This election cycle, what will separate Democrats from Republicans on energy policy and their approach to climate change? Republicans tend to be fairly strong supporters of the fossil fuel industry, and to various degrees deny that climate change is occurring. Democratic candidates emphasize the importance of further expanding the share of renewable energy at the expense of fossil fuels, and agree that climate change is a real problem—with some saying the challenge trumps most, if not all, other U.S. security concerns.

Now that there are presumptive nominees for both major political parties, it’s an important moment to outline, in broad strokes, the positions of Secretary Hillary Clinton and businessman Donald Trump. We realize that Democratic Presidential candidate Bernie Sanders has not dropped out of the race, but note that it is fairly unlikely at this point that he would clinch the nomination.

Clinton: Building on the Obama legacy 

Secretary Clinton has laid out the most comprehensive and detailed energy and climate policy proposals of the candidates to date. They are in essence a continuation, and in some cases a further expansion, of existing White House policies under President Obama. The Secretary has stated that she wants the United States to be the “clean energy superpower of the 21st century.”

This starts with the notion that climate change is an existential threat, which the global community has to address as soon as possible. In order to do that, in her view, the United States needs to continue to show leadership on the international stage, as the Obama administration sought to do surrounding the Paris agreement in December 2015. This will require substantial reforms to expand low-carbon options, including nuclear energy to some degree, while tightly regulating fossil fuels (and gradually phasing them out). 

[S]he wants the United States to be the “clean energy superpower of the 21st century.”

The first casualty of this transformation is the coal industry, which Clinton has explicitly acknowledged. She presented a $30 billion plan to revitalize communities where coal production is currently an important industry and job creator, for example, and has campaigned with this message in various state primaries. Implicitly, Secretary Clinton does not seem to believe in the economic viability of carbon capture and sequestration in the United States—this is despite the fact that most analyses, including those of the Intergovernmental Panel on Climate Change (IPCC), suggest that this technology could be a cost-efficient tool in a wider carbon emission mitigation portfolio. 

Clinton sees natural gas as a bridge fuel, though at this point it’s not clear how long that bridge is. Questions remain about the role that natural gas can play in scenarios of deep decarbonization in 2030 and beyond. At the moment, the gas industry is rather nervous of the Secretary’s statement that she’d increase regulations on, in particular, the fracking industry—if her conditions came to fruition, there would very few places where fracking would continue. 

Secretary Clinton believes that oil consumption has to be cut substantially in the coming years, and she has suggested that new drilling in places like the Arctic, off the Atlantic Coast, and on federal lands would be discouraged or banned. She has previously opposed crude oil exports, though we would not anticipate a roll-back of existing policies (in December 2015, the Obama administration lifted the decades-old ban). 

Clinton foresees a new energy economy built on rapidly increasing shares of renewable energy, which should comprise 25 percent of the U.S. fuel mix by 2025 according to her plan (solar energy would be a key focus, with half a billion panels to be installed by the end of her first term). To facilitate this transition, she presented an elaborate energy infrastructure plan to modernize the U.S. grid and improve efficiency in reviewing and approving projects. 

Tax credits to support renewables would be continued under a Clinton White House, whereas fossil fuel subsidies would be phased out. Increased energy efficiency, including harmonization of vehicle efficiency and fuel standards, are high on her agenda as well. The Secretary also supports the Clean Power Plan that the Environmental Protection Agency under the Obama administration has launched, and which is currently on hold in the Supreme Court. 

On the international stage, Clinton supports the Paris agreement on climate change. Should she win the presidency in November, she would make an effort to take this Treaty to the next step, thus continuing U.S. leadership. That would mean reinforcing U.S. leadership along the lines described above, while helping address current uncertainties about finance, transparency, and accountability, to name only a few challenges that remain.

Trump: Drill, baby, drill

Although Donald Trump’s candidacy remains highly controversial, he is now the presumptive Republican nominee for president. To the extent that we know any detailed plans, quod non, it is safe to say that his views on energy and climate change are diametrically opposed to most of Clinton’s. Broadly speaking, Mr. Trump has come out as a fervent supporter of the fossil fuel industry, and has expressed skepticism about the economic viability of renewable energy.

Mr. Trump’s views start with the belief that climate change is not man-made. In the past, the controversial businessman has suggested that climate change might be a hoax invention from China, in order to undermine U.S. industrial interests and job creation. This starting point allows Mr. Trump to be extremely supportive of existing industrial interests (if carbon and other greenhouse gas emissions are not a problem, the thinking goes, then business as usual is the way to go). 

In a speech in North Dakota in late May, Mr. Trump laid out some broad initial ideas for his energy policy. He declared that under his presidency the United States would “accomplish complete American energy independence,” leaving unaddressed arguments about what that would mean for existing international energy trade. 

It is probably safe to say that Mr. Trump would like to further expand oil, gas, and coal production in the country. The latter, in particular, is remarkable: even coal executives have declared that market forces (particularly very competitive natural gas) have been the primary threat to the coal industry. Since Mr. Trump is also a strong supporter of the natural gas industry—and considering the challenges of building new bulk terminals for exports—it is unclear how a revitalization of the coal industry would occur. 

If climate change is a hoax, it will come as no surprise that Mr. Trump will not support efforts to mitigate carbon and other greenhouse gas emissions.

Contrary to his opponent, Mr. Trump would also like to revoke restrictions on drilling for oil and gas, and would permit production on federal lands. He also supports further expansion of energy infrastructure, and would, if elected, ask Trans Canada to resubmit a permit application for the Keystone pipeline, which he’d approve. He has caveated his support for projects like these by demanding that a portion of the revenues from oil and gas flows be redistributed to local communities, to compensate them for intrusion on their private property. Mr. Trump has also indicated that he wants to use revenues from oil and gas production to rebuild U.S. infrastructure more broadly.

If climate change is a hoax, it will come as no surprise that Mr. Trump will not support efforts to mitigate carbon and other greenhouse gas emissions. The candidate has called the Obama administration’s Clean Power Plan “stupid,” and when asked what he would do about the Paris agreement on climate change, he said he’d cancel it. 

Though Trump says the United States must pursue all forms of energy—including renewables—he has expressed skepticism about their economic viability, calling solar energy “very expensive.” Wind energy received similar pejorative feedback, since Trump says it kills eagles and is noisy. During one of the few debates about renewable energy during the Iowa primary, he voiced his support for blending biofuels in vehicles. 

To the polls

The 2016 U.S. presidential election will have a profound impact on global affairs. Not only will it affect a range of security and economic issues in important ways, it also means a lot for global energy and climate policy. Will the United States continue on the trajectory that President Obama has started and continue a major energy transition strategy? Or will it shift course, potentially undermining existing domestic policies and investments, as well as international obligations? In November 2016, the American people will decide.

The terrible attack in Nice on July 14—Bastille Day—saddened us all. For a country that has done so much historically to promote democracy and human rights at home and abroad, France is paying a terrible and unfair price, even more than most countries. My colleagues Will McCants and Chris Meserole have carefully documented the toll that France, and certain other Francophone countries like Belgium, have suffered in recent years from global terrorism. It is heart wrenching.

From what we know so far, the attack was carried out by a deeply distraught, potentially deranged, and in any case extremely brutal local man from Nice of Tunisian descent and French nationality. Marital problems, the recent loss of his job, and a general sense of personal unhappiness seem to have contributed to the state of mind that led him to commit this heinous atrocity. Perhaps we will soon learn that ISIS, directly or indirectly, inspired the attack in one way or another as well. My colleague Dan Byman has already tapped into his deep expertise about terrorism to remind us that ISIS had in fact encouraged ramming attacks with vehicles before, even if the actual manifestation of such tactics in this case was mostly new. 

This attack will again raise the question: Why France? On this point, I do have a somewhat different take than some of my colleagues. The argument that France has partly brought these tragedies upon itself—perhaps because of its policies of secularism and in particular its limitations on when and where women can wear the veil in France—strikes me as unpersuasive. Its logical policy implications are also potentially disturbing, because if interpreted wrongly, it could lead to a debate on whether France should modify such policies so as to make itself less vulnerable to terrorism. That outcome, even if unintended, could dance very close to the line of encouraging appeasement of heinous acts of violence with policy changes that run counter to much of what French culture and society would otherwise favor. So I feel the need to push back.

Here are some of the arguments, as I see them, against blaming French culture or policy for this recent string of horrible attacks including the Charlie Hebdo massacre, the November 2015 mass shootings in Paris, and the Nice tragedy (as well as recent attacks in Belgium):

• Starting with the simplest point, we still do not know much about the perpetrator of the Nice killings. From what we do surmise so far, personal problems appear to be largely at the root of the violence—different from, but not entirely unlike, the case with the Orlando shooter, Omar Mateen.
• We need to be careful about drawing implications from a small number of major attacks. Since 2000, there have also been major attacks in the Western world by extremist jihadis or takfiris in New York, Washington, Spain, London, San Bernardino, Orlando, and Russia. None of these are Francophone. Even Belgium is itself a mixed country, linguistically and culturally.
• Partly for reasons of geography, as well as history, France does face a larger problem than some other European countries of individuals leaving its country to go to Syria or Iraq to fight for ISIS, and then returning. But it is hardly unique in the scale of this problem.
• Continental Europe has a specific additional problem that is not as widely shared in the United Kingdom or the United States: Its criminal networks largely overlap with its extremist and/or terrorist networks. This point may be irrelevant to the Nice attack, but more widely, extremists in France or Belgium can make use of illicit channels for moving people, money, and weapons that are less available to would-be jihadis in places like the U.K. (where the criminal networks have more of a Caribbean and sub-Saharan African character, meaning they overlap less with extremist networks).
• Of course, the greatest numbers of terrorist attacks by Muslim extremists occur in the broader Muslim world, with Muslims as the primary victims—from Iraq and Syria to Libya and Yemen and Somalia to South Asia. French domestic policies have no bearing on these, of course.

There is no doubt that good work by counterterrorism and intelligence forces is crucial to preventing future attacks. France has done well in this regard—though it surely can do better, and it is surely trying to get better. There is also no doubt that promoting social cohesion in a broad sense is a worthy goal. But I would hesitate, personally, to attribute any apparent trend line in major attacks in the West to a particular policy of a country like France—especially when the latter is in fact doing much to seek to build bridges, as a matter of national policy, with Muslims at home and abroad. 

There is much more to do in promoting social cohesion, to be sure, even here in America (though our own problems probably center more on race than on religion at the moment). But the Nice attacker almost assuredly didn’t attack because his estranged wife couldn’t wear a veil in the manner and/or places she wanted. At a moment like this in particular, I disagree with insinuations to the contrary.

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

Downloads

• The Four A's of Expanded Patient Access

For over 100 years, the driving force of Ohio’s economy has been the state’s so-called Big Eight cities—Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Canton, and Youngstown. Today, though, the driving reality of these cities is sustained, long-term population loss. The central issue confronting these cities—and the state and surrounding metropolitan area—is not whether these cities will have different physical footprints and more green space than they do now, but how it will happen.

The state must adopt a different way of thinking and a different vision of its cities’ future—and so must the myriad local, civic, philanthropic, and business leaders who will also play a role in reshaping Ohio’s cities. The following seven basic premises should inform any vision for a smaller, stronger future and subsequent strategies for change in these places:

• These cities contain significant assets for future rebuilding
  
• These cities will not regain their peak population
  
• These cities have a surplus of housing
  
• These cities have far more vacant land than can be absorbed by redevelopment
  
• Impoverishment threatens the viability of these cities more than population loss as such
  
• Local resources are severely limited
  
• The fate of cities and their metropolitan areas are inextricably inter-connected
  

These premises have significant implications for the strategies that state and local governments should pursue to address the issues of shrinking cities.

Full Paper on Ohio's Cities » (PDF)
Paper on Shrinking Cities Across the United States »

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Indian Prime Minister Narendra Modi’s recent visit to the United Arab Emirates revealed New Delhi’s intention to bolster bilateral relations with the Gulf states. It was the first visit by an Indian prime minister in over 30 years, demonstrating the country’s renewed focus on expanding ties with the region it has always called “West Asia.” Although India and the Middle East share a long history of trade, immigration and cultural exchange, relations have yet to reach their full potential.

Read "Dealing with Delhi: How culture shapes India’s Middle East policy"

In this policy briefing, Kadira Pethiyagoda highlights the importance of an under-reported aspect of the relationship – culture. The author explains the role it plays in India’s policies toward the region, particularly under the current government, and argues that Gulf states need to understand the impact of Indian values and identity. Pethiyagoda provides recommendations on how the Gulf states can, through better understanding the cultural drivers of Indian foreign policy, build stronger ties with India, thereby advancing both economic and strategic interests.

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Abstract

Progress in closing differences in many objective outcomes for blacks relative to whites has slowed, and even worsened, over the past three decades. However, over this period the racial gap in wellbeing has shrunk. In the early 1970s data revealed much lower levels of subjective well-being among blacks relative to whites. Investigating various measures of well-being, we find that the well-being of blacks has increased both absolutely and relative to that of whites. While a racial gap in well-being remains, two-fifths of the gap has closed and these gains have occurred despite little progress in closing other racial gaps such as those in income, employment, and education. Much of the current racial gap in well-being can be explained by differences in the objective conditions of the lives of black and white Americans. Thus making further progress will likely require progress in closing racial gaps in objective circumstances.

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• Subjective and Objective Indicators of Racial Progress

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There are currently an estimated 3 million people living with HIV/AIDS in Nigeria, making it the second most infected country worldwide. In light of these stark figures and the general failure by African countries to curb the HIV/AIDS pandemic, how can Nigeria expect to achieve a breakthrough in dealing with its HIV/AIDS epidemic? What policy actions should the global public health community, international donors and the Nigerian government take to help end this health crisis?

The Research Alliance to Combat HIV/AIDS (REACH), a joint collaboration between Northwestern University and the University of Ibadan in Nigeria, has sought to answer these questions. Since 2006, REACH has engaged social scientists in community-based research to explore the attitudes and behaviors related to HIV/AIDS prevention in four Nigerian states and advance strategies to reduce infection rates. On May 27, Global Economy and Development at Brookings and the Buffett Center for International and Comparative Studies at Northwestern University hosted a discussion on REACH’s most recent findings and policy recommendations. The first panel focused on the current state of the epidemic in Nigeria. The second panel examined a preventative approach to HIV/AIDS in Nigeria and other African countries.

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Social Security is the most popular legacy of Franklin Roosevelt's New Deal. Last year almost 60 million Americans received benefits from the program. Payments amounted to over $875 billion, nearly a quarter of all federal spending.  For more than two decades, most discussion of Social Security, at least in Washington, has centered on its funding shortfall. Contributions to the program are not high enough to pay for all benefits scheduled under current law. The Social Security Trust Fund is expected to be depleted around 2030. If Congress does not address the funding problem before reserves are exhausted, monthly payments will have to be cut about one-fifth.

Despite the projected shortfall, Democrats in Congress have begun to argue that Social Security benefits should be expanded rather than cut.  Senators Bernie Sanders and Brian Schatz have offered proposals to boost monthly pensions while at the same time shoring up Social Security finances through tax hikes on high-income Americans. 

That Democratic voters and lawmakers embrace these ideas is not surprising. But opinion polling suggests such reforms also enjoy broad support among self-identified independents and Republicans. For example, 57 percent of Republicans (versus 71 percent of Democrats) favor increasing cost-of-living adjustments in the benefit formula. Forty-eight percent of Republicans (versus 67 percent of Democrats) favor boosting the minimum benefit available to low-wage workers who have contributed for many years to the program.  Seventy-four percent of Republicans (versus 88 percent of Democrats) favor raising taxes in order to protect benefits. These polling numbers were obtained in 2013, but more recent polls show similar opinions. Even if debates among Washington insiders and GOP lawmakers focus on how to trim benefits in order to keep Social Security solvent, poll results suggest Senator Sanders holds views closer to those of the typical voter.

One question for both voters and policymakers is whether the aged population is really the most deserving target for additional government spending.  Much of the discussion of voter disaffection in the current election cycle has focused on the stagnation of middle class incomes and the rise in inequality.  While these represent major problems for families headed by a working-age person, they have not been notably troublesome for the nation’s elderly.  The incomes of the elderly, unlike those of the nonelderly, have increased steadily over the past three or four decades.  For low- and middle-income retirees, incomes have clearly improved. The same cannot be said for the incomes of low- and middle-income working-age families. Income inequality among the elderly has increased, to be sure, but much more slowly than among working-age families.

In new research with my colleagues Barry Bosworth and Kan Zhang, I have examined trends in real incomes and inequality among the nation’s elderly and compared them with the same trends in working-age families. We show that inequality has increased among both the elderly and nonelderly, but it has increased much faster among families headed by prime-age and younger adults than among families headed by someone past age 62.  More to the point, real money incomes have increased much faster among middle- and low-income aged families compared with middle- and low-income working-age families. 

Our estimates of the annual rate of change in real money income are displayed in the chart below. The changes are estimated over the period from 1979 to 2012 based on data reported in the Census Bureau’s annual income survey. The top panel shows changes in families with a head who is less than 62. The bottom panel shows changes in families with a head older than 62.  Each bar shows the annual rate of change in real income at the indicated position of the income distribution, either for nonaged families (in the top panel) or for aged families (in the bottom panel).  At the top of the two income distributions—that is, at the 98^th income percentile—real income gains are virtually the same in the two groups.  Further down the income ladder, the income gains differ noticeably, with bigger differences the further down we go.  Middle- and low-income working-age families have clearly fared much worse than families with an equivalent position in the old-age income distribution.

Estimates of income growth based solely on pre-tax cash incomes, such as the ones in the chart, almost certainly understate the improvement families have seen in their living standards, as I have argued elsewhere (here and here).  However, the understatement is bigger in the case of elderly and low-income Americans than it is for the nonelderly and affluent.  If we adjust family incomes to reflect the taxes families owe and the monetary value of their noncash benefits, the relative improvement in the standard of living of older Americans is even greater than is shown in the chart. Under almost any plausible income definition, the elderly have fared better than the nonelderly, especially at the bottom of the income distribution.

The income statistics do not prove the policy reforms urged by Congressional Democrats are unneeded or undesirable. Their proposals spring from an accurate reading of a long-term trend toward less pension coverage — ironically, a trend that has mainly affected working-age adults.  Whereas workers in the 1950s through the 1970s enjoyed continuous improvement in their access to employer-provided retirement benefits, the improvement ceased after 1980. Since that time, private-sector workers have seen reductions in the coverage and generosity of their employer-sponsored pensions. If the private sector voluntarily provides less retirement protection, it does not seem unreasonable to expect the government to provide more.

A crucial reason the nation’s elderly population fared better compared with the nonelderly after 1980 is that Social Security and Medicare provided them government protection that was far more generous (and more costly to taxpayers) than the protection available to working-age adults and their youngsters. The gap was especially glaring in the case of families headed by low-wage breadwinners, who have suffered sizeable reductions in pay and employment opportunities. In the years since 1980, their losses have been only modestly compensated through changes in the tax code and expansions of public health insurance.

Changes in the labor market make it important to protect future retirement benefits provided through Social Security. The same labor market developments make it even more urgent to expand the employment opportunities and improve the protections and work supports offered to working-age breadwinners.  In 2016, the weakening of future income protection for the aged is mostly theoretical. In contrast, the sinking fortunes of less skilled working-age adults are anything but theoretical. They are plain to anyone who can read Census and Bureau of Labor Statistics reports. If taxpayers can identify additional resources to pay for major new initiatives, my vote is for programs that improve the prospects of struggling wage earners. The equity arguments for such an initiative seem to me more persuasive than the case for an across-the-board benefit hike targeted on retirees.

Editor's note: This piece originally appeared in Real Clear Markets. 

With Washington adrift and the United Nations climate change panel again calling for action, the search for new clean energy finance solutions continues.  

Against this backdrop, the Metro Program has worked with state- and city-oriented partners to highlight such responses as repurposing portions of states’ clean energy funds and creating state green banks.  Likewise, the Center for American Progress just recently highlighted the potential of securitization and investment yield vehicles, called yield cos. And last week an impressive consortium of financiers, state agencies, and philanthropies announced the creation of the Warehouse for Energy Efficiency Loans (WHEEL) aimed at bringing low-cost capital to loan programs for residential energy efficiency. WHEEL is the country’s first true secondary market for home energy loans—and a very big deal. 

Another big deal is the potential of bond finance as a tool for clean energy investment at the state and local level. That’s the idea advanced in a new paper released this morning that we developed with practitioners at the Clean Energy Group and the Council for Development Finance Authorities.

Over 100 years, the nation’s state and local infrastructure finance agencies have issued trillions of dollars’ worth of public finance bonds to fund the construction of the nation’s roads, bridges, hospitals, and other infrastructure—and literally built America. Now, as clean energy subsidies from Washington dwindle, these agencies are increasingly willing to finance clean energy projects, if only the clean energy community will embrace them.

So far, these authorities are only experimenting. However, the bond finance community has accumulated significant experience in getting to scale and knows how to raise large sums for important purposes by selling bonds to Wall Street. Accordingly, the clean energy community—working at the state and regional level—should leverage that expertise. The challenge is for the clean energy and bond finance communities to work collaboratively to create new models for clean energy bond finance in states, and so to establish a new clean energy asset class that can easily be traded in capital markets.

Along these lines, our new brief argues that state and local bonding authorities, clean energy leaders, and other partners should do the following: 

• Establish mutually useful partnerships between development finance experts and clean energy officials at the state and local government levels
• Expand and scale up bond-financed clean energy projects using credit enhancement and other emerging tools to mitigate risk and through demonstration projects
• Improve availability of data and develop standardized documentation so that the risks  and rewards of clean energy investments can be better understood
• Create a pipeline of rated and private placement deals, in effect a new clean energy asset class, to meet the demand by institutional investors for fixed-income clean energy securities

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The financial crisis is now eight years behind us, but its legacy lingers on. Many Americans are concerned about their financial security and are particularly worried about whether they will have enough for retirement. Guaranteed benefit pensions are gradually disappearing, leaving households to save and invest for themselves. What role could equities play for retail investors?

Another concern about the lingering impact of the crisis is that business investment and overall economic growth remains weak compared to expectations. Large companies are able to borrow at low interest rates, yet many of them have large cash holdings. However, many small and medium sized enterprises face difficulty funding their growth, paying high risk premiums on their borrowing and, in some cases, being unable to fund investments they would like to make. Equity funding can be an important source of growth financing.

On Friday, April 15, the Initiative on Business and Public Policy at Brookings examined what role equity markets can play for individual retirement security, small business investment and whether they can help jumpstart American innovation culture by fostering the transition from startups to billion dollar companies.

You can join the conversation and tweet questions for the panelists at #EquityMarkets.

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• Keynote address by Richard G. Ketchum
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• Keynote address by Roger Ferguson

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• Not just for the professionals? Understanding equity markets for retail and small business investors

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• Equity Markets Retirement Security 2016 Apr 15 (2)
• 20160415_equity_markets_transcript

Abstract

An individual-based computational model of smallpox epidemics in a two-town county is presented and used to develop strategies for bioterror containment. A powerful and feasible combination of preemptive and reactive vaccination and isolation strategies is developed which achieves epidemic quenching while minimizing risks of adverse side effects. Calibration of the model to historical data is described. Various model extensions and applications to other public health problems are noted.

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There's a little more than a week to go before the Democratic National Convention begins in Boston. Senator John Kerry is both raising and spending money at a furious pace. The Kerry campaign raised about $182 million from March through June. Senator Kerry also outspent President George Bush in advertising throughout most of the summer. But the president still has more cash on hand, reportedly $63 million at the end of May. That's the latest figure available. The president also has more time to spend that money before accepting his Republican nomination on September 2. Anthony Corrado is an expert on campaign finance.

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After his first place finish in Iowa, which was supposed to propel him to a New Hampshire victory, “change” is probably a word Barack Obama does not like as much anymore. But, his support did not really change much between these two elections. He won 38 percent of Iowa’s delegates and 36 percent of New Hampshire’s vote. It was Hillary Clinton and John McCain who were the big change candidates.

What happens when a presidential candidate that does well in a primary or caucus state, does not do so well in the next? The dynamic of the presidential election can swiftly and stunningly change, as it did in New Hampshire on Tuesday.

How Barack Obama wishes John Edwards showed up in New Hampshire.

Edwards was awarded 30 percent of Iowa’s delegates, barely denying Clinton a second place finish. He finished a distant third in New Hampshire, receiving only 17 percent of the vote. There are strong indications that a shift among his supporters helped propel Hillary Clinton to her New Hampshire victory.

According to the exit polls, Edwards did 8 percentage points worse in New Hampshire among women, while Clinton did 16 percent better. Obama’s support was virtually identical, dropping a statistically insignificant 1 percentage point.

Obama’s support among young people remained strong, if slightly increasing among 18-24 and 30-39 year olds. Clinton’s support remained strong and slightly increased among those 65 and older. Edwards won Iowa’s middle-aged voters, age 40-64, but it was Clinton who decisively won this coveted age demographic in New Hampshire. And where these people were 38 percent Iowa caucus attendees, they were 54 percent of New Hampshire voters. (To understand why their turnout increased, see my analysis of Iowa’s turnout .)

Moving forward, the generational war is still a strong dynamic in the Democratic race, as evident in the candidates’ speech styles following the election results. In Iowa, Clinton was flanked by the ghosts of the Clinton administration. In New Hampshire, she shared the stage with a sea of young voters. In Iowa, Obama spoke of change, a message that resonates with younger people who are not part of the establishment. In New Hampshire his slogan was a message that echoes the can-do spirit of the greatest generation, “Yes, we can!”

In the days between Iowa and New Hampshire, Edwards spoke about how he wanted the election to become a two-way race. One should be careful with what one wishes for. Edwards and Clinton are vying for the same support base, that when united can defeat Obama, at least in New Hampshire. In the short-term, Obama most needs Edwards to do better so that support can continue to be divided.

Among Republicans, John McCain recreated his magic of eight years ago and bounced back strong from a poor Iowa showing to win New Hampshire.

The Iowa and New Hampshire electorates are so different it is difficult to compare them. In Iowa, Evangelical Christians were 60 percent of the electorate, while in New Hampshire, they were only 23 percent. Mike Huckabee’s move from first in Iowa to third in New Hampshire can be clearly attributed to the shrinking of his base. His collapse paved the way for a new winner to emerge.

It is thus tempting to attribute McCain’s victory solely to the different electorates, but he still had to defeat Mitt Romney to win New Hampshire.

According to the exit polls, the battle between McCain and Romney is a referendum on the Bush administration. Surprisingly, McCain, who has tried to rebuild bridges with the Bush establishment since his defeat in the 2000 presidential election, is still seen as the outsider and agent of change by voters participating in the Republican nomination process.

In both Iowa and New Hampshire, McCain drew his support from those who said they are angry or dissatisfied with the Bush administration. Romney drew his support from those who said they are enthusiastic or satisfied. Not surprisingly, McCain is also drawing more support from self-described Independents and Romney from Republicans.

The candidates seem to understand this dynamic, too, as they gave their speeches following the election results. In a contrived bit of acting, Romney showed up on stage without a podium and shoved a prepared speech back into his pocket (if he had needed a podium, his advance team would have provided it). He appeared relaxed, delivering his speech in a personable style reminiscent of Huckabee, who is competing with Romney for those who support Bush. But he also seemed to be reaching out to Independents with a message of change. In stark contrast, McCain delivered a carefully written, almost sedate speech designed to reassure Republicans of his conservative credentials.

This three-way dynamic between Huckabee, McCain, and Romney should prove fascinating as the Republican nomination process moves forward. Where Evangelicals are strong, Huckabee should do well. Where they are not, the rules governing if Independents can or cannot participate will dictate how McCain and Romney do. And we have yet to see regional candidates like Fred Thompson have their day in the sun. And then there is Rudy Giuliani, who is lying in wait in the larger states where his name recognition should give him a significant boost over the other candidates. All of this points to an extended campaign among Republicans.

Michael P. McDonald is an Associate Professor at George Mason University and a Non-Resident Senior Fellow at the Brookings Institution. He studies voter turnout and is a consultant to the national exit poll organization.

The terrible attack in Nice on July 14—Bastille Day—saddened us all. For a country that has done so much historically to promote democracy and human rights at home and abroad, France is paying a terrible and unfair price, even more than most countries. My colleagues Will McCants and Chris Meserole have carefully documented the toll that France, and certain other Francophone countries like Belgium, have suffered in recent years from global terrorism. It is heart wrenching.

From what we know so far, the attack was carried out by a deeply distraught, potentially deranged, and in any case extremely brutal local man from Nice of Tunisian descent and French nationality. Marital problems, the recent loss of his job, and a general sense of personal unhappiness seem to have contributed to the state of mind that led him to commit this heinous atrocity. Perhaps we will soon learn that ISIS, directly or indirectly, inspired the attack in one way or another as well. My colleague Dan Byman has already tapped into his deep expertise about terrorism to remind us that ISIS had in fact encouraged ramming attacks with vehicles before, even if the actual manifestation of such tactics in this case was mostly new. 

This attack will again raise the question: Why France? On this point, I do have a somewhat different take than some of my colleagues. The argument that France has partly brought these tragedies upon itself—perhaps because of its policies of secularism and in particular its limitations on when and where women can wear the veil in France—strikes me as unpersuasive. Its logical policy implications are also potentially disturbing, because if interpreted wrongly, it could lead to a debate on whether France should modify such policies so as to make itself less vulnerable to terrorism. That outcome, even if unintended, could dance very close to the line of encouraging appeasement of heinous acts of violence with policy changes that run counter to much of what French culture and society would otherwise favor. So I feel the need to push back.

Here are some of the arguments, as I see them, against blaming French culture or policy for this recent string of horrible attacks including the Charlie Hebdo massacre, the November 2015 mass shootings in Paris, and the Nice tragedy (as well as recent attacks in Belgium):

• Starting with the simplest point, we still do not know much about the perpetrator of the Nice killings. From what we do surmise so far, personal problems appear to be largely at the root of the violence—different from, but not entirely unlike, the case with the Orlando shooter, Omar Mateen.
• We need to be careful about drawing implications from a small number of major attacks. Since 2000, there have also been major attacks in the Western world by extremist jihadis or takfiris in New York, Washington, Spain, London, San Bernardino, Orlando, and Russia. None of these are Francophone. Even Belgium is itself a mixed country, linguistically and culturally.
• Partly for reasons of geography, as well as history, France does face a larger problem than some other European countries of individuals leaving its country to go to Syria or Iraq to fight for ISIS, and then returning. But it is hardly unique in the scale of this problem.
• Continental Europe has a specific additional problem that is not as widely shared in the United Kingdom or the United States: Its criminal networks largely overlap with its extremist and/or terrorist networks. This point may be irrelevant to the Nice attack, but more widely, extremists in France or Belgium can make use of illicit channels for moving people, money, and weapons that are less available to would-be jihadis in places like the U.K. (where the criminal networks have more of a Caribbean and sub-Saharan African character, meaning they overlap less with extremist networks).
• Of course, the greatest numbers of terrorist attacks by Muslim extremists occur in the broader Muslim world, with Muslims as the primary victims—from Iraq and Syria to Libya and Yemen and Somalia to South Asia. French domestic policies have no bearing on these, of course.

There is no doubt that good work by counterterrorism and intelligence forces is crucial to preventing future attacks. France has done well in this regard—though it surely can do better, and it is surely trying to get better. There is also no doubt that promoting social cohesion in a broad sense is a worthy goal. But I would hesitate, personally, to attribute any apparent trend line in major attacks in the West to a particular policy of a country like France—especially when the latter is in fact doing much to seek to build bridges, as a matter of national policy, with Muslims at home and abroad. 

There is much more to do in promoting social cohesion, to be sure, even here in America (though our own problems probably center more on race than on religion at the moment). But the Nice attacker almost assuredly didn’t attack because his estranged wife couldn’t wear a veil in the manner and/or places she wanted. At a moment like this in particular, I disagree with insinuations to the contrary.