billion people without further deforestation and environmental degradation has resurrected the specter of Malthusian limits to our planet’s ecological carrying capacity. These limits are expressed in food and water shortages, forced migrations, political instability, armed conflict, abatement and cleanup activities, and health care related to pollution and climate change. Even with the powerful tools of food crop bioscience–marker-assisted selection, targeted mutation-selection, genetic modification, and others–maintaining crop production levels at expected higher temperatures and with less water is highly questionable.

Precise genomic editing of cereal grains could equip rice, wheat, and corn with nitrogen fixation capabilities, thus reducing the need for synthetic fertilizers with their environmental and atmospheric costs. East and South Asia, facing major food production challenges, ecological limits, pollution from fertilizer use, and drought from climate change, may take the lead over the West in adopting innovative food crop technologies.

Meanwhile, hundreds of thousands of human beings of many ethnicities have had their genomes decoded over the past decade, with the number expected to increase exponentially as sequencing technologies grow in productivity and decline in price. Genomic information coupled with precise genomic editing and bioregenerative tools give us unprecedented power to shape the course of evolution, including our own.

Cost trend of sequencing a human-sized genome and Moore’s Law 2001 – 2015.
Source: Kris A. Wetterstrand, DNA Sequencing Costs: Data from the NHGRI Genome Sequencing Program.

The practice of technological innovation in the industrial era – the systematic application of ideas, inventions and technology to markets, trade, and social systems–is now being joined with the code of life, DNA, and the basic unit of life, the cell. Even as the economic gap between East and West narrows, no other convergence has such profound implications for our future and the future health of living systems and ecosystems. That makes the task for policymakers a daunting one.

Event Information

The biomedical innovation ecosystem continues to evolve and enhance the processes by which treatments are developed and delivered to patients. Given this changing biomedical innovation landscape, it is imperative that all stakeholders work to ensure that development programs, regulatory practices, and the policies that enable them are aligned on and achieving a common set of goals. This will require a thorough reexamination of our understanding of biomedical innovation – and the subsequent ways in which we seek to incentivize it – in order to more effectively bridge research and analysis of the process itself with the science and policy underpinning it.

Traditional research into the efficiency and effectiveness of drug development programs has tended to focus on the ‘inputs’ and process trends in product development, quantifying the innovation as discrete units. At the opposite end of the research spectrum are potential measures that could be categorized as “value” or “outcomes” metrics. Identifying the appropriate measures across this spectrum – from inputs and technological progress through outcomes and value – and how such metrics can be in conversation with each other to improve the innovation process will be the focus of this expert workshop. On October 14, the Center for Health Policy at Brookings, under a cooperative agreement with the U.S. Food and Drug Administration, convened a roundtable discussion that engaged key stakeholders from throughout the innovation ecosystem to explore the factors and characteristics that could improve our understanding of what constitutes modern “innovation” and how best to track its progress.

Event Materials

• FINAL 1014 BrookingsFDA Agenda
• FINAL 1014 BrookingsFDA Participant List

Event Information

The emerging field of precision medicine continues to offer hope for improving patient outcomes and accelerating the development of innovative and effective therapies that are tailored to the unique characteristics of each patient. To date, however, progress in the development of precision medicines has been limited due to a lack of reliable biomarkers for many diseases. Biomarkers include any defined characteristic—ranging from blood pressure to gene mutations—that can be used to measure normal biological processes, disease processes, or responses to an exposure or intervention. They can be extremely powerful tools for guiding decision-making in both drug development and clinical practice, but developing enough scientific evidence to support their use requires substantial time and resources, and there are many scientific, regulatory, and logistical challenges that impede progress in this area.

On October 27th, 2015, the Center for Health Policy at The Brookings Institution convened an expert workshop that included leaders from government, industry, academia, and patient advocacy groups to identify and discuss strategies for addressing these challenges. Discussion focused on several key areas: the development of a universal language for biomarker development, strategies for increasing clarity on the various pathways for biomarker development and regulatory acceptance, and approaches to improving collaboration and alignment among the various groups involved in biomarker development, including strategies for increasing data standardization and sharing. The workshop generated numerous policy recommendations for a more cohesive national plan of action to advance precision medicine.  

Event Materials

• 1027 Brookings biomarkers workshop agenda
• 1027 Biomarkers workshop backgrounderfinal
• 1027 Biomarkers workshop slide deckfinal
• 1027 Biomarkers workshop participant listfinal

Summary

Global education plays an important role in contributing to U.S. foreign policy objectives. In a recent speech, Secretary of State Hillary Clinton highlighted education, along with health, agriculture, security, and local governance as the core areas for U.S. international development investment. She emphasized the importance of education, particularly of girls and youth, in improving global stability, speeding economic growth, and helping global health, all of which advance U.S. interests in the world.

But how effective has the U.S. government been in supporting global education? Unfortunately, its many good education activities and programs are not leveraged for maximum impact on the ground, especially in situations of armed conflict and state fragility. Challenges of U.S. foreign assistance—for example, fragmentation across multiple agencies, lack of policy coherence, diminished multilateral engagement—generally affects its work in education. Luckily some of the core strengths of U.S. assistance have an impact as well, specifically the large amount of resources (in total terms, if not relative terms) devoted to education and the vast breadth and depth of American academic, philanthropic and NGO partners engaged in pioneering work on education in the developing world.

This report analyzes the effectiveness of U.S. government education work specifically in relation to conflict-affected and fragile states. Findings across five domains—global reach, resources, technical expertise, policy and multilateral partnerships—show that U.S. education aid falls critically short of what it is capable of achieving. The U.S. government has substantial strengths in this area, especially in global reach, resources, and technical expertise, demonstrating a real comparative advantage in the field of education in situations of conflict and fragility. However, its fragmented policy across agencies and its limited multilateral engagement prevent it from maximizing its strengths, leaving it punching below its weight on this important issue. In this sense, the U.S. government is a classic underachiever, failing to efficiently deploy its many capabilities and potential for maximum impact.

There has never been a better time for looking at the aid-effectiveness of U.S. government education work. The Obama administration is bringing increased focus on the Paris Principles for Aid Effectiveness to its development initiatives. The U.S. Congress is actively engaged with pending legislative action to modernize foreign assistance and improve U.S. support for universal education. Two major reviews of foreign assistance are underway: the Quadrennial Diplomacy and Development Review led by the Department of State and USAID, and the Presidential Study Directive on U.S. Global Development Policy led by the White House.

Questions about foreign assistance reform asked in these two reviews can be applied to the education sector. For example, how can the U.S. government improve its education assistance by using a “whole-of-government” approach, by focusing on comparative advantages and strengths, and by improving coordination and by increasing multilateral engagement?

Careful analysis and answers to these questions can help propel the U.S. from its current position as an underachiever to being a leader in global education, specifically in contexts of conflict and state fragility.

This report makes nine specific recommendations, many of which could be achieved without any substantial increase in funding, that would enable the U.S. government to greatly increase the effectiveness of its education aid to populations living in contexts of conflict and state fragility.

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Overview

Increasing educational attainment is likely to reduce conflict risk, especially in countries like Pakistan that have very low levels of primary and secondary school enrollment. Education quality, relevance and content also have a role to play in mitigating violence. Education reform must therefore be a higher priority for all stakeholders interested in a more peaceful and stable Pakistan. Debate within the country about education reform should not be left only to education policymakers and experts, but ought to figure front and center in national dialogues about how to foster security. The price of ignoring Pakistan’s education challenges is simply too great in a country where half the population is under the age of 17.

There has been much debate concerning the roots of militancy in Pakistan, and multiple factors clearly come into play. One risk factor that has attracted much attention both inside Pakistan and abroad is the dismal state of the national education sector. Despite recent progress, current school attainment and literacy levels remain strikingly low, as does education spending. The Pakistani education sector, like much of the country’s public infrastructure, has been in decline over recent decades. The question of how limited access to quality education may contribute to militancy in Pakistan is more salient now than ever, given the rising national and international security implications of continued violence.

The second half of 2009 witnessed not only the Pakistani government stepping up action against insurgents but also the release of a new Pakistan National Education Policy that aspires to far-reaching and important reforms, including a commitment to increase investment in education—from 2 to 7 percent of gross domestic product. Hundreds of millions of dollars in international education aid have been newly pledged by donor countries. This renewed emphasis on education represents a substantial opportunity to seek to improve security in Pakistan and potentially also globally over the medium to long term. Policymakers both inside and outside Pakistan should give careful consideration to whether and how education investments can promote peace and stability, taking into account what we now know about the state of the education sector and the roots of militancy.

This report takes a fresh look at the connection between schools, including but not limited to Pakistan’s religious seminaries, known as “madrasas,” and the rising militancy across the country. Poor school performance across Pakistan would seem an obvious area of inquiry as a risk factor for conflict. Yet to date, the focus has been almost exclusively on madrasas and their role in the mounting violence. Outside Pakistan, relatively little attention has been given to whether and how the education sector as a whole may be fueling violence, over and above the role of the minority of militant madrasas.

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EXECUTIVE SUMMARY

In the face of unprecedented global challenges, effective global cooperation increasingly requires a partnership between state and non-state actors. Many international institutions now involve non-state actors in arenas that were once the exclusive province of states. The paper analyzes the evolution of civil society participation in the governance of international institutions and highlights the shift from a model based on consultation toward a model of multistakeholder governance. The paper argues that consultation is a less effective approach to involving civil society in achieving the mission of these institutions and suggests that more robust forms of multi-stakeholder participation by civil society can foster greater accountability and better deliberation. It analyzes competing claims about the desirability of including civil society in the governance of international institutions and suggests that an emerging constituency model can promote more effective multi-stakeholder governance. Constituency structures are already central features of several global health institutions and are now being contemplated by institutions in other sectors, including by the Education for All—Fast Track Initiative.

Multi-stakeholder approaches to governance are likely to become more widespread in the years to come in order to harness the contributions of a plethora of private actors engaged in responding to a wide range of global challenges. Even with enhanced cooperation between states, it is increasingly clear that non-state actors are essential to responding to key challenges across a wide range of sectors. Although it is possible to imagine expanded cooperation between state and non-state actors without opening up the governance structures of international institutions, it is less likely that these institutions will be successful in the longrun without a shift toward greater multi-stakeholder involvement in the institutions themselves.

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