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United States Seeks Civil Contempt Against Bayer Corporation for Failure to Substantiate Promotional Claims for Phillips’ Colon Health

The Department of Justice announced today that it filed a motion to show cause why Bayer Corporation should not be held in civil contempt for violating a court order in the U.S. District Court for the District of New Jersey.



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FDA Site Inspections: 5 Tips for Success

Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.

Yep.  That’s the word that comes to mind whenever anyone mentions FDA inspections.

But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think.  There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome.   Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.



Pre-inspection Preparation
For-cause inspections may be unannounced, but routine FDA inspections of submission data are scheduled in advance*.  That means most inspections are not pop quizzes; they’re final exams.
Remember how happy you were when a teacher gave you access to a prior year’s exam to study from?  You knew the type of questions that would be asked.  You knew how to prepare.

So this is the first tip we’d like to share.  FDA has, indeed, given you a copy of their exam in advance, in the form of its Compliance Program Guidance Manual, CPGM 7348.811.  This is the document all FDA field investigators use to conduct inspections at clinical sites.  It outlines in great detail what documents investigators will review, what dates they’re going to verify, what processes they’ll evaluate, what data they’ll collect, and what records they’re going to compare.  Despite its rather uninspired title, this is your copy of the final exam.

You know cramming is a risky strategy, so the earlier you get familiar with the CPGM the better.  Inspection readiness is a state of preparedness more than it is a laundry list of activities; it takes some time to get there.

When the Inspector’s in the House
According to the CPGM, one of the first pieces of information the FDA investigator will obtain is a list of all of the studies performed by the clinical investigator, including protocol number, sponsor, and study dates.  So even though FDA has scheduled its inspection with you, and has told you what study the investigator is coming to inspect, any study is fair game.  An FDA investigator can look at any document she wants, or talk to any staff member he chooses, whether related to the “assigned” study or not.

Most of your preparation will have been study-specific; questions about other studies will catch your staff off-guard, and a review of records for other studies may find them less than inspection-ready.  So here’s our second tip.   Avoid anything that might pique the investigator’s curiosity about a study that is not the original subject of the inspection.  Make sure the room you reserve as your investigator’s “home base” is free of any documents, reports, notes, phone lists, and post-its.  Make sure you tidy up offices, workspaces, and facilities site-wide, and keep extraneous chatter in check.

After the Visit
If your FDA inspection resulted in zero observations, then stop reading, thank your awesome staff members, and go celebrate.  If, however, you did receive a Form FDA 483, it’s probably not the end of the world, but you do have some work to do.  Our third tip is this:  remember that the sponsor/CRO is your ally here.  They have as much invested in FDA’s assessment of your study data as you do, and they have the regulatory, QA, even legal resources that you might not.   You’re not required to formally respond to 483s, but if you do, you’re likely to receive a more favorable Establishment Inspection Report (EIR) in the end.  Let your sponsor/CRO help you with your response.

Tips Do Not a Plan Make
Tips are helpful, but you’ll need more than that to ensure a successful FDA site inspection.  You need an inspection readiness plan -- a plan that you document and keep current.  All site staff members need to train on the inspection procedures and the individual roles they will play.  (Fourth tip: don’t forget to train your temporary employees; an office temp working at the receptionist desk could be the first person your FDA investigator speaks with.)

A Last Thought
Inspections are stress-inducing events, and nervous people make mistakes.  Investigators know this, and expertly exercise the “pregnant pause,” knowing how difficult it is for people to withstand an excruciating silence without volunteering unsolicited information.

So one last tip:  conduct a mock inspection before the FDA comes to visit.  It will stress test your procedures and identify improvements you need to implement.  A thorough mock inspection will give staff members an opportunity to rehearse their roles and interview techniques so they can execute your plan and speak to the FDA investigator with confidence.

_______________________________
* For-cause inspections are also known as Investigator-oriented, and routine inspections are also known as study-oriented.

 A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites




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Delegation of Authority Log: Tips for Monitors

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.
  • Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
  • Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
  • Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.
  • Have any study tasks been conducted by staff members who have not received official delegation to do so?
  • Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?


PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

__________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.




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Clinical Trial Tips: Practical and Actionable

Over the years, attendees of MAGI Clinical Research Conferences have collected a set of practical, actionable suggestions for improving clinical trials. More than eighty such tips appear in the July 2019 edition of Journal of Clinical Research Best Practices*.  In this post, Polaris auditors weigh in on some of their favorite MAGI suggestions. Surprising no one, they also were eager to share some of their own.

Our Favorites Tips from MAGI

So how does a clinical trial tip earn a spot on our exalted Faves List?  First, it must be something we don’t see too often, or not as much as we’d like.(If most organizations already do a useful thing, it doesn’t really qualify as a helpful tip; it’s really just a common practice.) Second, the effort to implement the tip can’t be too onerous. If a practice requires too much interdepartmental coordination, change management, training, money, or resources, it’s not a tip. It’s a full-blown initiative.

So here they are. Each tip from MAGI attendees is in bold font. Our accompanying commentary is in plain text:

  • To help ensure quality study conduct, clinical sites should prepare protocol-specific quality checklists for each study. We’ve written about quality checklists from the auditing perspective before. They’re not a panacea, certainly, but that doesn’t mean they can’t be very useful.

  • After study close-out, sponsors and CROs should consider holding conference calls with groups of sites to capture lessons learned. This in turn could be used to improve training, SOPs, SIVs, etc.

  • As a recruitment aid, clinical sites should create pocket-sized, laminated study cards that list the inclusion/exclusion criteria for a study.  Site staff members can keep these cards in their lab coat pockets and quickly refer to them when treating a patient who could be a potential subject.

  • CROs should share risk assessments and mitigation plans with Sponsors. We agree, but would also encourage CROs to keep the sites involved and aware of risks so they can anticipate them and proceed accordingly.

  • Sponsors/CROs should ensure proper qualifications of vendors prior to executing contracts. It’s hard to argue with this logic, but we don’t see it as much as we should. Too often qualification audits come after the paperwork has been signed. Should the audit uncover noncompliance or quality risks at the vendor site, it’s much harder to get the vendor to make necessary changes after the contract is in place.

  • CROs should align 3rd party contracts with the Sponsor/CRO contract and the Clinical Trial Agreement. Yep.

Additional Tips from Polaris QA/Compliance Auditors

The MAGI list of clinical trial tips brought others to mind that we wanted to share. We applied the same criteria to these suggestions as we did to the MAGI contributions: (1) not necessarily rare, but not as common as it could be, and (2) not overly complex or expensive to implement.
  • When evaluating outsourcing partners and clinical sites, Sponsors and CROs should make sure to look at personnel turnover rates. Frequent turnovers may suggest underlying problems that could jeopardize study conduct and quality.

  • Sponsors and CROs should make sure their Monitoring Report templates are consistent with the Clinical Monitoring Plan (CMP). For example:

    • The CMP calls for a focus on a particular set of critical variables, but the report template only has a place for recording that 100% SDV was completed. This means that there’s no way to document that the monitor put special emphasis on anything.
    • The CMP requires bi-direction review of study data – a confirmation that what is in the CRF can be verified in the source, and all pertinent data in the source can be found in the CRF – but the report template only allows for the former to be documented.

  • Every member of the site team has valuable input. It’s important to include the study PI, CRC, pharmacist, and other key personnel in the discussions. In 2017, we wrote an article about the important, yet often overlooked, input that the pharmacist on site can provide.

  • There are many reasons that trial participants leave a study, many of which can’t be remedied with improved site practices. But sites that demonstrate they value the participation of their study volunteers, and honor the time they’re spending and contribution they’re making, tend to have better retention results. To that end:

    • To help participants schedule their time, sites can prepare calendars that include all study visit dates and indicate the activities and procedures they entail. (This, of course, needs to be approved by the IRB).
    • When participants arrive, they shouldn’t have to sit in a waiting room or empty exam room; they should be seen immediately so they don’t feel their time is being wasted.
    • Sites can provide beverages and light snacks to their study participants who especially appreciate them immediately after a fasting blood draw (protocol permitting, naturally). It’s a small courtesy, and not difficult to do. Whose day isn’t brightened by a proffered nosh?**
Uh oh. Now we got you all thinking about mini muffins and cheddar popcorn. Go ahead. Grab a treat. We'll talk later.

________________________________________________________________
 * Journal of Clinical Research Best Practices, July 2019

** Proffered Nosh™ would be a really great name for a restaurant. Or a fictional Scotland Yard Inspector -- legendary for his wit, brilliance, wine pairings, and fashion sense.




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Japan's State Guest House silently awaits return of VIPs




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Bank Exam Preparation Tips 2020 at Home: IBPS PO, IBPS Clerk, IBPS RRB, SBI Clerk, RBI, LIC

Bank Exams Preparation Tips 2020: Have a look at important Tips and Strategies for bank exam preparation to fetch recruitment in banks as PO/Clerk/SO. Know details of SBI Clerk 2020, IBPS RRB 2020, IBPS PO 2020, IBPS Clerk 2020, RBI Assistant 2020, LIC AAO/ADO 2020 and other bank exams. 




ips

Building Sustainable Relationships, Energy, and Security in the Middle East

While the Middle East Initiative is focused entirely on the MENA region, several other Center programs are also working on issues related to the Middle East, including Future of Diplomacy, Geopolitics of Energy, and the Managing the Atom.




ips

Building Sustainable Relationships, Energy, and Security in the Middle East

While the Middle East Initiative is focused entirely on the MENA region, several other Center programs are also working on issues related to the Middle East, including Future of Diplomacy, Geopolitics of Energy, and the Managing the Atom.




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2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

China’s African Envoys Take Twitter Tips from Trump in PR Offensive

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

China’s African Envoys Take Twitter Tips from Trump in PR Offensive

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

Building Sustainable Relationships, Energy, and Security in the Middle East

While the Middle East Initiative is focused entirely on the MENA region, several other Center programs are also working on issues related to the Middle East, including Future of Diplomacy, Geopolitics of Energy, and the Managing the Atom.




ips

China’s African Envoys Take Twitter Tips from Trump in PR Offensive

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi




ips

China’s African Envoys Take Twitter Tips from Trump in PR Offensive

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

Banning cars won’t solve America’s bigger transportation problem: Long trips

Cars are a fact of life for the vast majority of Americans, whether we’re commuting to work or traveling to just about anywhere. But a new development outside Phoenix is looking to change that. Culdesac Tempe, a 1,000-person rental community, aims to promote a new type of walkable neighborhood by banning residents from driving or…

       




ips

Building Sustainable Relationships, Energy, and Security in the Middle East

While the Middle East Initiative is focused entirely on the MENA region, several other Center programs are also working on issues related to the Middle East, including Future of Diplomacy, Geopolitics of Energy, and the Managing the Atom.




ips

Building Sustainable Relationships, Energy, and Security in the Middle East

While the Middle East Initiative is focused entirely on the MENA region, several other Center programs are also working on issues related to the Middle East, including Future of Diplomacy, Geopolitics of Energy, and the Managing the Atom.




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

China’s African Envoys Take Twitter Tips from Trump in PR Offensive

Chinese diplomats in Africa are robustly defending Beijing’s policies on Twitter as part of a new and sometimes aggressive public relations campaign which is playing out across the globe as the country’s envoys answer President Xi Jinping’s call to “tell China stories well”.south chi




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

2020–2021 International Security Program Research Fellowships: Apply Now

The International Security Program (ISP) is still accepting applications for 2020–2021.  ISP is a multidisciplinary research group that develops and trains new talent in security studies by hosting pre- and postdoctoral research fellows. 




ips

USAID's public-private partnerships: A data picture and review of business engagement


In the past decade, a remarkable shift has occurred in the development landscape. Specifically, acknowledgment of the central role of the private sector in contributing to, even driving, economic growth and global development has grown rapidly. The data on financial flows are dramatic, indicating reversal of the relative roles of official development assistance and private financial flows. This shift is also reflected in the way development is framed and discussed, never more starkly than in the Addis Abba Action Agenda and the new set of Sustainable Development Goals (SDGs). The Millennium Development Goals (MDGs), which the SDGs follow, focused on official development assistance. In contrast, while the new set of global goals does not ignore the role of official development assistance, they reorient attention to the role of the business sector (and mobilizing host country resources).

The U.S. Agency for International Development (USAID) has been in the vanguard of donors in recognizing the important role of the private sector to development, most notably via the agency’s launch in 2001 of a program targeted on public-private partnerships (PPPs) and the estimated 1,600 USAID PPPs initiated since then. This paper provides a quantitative and qualitative presentation of USAID’s public-private partnerships and business sector participation in those PPPs. The analysis offered here is based on USAID’s PPP data set covering 2001-2014 and interviews with executives of 17 U.S. corporations that have engaged in PPPs with USAID.

The genesis of this paper is the considerable discussion by USAID and the international development community about USAID’s PPPs, but the dearth of information on what these partnerships entail. USAID’s 2014 release (updated in 2015) of a data set describing nearly 1,500 USAID PPPs since 2001 offers an opportunity to analyze the nature of those PPPs.

On a conceptual level, public-private partnerships are a win-win, even a win-win-win, as they often involve three types of organizations: a public agency, a for-profit business, and a nonprofit entity. PPPs use public resources to leverage private resources and expertise to advance a public purpose. In turn, non-public sectors—both businesses and nongovernmental organizations (NGOs)—use their funds and expertise to leverage government resources, clout, and experience to advance their own objectives, consistent with a PPP’s overall public purpose. The data from the USAID data set confirm this conceptual mutual reinforcement of public and private goals.

The goal is to utilize USAID’s recently released data set to draw conclusions on the nature of PPPs, the level of business sector engagement, and, utilizing interviews, to describe corporate perspectives on partnership with USAID.

The arguments regarding “why” PPPs are an important instrument of development are well established. This paper presents data on the “what”: what kinds of PPPs have been implemented and in what countries, sectors, and income contexts. There are other research and publications on the “how” of partnership construction and implementation. What remains missing are hard data and analysis, beyond the anecdotal, as to whether PPPs make a difference—in short, is the trouble of forming these sometimes complex alliances worth the impact that results from them?

The goal of this paper is not to provide commentary on impact since those data are not currently available on a broad scale. Similarly, this paper does not recommend replicable models or case studies (which can be found elsewhere), though these are important and can help new entrants to join and grow the field. Rather, the goal is to utilize USAID’s recently released data set to draw conclusions on the nature of PPPs, the level of business sector engagement, and, utilizing interviews, to describe corporate perspectives on partnership with USAID.

The decision to target this research on business sector partners’ engagement in PPPs—rather than on the civil society, foundation, or public partners—is based on several factors. First, USAID’s references to its PPPs tend to focus on the business sector partners, sometimes to the exclusion of other types of partners; we want to understand the role of the partners that USAID identifies as so important to PPP composition. Second, in recent years much has been written and discussed about corporate shared value, and we want to assess the extent to which shared value plays a role in USAID’s PPPs in practice.

The paper is divided into five sections. Section I is a consolidation of the principal data and findings of the research. Section II provides an in-depth “data picture” of USAID PPPs drawn from quantitative analysis of the USAID PPP data set and is primarily descriptive of PPPs to date. Section III moves beyond description and provides analysis of PPPs and business sector alignment. It contains the results of coding certain relevant fields in the data set to mine for information on the presence of business partners, commercial interests (i.e., shared value), and business sector partner expertise in PPPs. Section IV summarizes findings from a series of interviews of corporate executives on partnering with USAID. Section V presents recommendations for USAID’s partnership-making.

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USAID’s public-private partnerships and corporate engagement


Brookings today releases a report USAID’s Public-Private Partnerships: A Data Picture and Review of Business Engagement, which will be the subject of a public discussion on March 8 featuring a panel of Jane Nelson (Harvard University), Ann Mei Chang (U.S. Agency for International Development (USAID)), Johanna Nesseth Tuttle (Chevron Corp.), and Sarah Thorn (Wal-Mart Stores Inc.).

The report is based on USAID’s database of 1,481 public-private partnerships (PPPs) from 2001 to 2014 and a series of corporate interviews.

The value of those partnerships totals $16.5 billion, two-thirds from non-U.S. government sources – private companies, nongovernmental organizations (NGOs), foundations, and non-U.S. public institutions. Over 4000 organizations have served as resource partners in these PPPs.  Fifty-three percent are business entities, 32 percent are from the non-profit world, and 25 percent are public institutions. Eighty-five organizations have participated in five or more PPPs, led by Microsoft (62), Coca Cola (36), and Chevron (33).

The partnerships are relatively evenly distributed among three major regions—Africa, Latin American/Caribbean, and Asia—but 36 percent of the value of all PPPs is from partnerships that are global in reach.

In analyzing the data, the researchers found that 77 percent of PPPs included one or more business partner, and that 83 percent of these partnerships are connected to a business partner’s commercial interest (either shared value or more indirect strategic interest). In almost 80 percent of those PPPs, the business partner contributes some form of corporate expertise to the partnership.

The purpose of the March 8 panel discussion is to examine the report but also to go beyond by addressing outstanding questions like: how should the impact of public-private partnerships be identified, measured, and evaluated? Is shared value the Holy Grail linking corporate interest to public goods and achieving sustainable results? Where do public-private partnerships fit in USAID’s strategy for engaging the private sector in development, particularly in light of the emphasis on the role of business in advancing the new set of Sustainable Development Goals?

We hope you can join us for what should prove to be an engaging discussion.

Authors

     
 
 




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David Brooks is correct: Both the quality and quantity of our relationships matter

It’s embarrassing to admit, since I work in a Center on Children and Families, but I had never really thought about the word “relative” until I read the new Atlantic essay from David Brooks, “The Nuclear Family Was a Mistake.” In everyday language, relatives are just the people you are related to. But what does…

       




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Japan’s G-7 and China’s G-20 chairmanships: Bridges or stovepipes in leader summitry?


Event Information

April 18, 2016
10:00 AM - 11:30 AM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

Register for the Event

In an era of fluid geopolitics and geoeconomics, challenges to the global order abound: from ever-changing terrorism, to massive refugee flows, a stubbornly sluggish world economy, and the specter of global pandemics. Against this backdrop, the question of whether leader summitry—either the G-7 or G-20 incarnations—can supply needed international governance is all the more relevant. This question is particularly significant for East Asia this year as Japan and China, two economic giants that are sometimes perceived as political rivals, respectively host the G-7 and G-20 summits. 

On April 18, the Center for East Asia Policy Studies and the Project on International Order and Strategy co-hosted a discussion on the continued relevancy and efficacy of the leader summit framework, Japan’s and China’s priorities as summit hosts, and whether these East Asian neighbors will hold parallel but completely separate summits or utilize these summits as an opportunity to cooperate on issues of mutual, and global, interest.

Join the conversation on Twitter using #G7G20Asia

Audio

Transcript

Event Materials

      
 
 




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COVID-19, Africans’ hardships in China, and the future of Africa-China relations

In the midst of the global scramble to deal with the COVID-19 crisis, relations have ruptured at a most unexpected front—between China and Africa. Since April 8, reports and social media discussions about the eviction and maltreatment of Africans in the Chinese city of Guangzhou have gone viral, leading to a series of formal and…

       




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The human costs of 'strategic partnerships' with South Caucasian states


I write this as I learn of the beating death of an Azerbaijani journalist Rasim Aliyev. His “crime” was to post a Facebook item about football. What follows seems insignificant compared to his murder.

Two articles have appeared in prominent Western outlets in the past month addressing developments in the South Caucasus and the need for adjustments in U.S. (and Western) policy toward the region. The first was an excellent, in-depth Brookings report titled "Retracing the Caucasian Circle—Considerations and Constraints for U.S., EU, and Turkish Engagement in the South Caucasus"; the second was a shorter essay that Bill Courtney, Denis Corboy, and I penned for Newsweek on the need to reboot policy toward Armenia, Azerbaijan, and Georgia. Both reflected the difficulty of writing about the “South Caucasus” as if the three countries had common interests and objectives. Increasingly these interests and objectives are diverging, except for a growing unhappiness with the United States and the West for not paying attention to—or doing enough to support—the region. In the case of Azerbaijan, the frustration stems from U.S. leaders paying too much attention to the appalling human rights situation in the country.

What’s making the Azerbaijanis so upset with the West?

The authors of the Brookings report point to elite cynicism over Western disinterest and policy failures in the region as sources of Azerbaijani leaders’ unhappiness. This, in their view, is causing Armenia, Georgia, and Azerbaijan—for different reasons and in different ways—to tack toward Russia.

We have a different take in our Newsweek piece. We argue that the unhappiness results from governing elites recognizing that U.S. and Western policy regarding human rights, democracy building, corruption, and conflict resolution (especially the Nagorno-Karabakh conflict) threaten regime stability. Therefore, the tacking toward Russia is a conscious choice to avoid pressure and the transparency that closer association with the United States and Europe would involve.

The new orientation of these countries requires serious adjustment in Western policies. There are four new drivers prompting change (beyond the role of Russia): the regional consequences of the Iran nuclear agreement; the growing economic crisis, which is affecting the South Caucasian states in different ways; the threat of renewed military conflict between Armenia and Azerbaijan; and the internal security implications of suppression of human rights. While each country responds to these drivers in different ways, they are the source of a new dynamic in the South Caucasus that requires a fresh Western policy approach.

Three wild cards will shape these drivers and the Western approach to them: First, how hard will Russian President Vladimir Putin push his objective of rolling back the degree of Western influence achieved since the fall of the Soviet Union? Second, how well will Iran play the nuclear agreement card, especially regarding its reentry into global energy markets? Third, how distracting will Turkey’s military response to the Islamic State and the Kurdistan Workers’ Party (PKK) be for Turkey’s interests in the South Caucasus and its objective of becoming a regional energy hub?

The shortcomings of soft regionalism

What is to be done? Faced with such a challenging situation, the default policy response is to provide more assistance (economic and military), dispatch senior officials from Western capitals to visit the region, and indulge (rather than criticize) democracy and human rights abuses, all in the name of developing a strategic partnership. In other words: Show more love.

That business-as-usual approach is inappropriate for these challenging times. In the case of Azerbaijan, it is an inappropriate response to the continued violations by the Baku regime of basic human rights and freedom of expression.

The Brookings paper suggests a multilateral approach (involving the United States, EU, and Turkey) based on soft regionalism. I do not believe that soft regionalism will work. The best we can hope for is parallel bilateral engagement on the basis of common interests (e.g. conflict prevention) and shared values (e.g. democratic evolution, observance of human rights). We need to treat the energy issue in the region as a commercial rather than geopolitical one. Changes in the global energy market have undermined the geopolitical significance of Caspian energy resources compared to two decades ago. With low energy prices likely the norm for the near future, energy no longer plays a strategic role for the region. Among other weaknesses, the soft regionalism prescription implies coordinated interests with Turkey—this will be difficult absent an opening in Turkish-Armenian relations.

Who needs who more?

The burden of choice in this relationship with the West must shift from the outside parties to the South Caucasian states themselves. The outsiders should stop talking about “strategic” partnerships, trans-Caspian pipelines and Silk Roads because this perpetuates a “you-need-us-more-than-we-need-you” starting point. Rather, the time has come for Armenia, Azerbaijan, and Georgia to decide on their own where their interests coincide with those of the West. That’s where we and they can begin to develop meaningful relationships, rather than trying to invent a veneer to cover differences—as in the case of Azerbaijan’s record on human rights.

Another recent article in Newsweek, by Theodore Gerber and Jane Zavisca, raised questions about promoting democracy and human rights where populations and elites are skeptical of U.S. motivations in promoting these issues. Fairly, the article questions the effectiveness of the traditional instruments of promoting opposition political parties and local NGOs as a way of winning “hearts and minds” in the former Soviet Union. Unfortunately, these traditional instruments tend to emphasize the attractiveness of the “American way of life” through student and scientific exchanges. This offers a variant on the soft regionalism theme advanced in the Brookings paper. Both require a receptivity to change that both elites and populations increasingly find threatening. Developing a values-based relationship is difficult when values diverge.

To the extent our interests do not coincide, then the Western policy focus must be transactional and rest exclusively on conflict prevention and/or amelioration. It also should not shy away from pressing all three South Caucasian states on their obligations to observe international standards regarding human rights, democracy, and freedom of expression.

      
 
 




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David Brooks is correct: Both the quality and quantity of our relationships matter

It’s embarrassing to admit, since I work in a Center on Children and Families, but I had never really thought about the word “relative” until I read the new Atlantic essay from David Brooks, “The Nuclear Family Was a Mistake.” In everyday language, relatives are just the people you are related to. But what does…

       




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COVID-19, Africans’ hardships in China, and the future of Africa-China relations

In the midst of the global scramble to deal with the COVID-19 crisis, relations have ruptured at a most unexpected front—between China and Africa. Since April 8, reports and social media discussions about the eviction and maltreatment of Africans in the Chinese city of Guangzhou have gone viral, leading to a series of formal and…

       




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Japan’s G-7 and China’s G-20 chairmanships: Bridges or stovepipes in leader summitry?


Event Information

April 18, 2016
10:00 AM - 11:30 AM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

Register for the Event

In an era of fluid geopolitics and geoeconomics, challenges to the global order abound: from ever-changing terrorism, to massive refugee flows, a stubbornly sluggish world economy, and the specter of global pandemics. Against this backdrop, the question of whether leader summitry—either the G-7 or G-20 incarnations—can supply needed international governance is all the more relevant. This question is particularly significant for East Asia this year as Japan and China, two economic giants that are sometimes perceived as political rivals, respectively host the G-7 and G-20 summits. 

On April 18, the Center for East Asia Policy Studies and the Project on International Order and Strategy co-hosted a discussion on the continued relevancy and efficacy of the leader summit framework, Japan’s and China’s priorities as summit hosts, and whether these East Asian neighbors will hold parallel but completely separate summits or utilize these summits as an opportunity to cooperate on issues of mutual, and global, interest.

Join the conversation on Twitter using #G7G20Asia

Audio

Transcript

Event Materials

      
 
 




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Inflation has been largely disconnected from business cycle ups and downs over the past 30 years.  This puzzling observation is one more reason why the Federal Reserve should consider adopting a systematic monetary policy strategy that reacts more forcefully to off-target inflation—whether too high or too low, suggests a paper to be discussed at the…

       




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Fewer field trips mean some students miss more than a day at the museum


As every good teacher knows, education is not just about academics. It is about broadening horizons and discovering passions. (The root of education is the Latin e ducere, meaning “to draw out.”) From this perspective, extra-curricular activities count for a great deal. But as Robert Putnam highlights in his book Our Kids, there are growing class gaps in the availability of music, sports, and other non-classroom activities.

Fewer field trips?

Schools under pressure may also cut back on field trips outside the school walls to parks, zoos, theaters, or museums. In the 2008-09 school year, 9 percent of school administrators reported eliminating field trips, according to the annual surveys by the American Association of School Administrators (AASA). That figure rose through the recession:

Just 12 percent of the administrators surveyed about 2015-16 said they had brought back their field trips to pre-recession levels. Museums around the country report hosting fewer students, from Los Angeles and Sarasota, to Minneapolis, and Columbia, Missouri. None of this is definitive proof of a decline in field trips, since we are relying on a single survey question. But it suggests a downward trend in recent years.

Museums help with science tests

If some children are missing out on field trips, does it matter? They may be nice treats, but do they have any real impact, especially when they take time away from traditional learning? There is some evidence that they do.

Middle school children with the chance to go on a field trip score higher on science tests, according to a 2015 study by Emilyn Ruble Whitesell.

She studied New York City middle schools with teachers in Urban Advantage, a program that gives science teachers additional training and resources—as well as vouchers for visiting museums. In some schools, the Urban Advantage teachers used the field trip vouchers more than others. Whitesell exploits this difference in her study, and finds that attending a school with at least 0.25 trips per student increased 8th grade scores by 0.026 standard deviations (SD). The odds of a student passing the exam improved by 1.2 percentage points. There were bigger effects for poor students, who saw a 0.043 SD improvement in test scores, and 1.9 percentage point increase in exam pass rates.

Art broadens young minds

Students visiting an art museum show statistically significant increases in critical thinking ability and more open-minded attitudes, according to a randomized evaluation of student visits to the Crystal Bridges Museum in northwest Arkansas. One example: those who visited the museum more often agreed with statements like: “I appreciate hearing views different from my own” and “I think people can have different opinions about the same thing.” The effects are modest. But the intervention (a single day at the museum) is, too. Again, there were larger effects for poor students:

All this needs to be put in perspective. In comparison with the challenge of closing academic gaps and quality teaching, field trips are small beer. But schools create citizens as well as undergraduates and employees. It matters, then, if we have allowed field trips to become a casualty of the great recession.

Authors

Image Source: © Jacob Slaton / Reuters
     
 
 




ips

Japan’s G-7 and China’s G-20 chairmanships: Bridges or stovepipes in leader summitry?


Event Information

April 18, 2016
10:00 AM - 11:30 AM EDT

Falk Auditorium
Brookings Institution
1775 Massachusetts Avenue NW
Washington, DC 20036

Register for the Event

In an era of fluid geopolitics and geoeconomics, challenges to the global order abound: from ever-changing terrorism, to massive refugee flows, a stubbornly sluggish world economy, and the specter of global pandemics. Against this backdrop, the question of whether leader summitry—either the G-7 or G-20 incarnations—can supply needed international governance is all the more relevant. This question is particularly significant for East Asia this year as Japan and China, two economic giants that are sometimes perceived as political rivals, respectively host the G-7 and G-20 summits. 

On April 18, the Center for East Asia Policy Studies and the Project on International Order and Strategy co-hosted a discussion on the continued relevancy and efficacy of the leader summit framework, Japan’s and China’s priorities as summit hosts, and whether these East Asian neighbors will hold parallel but completely separate summits or utilize these summits as an opportunity to cooperate on issues of mutual, and global, interest.

Join the conversation on Twitter using #G7G20Asia

Audio

Transcript

Event Materials

      
 
 




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Forging New Partnerships: Implementing Three New Initiatives in the Higher Education Act

       




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University-industry partnerships can help tackle antibiotic resistant bacteria


An academic-industrial partnership published last January in the prestigious journal Nature the results of the development of antibiotic teixobactin. The reported work is still at an early preclinical stage but it is nevertheless good news. Over the last decades the introduction of new antibiotics has slowed down nearly to a halt and over the same period we have seen a dangerous increase in antibiotic resistant bacteria.

Such is the magnitude of the problem that it has attracted the attention of the U.S. government. Accepting several recommendations presented by the President’s Council of Advisors on Science and Technology (PCAST) in their comprehensive report, the Obama Administration issued last September an Executive Order establishing an interagency Task Force for combating antibiotic resistant bacteria and directing the Secretary of Human and Health Services (HHS) to establish an Advisory Council on this matter. More recently the White House issued a strategic plan to tackle this problem.

Etiology of antibiotic resistance

Infectious diseases have been a major cause of morbidity and mortality from time immemorial. The early discovery of sulfa drugs in the 1930s and then antibiotics in the 1940s significantly aided the fight against these scourges. Following World War II society experienced extraordinary gains in life expectancy and overall quality of life. During that period, marked by optimism, many people presumed victory over infectious diseases. However, overuse of antibiotics and a slowdown of innovation, allowed bacteria to develop resistance at such a pace that some experts now speak of a post-antibiotic era.

The problem is manifold: overuse of antibiotics, slow innovation, and bacterial evolution.

The overuse of antibiotics in both humans and livestock also facilitated the emergence of antibiotic resistant bacteria. Responsibility falls to health care providers who prescribed antibiotics liberally and patients who did not complete their prescribed dosages. Acknowledging this problem, the medical community has been training physicians to avoid pressures to prescribe antibiotics for children (and their parents) with infections that are likely to be viral in origin. Educational efforts are also underway to encourage patients to complete their full course of every prescribed antibiotic and not to halt treatment when symptoms ease. The excessive use of antibiotics in food-producing animals is perhaps less manageable because it affects the bottom line of farm operations. For instance, the FDA reported that even though famers were aware of the risks, antibiotics use in feedstock increased by 16 percent from 2009 to 2012.

The development of antibiotics—perhaps a more adequate term would be anti-bacterial agents—indirectly contributed to the problem by being incremental and by nearly stalling two decades ago. Many revolutionary innovations in antibiotics were introduced in a first period of development that started in the 1940s and lasted about two decades. Building upon scaffolds and mechanisms discovered theretofore, a second period of incremental development followed over three decades, through to 1990s, with roughly three new antibiotics introduced every year. High competition and little differentiations rendered antibiotics less and less profitable and over a third period covering the last 20 years pharmaceutical companies have cut development of new antibiotics down to a trickle.

The misguided overuse and misuse of antibiotics together with the economics of antibiotic innovation compounded the problem taking place in nature: bacteria evolves and adapts rapidly.

Current policy initiatives

The PCAST report recommended federal leadership and investment to combat antibiotic-resistant bacteria in three areas: improving surveillance, increasing the longevity of current antibiotics through moderated usage, and picking up the pace of development of new antibiotics and other effective interventions.

To implement this strategy PCAST suggested an oversight structure that includes a Director for National Antibiotic Resistance Policy, an interagency Task Force for Combating Antibiotic Resistance Bacteria, and an Advisory Council to be established by the HHS Secretary. PCAST also recommended increasing federal support from $450 million to $900 million for core activities such as surveillance infrastructure and development of transformative diagnostics and treatments. In addition, it proposed $800 million in funding for the Biomedical Advanced Research and Development Authority to support public-private partnerships for antibiotics development.

The Obama administration took up many of these recommendations and directed their implementation with the aforementioned Executive Order. More recently, it announced a National Strategy for Combating Antibiotic Resistant Bacteria to implement the recommendations of the PCAST report. The national strategy has five pillars: First, slow the emergence and spread of resistant bacteria by decreasing the abusive usage of antibiotics in health care as well as in farm animals; second, establish national surveillance efforts that build surveillance capability across human and animal environments; third, advance development and usage of rapid and innovative diagnostics to provide more accurate care delivery and data collection; forth, seek to accelerate the invention process for new antibiotics, other therapeutics and vaccines across all stages, including basic and applied research and development; finally, emphasize the importance of international collaboration and endorse the World Health Organization Action Plan to address antimicrobial resistance.

University-Industry partnerships

Therefore, an important cause of our antibiotic woes seems to be driven by economic logic. On one hand, pharmaceutical companies have by and large abandoned investment in antibiotic development; competition and high substitutability have led to low prices and in their financial calculation, pharmaceutical companies cannot justify new developmental efforts. On the other hand, farmers have found the use of antibiotics highly profitable and thus have no financial incentives to halt their use.

There is nevertheless a mirror explanation of a political character.

The federal government allocates about $30 billion for research in medicine and health through the National Institutes of Health. The government does not seek to crowd out private research investment; rather, the goal is to fund research the private sector would not conduct because the financial return of that research is too uncertain. Economic theory prescribes government intervention to address this kind of market failure. However, it is also government policy to privatize patents to discoveries made with public monies in order to facilitate their transfer from public to private organizations. An unanticipated risk of this policy is the rebalancing of the public research portfolio to accommodate the growing demand for the kind of research that feeds into attractive market niches. The risk is that the more aligned public research and private demand become, the less research attention will be directed to medical needs without great market prospects. The development of new antibiotics seems to be just that kind of neglected medical public need. If antibiotics are unattractive to pharmaceutical companies, antibiotic development should be a research priority for the NIH. We know that it is unlikely that Congress will increase public spending for antibiotic R&D in the proportion suggested by PCAST, but the NIH could step in and rebalance its own portfolio to increase antibiotic research. Either increasing NIH funding for antibiotics or NIH rebalancing its own portfolio, are political decisions that are sure to meet organized resistance even stronger than antibiotic resistance.

The second mirror explanation is that farmers have a well-organized lobby. It is no surprise that the Executive Order gingerly walks over recommendations for the farming sector and avoid any hint at an outright ban of antibiotics use, lest the administration is perceived as heavy-handed. Considering the huge magnitude of the problem, a political solution is warranted. Farmers’ cooperation in addressing this national problem will have to be traded for subsidies and other extra-market incentives that compensate for loss revenues or higher costs. The administration will do well to work out the politics with farmer associations first before they organize in strong opposition to any measure to curb antibiotic use in feedstock.

Addressing this challenge adequately will thus require working out solutions to the economic and political dimensions of this problem. Public-private partnerships, including university-industry collaboration, could prove to be a useful mechanism to balance the two dimensions of the equation. The development of teixobactin mentioned above is a good example of this prescription as it resulted from collaboration between the university of Bonn Germany, Northeastern University, and Novobiotic Pharmaceutical, a start-up in Cambridge Mass.

If the NIH cannot secure an increase in research funding for antibiotics development and cannot rebalance substantially its portfolio, it can at least encourage Cooperative Research and Development Agreements as well as university start-ups devoted to develop new antibiotics. In order to promote public-private and university-industry partnerships, policy coordination is advised. The nascent enterprises will be assisted greatly if the government can help them raise capital connecting them to venture funding networks or implementing a loan guarantees programs specific to antibiotics.  It can also allow for an expedited FDA approval which would lessen the regulatory burden. Likewise, farmers may be convinced to discontinue the risky practice if innovation in animal husbandry can effectively replace antibiotic use. Public-private partnerships, particularly through university extension programs, could provide an adequate framework to test alternative methods, scale them up, and subsidize the transition to new sustainable practices that are not financially painful to farmers.

Yikun Chi contributed to this post

More TechTank content available here

Authors

Image Source: © Reuters Staff / Reuters
     
 
 




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