President Obama's announcement last month that earlier this year a “U.S. counterterrorism operation” had killed two hostages, including an American citizen, has become a fresh occasion for questioning the rationales for continuing attacks from unmanned aerial vehicles aimed at presumed, suspected, or even confirmed terrorists. This questioning is desirable, although not mainly for hostage-related reasons connected to this incident. Sometimes an incident has a sufficient element of controversy to stoke debate even though what most needs to be debated is not an issue specific to the incident itself. More fundamental issues about the entire drone program need more attention than they are getting.

The plight of hostages held by terrorists has a long and sometimes tragic history, almost all of which has had nothing to do with drones. Hostage-taking has been an attractive terrorist tool for so long partly because of the inherent advantages that the hostage-holders always will have over counterterrorist forces. Those advantages include not only the ability to conceal the location of hostages—evidently a successful concealment in the case of the hostages mentioned in the president's announcement—but also the ability of terrorists to kill the hostages themselves and to do so quickly enough to make any rescue operation extraordinarily difficult. Even states highly skilled at such operations, most notably Israel, have for this reason suffered failed rescue attempts.

It is not obvious what the net effect of operations with armed drones is likely to be on the fate of other current or future hostages. The incident in Pakistan demonstrates one of the direct negative possibilities. Possibly an offsetting consideration is that fearing aerial attack and being kept on the run may make, for some terrorists, the taking of hostages less attractive and the management of their custody more difficult. But a hostage known to be in the same location as a terrorist may have the attraction to the latter of serving as a human shield.

The drone program overall has had both pluses and minuses, as anyone who is either a confirmed supporter or opponent of the program should admit. There is no question that a significant number of certified bad guys have been removed as a direct and immediate consequence of the attacks. But offsetting, and probably more than offsetting, that result are the anger and resentment from collateral casualties and damage and the stimulus to radicalization that the anger and resentment provide. There is a good chance that the aerial strikes have created more new terrorists bent on exacting revenge on the United States than the number of old terrorists the strikes have killed.

This possibility is all the more disturbing in light of what appears to be a significant discrepancy between the official U.S. posture regarding collateral casualties and the picture that comes from nonofficial sources of reporting and expertise. The public is at a disadvantage in trying to judge this subject and to assess who is right and who is wrong, but what has been pointed out by respected specialists such as Micah Zenko is enough to raise serious doubt about official versions both of the efforts made to avoid casualties among innocents and of how many innocents have become victims of the strikes.

The geographic areas in which the drone strikes are most feasible and most common are not necessarily the same places from which future terrorist attacks against the United States are most likely to originate. The core Al-Qaeda group, which has been the primary target and concern in northwest Pakistan, is but a shadow of its former self and not the threat it once was. Defenders of the drone strikes are entitled to claim that this development is in large part due to the strikes. But that leaves the question: why keep doing it now?

The principal explanation, as recognized in the relevant government circles, for the drone program has been that it is the only way to reach terrorists who cannot be reached by other tools or methods. It has been seen as the only counterterrorist game that could be played in some places. That still leaves more fundamental questions about the motivations for playing the game.

Policy-makers do not use a counterterrorist tool just because the tool is nifty—although that may be a contributing factor regarding the drones—but rather because they feel obligated to use every available tool to strike at terrorists as long as there are any terrorists against whom to strike. In the back of their minds is the thought of the next Big One, or maybe even a not so big terrorist attack on U.S. soil, occurring on their watch after not having done everything they could to prevent it, or doing what would later be seen in hindsight as having had the chance to prevent it.

The principal driver of such thoughts is the American public's zero tolerance attitude toward terrorism, in which every terrorist attack is seen as a preventable tragedy that should have been prevented, without fully factoring in the costs and risks of prevention or of attempted prevention. Presidents and the people who work for them will continue to fire missiles from drones and to do some other risky, costly, or even counterproductive things in the cause of counterterrorism because of the prospect of getting politically pilloried for not being seen to make the maximum effort on behalf of that cause.

This piece was originally published by The National Interest.

As noted in our recent Brookings Institution report, unmanned aerial vehicles (UAVs), commonly referred to as drones, are an emerging technology that requires the attention of local governments. Unfortunately, regulations governing their usage are significantly lagging the pace of innovation. Individual citizens who do not want these devices flying over (or even near) their property due to privacy or safety concerns have limited options. You can stay in your home and turn the music up until it goes away. Or you can go about your business and ignore the possibility that the drone has a camera to see inside your home. Others might prefer a more active response. In fact, there have been several recent instances where residents have taken it upon themselves to remove these drones from the skies…by force.

Misuses of drones

The usage of UAVs and the lack of a functional regulatory environment have not been without incident. Fire personnel in southern San Bernardino County were fighting the first major fire of the season and had to abort their tanker flights due to someone flying a drone at approximately 12,000 feet and interfering with the safety of the pilots. Just two weeks later, firefighters in Southern California were using several manned aircraft to help put out 20 car fires on an interstate highway that were caused when a wildfire jumped the highway unexpectedly.  Pilots had to ground the planes when it was reported that five drones were flying around the area to get a good look at the fires (two of which were witnessed actually chasing the tanker planes!).

In addition to the general lack of common sense by a few users interfering with life-saving aircraft around the U.S., Britain, Poland, and elsewhere, there have been an increasing number of incidents involving drones accused of serving as remote “peeping toms.” UAVs have also crashed into cars and homes; they have even been used to smuggle drugs across the U.S.-Mexico border in addition to smuggling marijuana into prisons in South Carolina and in Ohio.

Uneven regulations

When it comes to regulations around drones, we are living in the proverbial wild-west. A few states, like Nevada and Wisconsin, have passed legislation to prevent the weaponization of drones. But in July, a YouTube video went viral of a teenager in Connecticut who modified his drone to fire a semi-automatic handgun successfully. When confronted by law enforcement officials, they determined that no laws had actually been broken. Virginia was the first state legislature to put in place a two-year moratorium on drone usage by state or law enforcement agencies. That moratorium expired July 1^st. By the end of 2014, 36 states had introduced legislation aimed at protecting individual privacy in some manner. Only four of those passed last year. Currently, there are 17 states with some form of drone regulation on their books, and several other states still have legislation pending. Most of the laws that have passed, such as those in Idaho and Florida, focus on limiting police usage of drones by requiring probable cause warrants.

Nevada has been one of the more active states in the drone legislation arena. In addition to their legislation prohibiting the weaponization of civilian drones, the state also has passed legislation to provide homeowners rights to sue drone owners who fly their drones over personal property in certain circumstances. Furthermore, Nevada now requires law enforcement agencies to get warrants when using drones near any home “where there is an expectation of privacy.”

Potential benefits and rulemaking challenges

We do acknowledge and are excited about the positive benefits that drone technology is poised to provide. Amazon has been testing their commercial “Prime Air” package delivery system under an experimental testing agreement with the FAA since early 2015, which will likely impact the nature of their almost two year old partnership with the U.S. Postal Service. Drone startup company Flirtey successfully demonstrated their ability to deliver medicine to a rural medical facility in Virginia as part of their proof of concept efforts this July. Drones may even represent the future of pizza delivery.

The challenge this rapidly developing technology is creating is well ahead of local government efforts to rein in excessive activities. State and local governments need to engage on this policy issue more proactively. To do so, however, requires a delicate balancing act of the multiple competing interests of legitimate commercial uses, policing, public safety, privacy, and private property concerns. And this balancing has to take place in an environment where federal law remains unsettled too.

One thing we would definitely caution against is ‘regulation by default.’ To date, the efforts to regulate drone policy has focused on the drones themselves. As is commonly the case with new technology, governments typically engaged with a heavy hand that sometimes misses the opportunities afforded by the new technologies to improve city services and quality of life. Examples of this possible overreaction is Iowa City, Iowa and Charlottesville, Virginia, both of which were early adopters of complete bans on all surveillance drones within city limits back in 2013.

Local governments need to accept that drone technology is here for the near future. They must recognize that technology is not the problem, but how it is used can be a potential problem. Given the potential drawbacks and benefits, there is justification for reasoned regulation of drone technology.

Technically, all of the Star Wars films occur a long time ago in a galaxy far, far away, but there are countless gadgets featured in the films that human beings in this galaxy can find here on Earth. Here are a handful of gadgets you will see this weekend when the seventh Star Wars film, "The Force Awakens," blasts into theaters.

Drone surveillance

The evil Galactic Empire has long employed drones and machines to do their dirty work. Way back when the empire was just a glint in Darth Sidious' eyes, his merciless apprentice Darth Maul used autonomous drones to search the desert landscape of Tatooine for fugitive Jedi. Later, when Darth Vader tirelessly searched the galaxy for Luke Skywalker and the Rebel Alliance, he sent similar autonomous drones to countless worlds such as the ice planet Hoth.

Sure, the Empire may call them droids, but on the planet Earth these instruments are essentially remote drones you might see flying in cities or around your neighborhood. In the U.S. the use of unmanned drones to aid law enforcement is on the cutting edge of technology and sparks a spirited debate among privacy advocates. Should fear law enforcement as we would a Sith lord and thus burden them with a warrant-based, technology-centric approach to drone surveillance that might curtail the beneficial use of drones?

Gregory McNeal wrote last year in a Brookings report that a property rights-centric approach with limits on surveillance would best appease privacy advocates and law enforcement, enabling drones to protect privacy in ways even manned surveillance can't achieve. By crafting simple, duration based surveillance legislation, law enforcement would only be permitted to surveil a person for a limited amount of time. Additionally, data retention guidelines could limit the amount of time that surveillance would be accessible to law enforcement.

"Legislators should reject alarmist calls that suggest we are on the verge of an Orwellian police state," McNeal writes, as privacy advocates almost always invoke the the novel 1984 when technology makes surveillance more widespread and pervasive.

As McNeal points out, the police state is hardly as nefarious as Darth Vader, so sensible legislation may be enough in this case to keep law enforcement from falling to the dark side.

Holography

In the first Star Wars film, Princess Leia recorded a short holographic message for Obi-Wan Kenobi asking for his help delivering the Death Star plans to the Rebel Alliance. The droid R2-D2 recorded the message almost as succinctly as many of use record short videos on our cell phone. But when can we expect to send and receive holographic messages ourselves?

Barring some laughable election night hologram shenanigans on CNN, there have been some notable uses of holography in this galaxy. In 2012, the late rapper Tupac Shakur took the stage at the Coachella Festival with contemporaries Snoop Dogg and Dr. Dre. At the 2014 Billboard Music Awards, Michael Jackson performed on stage—five years after his death. These holograms were made possible by artful projections and reflections, creating convincing illusions suitable only for crowded concert halls. The technology is especially popular in South Korea where K-Pop performers regularly "perform" at virtual concerts to adoring fans.

But a bona fide hologram? Researchers at Swinburne University this year used lasers and a specialized graphene mesh to project 3D objects in the air very much like you would see in Star Wars. As TIME Magazine reported, "It’s not quite Princess Leia-quality, and researchers say it has a long way to go before commercialization, but it’s a step."

BB-8 Droid

Since the first teaser for the new Star Wars films, fans have had questions about the new droid character BB-8. Rather than resort to computer animation to bring the droid to life, director J.J. Abrams and Lucasfilm designers sought to produce a live prop that could portray the droid on film.

The filmmakers demoed the droid on stage at Comic Con to the roar of audience applause and delight—"It was the first official confirmation that BB-8 was not a CG creation, but rather, a practical effect."

The use of practical effects in "The Force Awakens" is a return-to-form for the filmmakers who have shunned the special effects and digital artistry of the Star Wars prequel trilogies and instead embraced the kinds of practical effects and puppetry that made the original trilogy so beloved.

The droid BB-8 even has a cousin here on Earth—the robotic ball toy Sphero. Inventors Ian Bernstein and Adam Wilson have adapted their smartphone-controlled spherical toy into a BB-8 toy that performs many of the same practical effects the screen version of BB-8 does in "The Force Awakens."

As the new sequel trilogy continues, filmmakers are sure to wow audiences with amazing technologies—some we may even recognize from planet Earth.

Civilian drone activity has increased exponentially as drones become more easily accessible and affordable. With more drones in the sky every day, there have been some creative and sometimes dangerous attempts to disable drones. The reasons for disabling a drone can vary from boredom and curiosity to privacy and safety concerns. To be clear, the Center for Technology Innovation does not condone or promote the act of harming drones.

1. Guns

Shooting a drone out of the sky may be effective, but it’s also extremely dangerous. The consequences for shooting down a drone vary by state, but perpetrators could face reckless endangerment charges or be prosecuted under laws relating to the discharge of firearms. Additionally, the offender could be liable for civil damages paid to the destroyed drone’s owner.

2. Nets

Nets are a much safer alternative to capturing drones than shooting them with guns. Tokyo police are working to implement net-carrying drones that can intercept suspicious smaller drones. The Human-Interactive Robotics Lab at Michigan Tech is working a drone catcher system for removing intruding drones by developing a drone-mounted net cannon that can capture another drone in flight from a distance of up to 40 feet. Lastly, there’s anti-drone technology that can be assembled from hardware store items. The drone net gun is a plastic slingshot that releases a net from the user on the ground to capture a drone in-flight

3. Radio waves

Battelle’s DroneDefender is a device that emits an electromagnetic field meant to disrupt the most popular GPS and ISM radio frequencies, which keep drones in the air. The DroneDefender can then take control and guide the drone safely down to the ground. It is not yet available for consumer use and is awaiting authorization from the Federal Communications Commission.

4. Hacking

As drones are functionally flying computers, it’s been proven possible to hack into their software by using Wi-Fi to connect to an unsecured network port on the device. Conversely, at the DEFCON hacker conference in Las Vegas, David Jordan of Aerial Assault demonstrated a drone that can break into computer networks by scanning for unsecured networks, recording their locations using GPS, and relaying the information to the pilot.

5. Eagles

The Dutch National Police are creatively working with Guard From Above, a raptor training company, to determine whether eagles could be used as anti-drone weapon systems. For those worried about the potential dangers to the birds, Guard From Above responded, “In nature, birds of prey often overpower large and dangerous prey. Their talons have scales, which protect them, naturally, from their victims’ bites. Of course, we are continuously investigating any extra possible protective measures we can take in order to protect our birds. The Dutch National Police has asked the Dutch Organization for Applied Scientific Research (TNO) to research the possible impact on the birds’ claws. The results are not yet known. We are working closely with the Dutch National Police on the development of our services.”

6. Jet Skis

Jet Skis don’t seem to be the most practical way of disabling drones, but one jet skier at the 2016 Yamaha New Zealand Festival of Freeride 4 showed how effectively it could be done.

On Tuesday, May 24, Nigerian Central Bank Governor Godwin Emefiele announced that the country will adopt a more flexible foreign exchange rate system in the near future. This move signals a major policy shift by Emefiele and President Muhammadu Buhari, who had until this point opposed calls to let the naira weaken. Many international oil-related currencies have depreciated against the dollar as oil prices began their decline in 2014. Nigeria, however, has held the naira at a peg of 197-199 per U.S. dollar since March 2015, depleting foreign reserves and deterring investors, who remain concerned about the repercussions of a potential naira devaluation. Following the announcement, Nigerian stocks jumped to a five-month high and bond prices rose in anticipation that a new flexible exchange rate regime would increase the supply of dollars and help attract foreign investors.

For now it remains unclear exactly what a more flexible system will entail for Nigeria, however, some experts suggest that the Central Bank may introduce a dual-rate system, which allows select importers in strategic industries to access foreign currency at the current fixed rate, while more generally foreign currency will be available at a weaker, market-related level. This new regime raises a number of questions, including how it will be governed and who will have access to foreign currency (and at what rate). On Wednesday, Nigeria’s parliament requested a briefing soon from Emefiele and Finance Minister Kemi Adeosun to provide additional clarity on the new system, although the date for such a meeting has not yet been set.

Earlier this month, Kenya announced plans to close the Dadaab refugee camp, located in northeast Kenya, amid security concerns. The move to close the camp has been widely criticized by international actors. United States State Department Press Relations Director Elizabeth Trudeau urged Kenya to “uphold its international obligations and not forcibly repatriate refugees.” The United Nations High Commissioner for Refugees stated that the closure of the refugee camp would have “devastating consequences.” Despite these concerns, this week, at the World Humanitarian Summit, Kenya stated that it will not go back on its decision and confirmed the closure of the refugee camps within a six-month period.

The camp houses 330,000 refugees, a majority of whom fled from conflict in their home country of Somalia. Kenya insists that the camp poses a threat to its national security, as it believes the camp is used to host and train extremists from Somalia’s Islamist group al-Shabab. Kenya also argued that the developed world, notably the United Kingdom, should host its fair share of African refugees. This is not the first time Kenya has threatened to close the refugee camp. After the Garissa University attacks last April, Kenya voiced its decision to close the refugee camps, although it did not follow through with the plan.

From May 23-27, Lusaka, Zambia hosted 5,000 delegates and participants for the 2016 Annual Meetings of the African Development Bank (AfDB), with the theme, “Energy and Climate Change.” Held in the wake of December’s COP21 climate agreement and in line with Sustainable Development Goals 7 (ensure access to affordable, reliable, sustainable and modern energy for all) and 13 (take urgent action to combat climate change and its impacts), the theme was timely and, as many speakers emphasized, urgent. Around 645 million people in Africa have no access to electricity, and only 16 percent are connected to an energy source. To that end, AfDB President Akinwumi Adesina outlined the bank’s ambitious aim: “Our goal is clear: universal access to energy for Africa within 10 years; Expand grid power by 160 gigawatts; Connect 130 million persons to grid power; Connect 75 million persons to off grid systems; And provide access to 150 million households to clean cooking energy."

As part of a push to transform Africa’s energy needs and uses, Rwandan President Paul Kagame joined Kenyan President Uhuru Kenyatta on a panel to support the AfDB’s “New Deal on Energy” that aims to deliver electricity to all Africans by 2025. Kenyatta specifically touted the potential of geothermal energy sources. Now, 40 percent of Kenya's power needs come from geothermal energy sources, he said, but there is still room for improvement—private businesses, which make up 30 percent of Kenya’s on-grid energy needs, have not made the switch yet.

As part of the meetings, the AfDB, the Organization for Economic Cooperation and Development (OECD), and United Nations Development Program (UNDP) also launched their annual African Economic Outlook, with the theme “Sustainable Cities and Structural Transformation.” In general, the report’s authors predict that the continent will maintain an average growth of 3.7 percent in 2016 before increasing to 4.5 percent in 2017, assuming commodity prices recover and the global economy improves.  However, the focus was on this year’s theme: urbanization. The authors provide an overview of urbanization trends and highlight that successful urban planning can discourage pollution and waste, slow climate change, support better social safety nets, enhance service delivery, and attract investment, among other benefits.

For more on urbanization in sub-Saharan Africa, see Chapter 4 of Foresight Africa 2016: Capitalizing on Urbanization: The Importance of Planning, Infrastructure, and Finance for Africa’s Growing Cities.

Renewable energy is an important source to tackle against climate change, as the latest IPCC report has pointed out. However, due to the existence of multiple market failures such as negative externalities of fossil fuels and knowledge spillovers of new technology, government subsidies are still needed to develop renewable energy, such as solar photovoltaic (PV) cells. In the United States, there have been various forms of subsidies for PV, varying from the federal level to the state level, and from the city level to the utility level. California, as the pioneer of solar PV development, has put forward the biggest state-level subsidy program for PV, the California Solar Initiative (CSI). The CSI has planned to spend around $2.2 Billion in 2007–2016 to install roughly 2 GW PV capacity, with the average subsidy level as high as $1.1/W. How to evaluate the cost-effectiveness and incentive pass-through of this program are the two major research questions we are pursing.

Our cost-effectiveness analysis is based on a constrained optimization model that we developed, where the objective is to install as much PV capacity as possible under a fixed budget constraint. Both the analytical and computational results suggest that due to a strong peer effect and the learning-by-doing effect, one can shift subsides from later periods to early periods so that the final PV installed capacity can be increased by 8.1% (or 32 MW). However, if the decision-maker has other policy objectives or constraints in mind, such as maintaining the policy certainty, then, the optimally calculated subsidy policy would look like the CSI.

As to the incentive pass-through question, we took a structural approach and in addition used the method of regression discontinuity (RD). While in general, the incentive pass-through rate depends on the curvature of the demand and supply curve and the level of market competition, our two estimations indicate that the incentive pass-through for the CSI program is almost complete. In other words, almost all of the incentive has been enjoyed by the customer, and the PV installers did not retain much. Based on the RD design, we observe that PV installers tend to consider the CSI incentive as exogenous to their pricing decision.

The relative good performance of the CSI in terms of both the cost-effectiveness and the incentive pass-through aspect are tightly related to its policy design and program management. International speaking, the biggest challenge for the design of any PV subsidy program is the quick running out of the budget, and in the end, it looks like customers are rushing for the subsidy. Such rushing behavior is a clear indication of higher-than-needed incentive levels. Due to the policy rigidity and rapid PV technological change, the PV subsidy policy may lag behind the PV cost decline; and as a result, rational customers could rush for any unnecessarily high subsidy.

Due to the high uncertainty and unpredictability of future PV costs, the CSI put forward a new design that links the incentive level change and the installed capacity goal fulfillment. Specifically, the CSI has designed nine steps to achieve its policy goal; at each step, there is a PV capacity goal that corresponds to an incentive level. Once the capacity goal is finished, the incentive level will decrease to the next lower level. Furthermore, to maintain the policy certainty, the CSI regulated that every step-wise change in the incentive level should not be higher than $0.45/W, nor smaller than $0.05/W, together with other three constraints.

A good subsidy policy not only requires flexible policy design to respond to fast-changing environment, but also demands an efficient program management system, digitalized if possible. For the CSI, the authority has contracted out a third-party to maintain a good database system for the program. Specifically, the database has documented in detail every PV system that customers requested. Key data fields include 22 important dates during the PV installation process, customers’ zip code, city, utility and county information, and various characteristics of the PV system such as price, system size, incentive, PV module and installer. All information is publicly available, which to some extent fills in the information gap held by customers and fosters the market competition among PV installers. For customers to receive the incentive, their PV systems have to pass the inspection of the local government, and also to be interconnected to the grid. On the supply side, the CSI has also certified and created a list of PV installers that every customer can choose from.

Although the CSI has ended in 2014 due to fast PV cost reduction starting from 2009, its experience has been transferred to other areas in the United States and in Europe. It is highly possible that other similar new technologies and products (e.g. the electric car and the battery) can adopt the CSI policy design, too. In summary, a good and successful policy may need to be simply, clear, credible, foreseeable, flexible, end-able, and incentive-compatible. The PV subsidy policy in China still has a long way to go when compared to the CSI.

Senior Fellows Fiona Hill and Clifford G. Gaddy discuss their book, Mr. Putin: Operative in the Kremlin in a five part podcast series.

In the book, Hill and Gaddy write that Russian President Vladmir Putin’s style of rule is influenced by his identities as a Statist, a Man of History, a Free Marketeer, a Survivalist, an Outsider, and a Case Officer; these are distinct personalities, they note, that interact and affect policy decisions. On February 6, the Center on the United States and Europe at Brookings hosted an event for the launch of Mr. Putin with a discussion featuring the authors.

Video

• Fiona Hill: Putin’s Statist Personality: Restoring the Greatness of Russia
• Clifford Gaddy: Putin the History Man and Survivalist
• Fiona Hill and Cliff Gaddy: The Outsider Influenced Putin’s “Free Market” Personality
• Fiona Hill: Putin’s History in KGB Leads to “Case Officer” Personality
• Fiona Hill: Putin’s Personalities Leveraged to Boost Russia

Last night, retired lieutenant general Michael Flynn addressed the Republican convention as a headline speaker on the subject of national security. One of Donald Trump’s closest advisors—so much so that he was considered for vice president—Flynn repeated many of the themes found in his new book, The Field of Fight, How We Can Win the Global War Against Radical Islam and Its Allies, which he coauthored with Michael Ledeen. (The book is published by St. Martin’s, which also published mine.)

Written in Flynn’s voice, the book advances two related arguments: First, the U.S. government does not know enough about its enemies because it does not collect enough intelligence, and it refuses to take ideological motivations seriously. Second, our enemies are collaborating in an “international alliance of evil countries and movements that is working to destroy” the United States despite their ideological differences.

Readers will immediately notice a tension between the two ideas. “On the surface,” Flynn admits, “it seems incoherent.” He asks: 

“How can a Communist regime like North Korea embrace a radical Islamist regime like Iran? What about Russia’s Vladimir Putin? He is certainly no jihadi; indeed, Russia has a good deal to fear from radical Islamist groups.” 

Flynn spends much of the book resolving the contradiction and proving that America’s enemies—North Korea, China, Russia, Iran, Syria, Cuba, Bolivia, Venezuela, Nicaragua, al-Qaida, Hezbollah, and ISIS—are in fact working in concert.

No one who has read classified intelligence or studied international relations will balk at the idea that unlikely friendships are formed against a common enemy. As Flynn observes, the revolutionary Shiite government in Tehran cooperates with nationalist Russia and communist North Korea; it has also turned a blind eye (at the very least) to al-Qaida’s Sunni operatives in Iran and used them bargaining chips when negotiating with Osama bin Laden and the United States. 

Flynn argues that this is more than “an alliance of convenience.” Rather, the United States’ enemies share “a contempt for democracy and an agreement—by all the members of the enemy alliance—that dictatorship is a superior way to run a country, an empire, or a caliphate.” Their shared goals of maximizing dictatorship and minimizing U.S. interference override their substantial ideological differences. Consequently, the U.S. government must work to destroy the alliance by “removing the sickening chokehold of tyranny, dictatorships, and Radical Islamist regimes.” Its failure to do so over the past decades gravely imperils the United States, he contends.

The book thus offers two very different views of how to exercise American power abroad: spread democracies or stand with friendly strongmen...[P]erhaps it mirrors the confusion in the Republican establishment over the direction of conservative foreign policy.

Some of Flynn’s evidence for the alliance diverts into the conspiratorial—I’ve seen nothing credible to back up his assertion that the Iranians were behind the 1979 takeover of the Grand Mosque in Mecca by Sunni apocalypticists. And there’s an important difference between the territorially-bounded ambitions of Iran, Russia, and North Korea, on the one hand, and ISIS’s desire to conquer the world on the other; the former makes alliances of convenience easier than the latter. Still, Flynn would basically be a neocon if he stuck with his core argument: tyrannies of all stripes are arrayed against the United States so the United States should destroy them.

But some tyrannies are less worthy of destruction than others. In fact, Flynn argues there’s a category of despot that should be excluded from his principle, the “friendly tyrants” like President Abdel-Fatah el-Sissi in Egypt and former president Zine Ben Ali in Tunisia. Saddam Hussein should not have been toppled, Flynn argues, and even Russia could become an “ideal partner for fighting Radical Islam” if only it would come to its senses about the threat of “Radical Islam.” Taken alone, these arguments would make Flynn realist, not a neocon. 

The book thus offers two very different views of how to exercise American power abroad: spread democracies or stand with friendly strongmen. Neither is a sure path to security. Spreading democracy through the wrong means can bring to power regimes that are even more hostile and authoritarian; standing with strongmen risks the same. Absent some principle higher than just democracy or security for their own sakes, the reader is unable to decide between Flynn’s contradictory perspectives and judge when their benefits are worth the risks. 

It’s strange to find a book about strategy so at odds with itself. Perhaps the dissonance is due to the co-authors’ divergent views (Ledeen is a neocon and Flynn is comfortable dining with Putin.) Or perhaps it mirrors the confusion in the Republican establishment over the direction of conservative foreign policy. Whatever the case, the muddled argument offered in The Field of Fight demonstrates how hard it is to overcome ideological differences to ally against a common foe, regardless of whether that alliance is one of convenience or conviction. 

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

Scotland

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

Ireland

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

International affairs

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

The economy

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

Democracy

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

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

Editor’s Note: In the aftermath of the United Kingdom's vote to leave the European Union, we are left with more questions than answers. Dhruva Jaishankar writes that with all the questions about what happens next, there's a bigger question worth asking: What are the implications of Brexit for democracy? Arguably, Brexit represents the first major casualty of the ascent of digital democracy over representative democracy. This piece was originally posted by The Huffington Post.

In the aftermath of the United Kingdom's vote to leave the European Union, we are left with more questions than answers. What kind of relationship will the UK now forge with the EU, and how will that affect economic relations and migration? Will Scotland and Northern Ireland opt to leave? What is the future of British politics, given turbulence within both the Conservative and Labour Parties? Will a successful Brexit set a precedent for other EU members -- perhaps even some eurozone members-- to leave the union? What are the long-term economic consequences of the resulting uncertainty? Will Brexit even happen at all, given the absence of a clear post-referendum plan, the apparent unwillingness of 'Leave' campaign leaders to invoke Article 50 of the Lisbon Treaty, and the fact that the referendum was advisory and non-binding? Answers to these questions will make themselves evident in the coming weeks, months, and years.

[D]igital democracy... has contributed to polarization, gridlock, dissatisfaction and misinformation.

But there's a bigger question worth asking: What are the implications of Brexit for democracy? Arguably, Brexit represents the first major casualty of the ascent of digital democracy over representative democracy. This claim deserves an explanation.

When historians look back at the world of the past 25 years, they will likely associate it not with terrorism or growing inequality but with the twin phenomena of the "rise of the rest" (particularly China and India) and of globalization. Globalization involves the easier, faster and cheaper flow of goods, people, capital and information. One big enabler of globalization is the internet, the global network of networks that allows billions of people to cheaply and easily access enormous amounts of digital information. The rise of service and high-technology industries, trade liberalization, container shipping, and the development of financial markets have also been important enablers, as is the increased ease and lower cost of travel, particularly by air.

Many technology optimists have assumed that globalization would lead to the democratization of information and decision-making, and also greater cosmopolitanism. Citizens would be better informed, less likely to be silenced, and able to communicate their views more effectively to their leaders. They would also have greater empathy and understanding of other peoples the more they lived next to them, visited their countries, read their news, communicated, and did business with them. Or so the thinking went.

[L]eaders only exploit the vulnerabilities of a post-fact world. The conditions have been laid by the digital sphere.

But there has been little to justify such panglossianism. There is some evidence for a correlation between greater information, political democratization and economic progress, in that all three have advanced steadily, if at different paces, over the past two decades. But that correlation is weak. Instead, digital democracy -- the ability to receive information in almost real time through mass media and to make one's voice heard through social media -- has contributed to polarization, gridlock, dissatisfaction and misinformation. This is as equally applicable to the countries in which modern democracy took root -- in the United States and Europe -- as it is to India, the biggest and most complex democracy in the developing world.

The ascent of digital democracy around the world has some shared features. One characteristic is that access to greater information has, rather counterintuitively, contributed to a "post-fact" information environment. Nick Cohen -- speaking of British pro-"Leave" journalists-turned-politicians Boris Johnson and Michael Gove --called out their use of bold claims, their contempt for practical questions, their sneering disregard for expertise, and their transgressions of the bounds of political spin. These tactics are not all that dissimilar to Donald Trump's assertions about Barack Obama's birth certificate or immigration policies, or Subramanian Swamy's insinuations about the nationality of senior Indian policymakers.

But leaders only exploit the vulnerabilities of a post-fact world. The conditions have been laid by the digital sphere. A recent example springs to mind. There is a widespread belief on Indian social media that US presidential candidate Hillary Clinton is somehow anti-India, pro-Pakistan, and/or anti-Modi. I am no supporter of Ms. Clinton, but as someone who worked on foreign affairs in Washington and knows many of her advisors, I found these claims baffling. In fact, Clinton's political opponents (whether Barack Obama in 2008 or Donald Trump in 2016) have accused her of being too close to India, while Pakistanis often view her as critical of their country and Prime Minister Modi appears to enjoy cordial relations with her. After some inquiries, and a few tips, I managed to trace these sentiments to a single publication, a poorly sourced and misleading column that gained widespread circulation upon its release. The article's contents were deemed sufficiently credible to have now become instilled as absolute fact in the minds of many Indians active online. In a digital democracy, a lie or (better yet) a half-lie if told enough times becomes truth.

In a digital democracy, a lie or (better yet) a half-lie if told enough times becomes truth.

Another outcome of digital democracy may be a variation of what the psychologist Barry Schwartz has called the paradox of choice. Quite possibly, the greater abundance of political choice leads to less satisfaction, and the result is citizens increasingly voicing their displeasure with their available political and policy choices. The political platforms of mainstream parties rarely adhere entirely to individual voters' views. That may explain why many voters are gravitating towards parties, factions or leaders who offer the simplest messages, and project themselves as alternatives to the mainstream.

A third result of digital democracy, and one that has been better documented, is the political echo chamber. Social media, rather than creating connections with people who possess differing views and ideologies, tends to reinforce prejudices. As the psychologist Nicholas DiFonzo has noted, "Americans across the political spectrum tend to trust the news media (and 'facts' provided by the media) less than their own social group." This makes it easier for views and rumours to circulate and intensify within like-minded groups. Similar digital gerrymandering was evident in the EU Referendum in Britain and the polarization is palpable in the Indian online political space.

Finally, instant information has increased the theatricality of politics. With public statements and positions by governments, political parties and individual leaders now broadcast to constituents in real time, compromise, a necessary basis of good governance, has become more difficult. When portrayed as a betrayal of core beliefs, compromise often amounts to political suicide. Political grandstanding also contributes to legislative gridlock, with elected representatives often resorting to walkouts, sit-ins, or insults -- all manufactured for maximum viral effect -- instead of trying to reach solutions behind closed doors. Even as ease of travel allows legislators to spend more time in their constituencies, making them more sensitized to their constituents' concerns, less gets done at the national or supranational level. It is a trend that, once again, applies equally to the United States, Europe, and India.

Social media, rather than creating connections with people who possess differing views and ideologies, tends to reinforce prejudices.

The unintended consequences of digital democracy -- misinformation and discontent, polarization and gridlock -- mean that the boundary between politician and troll is blurring. The tone of democratic politics increasingly reflects that of anonymous online discourse: nasty, brutish, and short. And successful politicians are increasingly those who are able to take advantage of the resulting sentiments. Exploiting divisions, appealing to base instincts, making outlandish claims, resorting to falsehoods, and pooh-poohing details and expertise. All that could just as easily describe the playbooks of populists around the world, on the right and left: Marine Le Pen, Frauke Petry, Donald Trump or Subramanian Swamy as much as Jeremy Corbyn, Beppe Grillo, Bernie Sanders or Arvind Kejriwal.

The unintended consequences of digital democracy -- misinformation and discontent, polarization and gridlock -- mean that the boundary between politician and troll is blurring.

In all these cases, populists are willing to cross the lines that mainstream parties have flirted with, becoming forces that the centre cannot hold. US Republicans fanned the anti-immigration sentiments that first the Tea Party and then Trump are only taking to their natural conclusions, just as mainstream Democrats' economic protectionism has been seized upon by Sanders. Cameron's euroscepticism, explained away initially as constructive criticism, spiralled out of control with Brexit, just as those who pronounced the death of New Labour helped paved the way for Corbyn. Will the same one day apply in India, to the economic populism of the Congress, of which Kejriwal has become a new torchbearer, or to the chauvinism of the right, which Swamy now threatens to run away with?

Brexit is not anti-globalization so much as a product of globalization. It is also a product of democracy rather than an affront to it. But it is a democracy of a different sort, one that many of its ideological forebears anticipated. When James Madison warned of "the superior force of an interested and overbearing majority," or John Stuart Mill cautioned against "a social tyranny more formidable than many kinds of political oppression," or BR Ambedkar argued (in a slightly different context) that "political tyranny is nothing compared to social tyranny," they could just as easily have been speaking in 2016 as in 1787, 1859, or 1936. Democrats around the world may not yet be married to the mob, but plenty have been betrothed.

None of this should be interpreted as some kind of nostalgia for an older, simpler world. That world was not necessarily simpler, but it was more violent and chaotic, prejudiced and unfair, and poor and backward. It may be hard to discern amid the smoke and noise, but there are some benefits to digital democracy. Information is no longer in the hands of the few. It is easier than ever to bring injustices to light. And the same process can throw up mainstream leaders from backgrounds that are far from privileged, such as a Barack Obama, Angela Merkel, or Narendra Modi. Two of the three, Obama and Modi, rose to power on the backs of unprecedented social media movements.

But representative democracy as we have come to know it is under threat, and Brexit represents the first major casualty. Rather than fight the tide, a collective rethink is needed about how to make democracies resilient and productive in the digital age. It won't be easy.

Please note that this Engelberg Center for Health Care Reform Health Policy Issue Brief first appeared in the Health Affairs Blog on July 31, 2014. Click here for the Health Affairs Blog version.

Abstract

Individual patient expanded access is a process by which patients can obtain investigational drugs that have not been approved by the Food and Drug Administration (FDA) outside of a clinical trial setting from biopharmaceutical companies when no other alternative therapy is available. Currently, no industry-wide structural principles exist to help companies navigate this process while balancing the needs of getting a drug to the market as quickly as possible with providing potentially life-saving treatment to individual patients. The Engelberg Center convened a stakeholder group to identify common themes and identify common principles related to expanded access, as none currently exist. The result was 4 A’s - Anticipation, Accessibility, Accountability, and Analysis – to help assist patients, providers, and companies with expanded access. Process and capacity building recommendations for the FDA also were proposed to assist companies with sustaining expanded access programs.

Call to Action: The Importance of Expanded Access Programs

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer. Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage. Such cases included 7-year-old Josh Hardy (brincidofovir from Chimerix for disseminated adenovirus infection), 45-year-old Andrea Sloan (BMN673 from BioMarin for ovarian cancer), 41-year-old Nick Auden (pembrolizumab from Merck for melanoma), and 6-year-old Jack Fowler (intrathecal idursulfase from Shire for Hunter Syndrome). Expanded access requests to the FDA for new patients are increasing, from 1,000 patients nationwide in 2010 to more than 1,200 in 2012.[i] (This is likely an underestimate, since it does not include appeals made directly to companies.)

In the wake of these events, it became clear that many biopharmaceutical companies had varying experiences and policies related to such access. From the domestic regulatory standpoint, the FDA revised its expanded access regulations in 2009, which define criteria that must be met to authorize expanded access, list requirements for expanded access submissions, describe safeguards that will protect patients, and preserve the ability to develop meaningful data about the use of the drug. Biopharmaceutical companies typically face a complex global environment in which legal and regulatory frameworks can differ substantially. At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. Still, the public belief persists that the FDA is the main bottleneck that restricts access. In April 2014, Representative Morgan Griffith (R-VA) proposed H.R. 4475, The Compassionate Freedom of Choice Act of 2014, designed to restrict the FDA’s ability to prevent the use of investigational drugs in terminally ill patients. Similarly, some states have passed “Right to Try” legislation to reduce FDA oversight, but contains no requirement that companies must make drugs available.[ii]

The goal of our meeting was to identify common themes and possibly broad outlines to suggest industry-wide policies related to expanded access, as none currently exist. The group first discussed background issues related to expanded access and agreed on definitions. The meeting then focused on three topics. First, the group participants who play key roles in evaluating expanded access requests were invited to share narrative experiences in specific clinical cases, in an effort to lay the groundwork for trust and open discussion. Second, the group was asked to identify internal industry-specific structural barriers, such as the existence of clear procedures or tracking mechanisms within companies to handle requests. Finally, the participants reflected on situations in which expanded access may not be appropriate, or where regulatory barriers or liability concerns may hinder expanded access. This paper reflects the authors’ observations and assessment of the internal and external landscape, based upon information provided by the meeting participants.

Laying the Groundwork with Shared Experiences

The FDA allows companies to provide drugs and charge individual patients that do not meet the enrollment criteria for clinical trials geared towards regulatory approval through expanded access programs.[iii] These programs are meant to provide the drug directly to treat the patient’s condition, rather than having the primary goal of collecting efficacy or detailed safety data in support of approval. Before 1987, the FDA lacked formal recognition of expanded access, although investigational drugs were provided informally.[iv] Since then, the FDA has instituted novel classes of individual INDs so that a company sponsor or licensed physician can legally obtain treatment access from the FDA to provide a drug while it is still in the approval process.[v] Essentially, this provides companies a legal exception from the law to ship unapproved drugs across state lines, and if they desire, to charge for them. These INDs are designed solely for the potential benefit of desperate patients and not intended to formally collect safety or efficacy data that could potentially inform a regulatory decision, but can have regulatory impact, nonetheless.

At the outset, several participants objected to the term “compassionate use,” since it introduces inherent value decisions, can emotionally charge discussions, and does not recognize that there may be valid and ethically appropriate reasons for denial. The generally agreed upon term “expanded access,” is used throughout this paper. (One participant suggested the term “early access.”) Ideally, the term would make it obvious that this is access to an unapproved drug, in order to temper expectations of favorable results. Somewhat confusingly, the FDA uses the terms “expanded access,” “access,” and “treatment use” interchangeably to refer to the use of a drug, and of which none clearly identify the stage of development.[vi]

Participants shared numerous examples of requests for expanded access and explained that their companies handle anywhere from a handful to several hundred requests per year. The following selected stories illustrate the wide range of experiences and situations that companies encounter when navigating the complex decisions involved in administering an expanded access program. Several other examples were discussed and the specific participants expressed that they would be willing to share these particular examples publicly.

Chimerix, a 54-employee company based in Durham, North Carolina, is developing the drug brincidofovir and previously had created an intermediate expanded access protocol for the drug (CMX001-350) as encouraged by the FDA following over 200 emergency INDs granted for access to brincidofovir.[vii] One such case was for an armed services member with previously undiagnosed acute myelogenous leukemia who developed life-threatening vaccinia infection following smallpox vaccination in 2009.[viii] The patient received the drug from Chimerix through an emergency IND. After two years, the company had not secured FDA approval for the drug and eliminated expanded access in February 2012 in order to focus on studies which would inform a regulatory decision. In March 2014, Chimerix originally rejected an emergency IND request for 7-year old, Josh Hardy, who was critically ill from disseminated adenovirus infection after bone marrow transplantation. A highly public social media campaign targeted the company in the wake of this decision, and the experience was traumatizing for many of the employees. Following discussion with the FDA, Chimerix initiated a new clinical trial for the treatment of adenovirus infection in order to collect safety and efficacy data to support an NDA submission. Hardy was the first patient enrolled in the clinical trial, and his family reported through several media outlets that he recovered from the adenovirus infection and was discharged home.

One biopharmaceutical company representative described receiving a middle-of-the-night telephone call directly at home, with an emergent, time-sensitive request for an experimental therapy for a critically ill child with a rare acute disease in a foreign pediatric intensive care unit, where regulatory standards were different from those in the U.S. The ideal pediatric dosage was unknown, and only limited safety data and clinical details were available. Urgent efforts were made to gather more information and the request was approved, but despite these efforts the patient did not survive.

Bristol-Myers Squibb began a clinical trial for a cancer drug several years ago.[ix] A woman with pancreatic cancer enrolled in the trial and saw that her tumor was no longer growing. After the 3.5 year trial, the study closed because the drug was deemed ineffective for all other patients and was not approved for further development. However, the company continued to provide the drug for the one woman for whom the drug was effective through a single patient IND for an additional 9 years.

To demonstrate the volume of expanded access requests, one participant showed several messages on his mobile device during the half-day discussion, directly from patients who had located his email addresses through on-line searches, to plead for expanded access to an anticancer therapy.

Development of Structural Principles: The Four A's 

Broadly, no specific industry-wide consensus on expanded access procedures exists. As a result, there is significant variation in company policies and procedures. During this phase of discussion, participants shared their own company strategies and suggested possible areas of consensus that might form the basis for shared principles and industry-wide practices. These suggestions fell into four categories, which we termed the 4 “A’s”: Anticipation, Accessibility, Accountability, and Analysis (see Figure 1).

First, the group agreed that large and small companies should anticipate the need for and creation of expanded access programs when developing drugs expected to generate expanded access requests and as part of the drug development plan. This is particularly important for drugs that might be considered for priority or breakthrough designation during FDA approval. In these cases, companies should strongly consider developing a written expanded use policy with clear guidelines for inclusion and exclusion, which would also feature a defined review process, clear decision making criteria, and a defined time frame for response to requests. This also allows companies to plan for the demands that may be placed on their supply chain and staff resources to ensure sufficient supply for investigational and expanded use purposes. Identifying a decision maker within each company and for each disease area/product will also help patients or physicians reach the appropriate contact when requesting a drug, as well as assist the company in gaining expertise in responding to these requests. For example, one large company identifies one point of contact for all expanded access requests regarding each product and posts that individual’s contact information on the website.

In the early stages of drug development, supplies of investigational drugs are extremely limited. This is often because the technically-challenging process of optimizing drug product manufacture takes a considerable amount of time. Low yielding manufacture batches are not uncommon at the early phases of research. Some companies do not approve expanded access requests because they do not have enough of the drug in stock to supply these external requests and meet the needs of investigational study patients and individuals participating in clinical trials, an issue which may be particularly acute for biologics. Smaller companies may have more resource constraints, such as inadequate staff to manage requests or supply chain and logistics issues. One representative suggested that if a company had early transparency from regulators about the final numbers of subjects they would be willing to accept to achieve drug development milestones, it would make it much easier for the company to feel less reservation about its drug supply. (It may be beneficial for companies to analyze their financial ability to provide drugs potentially at no cost or when there is not a large enough supply, ideally in a transparent manner.)

Once an expanded access policy is anticipated and developed, the second key principle the group identified was making the policy accessible to all individuals who may qualify. First, for patients, with guidance from their treating physician, the company making the drug should always steer the patient to enter a clinical trial (if they meet eligibility criteria). If the contacted company cannot accommodate the patient, they should steer them to other open trials if possible, even if sponsored by another company. Many of our participants noted that this already occurs.

The group was particularly cognizant of the disparity in access to drug companies and their expanded access programs: patients with savvy social media strategies are more likely to succeed in navigating across organizational constraints than without similar sophistication. The group believes that increased accessibility would assist in making opportunities for expanded access more equitable. In addition, these policies could help educate patients and physicians about submitting legitimate expanded access requests and help decrease the costs of reviewing inappropriate requests on the company (for example, if there are other proven therapies or the situation is not life threatening).

If the patient is ineligible for a trial, the patient should be able to easily access the written expanded access policy online. For example, both large and small companies like Pfizer, Bristol-Myers Squibb, Shire, and Merck post their expanded access policies on their websites, though the terminology may in some cases be complex. In addition, Janssen has developed a video explaining their policies in non-technical terms. Ideally, such policies should be available in some web based or public facing platform to both patients and physicians and written in a clear manner that is jargon free and accessible to individuals at various education levels. Most participants felt strongly that requests for expanded access should originate from a medical provider, not from a patient, since expertise is needed to first screen appropriate candidates. This is consistent with current FDA regulations for an IND, in which a physician or qualified medical expert must sponsor an IND or serve as an investigator under an existing IND for expanded access.

Third, companies should have accountability to the requesting party for expanded use requests that they receive and review them within a specified, transparent amount of time. If the request could not be approved, the company should consider clear communication and provide an explanation of why the request was turned down. In these cases, some participants suggested that the company might also consider instituting an appeals process by which a patient can receive an additional review if not approved, potentially from a non-binding third party such as an independent, multidisciplinary body or a regulatory agency like the FDA. (Two participants, however, were uncomfortable with any third party review.)

The final principle would encourage companies to release timely analysis of data from expanded access patients. In addition to tracking communication, companies should keep a database of the number of requests and outcomes, in a manner that doesn’t slow getting drugs to needy patients rapidly. One company refined its internal tracking tools to determine who was requesting drugs, for what conditions, and where they lived. Where possible, companies might be encouraged to share anecdotal or preliminary safety or efficacy data from expanded access in peer-reviewed or other refereed venues in a prudent time frame following collections, if this is available or known. This is not always possible, because emergency INDs do not require provision of safety or outcome data to the company.

There are several challenges associated with operationalizing this in the current model, namely the appropriateness of anecdotal data, the level of detailed safety and efficacy data currently available through expanded access, suitability for publication, and funding for these activities in the current budget climate. One potential approach to address this is funding from federal or state regulatory agencies or payers for the reasonable costs of follow-up and reporting outcomes.

Regulatory Considerations

The participants then discussed the types of risks, including regulatory and financial, that may affect companies’ expanded access policies. When a company is considering expanded access requests, they consider the risks-benefits of providing the drug outside of a clinical trial as well as the potential for any regulatory issues in an era of litigation and an increased threshold for demonstration of safety. While a company’s provision of a drug for expanded access is voluntary, the FDA does require the company to collect and report safety data. Notably, none of the representatives felt that the FDA is a major regulatory barrier to processing and approving expanded access requests once the sponsor has reviewed the request, assessed the benefit-risk, and determined the request meets FDA requirements and evidentiary standards. In addition, the attendees felt that adverse effects and related liability risk were not of particular concern given that the drugs are assessed on a risk-benefit analysis.

However, companies that make drugs in particularly limited markets with small numbers of patients (for example, for unusual diseases with less than 200,000 patients nationwide which may justify a special designation called “orphan status”) may be more concerned about restrictive labeling if an unusual adverse event occurred even in one or two patients during expanded access of an orphan or small market therapy. However, there is no data of which participants were aware and no public reports that an adverse event during expanded access has harmed regulatory approval.[x] The group opinion was that that safety data would be available eventually in any event and an FDA “safe harbor” provision would not necessarily affect companies’ willingness to accept more requests for expanded access. A final concern was that there is no regulatory mechanism to consider data from expanded access in the evidence generation process for approval.

An Expanded Role for the FDA

While the FDA may not serve as a strong barrier to expanded access, the group considered strategies to promote equitable and fair access. For example, some argued that the breakthrough or priority review categories for FDA review might identify products that could have high potential for expanded access requests. This designation expedites “the development and review of drugs for serious or life-threatening conditions.”[xi] As of mid-April 2014, the FDA had received nearly 180 requests for breakthrough designation, with 44 requests granted.[xii] By hastening the drug development process, the FDA has already begun to bring drugs that have a reasonable expectation of benefit to the market faster. In order to receive breakthrough therapy designation, current legislation might be amended so companies could be asked to provide evidence that the 4 A’s are being followed in some capacity.

The FDA might also assist companies in establishing expanded access programs during open clinical trials in two main areas: process and capacity building. First, in terms of process, the FDA could be asked to create a defined path for regulatory approval with provisions that would encourage companies, both large and small, to include plans for expanded access programs when developing a drug. While FDA’s draft guidance related to INDs notes that larger expanded access programs could threaten enrollment in clinical trials,[xiii] and some participants agreed that this was a significant issue, not all companies have had difficulties enrolling patients in both clinical trials and expanded access programs. For example, one large pharmaceutical company left a Phase 1 clinical trial open for a promising therapy while concurrently enrolling individuals who didn’t qualify for open clinical trials into an expanded access program, without appreciable leakage of enrollees in their advanced phase trials that might affect the key development pathway.

Second, the FDA could support convening around capacity building and sharing best practices with companies. With the understanding that there are many small biotechnology or pharmaceutical companies with limited budgets and staff, the FDA could foster a partnership of large and small companies. This partnership could be achieved by convening meetings where companies share their experiences in creating and sustaining expanded access programs. This could be supported by creating a database for these shared ideas, as well as any expanded access data that can be made legally available, such as how many requests are granted or patient outcomes.

To ensure equitable, consistent, and transparent review of requests, some companies suggested the use of an impartial external advisory board. Similar to an unbiased review from an institutional review board (IRB), this committee could have an advisory or decision making function. Companies with supply constraints may feel that if they cannot give the drug to everyone who requests it, then they should give it to no one. This committee could help the company triage the patients who would benefit the most, and would be protected from liability.

Next Steps

The most efficient and equitable way to make new effective treatments to the largest number of needy patients is regulatory approval, accelerated or otherwise, following successful demonstration of efficacy and safety for a given indication in a specific population. Until that process is complete, access to an experimental therapy is by definition an additional risk, as the agreed necessary safety and efficacy have not yet been demonstrated. True informed consent in this setting is difficult to obtain (i.e. studies have shown that severely ill patients, such as those with life-threating circumstances requesting expanded access, had less retention of information discussed in the informed-consent process and less-clear understanding of the risks of therapy compared to healthier patients[xiv]).

One position companies and regulators can consider is that the default answer to expanded access requests should be affirmative, unless there are compelling reasons for not approving requests to patients with life-threatening illnesses. (Such reasons, for example, might include limited treatment supply or lack of reasonable expectation of benefits versus risks.) Such a position would require, however, that there be broader industry, clinician, regulatory, and patient advocacy agreement of shared principles. This paper outlines the experiences, structural principles, and regulatory considerations of a small group, but further meetings may convene a broader group of stakeholders to build upon these concepts. Such consensus-based approaches might lead to durable systems that meet the needs of desperate patients who have run out of options—while allowing innovation to continue to benefit those who may come afterwards.

Acknowledgements: We are grateful for the participation of the following representatives in the roundtable: Jeff Allen (Friends of Cancer Research), Michelle Berrey (Chimerix), Renzo Canetta (Bristol-Myers Squibb), Anne Cropp (Pfizer), Joseph Eid (Merck), Aaron Kesselheim (Harvard Medical School), Howard Mayer (Shire), Jeffrey Murray (FDA), Lilli Petruzzelli (Novartis), Amrit Ray (Janssen), and Robert Truog (Harvard Medical School). We thank Mark McClellan (Brookings Institution) for helpful discussions of this topic and comments on the manuscript, and to the Richard Merkin Foundation for support. The views and opinions expressed in this article were interpreted and organized by the staff of the Brookings Institution. They do not necessarily reflect the official policy or position of any individual roundtable representative, their companies, or their employers.

References

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Over the past few years, more than 600 Accountable Care Organizations (ACOs) have formed across the country, charged with the dual goals of improving health while also reducing health care costs. Increasingly, evidence on how public and private ACOs are progressing toward these goals is beginning to emerge. Based on these results, major regulatory changes are anticipated in the months ahead that will impact accountable care programs in Medicare, as well as future uptake within the private sector.

On October 20, the Engelberg Center for Health Care Reform hosted a half day forum to assess the latest evidence on accountable care, discuss strategies to overcome unique ACO challenges, and provide an overview of accountable care reforms. Sean Cavanaugh of the Centers for Medicare and Medicaid Services (CMS) provided keynote remarks on the latest Medicare ACO results and potential changes to the Medicare Shared Savings Program (MSSP). Panel sessions featured leading experts in ACO research, implementation and health care policy.

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• The Medicare Shared Savings Program (MSSP): Looking Ahead
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Introduction

Ohio has already taken important steps to address the state’s ongoing foreclosure crisis, yet the crisis continues, causing distress for thousands of families and individuals, and destabilizing cities, towns and neighborhoods across the state. Therefore, the state, its local governments and private stakeholders need to do still more to deal more effectively with the crisis and its impacts on the state’s housing stock, cities and neighborhoods.

What is often termed the “foreclosure crisis” is actually a multi-dimensional crisis, in which the collapse of the housing bubble, the devastation caused by the lax and often irresponsible credit practices that accompanied and perpetuated that bubble, the resulting freeze on commercial and consumer credit, and the worldwide recession are interwoven, and can only with great difficulty be untangled. In Ohio, those forces are further exacerbated by profound changes to the state’s historical economic underpinnings. Ohio cannot solve the crisis by itself, but it can significantly mitigate its impact on people, neighborhoods, and towns and cities. These mitigating efforts will also help preserve the value of homes and neighborhoods in the state, and place Ohio in a stronger position to benefit from the future economic recovery.

The paper begins with a short summary of current conditions and the actions the state has already taken to address the wave of foreclosures, followed by a discussion of areas for future action. This discussion will address mitigating both the individual and community impacts of foreclosure, but will give particular emphasis to the critical issue of softening the blow of foreclosure on communities, which up to now has been less of a focus for state action.

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Ohio, like most other states in the country and particularly its neighbors in the Great Lakes region, is still reeling from the “Great Recession.” This economic crisis, the worst in a half century, has devastated economies across the globe.

While economists have declared that the recession has abated, it will be a long time before the businesses, households, and government treasuries across the country, and specifically in the state of Ohio, shake off the effects. And when the recession’s grip finally breaks, what will Ohio’s economy and landscape look like?

The choices that Ohio’s people and its leaders make—starting now and continuing over the next few years—will determine that answer. Ohioans can decide whether to shy away from manufacturing after the loss of so many jobs, or to transform the state’s old manufacturing strengths, derived from its role in the auto supply chain, into new products, markets, and opportunities. They can decide to opt out of the national shift to a lower-carbon economy, or to be at the forefront of developing clean coal and renewable energy industries and jobs.

They can choose a workforce system that is aligned to the true metropolitan scale of the economy and oriented to the needs of workers and employers. They can choose transformative transportation networks over more roads; smaller, greener, stronger cities; collaboration and regional cooperation to save money, reduce duplication, and bolster regional competitiveness. And instead of trying to go it alone in the 21st century global marketplace, they can maximize the federal resources on offer to support Ohio’s economic transformation and choose to compete effectively for new federal investments.

This report, Restoring Prosperity: Transforming Ohio’s Communities for the Next Economy, lays out some of the specific policy options that will help Ohioans restore the prosperity that the state enjoyed for much of the 19th and 20th centuries, but that it has been struggling to regain for at least a decade, if not longer.

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• Bruce Katz's Speech in Ohio