The news Monday from the Centers for Disease Control and Prevention (CDC) on the incidence of resistant infections is disturbing but not surprising. CDC estimates that over two million Americans every year are affected by drug-resistant infections and of those, 23,000 die annually. The report notes that these figures are conservative and are likely an underestimate of the burden of resistant infections. While these numbers reflect domestic rates, antibiotic resistance is a global issue as well.

To further compound the issue, today’s antibiotic pipeline is nearly dry and has been for some time, with only a handful of large pharmaceutical companies and smaller biotech firms still engaged in antibiotic development. The threat of a so-called ‘post-antibiotic era’ – a time when there are no longer any effective antibiotic treatments – could become a reality without a concerted and comprehensive effort to combat this global threat. The evolution of drug resistance is an inherent risk of antibiotic use. The CDC report cited the development of new antibiotics and diagnostic tools, as well as programs and policies to support appropriate use of antibiotics, as being among the core strategies to combat resistance.

Clinical effectiveness and the relatively low cost of antibiotics have had the unintended consequence of contributing to overuse, accelerating the development of antibiotic resistance to all major classes of antibiotics. While there are some diagnostic tools available to support targeted treatment, it is often more time- and cost-effective for a physician to prescribe a relatively inexpensive, broad-spectrum antibiotic than to conduct a diagnostic test (if one exists at all). Antibiotic overuse can also be driven by patients who see antibiotics as safe and often low-cost cure-alls. Recognizing that these past patterns of overuse are dangerous, the clinical community is working diligently to curb inappropriate use and promote public health through stewardship and education programs. However, given the weakness of the current antibiotic development environment, it may be too little-too late; rates of resistance continue to rise globally while the number of effective therapies to treat many pathogens is dwindling. According to the CDC, resistance can be ”slowed but not stopped” – there will always be a need for novel antibiotics that can combat the evolution of these pathogens.

The current system for manufacturer return on investment for antibiotics, which are typically reimbursed at very low levels, is oriented towards volume sales. As a result, stewardship and educational programs geared toward limiting use of novel antibiotics create an ‘antibiotic development paradox.’ How can we incentivize investment in developing new effective antibiotics and also have successful programs that limit the use of these antibiotics in an effort to prevent or delay the development of resistance? Unless this fundamental conflict in the current business model is addressed, pharmaceutical firms are unlikely to expand development efforts.

How do we turn the tide?

There are several proposals that address aspects of the antibiotic development paradox with the goal of reinvigorating the antibiotic drug development ecosystem in a way that maximizes our ability to stay ahead of resistance. While none of these proposals alone will solve this problem, each could support the long-term goal of reinvigorating antibiotic discovery, development, and treatment.

Creating incentives for drug development

Antibiotic drug development has been a losing prospect for drug developers and has driven many of them to exit the antibiotic innovation space in the last few decades in favor of other therapeutic areas that have much larger markets and are easier areas to study. In order to make antibiotic development more attractive, various mechanisms have been proposed to stimulate or better reward successful clinical development. Incentives that can lower the financial risks associated with development include grants, tax credits, public-private partnerships, and intellectual property protections. Post-approval, prizes, advanced market commitments, and value-based pricing could all potentially provide additional incentives to invest in this research. Some potential incentives were discussed at the Incentives for Change: Addressing the Challenges in Antibacterial Drug Development workshop convened by Brookings in February 2013.

Balancing benefit and risk for severely-ill patients

Other incentives are related to the drug approval process. Novel mechanisms for expedited development and approval can speed time to market while still meeting traditional evidentiary requirements for safety and efficacy. In the last several years, a number of proposals – including from the Infectious Diseases Society of America and the President’s Council of Advisors on Science and Technology – have sought to reduce development time and cost and increase regulatory clarity through a more targeted clinical trial process directed at the highest-risk patients. A narrower study population would allow the U.S. Food and Drug Administration to make a more targeted assessment of the product’s safety, efficacy, and benefit-risk profile that could accelerate innovation for patients with serious drug-resistant infections. The need to steward these antibiotics, which was noted as a core action in the CDC report, would be especially important to both prevent the growth of resistance and to reduce the risk of adverse effects in less seriously-ill populations. Additional information on the proposed limited-use pathway and appropriate use is available on the Brookings website.

De-link reimbursement from return on investment

In order to attract investment for new antibiotic research, we must develop a business model that can support ongoing and expanding development without compromising the effectiveness of new therapies. Recognizing the need to “de-link” return on investment from the volume of antibiotics sold, efforts to move away from the volume-based reimbursement system could become an attractive path forward. Promising models, which were discussed at the Brookings workshop in February, included several guaranteed payment schemes supported by public funding. Taken to an extreme, such a system could even allow new antibiotics to be reserved indefinitely until needed, removing the developer’s incentive to sell any drugs in the years following approval. While such a program would likely be expensive (with sufficient returns estimated on the order of $1.75-2.5 billion over five years), government intervention is needed to fix this public health crisis and dangerous market failure. Its societal value in curtailing resistance and providing critical drugs would outweigh the cost to taxpayers.

The antibiotic development paradox will require a multi-pronged strategy that includes incentives to support front-end drug discovery and development, and new reimbursement policies that de-link unit volume sales from return on investment. However, this is by no means a quick fix. Even if this approach is successful, it will take decades for manufacturers to rebuild lost antibiotic development infrastructure and expertise, and to successfully develop and market new treatments. For the few drugs currently in development, even with expedited development and review pathways, they are still years from reaching the market.

Event Information

Antibacterial drug resistance is a global public health threat poised to worsen due to the combination of the inappropriate use of existing drugs and a marked decline in innovative antibacterial drug development. In order to tackle this problem, stakeholders must consider comprehensive strategies that address both drug development and stewardship.

On February 7, the Engelberg Center for Health Care Reform convened an expert workshop, “Modernizing Antibacterial Drug Development and Promoting Stewardship” to explore a two-pronged approach to combating antibacterial drug resistance that includes: 1) the development of pathogen-focused antibacterial drugs that target the most serious public health threats; and 2) stewardship efforts for all antibacterial products in order to preserve their utility. Participating stakeholders included experts from the drug development and health care industries, the clinical community, government, and academia. These stakeholders shared their insights on potential frameworks and evidentiary considerations for pathogen-focused drug development, and efforts underway to promote the appropriate use of commonly used antibacterial drugs in the ambulatory care setting.

Event Materials

• Antibiotic Development Slides
• 07 antibacterial expert workshop discussion guide
• 07 antibacterial expert workshop public agenda
• 07 antibacterial expert workshop meeting summary

Event Information

Antibacterial drugs are a critical component of the nation’s public health armamentarium, and have saved millions of lives by preventing and treating a range of bacterial infections. However, antibacterial drug development has been hampered by challenges unique to the antibacterial drug market, which have stifled innovation and left patients and providers with fewer options to treat increasingly resistant infections. One consequence of the dwindling antibacterial drug pipeline has been a reduction in effective oral antibacterial drug treatment options, which are particularly important in the ambulatory and transitional care contexts. Recent proposals to re-invigorate the antibacterial pipeline are geared towards serious infections treated in the inpatient setting, which may lead to a greater focus on intravenous therapies. However, addressing both current and future needs in the infectious diseases space will require a balanced mix of both oral and parenteral antibacterial drugs.

In cooperation with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform at Brookings held an expert workshop on November 20, 2014, to identify the most promising strategies to support oral antibacterial drug development. Participating stakeholders included experts from the drug development and health care industries, the clinical community, government, and academia. These stakeholders shared their insights on potential regulatory, scientific, and economic strategies to reinvigorate the oral antibacterial drug pipeline. 

Event Materials

• Reinvigorating the Oral Antibacterial Drug Development Pipeline Agenda
• Reinvigorating the Oral Antibacterial Drug Development Pipeline Discussion Guide
• Biographies 20141118
• Reinvigorating the Oral Antibacterial Drug Development Pipeline Slide Deck

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

Barack Obama’s presidency has witnessed widespread change throughout Africa. His four trips there, spanning seven countries, reflect his belief in the continent’s potential and importance. African countries face many challenges that span issues of trade, investment, and development, as well as security and stability. With President Obama’s second term coming to an end, it is important to begin to reflect on his legacy and how his administration has helped frame the future of Africa.

On July 19, the Center for 21st Century Security and Intelligence at Brookings hosted a discussion on Africa policy. Matthew Carotenuto, professor at St. Lawrence University and author of “Obama and Kenya: Contested Histories and the Politics of Belonging” (Ohio University Press, 2016) discussed his research in the region. He was joined by Sarah Margon, the Washington director of Human Rights Watch. Brookings Senior Fellow Michael O'Hanlon partook in and moderated the discussion.

Video

• President Obama’s role in African security and development

Audio

• President Obama’s role in African security and development

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20160719_us_africa_transcript

The greatest tragedy of the Israeli-Palestinian gridlock, aside from the many lives lost, is that the parameters of any future agreement are already known to all sides involved. These are the common parameters of then-Prime Minister Ehud Barak’s proposal at Camp David II in 2000, the Clinton Parameters of December of that year, and former Prime Minister Ehud Olmert’s initiative in 2008.

Broadly speaking, Israel would be required to forfeit the dream of a Greater Israel, to agree to the two-state solution based on the 1967 borders with land swaps, and to accept some Palestinian presence in the Arab neighborhoods of East Jerusalem and in the Holy Basin. The Palestinians would have to agree to an end of conflict and an end of claims, a solution for the Palestinian refugee problem only within the borders of a future Palestinian state (not Israel), and limitations on their sovereignty due to security concerns. Unfortunately, national narratives and aspirations, religious beliefs, perceptions of historic justice, and the practical lessons each side learned in the recent past have all prevented the leaders of both sides from convincing their publics of the need for such concessions—which are necessary for an agreement.

Plans A and B

Reaching an agreement is harder today than it was in either 2000 or 2008. Even the moderates among the Palestinians are unwilling to concede a right of return, to acknowledge an “end of conflict and end of claims,” to recognize Israel as a Jewish state, or to allow basic security arrangements that will ease Israel’s justified concerns. It appears that in 2016, the Palestinians do not view a two-state solution, along the Clinton Parameters, as a preferred outcome. Instead, their discourse is rooted in a "return of rights" in historic Palestine as a whole (including Israel), in accordance with both the Hamas and Palestine Liberation Organization (PLO) charters. Indeed, the Palestinian positions have not budged much since Camp David II in 2000.

Photo courtesy of REUTERS/Carlo Allegri

Instead, the Palestinians have an attractive (in their view) “Plan B,” which is to get the Israeli concessions in international decisions, without having to make their own concessions—all while denouncing Israel and delegitimizing it in international forums. Since 2008, there are strong indications that the international route was actually the Palestinian "Plan A"—hence their intransigence in entering the talks and in the negotiations themselves. 

A sustainable—but undesirable—status quo

The continuation of the status quo—which appears so problematic to many Israelis and Americans—represents for the Palestinians a favorable strategic avenue that would lead, eventually, to an Arab-majority, one-state outcome. When Americans, Europeans, and even elements of the Israeli public repeatedly warn that Israel will be “lost” if it allows the status quo to persist, it does not encourage Palestinian moderation or willingness to compromise. Instead, it strengthens the underlying Palestinian assumption that a failure of negotiations is a reasonable option from their perspective. For the Palestinian leadership, all paths lead to the same destination: either Israel accepts their conditions (which, through flooding Israel with refugees, will lead to the demise of Israel as a Jewish state) or the status quo persists and Israel is supposedly lost.

Photo courtesy of REUTERS/Amir Cohen

Moreover, any demand made of Israel that it alter the status quo must convince the Israelis that their situation will not deteriorate further. The days of the Second Intifada—a terror campaign initiated by Yasser Arafat after the failure of Camp David with dozens of dead each month—are still etched in the collective Israeli memory. Similarly, Israelis are unwilling to accept a West Bank that would be a base for rocket launching, tunnels, and a continuation of terrorism against Israel, as is Gaza, which Israel fully evacuated. Only a move that would provide Israel security and full legitimacy to act against future Palestinian terrorism will create public support in Israel to move toward a two-state solution. 

Yet, while the status quo is much more sustainable than the conventional wisdom claims—for reasons beyond the scope of this post—it is certainly not desirable, since it furthers Israel from its goal of a Jewish, democratic, safe, and just state of Israel. It is therefore important that Israel have a viable alternative plan that is not merely a continuation of the status quo. 

Four paths for an Israeli alternative

There are more than two options, muddling through in the status quo or accepting Palestinian demands in full. If Israelis cannot get peace in terms that secure an end of conflict, security, and no "right of return," we must look for another option—an Israeli Plan B. 

An Israeli Plan B would consist of a proactive effort to formulate the future borders of the state of Israel in one of four paths in order of preference: 1) a negotiation process resulting in a final status agreement, 2) a regional agreement, 3) an interim bilateral agreement, or 4) in the case a negotiated agreement cannot be realized, an independent Israeli determination of its own borders. 

First, Israel should present an initiative for a final agreement with the Palestinians, based on the Clinton Parameters: generous borders for a future Palestinian state, demilitarized Palestinian state and no compromises on Israeli security, a commitment to an end of conflict and end of claims, and a Palestinian relinquishment of implementing a “right of return.” This should be followed by a comprehensive effort to reach an agreement on the basis of the Israeli proposal. Such a move should be led by the leadership on both sides in order to foster genuine relations based on trust. 

Photo courtesy of REUTERS/Asmaa Waguih

Should the (preferable) bilateral track fail, Israel should move to a regional track, including the moderate Arab states—led by Egypt, Saudi Arabia, and Jordan—in an effort to reach a final status agreement. This effort could be grounded in an updated version of the Arab Peace Initiative—as a starting point rather than a take-it-or-leave-it proposition. Such a plan should be decoupled from the issue of the Golan Heights (given the situation in Syria today and in the foreseeable future) and should not be conditional on a solution to the refugee problem according to U.N. Security Council Resolution 194 from 1949. 

The pragmatic Arab states have the capacity to add much-needed value to the table in order to move the negotiations beyond a zero-sum game on the territorial, financial, security, and ideological levels. However, if the moderate Arab states are unwilling or unable to contribute, Israel can aim to secure interim agreements with the Palestinians. Interim agreements would necessitate abandoning the principle of “nothing is agreed until everything is agreed” and shifting the paradigm to a principle of gradual implementation of any area of agreement, deferring talks on more contentious subjects to a later time. 

Only if all these paths fail, Israel should embark on a long-term independent strategy for shaping its borders. This strategy should be innovative and creative, removing the effective veto Palestinians have through negotiations on Israel future. It would require as much coordination as possible with the United States and the international community. It would leave open the option for a return to the negotiating table and to a negotiated settlement, and reinforces the agreed two-state solution paradigm. Likewise, this route undermines and prevents the most problematic outcomes, namely the continuation of the status quo or a final agreement without an end of conflict and security arrangements, and the flooding of Israel with refugees. 

An independent route suffers from a bad reputation within Israeli society, as a consequence of the perceived failure of the unilateral withdrawal from Gaza in 2005. As discussed below however, the Gaza precedent can provide valuable lessons for the West Bank that can mitigate the potential pitfalls of such a move. 

Four lessons from the disengagement plan

Any independent move with unilateral elements suffers from strong negative connotations among Israelis because of the perceived failure of the "disengagement" from Gaza in 2005, though I know of no one in Israel who wants to regain control over the 1.7 million Palestinians in the Gaza Strip. Still, while then-Prime Minister Ariel Sharon was right to initiate the disengagement plan, it was riddled with strategic errors. Four major miscalculations also offer lessons for a future independent move:

1. The plan was initiated without securing a strong internal Israeli or international backing. Israel must show that it is ready for substantial concessions in certain areas in order to be able to put forward significant demands in others. Therefore, the first move in a future plan should begin with a genuine and generous peace proposal to the Palestinians. If the Palestinians again show intransigence, and if Israel demonstrates a willingness to accept compromise, then there will be a significantly increased likelihood for international acceptance of independent Israeli measures to work toward building a two-state reality.
2. The Israelis left an open border between the Gaza Strip and Sinai, evacuating the “Philadelphi line” on the Gaza's Strips border with Egypt, which Hamas subsequently used to rearm with smuggled weapons from Iran and Libya. This mistake must not be repeated in the West Bank, and so the Jordan Valley—that separates the West Bank from Jordan—must stay under Israeli control, preventing arms smuggling into the West Bank. These moves therefore offer a clear separation between ending the occupation and expanding Palestinian self-rule on the one hand, and taking decisive action to prevent the buildup of terrorism in the West Bank, on the other.
3. Sharon ordered the complete evacuation of all of the Gaza Strip in order to gain world recognition of an end of the occupation there. In reality, it did not achieve this outcome and left Israel without any bargaining chips for future negotiations. A future Israeli redeployment should only be to the security barrier, or close to it, leaving Israel in possession of the main settlement blocs and other strategic areas, some of which could be used as future bargaining chips.
4. There was a complete lack of communication between the Israeli leadership and the evicted Israelis, as well as the lack of planning that botched their resettlement to this day. In order for any future plan to succeed, there is a need for an open and serious conversation within Israeli society—including through elections or a referendum—that would gradually build the societal trust needed for such a move. 

Photo courtesy of REUTERS/Amir Cohen

So, an independent Israeli strategy would therefore involve:

• Israel’s willingness to hand over 80 to 85 percent of the West Bank—a willingness demonstrated by undertaking concrete steps on the ground. Israel would need to initiate further redeployments from the West Bank not including the Jordan Valley and East Jerusalem;
• The transfer of Area B and much of Area C to a full Palestinian responsibility;
• The full completion of the Security Barrier in areas that are currently lacking in order to provide Israel with a contiguous and defensible border;
• A full cessation of Israeli settlement construction beyond the declared lines;
• A plan, preferably under an agreement, to resettle Israelis living east of these lines into Israel-proper, preferably to the Galilee, the Negev, and the main settlements blocs; and 
• The responsibility for the security of Israel remaining in the hands of the Israeli Defense Forces (IDF) and the proper Israeli authorities. Israel must preserve its capacity to conduct preventive action, hot pursuit, border control, and air security. However, the IDF must try to minimize such operations in the evacuated territories.

Drawbacks of an independent strategy

The proposed independent course of action is not ideal, and has elements that will be difficult to implement. Its main weaknesses are:

• The difficulty of formulating a political plan that would be all-inclusive and that could feasibly garner wide acceptance within Israeli society. Today, the right wing in Israel would view such a plan as a capitulation to the Palestinians, a forfeiture of parts of the Land of Israel, and a withdrawal from territory without gaining anything in return. The left would also be appalled from the lack of agreement with the Palestinians. The Israeli public at large does not recognize the need to change the status quo.
• The widespread unpopularity of evacuating Israelis from the settlements. Since the 2005 Disengagement Plan, no Israeli government has dared to directly address this topic. Israel’s leadership would need to oversee prolonged financial, social, and political preparations for such a strategy. Likewise, it would require coordination with the settler leadership to ensure the maximum possible cooperation from the settler population.
• Obtaining international legitimacy—something that should not be taken for granted. Israel can mobilize the international community only if it shows that this course preserves the feasibility of a two-state solution. It must work to counter the perception in the international community that this two-state framework is rapidly becoming irrelevant. Halting settlement construction would provide a much-needed signal from Israel showing its sincere desire to end the conflict, and would promote international efforts to build a future Palestinian state.
• The inherent tension between Israel’s need to ensure its future security and its desire to provide the Palestinians with the essential tools for self-government. Balancing these two requirements would continue to pose major challenges for the future.

Photo courtesy of REUTERS/Amir Cohen

Try, try, try again

This independent strategy would allow Israel to pursue a solution from a point of strength, rather than being dictated by outside forces or waves of terror. It represents a long-term, paradigm-changing option which would preserve the two-state solution while removing several of the most serious obstacles to such a solution. 

Zionism always yearned for a future that has seemed impossible at times. Generations of people have strived to achieve it, often overcoming great obstacles amid harsh realities. In our generation, we too can succeed.

Event Information

The Brookings Doha Center (BDC) hosted a panel discussion on April 19, 2016, about the ongoing reconstruction of the Gaza Strip. The panelists included Omar Shaban, director of Pal-Think, a research institution based in Gaza; and Naglaa Elhag, head of rehabilitation and international development at the Qatar Red Crescent Society (QRCS). Sultan Barakat, the BDC’s director of research, moderated the event, which was attended by members of Qatar’s diplomatic, academic, and media community.

Barakat opened by noting the slow progress of reconstruction in Gaza. Almost two years since the cessation of hostilities between Hamas and Israel, the rebuilding process has stalled for a number of reasons. First, the distribution of aid money pledged by donor countries during the October 2014 Cairo Conference has slowed. According to the World Bank, as of March 31, 2016, donor countries had dispersed only 40 percent of the pledged money. At the current rate, the fulfillment of all pledges will not occur until 2019, two years after the target date. Second, construction materials only enter Gaza from one border crossing. As a result of the sluggish rebuilding process, only 9 percent of totally damaged houses and 45 percent of partially damaged houses in Gaza have been repaired, leaving over 14,800 families internally displaced. Additionally, job opportunities promised by various construction projects have failed to materialize, leading to increased feelings of desperation and frustration among Gaza’s population.

Shaban expanded on these developments, expressing the notion that the people in Gaza feel neglected. Due to the high levels of frustration, he feels that a new round of hostilities between militants and Israel could happen at any moment. He explained further by highlighting the volatility of the area and mentioning how previous conflicts were easily ignited by an array of incidents: a kidnapping, a cross-border raid, an assassination, continuous rocket fire. Since frustration among Gazans continues to mount, arguably to its highest level, renewed conflict seems almost certain. Consequently, Shaban argued, fear of another round of conflict between Hamas and Israel has instilled a sentiment of donor fatigue. Donors do not want to see their support go to waste in another round of destruction, turning the delivery of assistance into an exercise of futility.

Shaban attributed this attitude among some donors to the lack of a political solution to the crisis in Gaza. Hamas, the de-facto governing authority in Gaza, does not work for the people, nor does the Palestinian Authority (PA), based in Ramallah. Neither body provides economic opportunities for Gazans, as those employed by either the PA or Hamas often do not receive their salaries. Reconciliation talks between both groups failed to establish a unity government. Egypt, Israel, and the United States would feel more comfortable negotiating with a unity government, presumably dominated by the PA, not Hamas, which each of the aforementioned countries designate as a terrorist organization. If the PA does reach an agreement with Hamas, Egypt has implied that it would open its border with Gaza at Rafah, as long as the PA stations a security presence at the crossing. This could enhance the slow trickle of construction materials into Gaza, allow for the increased export of commercial goods, and also enable Gazans to leave and return at a higher rate than currently permitted. According to Shaban, opening another access point for Gaza to the outside world would temporarily ease the burden faced by Gaza’s citizens, but the current crisis requires a solution to ameliorate the economic and political situation in the long term.

Elhag opened her remarks by reviewing the difficulties of implementing aid projects in Gaza. While working in Gaza for the QRCS, she noticed little progress from international agencies, as they do not address the main problems, typically taking short cuts, which she highlighted by stating, “We don’t treat the wounds, we cover it with a bandage.” To elaborate on this point she mentioned that lack of access in and out of Gaza and the Israeli naval blockade as two factors hindering reconstruction. Due to these restrictions, aid workers have difficulty entering Gaza. Elhag surmised that the lack of accountability on the part of international agencies and the Israelis and the fear of aid projects being destroyed again because of the political situation both contribute to the stalled reconstruction, producing grim realities in Gaza.

Furthermore, Elhag explained that a resolution to the Gaza crisis does not rest on the distribution of money. She believes that only solutions from both sides of the conflict will end the suffering in Gaza. To exemplify the frustrations felt by donors, Elhag noted that since 2008, QRCS invested $100 million in housing units and other aid projects in Gaza, but some of these projects were destroyed during the 2014 war. QRCS observed this and shifted their focus to securing food sources and enhancing the education and health sectors in Gaza.

At the conclusion of Elhag’s observations, Barakat asked the panel where the money donated for reconstruction goes and how the Gaza reconstruction mechanism (GRM) works. Shaban described how the money actually gets funneled through the PA’s ministry of finance in Ramallah, before it reaches Gaza. Hamas officials or members of Gaza’s civil society do not oversee any aspect of aid distribution. So from the start, the distribution of funds lacks transparency, as the PA gives the money to the U.N. office in Gaza, which administers the GRM. From there, the United Nations composes a list of people in Gaza that require construction materials. The Israeli administrative body in the ministry of defense, the Coordination of Government Activities in the Territories (Cogat), must approve the names on the list. Construction materials can then be distributed through the GRM. Shaban concluded his explanation of the GRM by noting the many levels of bureaucracy involved have created a slow distribution process for a populace in desperate need.

From the regional perspective, some Arab states’ past political differences with Hamas has stymied political progress in Gaza, but the panel agreed that some of these relationships, especially with Saudi Arabia, are on the mend. The work of regional actors like Egypt, Qatar, Saudi Arabia, and Turkey could help push a reconciliation deal between Fatah and Hamas. Shaban proposed allowing some Hamas members to take part in any future coalition government, as some of their relationships in Sinai could help Egypt secure the troubled region. Cooperation on security matters between Egypt and Hamas could inspire enough confidence in the Egyptians for them to open the Rafah crossing.

Ending the discussion, Barakat clarified the proposals of the panel by reiterating the need for donors to fulfill aid pledges. The GRM needs reform, especially through the inclusion of Gaza’s civil society in the reconstruction process. Finally, reconciliation between Fatah and Hamas, as well as Egypt and Hamas, would help foster security cooperation at the borders.

Video

• Reviving the stalled reconstruction of Gaza

Transcript

• Event Transcript (.pdf)

Event Materials

• gaza transcript

Two years after Hamas and Israel agreed to a cessation of hostilities, reconstruction in Gaza has been painfully slow. This was the focus of a panel discussion at the Brookings Doha Center on April 19. As Senior Fellow and Director of Research Sultan Barakat explained, rebuilding has stalled in part because the distribution of aid money pledged by donor countries during the October 2014 Cairo Conference has slowed; according to the World Bank, donor countries had dispersed only 40 percent of the pledged money as of the end of March. At this rate, the pledged funds will not be dispersed until 2019, two years after the target date.

Moreover, construction materials only enter Gaza through one border crossing and must be cleared by layers of bureaucracy. As Omar Shaban—director of Pal-Think, a research institution in Gaza—explained, money for Gaza reconstruction is funneled through the PA’s ministry of finance in Ramallah, which transfers it to the U.N. office in Gaza. The United Nations composes a list of people in Gaza that require construction materials, and the Coordination of Government Activities in the Territories (Cogat)—an Israeli administrative body in the ministry of defense—must approve the names on the list. The U.N. then distributes construction materials. Shaban emphasized that the bureaucratic nature of this process has slowed reconstruction considerably, adding that the process isn’t transparent enough, since neither Hamas officials nor members of Gaza’s civil society oversee any aspect of aid distribution.

As a result of the sluggish rebuilding process, Barakat said, only 9 percent of totally damaged houses and 45 percent of partially damaged houses in Gaza have been repaired, leaving over 14,800 families internally displaced. Meanwhile, promised job opportunities in construction projects have failed to materialize, exacerbating feelings of desperation and frustration among Gaza’s population.

[T]he process isn’t transparent enough [said Shaban], since neither Hamas officials nor members of Gaza’s civil society oversee any aspect of aid distribution.

Shaban agreed that people in Gaza feel neglected. With high levels of frustration, he expressed fear that a new round of hostilities between militants and Israel could begin at any time. Previous conflicts were easily ignited—by a kidnapping, a cross-border raid, an assassination, or continuous rocket fire. Shaban argued that the volatility of the situation may be heightening fatigue among donors, who do not want to see their support go to waste in another round of destruction.

Naglaa Elhag, head of rehabilitation and international development at the Qatar Red Crescent Society (QRCS), discussed the difficulties of implementing aid projects in Gaza. She argued that international agencies do not always address the main problems and typically take shortcuts, saying of her own organization and others: “We don’t treat the wounds, we cover it with a bandage.” She highlighted various factors slowing reconstruction, including the lack of accountability on the part of international agencies, fears of renewed conflict, and the Palestinian political stalemate. Since 2008, according to Elhag, QRCS invested $100 million in housing units and other aid projects in Gaza, but some were destroyed during the 2014 war. As a result, QRCS shifted its focus away from physical reconstruction and towards food security, education, and health. 

A related problem is the Palestinian political stalemate. According to Shaban, neither Hamas (the de-facto governing authority in Gaza) nor the Palestinian Authority (PA, based in Ramallah) provides economic opportunities for Gazans, and those nominally on Palestinian government payrolls often do not receive their salaries. Reconciliation talks have failed to establish a unity government, making Egypt, Israel, and the United States reticent to negotiate. Egypt has indicated that if the PA does reach an agreement with Hamas, it would open its border with Gaza at Rafah (presuming the PA has a security presence there). This could increase the flow of construction materials into Gaza, allow for the increased export of commercial goods, and enable Gazans to come and go more frequently. But while opening another crossing for Gaza would temporarily ease the burden faced by the people there, Shaban stressed that a long-term political and economic solution is needed. Elhag, too, emphasized that a resolution to the Gaza crisis isn’t about the distribution of money—rather, she believes a joint Israeli-Palestinian solution is needed to end the suffering in Gaza. 

In the past, tensions between some Arab states and Hamas have also hampered progress in Gaza, but the panelists agreed that some of these relationships—especially with Saudi Arabia—are on the mend. Regional actors like Egypt, Qatar, Saudi Arabia, and Turkey could help push a reconciliation deal between Fatah and Hamas, which would help improve the situation in Gaza. And as Barakat stressed in conclusion, there is an urgent need for donors to fulfill aid pledges and for the Gaza reconstruction mechanism to become more inclusive, so that Gazans themselves can more fully participate in rebuilding their neighborhoods. 

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.

Quickly following on the heels of the midterm elections, Senate Majority Leader Mitch McConnell (R-KY) indicated that the medical device tax was a key target for repeal in the 114th Congress. Today, the Senate Finance Health Care Subcommittee will hold a hearing about the effects of the 2.3 percent tax that was included in the Affordable Care Act. Many believe that a repeal is, in fact, possible. Below is a basic primer about the tax and its contentious history.

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

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

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

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

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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

Event Information

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

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

Event Materials

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

Summary

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

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

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

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

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

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

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

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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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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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This paper lays out the fundamentals of a downtown turnaround plan and the unique "private/public" partnership required to succeed. Beginning with visioning and strategic planning to the reemergence of an office market at the end stages, these 12 steps form a template for returning "walkable urbanism" downtown.

Though every downtown is different there are still common revitalization lessons that can be applied anywhere. While any approach must be customized based on unique physical conditions, institutional assets, consumer demand, history, and civic intent, this paper lays out the fundamentals of a downtown turnaround plan and the unique "private/public" partnership required to succeed. Beginning with visioning and strategic planning to the reemergence of an office market at the end stages, these 12 steps form a template for returning "walkable urbanism" downtown.

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In this speech at the annual meeting of the Downtown Detroit Partnership, Chris Leinberger discussed the downtown Detroit strategic planning process Brookings has started in partnership with the University of Michigan.

The metro program hosts and participates in a variety of public forums. To view a complete list of these events, please visit the metro program's Speeches and Events page which provides copies of major speeches, PowerPoint presentations, event transcripts, and event summaries.

Selected Media Coverage
Expert Offers Tips to Give Downtown a Lift
UM Land-Use Strategist: Detroit Poised for Downtown Redevelopment

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Demand for more walkable, mixed use neighborhoods is growing across the United States. However, the challenges associated with fi nancing these developments are allowing much of this demand to go unmet. This paper discusses how more, and more upfront, patient equity in walkable projects—from various sources and providers—would facilitate their development, and yield high returns over the long term. The paper also examines how patient equity contributed to the success of several such developments built over the past 15 years, illustrating untapped potential. Finally, it notes the role the public sector can play in providing patient equity investments.

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It is hard to find good news these days, especially coming from Sacramento, the capital of one of the most hard-pressed states in the country. Yet an evolving model of development is emanating from the metropolitan area that is being watched carefully around the country.

This model could inspire sweeping national transportation, energy and climate change legislation and future infrastructure investment and real estate development.

The model started with the much-admired Blueprint Project, led by the Sacramento Area Council of Governments. Next came Senate Bill 375, calling for regional transportation and development plans that minimize auto dependency, reduce climate change gas emissions and encourage walkable urban development. The next steps are the Sacramento Regional Transit Master Plan and Transit-Oriented Guidelines, to be released in May. Taken together, they offer a bold effort to give the market what it wants: the choice of the well-known drivable suburban or walkable urban development, the basis of the next American Dream.

For the past half-century, American households demanded and got only one way of living and working, the suburban way that meant driving. Basically, California invented this way of life and exported it across the country and around the world. We all reveled in it. The songs of the Beach Boys and Jan and Dean still echo through my mind, reminding me of a way of life and a way of developing our communities that was seductive at the time.

Little did we know of the unintended consequences of drivable suburban development pattern, including:

• Land consumption eight to 12 times that of population growth.
• Significant increase in car-miles driven and foreign oil consumed, mostly from hostile countries.
• The onset of the obesity, diabetes and asthma epidemics related to a car-dependent lifestyle, especially among our children who cannot even walk to school anymore.
• Household income diverted from wealth building to paying for a fleet of depreciating cars, taking at least 25 percent of income vs. less than 5 percent a century ago.
• The quality of life for the community goes down when more drivable suburban development occurs, such as the next strip mall. This leads to not-in-my-backyard opposition. According to a soon-to-be-released Brookings Institution study, car-dependent households emit three times the climate change gases, such as carbon dioxide, as a walkable urban household.

Editor's Note: In this blog, Vera Songwe introduces the African Leadership Transitions Tracker, a new interactive that aims to start a broader conversation about leadership transitions and what they mean for the region and beyond.

On March 28, Nigerians voters will go to the polls to participate in their nation’s fifth election since the military handed over power to civilians in 1999. As Africa’s largest economy and an important oil exporter, this election comes at an important time for Nigeria and for the continent as a whole.

The recent passing of Singapore’s 30 year-long leader Lee Kwan Yew credited with having taken Singapore from a third world country to a fully developed country in less than a generation, has brought the question of leadership and leadership transitions back to the fore. A 2010 report by Michael Spence’s Growth Commission heralds Lee Kuan Yew as the hero of Singapore’s growth story. The African Leadership Transition Tracker hopes to launch a dialogue on what the frequency, nature, and scope of leadership transitions mean for African countries’ growth, stability, and development trajectory overall. Moreover, how have transition trends in the region changed from the time of the African founding fathers and the tumultuous years of the 1960s to the present day?

As an initial step towards thinking this question through, Brookings’s African Growth Initiative is today launching the African Leadership Transitions Tracker as a resource both to inform readers about African political history and a tool to initiate analysis on what leadership changeover might mean (or not mean) for development. The Transitions Tracker specifically records all changes that have occurred at the head-of-state level in every African country between the end of the colonial period and the present day. We are hoping that recording this information and presenting it visually (and as a downloadable data set) will help start a broader conversation and support additional work on these issues. Brookings will update this data on a regular basis, and we welcome your feedback as we further refine this interactive. Moreover, the information we present today is by no means the full story—key variables are needed to complement this study, including, for example, the various political party affiliations of leaders within a country or cross tabulations with resources that seek to measure the level of citizen participation and engagement in these transitions. However, as further analysis takes place, we are hoping that the African Leadership Transitions Tracker will enrich dialogue about developments occurring in the region and place current news on elections or other types of changeover events within the broader context of the continent’s leadership story overall.  Over the next few months, we will be running a series of articles based on this data.  

Special thanks to Ehui Adovor, graduate student at George Washington University and the many AGI research assistants, analysts, and program staff that have supported this project, including Jessica Pugliese, Brandon Routman, Christina Golubski, Andrew Westbury, and Amy Copley.

Editors' Note: It has perhaps never been more important to question the prevailing wisdom on the 2011 United States-led intervention in Libya, writes Shadi Hamid. Even with the benefits of hindsight, he argues, many of the criticisms of the intervention fall short. This post originally appeared on Vox.

Libya and the 2011 NATO intervention there have become synonymous with failure, disaster, and the Middle East being a "shit show" (to use President Obama’s colorful descriptor). It has perhaps never been more important to question this prevailing wisdom, because how we interpret Libya affects how we interpret Syria and, importantly, how we assess Obama’s foreign policy legacy.

Of course, Libya, as anyone can see, is a mess, and Americans are reasonably asking if the intervention was a mistake. But just because it’s reasonable doesn’t make it right.

Most criticisms of the intervention, even with the benefit of hindsight, fall short. It is certainly true that the intervention didn’t produce something resembling a stable democracy. This, however, was never the goal. The goal was to protect civilians and prevent a massacre.

Critics erroneously compare Libya today to any number of false ideals, but this is not the correct way to evaluate the success or failure of the intervention. To do that, we should compare Libya today to what Libya would have looked like if we hadn’t intervened. By that standard, the Libya intervention was successful: The country is better off today than it would have been had the international community allowed dictator Muammar Qaddafi to continue his rampage across the country.

Critics further assert that the intervention caused, created, or somehow led to civil war. In fact, the civil war had already started before the intervention began. As for today’s chaos, violence, and general instability, these are more plausibly tied not to the original intervention but to the international community’s failures after intervention.

The very fact that the Libya intervention and its legacy have been either distorted or misunderstood is itself evidence of a warped foreign policy discourse in the U.S., where anything short of success—in this case, Libya quickly becoming a stable, relatively democratic country—is viewed as a failure.

NATO intervened to protect civilians, not to set up a democracy

As stated in the U.N. Security Council resolution authorizing force in Libya, the goal of intervention was "to protect civilians and civilian populated areas under threat of attack." And this is what was achieved.

In February 2011, anti-Qaddafi demonstrations spread across the country. The regime responded to the nascent protest movement with lethal force, killing more than 100 people in the first few days, effectively sparking an armed rebellion. The rebels quickly lost momentum, however.

I still remember how I felt in those last days and hours as Qaddafi’s forces marched toward Benghazi. In a quite literal sense, every moment mattered, and the longer we waited, the greater the cost.

It was frightening to watch. I didn’t want to live in an America where we would stand by silently as a brutal dictator—using that distinct language of genocidaires—announced rather clearly his intentions to kill. In one speech, Qaddafi called protesters "cockroaches" and vowed to cleanse Libya "inch by inch, house by house, home by home, alleyway by alleyway."

Already, on the eve of intervention, the death toll was estimated at somewhere between 1,000 and 2,000. (This was when the international community’s tolerance for Arab Spring–related mass killings was still fairly low.)

As Obama’s advisers saw it, there were two options for military action: a no-fly zone (which, on its own, wouldn’t do much to stop Qaddafi’s tanks) or a broader resolution that would allow the U.S. and its allies to take further measures, including establishing what amounted to a floating no-drive zone around rebel forces. The president went with the latter option.

The NATO operation lasted about seven months, with an estimated death toll of around 8,000, apparently most of them combatants on both sides (although there is some lack of clarity on this, since the Libyan government doesn’t clearly define "revolutionaries" or "rebel supporters"). A Human Rights Watch investigation found that at least 72 civilians were killed as a result of the NATO air campaign, definitively contradicting speculative claims of mass casualties from the Qaddafi regime.

Claims of "mission creep" have become commonplace, most forcefully articulated by the Micah Zenko of the Council on Foreign Relations. Zenko may be right, but he asserts rather than explains why mission creep is always a bad thing. It may be that in some circumstances, the scope of a mission should be defined more broadly, rather than narrowly.

If anything, it was the Obama administration’s insistence of minimizing the mission—including the absurd claim that it would take "days, not weeks"—that was the problem from the very start. Zenko and others never make clear how civilians could have been protected as long as Qaddafi was waging war on them.

What Libya would look like today if NATO hadn’t intervened

It’s helpful to engage in a bit of counterfactual history here. As Niall Ferguson notes in his book Virtual Alternatives, "To understand how it actually was, we therefore need to understand how it actually wasn’t."

Applied to the Libyan context, this means that we’re not comparing Libya, during or after the intervention, with some imagined ideal of stable, functioning democracy. Rather, we would compare it with what we judge, to the best of our ability, the most likely alternative outcome would have been had the U.S. not intervened.

Here’s what we know: By March 19, 2011, when the NATO operation began, the death toll in Libya had risen rapidly to more than 1,000 in a relatively short amount of time, confirming Qaddafi’s longstanding reputation as someone who was willing to kill his countrymen (as well as others) in large numbers if that’s what his survival required.

There was no end in sight. After early rebel gains, Qaddafi had seized the advantage. Still, he was not in a position to deal a decisive blow to the opposition. (Nowhere in the Arab Spring era has one side in a military conflict been able to claim a clear victory, even with massive advantages in manpower, equipment, and regional backing.)

Any Libyan who had opted to take up arms was liable to be captured, arrested, or killed if Qaddafi "won," so the incentives to accept defeat were nonexistent, to say nothing of the understandable desire to not live under the rule of a brutal and maniacal strongman.

The most likely outcome, then, was a Syria-like situation of indefinite, intensifying violence. Even President Obama, who today seems unsure about the decision to intervene, acknowledged in an August 2014 interview with Thomas Friedman that "had we not intervened, it’s likely that Libya would be Syria...And so there would be more death, more disruption, more destruction."

What caused the current Libyan civil war?

Critics charge that the NATO intervention was responsible for or somehow caused Libya’s current state of chaos and instability. For instance, after leaving the Obama administration, Philip Gordon, the most senior U.S. official on the Middle East in 2013-'15, wrote: "In Iraq, the U.S. intervened and occupied, and the result was a costly disaster. In Libya, the U.S. intervened and did not occupy, and the result was a costly disaster. In Syria, the U.S. neither intervened nor occupied, and the result is a costly disaster."

The problem here is that U.S. intervention did not, in fact, result in a costly disaster, unless we are using the word "result" to simply connote that one thing happened after a previous thing. The NATO operation ended in October 2011. The current civil war in Libya began in May 2014—a full two and a half years later. The intervention and today’s violence are of course related, but this does not necessarily mean there is a causal relationship.

To argue that the current conflict in Libya is a result of the intervention, one would basically need to assume that the outbreak of civil war was inevitable, irrespective of anything that happened in the intervening 30 months.

This makes it all the more important to distinguish between the intervention itself and the international community’s subsequent failure—a failure that nearly all the relevant actors acknowledge—to plan and act for the day after and help Libyans rebuild their shattered country.

Such measures include sending training missions to help the Libyan army restructure itself (only in late 2013 did NATO provide a small team of advisers) or even sending multinational peacekeeping forces; expanding the United Nations Support Mission in Libya’s (UNSMIL) limited advisory role; and pressuring the Libyan government to consider alternatives to a dangerous and destabilizing political isolation law.

While perhaps less sexy, the U.S. and its allies could have also weighed in on institutional design and pushed back against Libya’s adoption, backed by UNSMIL, of one of world’s most counterproductive electoral systems—single non-transferable vote—along with an institutional bias favoring independents. This combination exacerbated tribal and regional divisions while making power sharing even more difficult.

Finally, the U.S. could have restrained its allies, particularly the Gulf States and Egypt, from excessive meddling in the lead-up to and early days of the 2014 civil war.

Yet Libya quickly tumbled off the American agenda. That’s not surprising, given that the Obama administration has always been suspicious of not just military entanglements but any kind of prolonged involvement—diplomatic, financial, or otherwise—in Middle East trouble spots. Libya "was farmed out to the working level," according to Dennis Ross, who served as a special assistant to President Obama until November 2011.

There was also an assumption that the Europeans would do more. This was more than just a hope; it was an organizing principle of Obama administration engagement abroad. Analysts Nina Hachigian and David Shorr have called it the "Responsibility Doctrine": a strategy of "prodding other influential nations…to help shoulder the burdens of fostering a stable, peaceful world order."

This may be the way the world should operate, but as a set of driving assumptions, this part of the Obama doctrine has proven to be wrong at best, and rather dangerous at worst.

We may not like it—and Obama certainly doesn’t—but even when the U.S. itself is not particularly involved in a given conflict, at the very least it is expected to set the agenda, convene partners, and drive international attention toward an issue that would otherwise be neglected in the morass of Middle East conflicts. The U.S., when it came to Libya, did not meet this minimal standard.

Even President Obama himself would eventually acknowledge the failure to stay engaged. As he put it to Friedman: "I think we [and] our European partners underestimated the need to come in full force if you’re going to do this."

Yet it is worth emphasizing that even with a civil war, ISIS’s capture of territory, and as many as three competing "governments," the destruction in Libya still does not come close to the level of death and destruction witnessed in Syria in the absence of intervention.

In other words, even this "worst-case scenario" falls well short of actual worst-case scenarios. According to the Libya Body Count, around 4,500 people have so far been killed over the course of 22 months of civil war.

In Syria, the death toll is about 100 times that, with more than 400,000 killed, according to the Syrian Center for Policy Research.

We’re all consequentialists now

For the reasons outlined above, Libya’s descent into civil conflict—and the resulting power vacuum, which extremist groups like ISIS eagerly filled—wasn’t inevitable. But let’s hypothesize for a moment that it was. Would that undermine support for the original intervention?

The Iraq War, to cite the most obvious example, wasn’t wrong because it led to chaos, instability, and civil war in the country. It was wrong because the decision to intervene in the first place was not justified, being based as it was on faulty premises regarding weapons of mass destruction.

If Iraq had quickly turned out "well" and become a relatively stable, flawed, yet functioning democracy, would that have retroactively justified an unjustified war? Presumably not, even though we would all be happy that Iraq was on a promising path.

The near reverse holds true for Libya. The justness of military intervention in March 2011 cannot be undone or negated retroactively. This is not the way choice or morality operates (imagine applying this standard to your personal life). This may suggest a broader philosophical divergence: Obama, according to one of his aides, is a "consequentialist."

I suspect that this, perhaps more than narrower questions of military intervention, drives at least some of the revisionism over Libya’s legacy. If we were consequentialists, it would be nearly impossible to act anywhere without some sort of preordained guarantee that a conflict area—which likely hadn’t been "stable" for years or decades—could all of a sudden stabilize.

Was the rightness of stopping the Rwandan genocide dependent on whether Rwanda could realistically become a stable democracy after the genocide was stopped? And how could policymakers make that determination, when the stabilization of any post-conflict situation is dependent, in part, not just on factual assessments but on always uncertain questions of the international community’s political will—something that is up to politicians—in committing the necessary time, attention, and resources to helping shattered countries rebuild themselves?

The idea that Libya, because it had oil and a relatively small population, would have been a relatively easy case was an odd one. Qaddafi had made sure, well in advance, that a Libya without him would be woefully unprepared to reconstruct itself.

For more than four decades, he did everything in his power to preempt any civil society organizations or real, autonomous institutions from emerging. Paranoid about competing centers of influence, Qaddafi reduced the Libyan army to a personal fiefdom. Unlike other Arab autocracies, the state and the leader were inseparable.

To think that Libya wouldn’t have encountered at least some major instability over the course of transition from one-person rule to an uncertain "something else" is to have a view of political development completely detached from both history and reality.

A distorted foreign policy discourse

The way we remember Libya suggests that the way we talk about America’s role in the world has changed, and not for the better. Americans are probably more likely to consider the Libya intervention a failure because the U.S. was at the forefront of the NATO operation. So any subsequent descent into conflict, presumably, says something about our failure, which is something we’d rather not think about.

Outside of the foreign policy community, politicians are usually criticized for what they do abroad, rather than what they don’t do. As former Secretary of Defense Robert Gates put it, "[Qaddafi] was not a threat to us anywhere. He was a threat to his own people, and that was about it." If the U.S had decided against intervention, Libya would have likely reverted to some noxious combination of dictatorship and insurgency. But we could have shirked responsibility (a sort of inverse "pottery barn" principle—if you didn’t break it, you don’t have to fix it). We could have claimed to have "done no harm," even though harm, of course, would have been done.

There was a time when the United States seemed to have a perpetual bias toward action. The instinct of leaders, more often than not, was to act militarily even in relatively small conflicts that were remote from American national security interests. Our country’s tragic experience in Iraq changed that. Inaction came to be seen as a virtue. And, to be sure, inaction is sometimes virtuous. Libya, though, was not one of those times.

Editor’s Note: Brookings will hold an event and live webcast on Thursday, August 4 to discuss the findings of the forthcoming 2016 Financial and Digital Inclusion Project (FDIP) Report. Follow the conversation on Twitter using #FinancialInclusion.

The 2016 Brookings Financial and Digital Inclusion Project (FDIP) Report, the second annual report produced by the FDIP team, assesses national commitment to and progress toward financial inclusion through traditional and digital mechanisms in 26 countries.  

As in the 2015 report, the FDIP team analyzed four key dimensions of financial inclusion: country commitment, mobile capacity, regulatory environment, and adoption of formal financial services. The 2016 report amplifies the geographic diversity of the FDIP country sample by adding five new countries and features descriptions of the financial inclusion landscape in all 26 countries.

The 2016 FDIP Report finds that significant progress has been made toward advancing financial inclusion in many countries, and robust commitment to strengthening the digital financial services ecosystem is evident across diverse geographic, political, and economic contexts.

On August 4, the Center for Technology Innovation will discuss the key findings of the 2016 FDIP Report and host a conversation with public sector representatives about key trends, opportunities, and obstacles regarding financial inclusion in their respective countries and around the world.

Below we provide some context regarding the role of financial inclusion within the global drive for sustainable development.

What is financial inclusion?

The common themes that emerge from many definitions of financial inclusion are the ability to access formal financial services and to utilize those services in a way that promotes financial health.

For example, the Center for Financial Inclusion at Accion defines financial inclusion as a “state in which everyone who can use them has access to a range of quality financial services at affordable prices, with convenience, dignity, and consumer protections, delivered by a range of providers in a stable, competitive market to financially capable clients.”

In short, financial inclusion in itself is not the end goal, but instead serves as a key mechanism for advancing the well-being of individuals, families, and communities. At the macroeconomic level, financial inclusion provides opportunities to advance economic growth, reduce income inequality, and combat poverty.

For the purposes of FDIP, we primarily focus on individuals’ access to and usage of affordable, secure, basic financial services and products, such as person-to-person payments and savings accounts. However, we also recognize the important role that more extensive financial services (e.g., microinsurance and microcredit) can play in enabling individuals to plan for the future and absorb financial shocks. Where possible, we highlight examples of a broad suite of financial services within the country profiles of the 2016 report.

To learn more about the 2016 FDIP Report, please register to attend the launch event in-person or watch the live webcast.