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.

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.” 

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.

Event Information

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

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

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• State of biomedical innovation conference

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• Uncorrected Transcript (.pdf)

Event Materials

• 20150313_biomed_transcript
• 313 MASTER DECK2

Editor's note: This article appears in the April 2015 issue of Global Forum. Click here to view the full publication.

Since passage of the Affordable Care Act in 2010, the last several years have seen a groundswell in physician payment and delivery reforms designed to achieve higher value health care through incentivizing higher quality care and lower overall costs. Accountable care models, for example, are achieving marked progress by realigning provider incentives toward greater risk-sharing and increased payments and shared savings with measured improvements in quality and cost containment. Medical homes are introducing greater care coordination and team-based care management, while the use of episode-based or bundled payments is removing perverse incentives that reward volume and intensity.

These reforms are coming just as the number of highly targeted, highly priced treatments continues to expand. The U.S. Food and Drug Administration (FDA) approved a decade-high 41 novel new drugs in 2014, many of them targeted therapies approved on the basis of increasingly sophisticated progress in genomics and the understanding of disease progression. In areas like oncology, such targeted treatments have grown as a percentage of global oncology market size from 11% in 2003 to 46% in 2013. New brand specialty drug spending in the U.S. is estimated to have been $7.5 billion in 2013, or 69% of total new drug spending. The growing prevalence of these drugs and their cost to the health system are setting the stage for significant flashpoints between industry, payers, and providers, seen most clearly in the debate over hepatitis C treatment costs that roiled stakeholder interactions for most of the past year. 

More of these targeted treatments are in the development pipeline, and a growing number of public policy efforts taking shape in 2015 are focused on accelerating their availability. The House of Representatives' 21st Century Cures Initiative, for example, has released a slew of legislative proposals aimed at promoting breakthrough innovation by increasing the efficiency of drug development and regulatory review. These efforts have significant downstream implications for the pace at which targeted and specialty therapies will become available, their associated costs, and the growing importance of demonstrating value in the postmarket setting.

As payers and providers continue their push toward increased value-based care, more innovative models for connecting such reforms to drug development are needed. Earlier collaboration with industry could enable more efficient identification of unmet need, opportunities to add value through drug development, and clearer input on the value proposition and evidentiary thresholds needed for coverage. Equally important will be unique public-private collaborations that invest in developing a better postmarket data infrastructure that can more effectively identify high value uses of new treatments and support achieving value through new payment reforms.

Stronger collaboration could also improve evidence development and the coverage determination process after a targeted  treatment has gained regulatory approval. Facilitated drug access programs like those proposed by the Medicare Administrative Contractor Palmetto GBA create access points for patients to receive targeted anti-cancer agents off-label while payers and industry gather important additional outcomes data in patient registries. More systematic and efficient use of policies like Medicare's Coverage with Evidence Development (CED), which allows for provisional coverage for promising technologies or treatments while evidence continues to be collected, could enable industry and payers to work together to learn about a medical product's performance in patient populations not typically represented in clinical studies. A CED-type model could be especially useful for certain specialty drugs: data collected as a condition of payment could help payers and providers develop evidence from actual practice to improve treatment algorithms, increase adherence, and improve outcomes. 

Finally, collaborations that support stronger postmarket data collection can also support novel drug payment models that further reward value. Bundled payments that include physician-administered drugs, for example, could encourage providers to increase quality while also incentivizing manufacturers to help promote evidence-based drug use and lower costs for uses that generate low value. Outcomes-based purchasing contracts that tie price paid to a medical product's performance could be another promising approach for high-expense treatment with clearly defined and feasibly measured outcomes.

Many of these ideas are not new, but as manufacturers, payers, providers, and patients move into an increasingly value-focused era of health care, it is clear that they must work together to find new ways to both promote development of promising new treatments while also making good on the promise of value-based health care reforms.

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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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 Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

Event Materials

• Bio sheet
• REMS CE Meeting Agenda
• REMS_CE_Meeting_Discussion_Guide_Final
• REMS CE Meeting Summary

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18 titled, “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.

Downloads

• Download discussion guide

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

Event Information

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

Event Information

The role of clinical pharmacology and experimental medicine

The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development. 

On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.

Click here to access the full event agenda.

Video

• Introductory keynotes: Framing the issues
• Optimizing target and compound selection to enhance early stage decision-making
• The right dose for the right patient: Challenges and opportunities in dose optimization
• Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection
• Applications of clinical pharmacology to support demonstration of efficacy

Event Materials

• Event Slide Deck
• Clinical Pharmacology Public Conference
• Clinical Pharmacology Backgrounder
• Clinical Pharmacology Private Roundtable

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 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

It has been hailed as the most significant discovery in biology since polymerase chain reaction allowed for the mass replication of DNA samples. CRISPR-Cas9 is an inexpensive and easy-to-use gene-editing method that promises applications ranging from medicine to industrial agriculture to biofuels. Currently, applications to treat leukemia, HIV, and cancer are under experimental development.¹ However, new technical solutions tend to be fraught with old problems, and in this case, ethical and legal questions loom large over the future.

Disagreements on ethics

The uptake of this method has been so fast that many scientists have started to worry about inadequate regulation of research and its unanticipated consequences.² Consider, for instance, the disagreement on research on human germ cells (eggs, sperm, or embryos) where an edited gene is passed onto offspring. Since the emergence of bioengineering applications in the 1970s, the scientific community has eschewed experiments to alter human germline and some governments have even banned them.³ The regulation regimes are expectedly not uniform: for instance, China bans the implantation of genetically modified embryos in women but not the research with embryos.

Last year, a group of Chinese researchers conducted gene-editing experiments on non-viable human zygotes (fertilized eggs) using CRISPR.⁴ News that these experiments were underway prompted a group of leading U.S. geneticists to meet in March 2015 in Napa, California, to begin a serious consideration of ethical and legal dimensions of CRISPR and called for a moratorium on research editing genes in human germline.⁵ Disregarding that call, the Chinese researchers published their results later in the year largely reporting a failure to precisely edit targeted genes without accidentally editing non-targets. CRISPR is not yet sufficiently precise.

CRISPR reignited an old debate on human germline research that is one of the central motivations (but surely not the only one) for an international summit on gene editing hosted by the U.S. National Academies of Sciences, the Chinese Academy of Sciences, and the U.K.'s Royal Society in December 2015. About 500 scientists as well as experts in the legal and ethical aspects of bioengineering attended.⁶ Rather than consensus, the meeting highlighted the significant contrasts among participants about the ethics of inquiry, and more generally, about the governance of science. Illustrative of these contrasts are the views of prominent geneticists Francis Collins, Director of the National Institutes of Health, and George Church, professor of genetics at Harvard. Collins argues that the “balance of the debate leans overwhelmingly against human germline engineering.” In turn, Church, while a signatory of the moratorium called by the Napa group, has nevertheless suggested reasons why CRISPR is shifting the balance in favor of lifting the ban on human germline experiments.⁷

The desire to speed up discovery of cures for heritable diseases is laudable. But tinkering with human germline is truly a human concern and cannot be presumed to be the exclusive jurisdictions of scientists, clinicians, or patients. All members of society have a stake in the evolution of CRISPR and must be part of the conversation about what kind of research should be permitted, what should be discouraged, and what disallowed. To relegate lay citizens to react to CRISPR applications—i.e. to vote with their wallets once applications hit the market—is to reduce their citizenship to consumer rights, and public participation to purchasing power.⁸ Yet, neither the NAS summit nor the earlier Napa meeting sought to solicit the perspectives of citizens, groups, and associations other than those already tuned in the CRISPR debates.⁹

The scientific community has a bond to the larger society in which it operates that in its most basic form is the bond of the scientist to her national community, is the notion that the scientist is a citizen of society before she is a denizen of science. This bond entails liberties and responsibilities that transcend the ethos and telos of science and, consequently, subordinates science to the social compact. It is worth recalling this old lesson from the history of science as we continue the public debate on gene editing. Scientists are free to hold specific moral views and prescriptions about the proper conduct of research and the ethical limits of that conduct, but they are not free to exclude the rest of society from weighing in on the debate with their own values and moral imaginations about what should be permitted and what should be banned in research. The governance of CRISPR is a question of collective choice that must be answered by means of democratic deliberation and, when irreconcilable differences arise, by the due process of democratic institutions.

Patent disputes

More heated than the ethical debate is the legal battle for key CRISPR patents that has embroiled prominent scientists involved in perfecting this method. The U.S. Patent and Trademark Office initiated a formal contestation process, called interference, in March 2016 to adjudicate the dispute. The process is likely to take years and appeals are expected to extend further in time. Challenges are also expected to patents filed internationally, including those filed with the European Patent Office.

To put this dispute in perspective, it is instructive to consider the history of CRISPR authored by one of the celebrities in gene science, Eric Lander.¹⁰ This article ignited a controversy because it understated the role of one of the parties to the patent dispute (Jennifer Doudna and Emmanuelle Charpentier), while casting the other party as truly culminating the development of this technology (Feng Zhang, who is affiliated to Lander’s Broad Institute). Some gene scientists accused Lander of tendentious inaccuracies and of trying to spin a story in a manner that favors the legal argument (and economic interest) of Zhang.

Ironically, the contentious article could be read as an argument against any particular claim to the CRISPR patents as it implicitly questions the fairness of granting exclusive rights to an invention. Lander tells the genesis of CRISPR that extends through a period of two decades and over various countries, where the protagonists are the many researchers who contributed to the cumulative knowledge in the ongoing development of the method. The very title of Lander’s piece, “The Heroes of CRISPR” highlights that the technology has not one but a plurality of authors.

A patent is a legal instrument that recognizes certain rights of the patent holder (individual, group, or organization) and at the same time denies those rights to everyone else, including those other contributors to the invention. Patent rights are thus arbitrary under the candle of history. I am not suggesting that the bureaucratic rules to grant a patent or to determine its validity are arbitrary; they have logical rationales anchored in practice and precedent. I am suggesting that in principle any exclusive assignation of rights that does not include the entire community responsible for the invention is arbitrary and thus unfair. The history of CRISPR highlights this old lesson from the history of technology: an invention does not belong to its patent holder, except in a court of law.

Some scientists may be willing to accept with resignation the unfair distribution of recognition granted by patents (or prizes like the Nobel) and find consolation in the fact that their contribution to science has real effects on people’s lives as it materializes in things like new therapies and drugs. Yet patents are also instrumental in distributing those real effects quite unevenly. Patents create monopolies that, selling their innovation at high prices, benefit only those who can afford them. The regular refrain to this charge is that without the promise of high profits, there would be no investments in innovation and no advances in life-saving medicine. What’s more, the biotech industry reminds us that start-ups will secure capital injections only if they have exclusive rights to the technologies they are developing. Yet, Editas Medicine, a biotech start-up that seeks to exploit commercial applications of CRISPR (Zhang is a stakeholder), was able to raise $94 million in its February 2016 initial public offering. That some of Editas’ key patents are disputed and were entering interference at USPTO was patently not a deterrent for those investors.

Towards a CRISPR democratic debate

Neither the governance of gene-editing research nor the management of CRISPR patents should be the exclusive responsibility of scientists. Yet, they do enjoy an advantage in public deliberations on gene editing that is derived from their technical competence and from the authority ascribed to them by society. They can use this advantage to close the public debate and monopolize its terms, or they could turn it into stewardship of a truly democratic debate about CRISPR.

The latter choice can benefit from three steps. A first step would be openness: a public willingness to consider and internalize public values that are not easily reconciled with research values. A second step would be self-restraint: publicly affirming a self-imposed ban on research with human germline and discouraging research practices that are contrary to received norms of prudence. A third useful step would be a public service orientation in the use of patents: scientists should pressure their universities, who hold title to their inventions, to preserve some degree of influence over research commercialization so that the dissemination and access to innovations is consonant with the noble aspirations of science and the public service mission of the university. Openness, self-restraint, and an orientation to service from scientists will go a long way to make of CRISPR a true servant of society and an instrument of democracy.

Other reading: See media coverage compiled by the National Academies of Sciences.

¹Nature: an authoritative and accessible primer. A more technical description of applications in Hsu, P. D. et al. 2014. Cell, 157(6): 1262–1278.

³More about ethical concerns on gene editing here: http://www.geneticsandsociety.org/article.php?id=8711

⁴Liang, P. et al. 2015. Protein & Cell, 6, 363–372

⁵Science: A prudent path forward for genomic engineering and germline gene modification.

⁶Nature: NAS Gene Editing Summit.

⁷While Collins and Church participated in the summit, their views quoted here are from StatNews.com: A debate: Should we edit the human germline. See also Sciencenews.org: Editing human germline cells sparks ethics debate.

⁸Hurlbut, J. B. 2015. Limits of Responsibility, Hastings Center Report, 45(5): 11-14.

⁹This point is forcefully made by Sheila Jasanoff and colleagues: CRISPR Democracy, 2015 Issues in S&T, 22(1).

¹⁰Lander, E. 2016. The Heroes of CRISPR. Cell, 164(1-2): 18-28.

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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Despite the undeniable benefits of education to society, the educational needs, particularly in the world’s poorest countries, remain strikingly great. There are more than 67 million children not enrolled in primary school around the world, millions of children who are enrolled in school but not really learning, and too few young people are advancing to secondary school (van der Gaag and Adams 2010). Consider, for instance, the number of children unable to read a single word of connected text at the end of grade two: more than 90 percent in Mali, more than 50 percent in Uganda, and nearly 33 percent in Honduras (USAID n.d.).

With more young people of age 12 to 24 years today than ever before who are passing through the global education system and looking for opportunities for economic and civic participation, the education community is at a crossroads. Of the 1.5 billion young people in this age group, 1.3 billion live in developing countries (World Bank 2007). The global community set the goal of achieving universal primary education by 2015 and has failed to mobilize the resources necessary, as UNESCO estimates that $16.2 billion in external resources will be need to reach this goal.

Read the full report »

Read the executive summary »

Results from this report were presented at an April 6 Center on Universal Education event at the Brookings Institution.

Learn more about the launch event »

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INTRODUCTION

In August, 2010 the government of Kenya adopted a new constitution. This followed a referendum in which an overwhelming majority of Kenyans voted for change. The decisive impetus for reform came from the widespread violence and political crisis that followed the 2007 election. While claims of electoral fraud provided the immediate catalyst for violence, the deeper causes were to be found in the interaction of a highly centralized ‘winner-take-all’ political system with deep social disparities based in part on group identity (Hanson 2008).

Provisions for equity figure prominently in the new constitution. Backed by a bill of rights that opens the door to legal enforcement, citizenship rights have been strengthened in many areas,including access to basic services. ‘Equitable sharing’ has been introduced as a guiding principle for public spending. National and devolved governments are now constitutionally required to redress social disparities, target disadvantaged areas and provide affirmative action for marginalized groups.

Translating these provisions into tangible outcomes will not be straightforward. Equity is a principle that would be readily endorsed by most policymakers in Kenya and Kenya’s citizens have provided their own endorsement through the referendum. However, there is an ongoing debate over what the commitment to equity means in practice, as well as over the pace and direction of reform. Much of that debate has centered on the constitutional injunction requiring ‘equitable sharing’ in public spending.

On most measures of human development, Kenya registers average outcomes considerably above those for sub-Saharan Africa as a region. Yet the national average masks extreme disparities—and the benefits of increased prosperity have been unequally shared.

There are compelling grounds for a strengthened focus on equity in Kenya. In recent years, the country has maintained a respectable, if less than spectacular, record on economic growth. Social indicators are also on an upward trend. On most measures of human development, Kenya registers average outcomes considerably above those for sub-Saharan Africa as a region. Yet the national average masks extreme disparities—and the benefits of increased prosperity have been unequally shared. Some regions and social groups face levels of deprivation that rank alongside the worst in Africa. Moreover, the deep fault lines running through society are widely perceived as a source of injustice and potential political instability.

High levels of inequality in Kenya raise wider concerns. There has been a tendency in domestic debates to see ‘equitable sharing’ as a guiding principle for social justice, rather than as a condition for accelerated growth and enhanced economic efficiency. Yet international evidence strongly suggests that extreme inequality—especially in opportunities for education— is profoundly damaging for economic growth. It follows that redistributive public spending has the potential to support growth.

The current paper focuses on a group of 12 counties located in Kenya’s Arid and Semi-Arid Lands (ASALs). They are among the most disadvantaged in the country. Most are characterized by high levels of income poverty, chronic food insecurity and acute deprivation across a wide range of social indicators.

Nowhere is the deprivation starker than in education. The ASAL counties account for a disproportionately large share of Kenya’s out-of-school children, pointing to problems in access and school retention. Gender disparities in education are among the widest in the country. Learning outcomes for the small number of children who get through primary school are for the most part abysmal, even by the generally low national average standards.

Unequal public spending patterns have played no small part in creating the disparities that separate the ASAL counties from the rest of Kenya—and ‘equitable sharing’ could play a role in closing the gap. But what would a more equitable approach to public spending look like in practice?

This paper addresses that question. It looks in some detail at education for two reasons. First, good quality education is itself a powerful motor of enhanced equity. It has the potential to equip children and youth with the skills and competencies that they need to break out of cycles of poverty and to participate more fully in national prosperity. If Kenya is to embark on a more equitable pattern of development, there are strong grounds for prioritizing the creation of more equal opportunities in education. Second, the education sector illustrates many of the wider challenges and debates that Kenya’s policymakers will have to address as they seek to translate constitutional provisions into public spending strategies. In particular, it highlights the importance of weighting for indicators that reflect need in designing formulae for budget allocations.

Our broad conclusion is that, while Kenya clearly needs to avoid public spending reforms that jeopardize service delivery in wealthier counties, redistributive measures are justified on the grounds of efficiency and equity.

The paper is organized as follows. Part 1 provides an overview of the approach to equity enshrined in the constitution. While the spirit of the constitution is unequivocal, the letter is open to a vast array of interpretations. We briefly explore the implications of a range of approaches. Our broad conclusion is that, while Kenya clearly needs to avoid public spending reforms that jeopardize service delivery in wealthier counties, redistributive measures are justified on the grounds of efficiency and equity. Although this paper focuses principally on basic services, we caution against approaches that treat equity as a matter of social sector financing to the exclusion of growth-oriented productive investment.

Part 2 provides an analysis of some key indicators on poverty, health and nutrition. Drawing on household expenditure data, the report locates the 12 ASAL counties in the national league table for the incidence and depth of poverty. Data on health outcomes and access to basic services provide another indicator of the state of human development. While there are some marked variations across counties and indicators, most of the 12 counties register levels of deprivation in poverty and basic health far in excess of those found in other areas.

Part 3 shifts the focus to education. Over the past decade, Kenya has made considerable progress in improving access to basic education. Enrollment rates in primary education have increased sharply since the elimination of school fees in 2003. Transition rates to secondary school are also rising. The record on learning achievement is less impressive. While Kenya lacks a comprehensive national learning assessment, survey evidence points to systemic problems in education quality. In both access and learning, children in the ASAL counties—especially female children—are at a considerable disadvantage. After setting out the national picture, the paper explores the distinctive problems facing these counties.

In Part 4 we look beyond Kenya to wider international experience. Many countries have grappled with the challenge of reducing disparities between less-favored and more-favored regions. There are no blueprints on offer. However, there are some useful lessons and guidelines that may be of some relevance to the policy debate in Kenya. The experience of South Africa may be particularly instructive given the weight attached to equity in the post-apartheid constitution.

Part 5 of the paper explores a range of approaches to financial allocations. Converting constitutional principle into operational practice will require the development of formulae-based approaches. From an equitable financing perspective there is no perfect model. Any formula that is adopted will involve trade-offs between different goals. Policymakers have to determine what weight to attach to different dimensions of equity (for example, gender, income, education and health), the time frame for achieving stated policy goals, and whether to frame targets in terms of outcomes or inputs. These questions go beyond devolved financing. The Kenyan constitution is unequivocal in stipulating that the ‘equitable sharing’ provision applies to all public spending. We therefore undertake a series of formula-based exercises illustrating the allocation patterns that would emerge under different formulae, with specific reference to the 12 ASAL focus counties and to education.

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EXECUTIVE SUMMARY

Parents, educators, government ministers and policymakers in all contexts and countries around the world are concerned with learning and how to improve it. There are many reasons for this, but none is more important than the fact that learning is at the heart of success at the individual, community and global levels. Learning First is the title of this report, with the strong implication that learning should be the foremost goal of education policies worldwide.

The present review seeks not only to explain why this is the case but also focuses on what we need to know—that is, what research is needed—in order to improve learning in the decades to come, particularly among those children most in need. This question is addressed in the following six sections.

1. Learning Goals and Research. The first section begins with a historical synopsis of international education goals put forward in 1990 at the World Conference on Education for All in Jomtien (Thailand), in 2000 at the Education for All conference in Dakar, and later in 2000 as a part of the UN Millennium Development Goals for 2015. In 2011, the Center for Universal Education at the Brookings Institution published A Global Compact on Learning: Taking Action on Education in Developing Countries, which stated that there is a “global learning crisis—which affects children and youth who are out of school with limited learning opportunities and those who are in school but not learning the skills they need for their futures.” The present review of learning research in low-income countries follows from that report. The overall purpose is to explore the most pressing learning issues today that require further research attention in the years to come.
    
2. Learning Definitions and Contexts. This section reviews how the field of education has defined learning over the years. Here, learning is defined as a modification of behavior due to experience—such as in knowledge, skills, attitudes and values. Three main principles of effective learning are suggested: individual active involvement, social participation, and meaningful engagement. As a way to emphasize the importance of learning contexts, three individual stories—Illa, a four-year-old Quechua-speaking girl in Peru; Pawan, an eight-year-old primary school student in urban India; and Rachida, a young illiterate woman in rural Morocco—are provided in order to better explain the importance of learning as a culturally specific phenomenon. These stories help to illustrate a more general learning framework, encompassing the relationship between two dimensions of learning—its processes and contexts. A discussion follows concerning the need to disaggregate learners and their learning contexts—between countries and within countries—as a way to overcome frequent and simplistic generalizations about how the “average” child learns.
    
3. Global Change and the Contexts of Learning. This section considers the issue of global change on how learning and learning contexts are being transformed around the world. For example, researchers need to pay more attention to the impact of migration on children’s learning and on educational systems more broadly. In each instance of translocation, children confront the challenges of adapting to a new environment that may include different languages, dialects or cultures within the nonformal learning contexts of daily life. Similarly, in formal education contexts, student migrants have to cope with contrasts in culture, lifestyle and language of schooling, and demonstrate skills and achievement that may vary dramatically with their culture of origin. Other changes due to globalization include increased multilingualism in schools, growing overcrowding in classrooms, inability to keep up with teacher training, changes in intergenerational learning, and the growing importance of 21st-century skills. Based on these observations, it is suggested that learning contexts and needs should be understood as a shifting target.

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INTRODUCTION

With fewer than three years until the planned end-date of the United Nations Millennium Development Goals (MDGs), attention is rapidly turning to what will follow. The elaboration of the next global development agenda is a complex, multi-pronged process that is academic, political and practical, involving experts from a myriad of social and economic sectors and representing a cross-section of constituencies. While the formal U.N. process is still in the early stages, the ongoing discourse (predominantly occurring in the global north, but not exclusively) has introduced several potential frameworks for this agenda. This paper describes the leading frameworks proposed for the post-2015 global development agenda and discusses how education and learning fit within each of those frameworks. While many within the education community are working to develop a cohesive movement to advance an “access plus learning” agenda, it remains equally important to engage proactively with the broader development community to ensure that education fits within the agreed upon overarching organizing framework.

The frameworks described below represent a snapshot of current thinking in 2012. On the road to 2015, the education community will need to refine and sharpen its thinking with respect to how learning is incorporated into the prevailing framework. The seven frameworks that will be addressed in this paper are:

1. Ending Absolute Poverty
2. Equity and Inclusion
3. Economic Growth and Jobs
4. Getting to Zero
5. Global Minimum Entitlements
6. Sustainable Development
7. Well-Being and Quality of Life

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INTRODUCTION

In an earlier policy brief, Where is the Learning? Measuring Schooling Efforts in Developing Countries, we drew attention to what was labeled “the global learning crisis.” While tremendous progress has been made over the past couple of decades to get tens of millions of additional children to enroll in school, progress in improving learning outcomes has been considerably less impressive. Although, shockingly, comprehensive learning outcome data are not available for most of the developing world, the many small scale, local or, in some cases, national studies that have been done show a dismal picture. For instance, Uwezo, an East African initiative, found that in Tanzania, only 44 percent of students in Grade 4 were able to read a basic story from Grade 2. Similarly, the Annual Status of Education Report (ASER) facilitated by Pratham found that in rural India, less than half of Grade 4 students were able to do basic subtraction. These examples demonstrate the gravity of “the global learning crisis” as students fail to master competencies appropriate for their grade level, hindering the development of life skills and success in further schooling, as well as performance in the labor market.

With about 61 million children in the developing world still not yet in school, it is too early to declare victory on the “enrollment agenda”. But we would do a disservice to the 250 million children around the world who fail to reach Grade 4 or attain minimum learning standards, if we don’t step up efforts to improve learning outcomes.

This policy brief is part of a larger effort to link resources in the education sector with outcome measures. As we have documented elsewhere, few countries systematically collect comprehensive financial data on education, although fortunately an increasing number of initiatives is trying to address this issue by producing, for instance, National Education Accounts (NEAs). When the focus of the sector changes from enrollment to enrollment plus learning, efforts to better grasp the size and use of financial resources should evolve accordingly. For instance, much learning takes place outside of the classroom, especially in the early years. For NEAs to be a useful tool for adjusting the allocation of scarce resources, the “learning” sector should be defined more broadly than the education or “schooling” sector. We will address this and related issues in a subsequent policy brief.

Once our focus becomes enrollment plus learning, we have to broaden our view and look at the entire environment in which a child develops skills, starting with the households in which children are born. It has beenknown for many decades and throughout the world, that among the best predictors of future school performance are some basic household characteristics, such as income and mother’s education level.

Data from international assessments also show a relationship between income and educational performance, exemplified by intra and intercountry results. In Colombia, average Trends in International Mathematics and Science Study (TIMSS) math scores at Grade 8 for the richest quintile of students were close to 100 points higher than those from the poorest quintile. On the other hand, the difference in average scores between the poorest quintile in the United States and the richest quintile in Colombia was about 50 points. Income is not the only predictor of success, as exemplified in Peru, where children whose mothers have completed primary school and whose maternal language is Spanish rather than an indigenous language, have a greater probability of reaching the appropriate school grade for their age. In Kenya, Uwezo found that the higher their father’s educational attainment, the more likely children were able to read a story at Grade 3 or attend extra tutoring sessions.

In addition, the larger environment (such as the village or the urban neighborhood) in which the young child grows up also has a major and lasting impact. In Tanzania, urban students in Grade 3 are three times more likely than their rural counterparts to meet standards in literacy and numeracy. Related to the impact of the larger environment, data from Nigeria suggest that girls are more disadvantaged in school attendance, as parents may be reluctant to send girls to school because of perceived fears for their safety while traveling and concerns about the physical strength required for walking the distance.

Clearly, especially in the early years, most learning takes place outside of the classroom. Consequently, children who grow up in deprived circumstances will start life with a disadvantage leading to a lack of learning in the early grades, which will have lifetime effects.

In the next section, we will summarize the evidence that the early years (ages 0 to 5) are crucial for subsequent learning achievements. From this evidence we conclude that many of the problems with learning outcomes in the developing world (and in many developed countries) need to be addressed well before school age. Before delving into what happens in schools, we explore the relationship between enrollment, learning and dropout. As the crux of this brief is to lay out the evidence on what contributes to learning, we must acknowledge the factors leading to low enrollment and dropout. Next, we turn our attention to what happens in schools and what can be done to improve these activities, as well as try to summarize the evidence about the relationship between specific school-based inputs and learning outcomes. As it turns out, this evidence is, in many cases, rather feeble. Therefore, we will first focus on school-level inputs that are necessary for a good learning environment, i.e. without which we cannot expect any learning to take place. Most of these inputs are rather obvious, but they are worth mentioning. Subsequently, we will discuss additional inputs that have proven to contribute to learning outcomes in some cases, but not in others. Clearly how these inputs are applied matters.

Next, we address factors that contribute to learning outside of a formal environment, after which we review issues in health and nutrition that are closely linked to learning outcomes. We then review the need for the collection and dissemination of learning assessments in order to impact further improvements in these areas and we try to answer the question: what are the building blocks for an education sector that promote learning? Finally we explore needs for future research in learning.

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In the 13 years since the dawn of the new millennium, significant progress has been made in addressing some of the world’s most important problems. One billion fewer people live in extreme poverty, 3 million children’s lives are saved annually and 610 million children in developing countries are enrolled in primary school, more than ever before. However, this progress has not been shared evenly around the globe. Populations affected by weak systems of governance and that suffer violence and disasters have systematically been left behind.

They are much less likely to enjoy progress vis-à-vis any of the United Nations’ Millennium Development Goals (MDGs), which include eradicating extreme poverty and hunger, improving children and women’s health, and enrolling children in school. No country classified as a “fragile state,” for example, has met all eight of the MDGs. Children born in low-income, conflict-affected countries are twice as likely to die before the age of five years, twice as likely to lack access to clean water and more than three times as likely to not attend school than children living in peaceful, low-income countries. People living in poverty, many of whom are affected by conflict, are more vulnerable to the effects of climate change and disasters. Children are especially affected, and those from the poorest families are up to 10 times more likely to bear the brunt of environmental disasters linked to climate change.

The needs of people living in fragile states are an urgent priority for our time, and thus will almost certainly be prominent in the next round of global development goals. As the global community reflects on the new agenda that will replace the MDGs when they expire in 2015, it will do well to take stock of the existing strategies for supporting the needs of populations in fragile states. A range of strategies are undoubtedly needed, and there is good reason why there is a heavy emphasis on the economic, legal and security dimensions of development efforts in fragile states. However, efforts in the social sphere are equally needed, and education is one important strategy for supporting populations in fragile states that was often overlooked until recently.

This report provides a broad review of the field of education in fragile states and charts a new agenda for maximizing education’s contribution to the development and well-being of people living in these contexts. We hope it serves as a comprehensive introduction to the topic for those coming to this issue for the first time as well as provides new insights for those already actively engaged in the subject. The arguments we make here are based on evidence developed both from careful analysis and synthesis of the latest available data as well as primary research.

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Interpreting employment stats among young people can be tricky. No one expects employment rates among teens or people in their early 20s to reach those of prime-age workers. These are prime years for what economists call “investing in human capital,” an activity most people would describe as “going to school.”

Education requirements for good jobs are getting higher, so finishing high school and earning a post-secondary credential like two or four-year college degrees, apprenticeships, or certifications are top priorities. But early work experiences can allow young people to learn new skills, gain experience, and expand networks. Evidence suggests that it can improve employment prospects down the line. And the earlier that people are exposed to the workplace, the earlier they learn such skills as teamwork, communication, and dependability—skills that employers say are in short supply. 

The employment rate for teens fell from 43 percent in 2000 to 26 percent in 2014, and for young adults aged 20 to 24, it fell from 70 to 62 percent. These are big drops. In a new analysis, I take a deeper look at employment trends among young people. When employment rates are broken out by age and race/ethnicity, you see the same downward pattern, but also substantial variation among whites, blacks, Latinos, and Asians.

Do these declines spell trouble? The answer is, it depends:  on how young people spend their time, what resources and support are available to them, and how the person making the judgement values academics and enrichment relative to employment.

Some argue that workplace experience provides key developmental opportunities that benefit all young people. Robert Halpern, for example, wryly notes that high school students are isolated from the adult world “at just the moment when [they] need to begin learning about participating in it.” 

Others say that employment matters more for some young people than others. For example, disadvantaged youth—those not on track to earn a post-secondary credential and without strong family or community  networks to help them find jobs—can particularly benefit from formal programs that connect them to the labor market. As Jeylan Mortimer concluded about “low academic promise” high school students (those with poor grades and low educational goals): “[H]aving a positive work experience can help to turn you around.  For those who have a lot of disadvantages, any positive experience is likely to have a greater impact than on people with a lot of advantages already.” Research on Career Academies, high schools that combine academics with career development, support this view. Career Academy students, disproportionately low-income, black, and Latino, posted significant earnings gains eight years after graduation, and young male graduates also had higher rates of marriage and custodial parenthood.

And some would say that it’s appropriate to prioritize education over employment, especially for teens, who are typically not responsible for supporting themselves and their families.

So what do the data tell us? Voluntarily dropping out of the labor force to concentrate on academics as a young person can pay off when people enter their prime working years, generally considered to be 25 to 54. Though education and work are not necessarily incompatible, employment rates are generally lower among students than among those not enrolled in school. Among teens and young adults, Asians have the lowest employment rates, but they also have the highest school enrollment rates. 92 percent of Asian 16- to 19-year-olds and 63 percent of Asian 20- to 24-year-olds are in school, compared to 80 percent and 38 percent among all races. It follows, then, that Asians have high levels of educational attainment. In fact, 50 percent of 23- to 24-year-old Asians have a Bachelor’s degree, double the average rate. Given the strong correlation between education and employment, it is not a coincidence that prime-age Asians have high employment rates and low unemployment rates. Their low employment rates as young people do not, on the whole, seem to lead to problems as adults. (Of course, this is not to downplay the diversity of the Asian population and to suggest that all Asians are doing well economically.)

On the other hand, blacks have the second lowest employment rates as teens and young adults, and the lowest rate as prime age workers. They also have the highest unemployment rates, showing an active desire to work. Among black teens in 2014, the unemployment rate was 38 percent, compared to 23 percent overall, and it was 22 percent among black young adults, compared to 13 percent overall. The trend continues into prime working years: blacks have an unemployment rate of 11.4 percent, nearly double the overall rate of 6.2 percent.  The low employment rate among young black people is not driven by school enrollment. Latinos have similar (below-average) enrollment levels but higher employment rates, and whites have much higher employment rates but only slightly higher enrollment levels. The weaker employment outcomes of blacks at all ages is probably related to multiple factors: relatively low levels of educational attainment, discrimination, and the neighborhood effects of living in concentrated poverty.

Blacks and Latinos are disproportionately represented among so-called “disconnected youth,” young people aged 16 to 24 who are neither working nor in school. 17 percent of black young adults aged 20 to 24 are disconnected, as are 13 percent of Latinos, 7 percent of whites, and 4 percent of Asians. Half of disconnected young adults have a high school credential and another 20 percent have taken some college courses, suggesting that getting these young people on a better path involves not only reducing the high school dropout rate, but also strengthening the transition from high school to post-secondary education and the labor market. 

In short, employment rates among young people tell different stories that often track by race and ethnicity. Some voluntarily withdraw from the labor market to focus on academics and extra-curricular activities, others would really like a job but can’t find one, and some—the most disadvantaged—are alienated from both school and the labor market.

May’s jobs gains, released this morning, show that only 38,000 new jobs were added this May, down from an average of 178,000 over the first four months of the year, and the least new jobs added since September 2010.

This year’s monthly job gains and losses can indicate how the economy is doing once they are corrected to account for the pattern we already expect in a process called seasonal adjustment. The approach for this seasonal adjustment that is presently used by the Bureau of Labor Statistics (BLS) puts very heavy weight on the current and last two years of data in assessing what are the typical patterns for each month.

In my paper “Unseasonal Seasonals?” I argue that a longer window should be used to estimate seasonal effects. I found that using a different seasonal filter, known as the 3x9 filter, produces better results and more accurate forecasts by emphasizing more years of data. The 3x9 filter spreads weight over the most recent six years in estimating seasonal patterns, which makes them more stable over time than in the current BLS seasonal adjustment method.

I calculate the month-over-month change in total nonfarm payrolls, seasonally adjusted by the 3x9 filter, for the most recent month. The corresponding data as published by the BLS are shown for comparison purposes. According to the alternative seasonal adjustment, the economy actually lost about 4,000 jobs in May (column Wright SA), compared to the official BLS total of 38,000 gained (column BLS Official).

In addition to seasonal effects, abnormal weather can also affect month-to-month fluctuations in job growth. In my paper “Weather-Adjusting Economic Data” I and my coauthor Michael Boldin implement a statistical methodology for adjusting employment data for the effects of deviations in weather from seasonal norms. This is distinct from seasonal adjustment, which only controls for the normal variation in weather across the year. We use several indicators of weather, including temperature and snowfall.

We calculate that weather in May had a negligible effect on employment, bringing up the total by only 4,000 jobs (column Weather Effect). Our weather-adjusted total, therefore, is 34,000 jobs added for May (column Boldin-Wright SWA). This is not surprising, given that weather in May was in line with seasonal norms.

Unfortunately, neither the alternative seasonal adjustment, nor the weather adjustment, makes todays jobs report any more hopeful. They make little difference and, if anything, make the picture more gloomy.

a. Applies a longer window estimate of seasonal effects (see Wright 2013).
b. Includes seasonal and weather adjustments, where seasonal adjustments are estimated using the BLS window specifications (see Boldin & Wright 2015). The incremental weather effect in the last column is the BLS official number less the SWA number.

Editor’s note: In the "Becoming Brilliant" blog series, experts explore the six competencies that reflect how children learn and grow as laid out by Kathy Hirsh-Pasek and Roberta Golinkoff in their new book "Becoming Brilliant."

The world is morphing into a place that no one can foresee. How can we prepare students to live and work in that place?

Not long ago, people could learn job skills and use them indefinitely, but now jobs and skill sets are becoming obsolete at an alarming rate. This means that students, and later adults, need to expect and thrive on challenges and know how to turn failures into stepping stones to a brighter future.

When I was a beginning researcher I wanted to see how children coped with setbacks, so I gave 5th graders simple problems followed by hard problems—ones they couldn’t solve. Some hated the hard ones, some tolerated them, but, to my surprise, some relished them. One unforgettable child rubbed his hands together, smacked his lips, and declared, “I love a challenge!” Another said, “I was hoping this would be informative.” They didn’t think they were failing, they thought they were learning. Although this was years ago, they were already 21st century kids.

I knew then that I had to figure out their secret and, if possible, bottle it. With help from my graduate students, figure it out we did. And we are learning how to bottle it too. 

So, what was their secret?

Our research has shown that these children tend to have a “growth mindset.” They believe that their basic abilities, even their intelligence, can be developed through learning. That’s why they love challenges and remain confident through setbacks. Their more vulnerable counterparts, however, have more of a “fixed mindset.” They believe their basic abilities are just fixed—set in stone­. So their key goal is to look and feel smart (and never dumb). To accomplish this they often seek easy over hard tasks. And when they do encounter setbacks, they tend to feel inept and lose confidence. Research shows that even exerting effort can make them feel unintelligent. If you’re really good at something, they believe, you shouldn’t have to work at it.

These mindsets make a difference. In one study we tracked hundreds of students across the difficult transition to seventh grade, akin to entering a new world with harder work, higher standards, and a whole new structure. Those who entered with more of a growth mindset (the belief that they could develop their intelligence) fared better. Their math grades quickly jumped ahead of those of students with a fixed mindset and the gap became wider and wider over the next two years. This was true even though the two groups entered with equivalent past achievement test scores.

Recently, we were able to study all the 10th-graders in the country of Chile. We found that at every socioeconomic level students with a growth mindset were outperforming their peers with a fixed mindset. What was most striking was that when the poorest students held growth mindsets they were performing at the level of far richer students with fixed mindsets.

What’s exciting is that we have been able to teach a growth mindset to students through carefully designed workshops. In these workshops, students learn that their brain can grow new, stronger connections when they take on hard learning tasks and stick to them. They learn to avoid categorical smart-dumb thinking and instead focus on their own improvement over time. They hear from other students who have benefitted from learning a growth mindset. And they learn how to apply growth mindset thinking to their schoolwork. In these workshops students also do exercises, such as mentoring a struggling peer using what they learned about the growth mindset. Such workshops have been delivered both in person and online and have typically led to an increase in students’ motivation and achievement, particularly among students who are encountering challenges—such as difficult courses, school transitions, or negative stereotypes.

We have also studied how teachers and parents can foster a growth mindset in children. Sadly, many do not—even many of those who hold a growth mindset themselves! This is because adults, in their eagerness to motivate children and build their confidence, can tend to do things that foster a fixed mindset.

Here is what we’ve found:

• Praising children’s intelligence conveys that intelligence is fixed and promotes a fixed mindset and its vulnerabilities. Praising the children’s learning process—their strategies, hard work, and focus—and linking it to their progress conveys a growth mindset.

• Reacting to children’s failures with anxiety, false reassurances, or comfort for their lesser ability (“Don’t worry, not everyone can be good at math”) can foster a fixed mindset. Reacting with compassionate questions and plans for future learning conveys a growth mindset.

• Research shows that how math teachers react to their students when the students are stuck is critical. Teachers can help students develop growth mindsets by sitting with them, trying to understand their thinking, and then collaborating with them on how to move forward and what to try next.

But how can teachers themselves develop more of a growth mindset?

In some quarters, a growth mindset became a “requirement.” This led many educators to claim a growth mindset without really understanding what it is or how to develop it. We have suggested that educators understand, first, that a growth mindset is the belief that everyone can develop their abilities. It is not simply about being open-minded or flexible. Second, they must understand that all people have both mindsets and that many situations, such as struggles or setbacks, can trigger a fixed mindset. Finally, they must learn how their own fixed mindset is triggered so that they can work to stay in a growth mindset more often.

As we prepare students to thrive in the new world, we can influence whether they see that world as overwhelming and threatening or whether they greet it with the confident words “I love a challenge.” The latter are the ones who can make the world, whatever it’s like, a better place.  

Ghana attained middle-income status after rebasing its National Accounts, pushing per capita gross domestic product (GDP) of the country above $1,000 in 2007. After recovering from economic recession in 1984 on account of the Bretton Woods sponsored economic reform introduced at that time, Ghana’s growth has been remarkably strong, with its lowest economic growth of 3.3 percent recorded in 1994. The country’s growth rate reached its peak of 15 percent in 2011 on the back of the commencement of commercial production of oil, making it one of the fastest growing economies globally during that year. This has translated into increased per capita income, which reached a high of about $1,900 in 2013.

The concern, however, has been the ability of the country to sustain this growth momentum given the level and quality of education and skills, and, more importantly, the failure of this strong growth performance to be translated into the creation of productive and decent jobs, improved incomes and livelihoods. The structure of the economy remains highly informal, with a shift in the country’s national output composition from agriculture to low-value service activities in the informal sector. The commencement of commercial production of oil raised the share of the industrial sector in national output. However, the continuous decline in manufacturing value added undermines Ghana’s economic transformation effort to promote high and secure incomes and improve the livelihoods of the people.

Structural change towards higher value added sectors, and upgrading of technologies in existing sectors, is expected to allow for better conditions of work, better jobs, and higher wages. But the low level and quality of human resources not only diverts the economy from its structural transformation path of development but also makes it difficult for the benefits of growth to be spread through the creation of gainful and productive employment. Thus, productive structural economic transformation hinges on the level and quality of education and labor skills. A highly skilled, innovative and knowledgeable workforce constitutes a key ingredient in the process of structural economic transformation, and as productive sectors apply more complex production technologies and research and development activities increase the demand for education and skills. However, the observed weak human capital base does not provide a strong foundation for structural economic transformation of Ghana.

Ghana’s employment growth lags behind economic growth, with an estimated employment elasticity of output of 0.47, suggesting that every 1 percent of annual economic growth yields 0.47 percent growth of total employment.

There is also widespread concern about the quality of the country’s growth in terms of employment and inequality, as well as general improvement in the livelihood of the people (see Alagidede et al. 2013; Aryeetey et al. 2014; Baah-Boateng 2013). A key indicator for measuring the extent to which macroeconomic growth results in gains in the welfare of the citizenry is the quality of jobs that the economy generates. Ghana’s employment growth lags behind economic growth, with an estimated employment elasticity of output of 0.47 (see Baah-Boateng 2013), suggesting that every 1 percent of annual economic growth yields 0.47 percent growth of total employment. Besides the slow rate of job creation is the dominance of vulnerable employment and the working poverty rate in the labor market. In 2010, 7 out of 10 jobs were estimated to be vulnerable while only 1 out of 5 jobs could be considered as productive jobs that meet the standard of decent work (Baah-Boateng and Ewusi 2013). Workers in vulnerable employment tend to lack formal work arrangements as well as elements associated with decent employment such as adequate social security and recourse to effective social dialogue mechanisms (Sparreboom and Baah-Boateng 2011). The working poverty rate remains a challenge with one out of every five persons employed belonging to poor households.

The article seeks to provide an analytical assessment of Ghana’s economic growth as one of Africa’s growth giants over a period of more than two decades and the implication for labour market and livelihood outcomes. Growth of labor productivity at the national and sectoral level is examined, as well as the sectoral contribution to aggregate productivity growth. The article also analyses the effect of growth on employment and the employment-poverty linkage in terms of elasticity within the growth-employment-poverty nexus in Ghana. It also delves into a discussion of the constraints on growth and productive employment from both demand and supply perspectives, and identifies skills gaps and the opportunities offered in the country, which has experienced strong growth performance. The article has five sections, with an overview of Ghana’s economic growth performance in Section 2, after this introductory section. This is followed by an overview of the developments in the labor market, specifically in the area of employment, unemployment, poverty, and inequality in Ghana in Section 3. The growth-employment-poverty linkage analysis is carried out in Section 4 followed by a discussion of constraints to growth and employment generation in Section 5. Section 6 provides a summary and conclusion, with some policy suggestions for the future.

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On Monday, the White House Council of Economic Advisers (CEA) released a report examining the long-term decline in the share of prime-age men (aged 25 to 54) who are either working or actively looking for work. What economists call the labor force participation rate for this population decreased from 98 percent in 1954 to 88 percent today, the second largest decrease among OECD countries. This trend has raised concerns not only for its impact on economic growth, but also because it seems to track an increase in mortality over that time, particularly among white males, as economists Anne Case and Angus Deaton have found.

The CEA report documents a number of possible explanations for this trend, including increasing rates of women in the workforce, rising disability insurance claims, falling demand for less-skilled workers, and barriers to employment for those with criminal records.

The report’s national analysis alone, however, obscures tremendous variation across the United States in employment among this critical group.

According to data from the Census Bureau’s American Community Survey, in 2014, 81 percent of prime-age men nationwide were employed (this statistic differs from the labor force participation rate in that it omits those who are looking for, but not in, work). Yet among the nation’s 374 metropolitan areas for which data are available, that rate ranged from over 93 percent in the oil boomtown of Midland, TX, to just over 50 percent in Kings County in California’s Central Valley.

There are clear regional patterns to this important statistic. Many of the metro areas with the highest employment rates for prime-age men are smaller places located in the middle of the country, from the Upper Midwest, to energy-rich areas in Texas and the Plains states, to the Intermountain West. In several large, economically dynamic metro areas such as Denver, Houston, Minneapolis, San Jose, and Washington, D.C., rates of work among prime-age men are also very high.

Of much greater concern is the large number of metropolitan regions with very low rates of work among prime-age men. These include many small former industrial centers in states like Michigan, Indiana, and Ohio; areas of West Virginia and Louisiana that rely on declining-employment industries like mining; and long-struggling agricultural economies in Arkansas, Texas, and inland California.

These patterns echo findings from the CEA report that falling demand for labor is an important part of the long-term decline in prime-age male employment. In many places where a high school diploma alone once provided the gateway to a middle-class job, nearly one-third of men in this age group are out of work. This is also evident in the local relationship between educational attainment and work—where educational attainment rates are higher among prime-age men, members of that group are more likely to be employed. A 10-percentage point difference in employment rates separates the most highly-educated quarter of metro areas from the least highly-educated quarter.

Beyond education, size seems to matter, too. Large metro areas exhibit higher rates of work among prime-age men than small metro areas. Across the 100 largest U.S. metro areas, 83.2 percent of prime-age males are employed, compared to 79.8 percent in the smaller 274 metro areas. This relationship partly reflects that men in large metro areas have higher rates of educational attainment than those in small metro areas. Yet even men who have no more than a high-school diploma work at higher rates in large metro areas (64 percent) than similarly educated men in smaller metro areas (62 percent). Larger regional economies with greater economic diversity may stimulate stronger demand for workers at lower skill levels.

Several of the policies that the CEA report recommends to improve prime-age male labor force participation, such as bolstering investment in public infrastructure, reforming unemployment insurance, and boosting educational attainment could help boost rates of work in lagging U.S. metro areas. However, none directly addresses the fact that problems in male employment disproportionately affect small and often economically isolated U.S. regions. This evidence suggests that policies to help dislocated workers relocate to larger, more economically dynamic metro areas—particularly by improving the supply of affordable housing in those regions—should be part of a comprehensive strategy to help reverse the troubling long-term decline in men’s work.

American voters are angry. But while the ill effects of globalization top their list of grievances, nobody is well served when complex economic issues are reduced to bumper-sticker slogans – as they have been thus far in the presidential campaign.

It is unfair to dismiss concerns about globalization as unfounded. America deserves to have an honest debate about its effects. In order to yield constructive solutions, however, all sides will need to concede some inconvenient truths – and to recognize that globalization is not the same phenomenon it was 20 years ago.

Protectionists fail to see how the United States’ eroding industrial base is compatible with the principle that globalization boosts growth. But the evidence supporting that principle is too substantial to ignore.

Recent research by the McKinsey Global Institute (MGI) echoes the findings of other academics: global flows of goods, foreign direct investment, and data have increased global GDP by roughly 10% compared to what it would have been had those flows never occurred. The extra value provided by globalization amounted to $7.8 trillion in 2014 alone.

And yet, the shuttered factories dotting America’s Midwestern “Rust Belt” are real. Even as globalization generates aggregate growth, it produces winners and losers. Exposing local industries to international competition spurs efficiency and innovation, but the resulting creative destruction exacts a substantial toll on families and communities.

Economists and policymakers alike are guilty of glossing over these distributional consequences. Countries that engage in free trade will find new channels for growth in the long run, the thinking goes, and workers who lose their jobs in one industry will find employment in another.

In the real world, however, this process is messy and protracted. Workers in a shrinking industry may need entirely new skills to find jobs in other sectors, and they may have to pack up their families and pull up deep roots to pursue these opportunities. It has taken a popular backlash against free trade for policymakers and the media to acknowledge the extent of this disruption.

That backlash should not have come as a surprise. Traditional labor-market policies and training systems have not been equal to the task of dealing with the large-scale changes caused by the twin forces of globalization and automation. The US needs concrete proposals for supporting workers caught up in structural transitions – and a willingness to consider fresh approaches, such as wage insurance.

Contrary to campaign rhetoric, simple protectionism would harm consumers. A recent study by the US President’s Council of Economic Advisers found that middle-class Americans gain more than a quarter of their purchasing power from trade. In any event, imposing tariffs on foreign goods will not bring back lost manufacturing jobs.

It is time to change the parameters of the debate and recognize that globalization has become an entirely different animal: The global goods trade has flattened for a variety of reasons, including plummeting commodity prices, sluggishness in many major economies, and a trend toward producing goods closer to the point of consumption. Cross-border flows of data, by contrast, have grown by a factor of 45 during the past decade, and now generate a greater economic impact than flows of traditional manufactured goods.

Digitization is changing everything: the nature of the goods changing hands, the universe of potential suppliers and customers, the method of delivery, and the capital and scale required to operate globally. It also means that globalization is no longer exclusively the domain of Fortune 500 firms.

Companies interacting with their foreign operations, suppliers, and customers account for a large and growing share of global Internet traffic. Already half of the world’s traded services are digitized, and 12% of the global goods trade is conducted via international e-commerce. E-commerce marketplaces such as Alibaba, Amazon, and eBay are turning millions of small enterprises into exporters. This remains an enormous untapped opportunity for the US, where fewer than 1% of companies export– a far lower share than in any other advanced economy.

Despite all the anti-trade rhetoric, it is crucial that Americans bear in mind that most of the world’s customers are overseas. Fast-growing emerging economies will be the biggest sources of consumption growth in the years ahead.

This would be the worst possible moment to erect barriers. The new digital landscape is still taking shape, and countries have an opportunity to redefine their comparative advantages. The US may have lost out as the world chased low labor costs; but it operates from a position of strength in a world defined by digital globalization.

There is real value in the seamless movement of innovation, information, goods, services, and – yes – people. As the US struggles to jump-start its economy, it cannot afford to seal itself off from an important source of growth.

US policymakers must take a nuanced, clear-eyed view of globalization, one that addresses its downsides more effectively, not only when it comes to lost jobs at home, but also when it comes to its trading partners’ labor and environmental standards. Above all, the US needs to stop retrying the past – and start focusing on how it can compete in the next era of globalization.

Editor's note: this piece first appeared on Project-Syndicate.org.

In a recent analysis, I highlighted how employment and disconnection among young people vary by age, race, and place. In this podcast, I dig deeper into the data on the Washington, D.C. region. Although the area generally performs well on employment measures, not all young people are faring equally well.

Listen to the full podcast segment here: 

June’s jobs gains, released this morning, show that 287,000 new jobs were added in June, an impressive rebound after only 11,000 new jobs were added in May (revised down from from 38,000 at the time of the release).

This year’s monthly job gains and losses can indicate how the economy is doing once they are corrected to account for the pattern we already expect in a process called seasonal adjustment. The approach for this seasonal adjustment that is presently used by the Bureau of Labor Statistics (BLS) puts very heavy weight on the current and last two years of data in assessing what are the typical patterns for each month.

In my paper “Unseasonal Seasonals?” I argue that a longer window should be used to estimate seasonal effects. I found that using a different seasonal filter, known as the 3x9 filter, produces better results and more accurate forecasts by emphasizing more years of data. The 3x9 filter spreads weight over the most recent six years in estimating seasonal patterns, which makes them more stable over time than in the current BLS seasonal adjustment method.

I calculate the month-over-month change in total nonfarm payrolls, seasonally adjusted by the 3x9 filter, for the most recent month. The corresponding data as published by the BLS are shown for comparison purposes. According to the alternative seasonal adjustment, the economy added 286,000 jobs in June (column Wright SA), almost identical to the official BLS total of 287,000 (column BLS Official).

Data updates released today for prior months also reveal some differences between my figure and the official jobs gains from prior months. The official BLS numbers for May were revised down from 38,000 new jobs to a dismal 11,000. My alternative adjustment shows that the economy actually lost 6,000 jobs in May, down from 17,000 jobs gained at the time of the release. [i] The discrepancies between the two series are explained in my paper.

In addition to seasonal effects, abnormal weather can also affect month-to-month fluctuations in job growth. In my paper “Weather-Adjusting Economic Data” I and my coauthor Michael Boldin implement a statistical methodology for adjusting employment data for the effects of deviations in weather from seasonal norms. This is distinct from seasonal adjustment, which only controls for the normal variation in weather across the year. We use several indicators of weather, including temperature and snowfall.

We calculate that weather in June brought up the total by 25,000 jobs (column Weather Effect), but this should be considered a transient effect. Our weather-adjusted total, therefore, is 262,000 jobs added for June (column Boldin-Wright SWA). This is not surprising, given that weather in June was in line with seasonal norms.

It’s good to see the jobs numbers rebounding this month. The May number was somewhat affected by the Verizon strike. Also, it is important to remember that pure sampling error in any one month’s data is large, and that could explain part of the weak employment report for May. Averaging over the last three months, employment is expanding by about 150,000 jobs per month—a healthy pace, although a bit of a step down from last year.

a. Applies a longer window estimate of seasonal effects (see Wright 2013). The June 2015 to May 2016 values in this column have been corrected to remove a coding error that affected the previously reported values.

b. Includes seasonal and weather adjustments, where seasonal adjustments are estimated using the BLS window specifications (see Boldin & Wright 2015). The incremental weather effect in the last column is the BLS official number less the SWA number.

[i] Note that, due to a small coding error, my alternative seasonal adjustment for May, at the time of the release, should have been 17,000 new jobs, not -4,000, as was reported in my previous post. In addition to the underlying data revisions, and correcting for this error, the revised alternative seasonal adjustment for May is -6,000 jobs added (second row of column Wright SA).