Problem: "Shortages of key drugs endanger patients"/ Solution?

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Shortages of key drugs endanger patients
By Rob Stein, Published: May 1 | Updated: Tuesday, April 26, 3:14 PM

Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.

A record 211 medications became scarce in 2010 — triple the number in 2006 — and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities.

The paucities are forcing some medical centers to ration drugs — including one urgently needed by leukemia patients — postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.

“It’s a crisis,” said Erin R. Fox, manager of the drug information service at the University of Utah, who monitors drug shortages for the American Society of Health-System Pharmacists. “Patients are at risk.”

The causes vary from drug to drug but experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.

Note: Remember - Pharma changed their business model to focus on VACCINES, not medications.
See this thread:
Drug Companies Shift Emphasis to Vaccines

“It seems like there were lot of things happening with consolidations and quality issues and more things coming from overseas,” said Allen J. Vaida, executive director of the Institute for Safe Medicine Practices, a nonprofit group that helped organize a conference last fall to examine the issue. “It just reached a point where the number of shortages was slowly going up and up, and now we have national crisis with this huge shortage of critical medications.”

While the dearth that has garnered the most public attention is — ironically — for a barbiturate that is hindering prisons trying to execute inmates, the scarcities are having a much broader impact on keeping people alive, especially in emergency rooms, oncology wards and intensive care units.

No one is systematically tracking the toll of the shortages, but reports are emerging of delayed treatments, anxious searches for desperately needed drugs, devastating injuries from mistakes and less-adequate drugs, and even possible deaths.

Federal regulators have been rushing to alleviate the shortages, sometimes helping firms resume production more quickly or approving emergency imports of supplies from overseas. The Food and Drug Administration eased a shortage of the anesthetic propofol last year by allowing foreign importation, for example, and this year approved bringing in several other medications, including two cancer drugs.

“The types of products we’re seeing shortages of are really concerning,” said Valerie Jensen, who heads the FDA’s Drug Shortages Program. “This is affecting oncology drugs, critical-care drugs, emergency medicine drugs. We’re doing everything we can under our current authority to try to deal with this situation.”

In Congress, legislation has been introduced to address the problem. For example, a bill would require companies to notify the FDA in advance about anything that might cause a shortage and give the agency new powers to try to assuage them.

“We can’t put patients lives at risk simply because there’s some snafus in a process or a manufacturer decides it’s less profitable to make a certain drug,” said Sen. Amy Klobuchar (D-Minn.). “Patients deserve better than that.”
‘Very global supply chain’

Many of the shortages involve older, cheaper generic medications that are less profitable, causing many firms to stop producing them and leaving fewer sources. Most involve “sterile injectable” medications that are more complicated to produce and therefore are more prone to manufacturing problems. In addition, drug companies increasingly rely on raw materials from other countries.

“We’ve certainly reached a very global supply chain for drug products, with the active ingredients typically made outside of the United States,” said Gordon Johnston, vice president for regulatory sciences at the Generic Pharmaceutical Association. “It could be Europe, India — some cases China. If there’s a problem at a facility in Italy or India, it leads to disruption of the drug supply in the United States.”

Some industry representatives blame part of the problem on increased oversight by the FDA, which has made drug safety a higher priority after coming under intense criticism for being too lax.

“As you know right now, FDA has taken a heightened approach towards drug safety,” said Maya Bermingham, senior assistant general counsel at the Pharmaceutical Research and Manufacturers of America. “FDA has stepped up inspections. The more you look, the more you may discover problems.”

While acknowledging that the industry needs to do a better job of coordination, some company officials said the agency should coordinate enforcement actions and drug shortage issues more closely to avoid administrative requirements that cause interruptions.

“We’re not sure how much of that is going on recently because we’ve seen more and more shortages in the industry. We think that maybe some of those coordination issues can be worked on,” said Joshua Gordon, vice president and general manager of specialty pharmaceuticals at Hospira, the largest producer of specialty generic sterile injectables.

Shortages of pre-loaded epinephrine syringes and propofol, for example, occurred when suppliers dropped out just as the FDA was demanding additional documentation, he said.

“They are very focused on taking quick and and aggressive action,” Gordon said. “We applaud the agency’s role in assuring quality, but it can slow things down significantly.”

FDA officials dispute that greater government oversight is a major factor, saying manufacturing problems were the cause of most shortages.

“There has not been a significant increase in domestic enforcement actions (seizure or injunction) for this class of products in recent years,” Jensen wrote in an e-mail.

‘Too many . . . will die’

Whatever the causes, many of the affected drugs are mainstays of medical care, such as the potent painkiller morphine, norepinephrine, which is commonly used in emergency rooms, and electrolytes, which are often given to patients in intensive care.

But shortages have been reported in many categories of drugs, including antibiotics, and drugs central to the treatment of many cancers, forcing oncologists to delay or alter carefully timed chemotherapy regimens.

“We have heard some horror stories where patients are really begging to get the drugs from other sources and where practices or institutions are forced to kind of triage patients and save the drugs for those — quote — most curable, where they have the best prognosis and using substitutes where there isn’t a cure possibility,” Michael Link, president-elect of the American Society of Clinical Oncology.

The drug cytarabine has caused the most concern and gotten the most attention because it is highly effective for treating several forms of leukemia and lymphoma but must be administered as quickly as possible, especially to patients with acute myeloid leukemia.

“With this drug they can be cured and without this drug too many of them will certainly die. That’s the simplest way to put it,” said Deborah Banker, vice president for research communication at the Leukemia & Lymphoma Society. “The disease progresses so rapidly that untreated patients can sadly die within days. There is no time for delay and no certainty of a good outcome if you can’t get a full dose.”

Many hospitals are running low, and some have run out completely. That has required many facilities to ration the drug, giving priority to those who need it most urgently.

“It’s so unbelievable,” said Mary Collins, 57, of La Crosse, Wis., whose husband, Michael, 66, had problems obtaining cytarabine to fight lymphoma. “A cancer diagnosis is a long, very, very stressful circumstance. And then to learn that a particular drug is no longer available to you and that there seems to be no formalized mechanism in place to correct it just makes it worse.”

Cytarabine’s scarcity was caused by hitches that two out of the three manufacturers hit in obtaining raw materials, as well as the discovery of crystals in some shipments. The third manufacturer was unable to make up for the shortfall. Some of the problems have been resolved, however, and the FDA is working on importing the drug.


The solution they want to implement?

Complete militarized takeover of the supply chain - a plan that has been in the works for a while.

Their solution will be Cybernetic command and control of the supply chain: using RFID-type control mechanisms along the entire route of the manufacture-to-market process.)

The shortages are forcing hospital pharmacists to juggle supplies and hunt for new sources. Many hospitals, including several contacted in the Washington area, say they are usually able to patch together solutions. But some resort to paying inflated prices or buying from unfamiliar suppliers, increasing the risk they may be getting counterfeits.

“When it becomes clear that some drug may be in short supply or going into a shortage, what happens is sometimes there are unsavory folks — small distributors — who buy up whatever is left and sell it back at exorbitant prices,” said Roslyne Shulman, director of policy development for the American Hospital Association.

‘Panic in the pharmacy’

When shortages occur, physicians turn to less optimal alternatives or find out too late that the drug they need is unavailable. Mark Warner, president of the American Society of Anesthesiologists, described two calamities that occurred in the past year because of shortages. In one, a 16-year-old boy suffered brain damage because doctors did not have one muscle relaxer needed to treat a complication from jaw surgery. In another, a middle-aged woman was left in a permanent vegetative state because doctors did not have the drug epinephrine after she experienced complications from heart surgery.

“These are tragic cases,” said Warner. “It’s one of those things most anesthesiologists in the country think about when they are driving to work every day. We don’t know where the shortages are and they come on very quickly. ”

Nurses and doctors responding to emergencies, meanwhile, are losing precious minutes when they must work with unfamiliar substitutes or recalculate dosages, increasing the chances of overdosing or under-dosing patients. One of the biggest problems is a shortage of syringes pre-filled with precisely measured doses.

“Grabbing the right medication out of a crash cart that’s already in a syringe is a big advantage over having to get out the syringe, get out the needle, get the medication and get the measurement right,” said Angela Gardner, an emergency medicine physician at the University of Texas Southwestern Medical Center in Dallas and immediate past president of the American College of Emergency Physicians. “Those minutes are lives.”

Many hospitals are recalibrating electronic medication delivery systems or preparing the correct doses ahead of time, especially for the emergency room, to minimize mistakes.

“We’ve been extremely fortunate using strategies in cooperation with our medical staff,” said Jay Barbaccia, head pharmacist at the Washington Hospital Center. “We’ve had a lot of panic and inconvenience but minimal, if any, impact on our ability to provide care. It makes my life miserable — the panic is in the pharmacy when we’re scrambling around to find alternatives.”

Nevertheless, a long list of errors and near-misses have been reported, including incidents in which patients required emergency care to save them. At least two patients reportedly died from overdoses of hydromorphone they received because of a morphine shortage.

At least 19 patients were sickened and nine died in Alabama this year after being infused with a solution through their feeding tubes that was apparently contaminated with bacteria by a pharmacy using an unfamiliar ingredient because of a shortage. The shortage occurred because the manufacturer had trouble getting the product’s packaging.

“It’s horrible. It’s something that shouldn’t have happened,” said Donald J. Mottern of Alabaster, Ala., whose 71-year-old mother was one of the victims. “We lost the matriarch of our family. The loss to our family has left each of us very hollow.”

Check out this article from 2005....

Counterfeit Pharmaceuticals And the Public Health
October 4, 2005
..."Technologies such as radio frequency ID-based wireless track-and-trace technologies enable the tracking of drugs during the manufacturing and distribution process. The adoption and common use of these safeguards would help secure the integrity of the drug supply chain."

Here's the "solution" -- the real agenda:

Motive for globalist supply chain logistics false flags exposed in IBM document

See PDF file itself for embedded images.  Notice IBM pretends they give a damn about "civil liberties" (notice the globalists never use the correct term--unalienable rights).  They pretend to do this throughout the document to try to counter the incredibly treasonous and unconstitutional, false-flag born solutions they are implementing.

Related document:

Executive Summary

The global movement system is the engine of global prosperity today. Economic integration and improvements in system efficiency have created a single global economy, but one whose very strengths – speed, openness, and efficiency – put it at risk of disruption from external threats. There have always been threats to the global movement system, but the attacks of 9/11 provided a paradigm shift in the potential severity and nature of these threats. This new and greater threat creates the need for a comprehensive framework for securing the system: Global Movement Management.

Global Movement Management (GMM) is a comprehensive and achievable framework for securing the key flows – people, goods, conveyances, money, and information – in the global economy against disruptive threats and building resiliency into the system. The framework is aligned with the existing commercial imperatives of the global system and the protection of important societal values such as privacy and civil liberties. The framework consists of two conceptual parts: a governance structure  and a system architecture.  

Numerous steps have been taken to improve the security of the global movement system since 9/11, but these have been largely piecemeal. Many efforts have stalled due to an uncertain governance structure, both among nations and between the public and private sectors. Key stakeholders have been hesitant to adopt new security measures, uncertain of their potential impact on commerce, or on privacy and data protection. The Global Movement Management framework meets these challenges by proposing a governance structure  that is distributed and decentralized, using rules, standards, and market-driven incentives to encourage investment in the security and resilience of the system.

Global Movement Management is an integrated framework that looks holistically at the key variables in the system – flows, locations, modes of transport  and exchange, and time – and finds areas of convergence across the existing system that are building blocks for enhancing security. These include: (a) common security and business functions, (b) existing borders and checkpoints, (c) existing data sources and information flows, and (d) existing relationships among key system participants. These system elements can be woven together to form a common system architecture – one that is flexible, adaptable, and largely decentralized, with the exception of a core set of seamless and closely controlled security applications.
This Global Movement Management framework can help overcome the key impediments to efforts to promote  security in the global movement system, and motivate key stakeholders to work together to integrate security and resilience into the system. It can protect and strengthen the common foundations of global interconnectedness and prosperity.

I.  The Global System Today

The global economy of the 21st century is built upon a foundation of openness and mobility. Goods are shipped across oceans and continents, and delivered to consumers with efficiency and breakneck speed. People can travel by plane to the far corners  of the world in a matter of hours. Information moves instantly around the world via the Internet and the global communications grid, connecting people and nations. Money flows across borders just as quickly through the global financial system by means of electronic transactions. Business is conducted collaboratively and virtually on a global basis.

All of these flows – of people, goods, conveyances, money, and information – are the connective tissue of globalization, and the foundation upon which the global economy is able to endure and grow. The system is the result of successive waves of innovation in the 20th century – built on technologies such as flight, containerized shipping, ground transport,  telecommunications, computing, and the Internet. As a result, the global economy is interconnected today to a degree that is unprecedented in human history.

But this interconnectedness creates new risks. The impacts of negative events, such as a hurricane or earthquake in the United States, a terrorist attack in Europe, or the outbreak of an infectious disease in Asia, are no longer isolated, but can ripple through the system and have a profound and multiplying disruptive effect around the world. And various types of bad actors – rogue states, drug cartels, organized crime syndicates, or terrorist groups – can exploit the system’s openness and anonymity to facilitate their illicit and harmful activities. Criminals, fanatics, and terrorists  no longer need to leave the isolation of the basement or the cave to conduct their business on a global scale.1 The system’s core strengths – its performance, speed, efficiency, interconnectedness, precision, and predictability – are also now sources of systemic risk and vulnerability. One of the most important challenges that leaders in the public and private sector currently face is finding new ways to strengthen this system in an evolving political environment, and protecting it from the buffeting forces of external disruption and misuse.

The terrorist attacks of 9/11 exposed the intrinsic fragility of this system and the need for greater security within it. The global economic system has always been at the risk of misuse, but after 9/11, the known risks are different. The threat of large-scale terrorism  or rogue state aggression involving weapons of mass destruction poses an existential threat to the civilized world – and puts the global system at the risk of massive disruption or total breakdown.  

There are two important aspects to the threat as it specifically pertains to the global economic system. First, the system itself is a target. One of al-Qaeda’s2 key tactical objectives is to undermine the economies of the Western  world. The attacks of 9/11 were directly aimed at the commercial aviation system and the financial, political, and military nerve centers in New York and Washington. But they were also collaterally targeted at the global economy itself. In a video released in April 2002, Osama Bin Laden famously joked with his cohorts about $640 billion in short-term lost value on the stock market as a result of 9/11. In November 2004, he boasted that for every single dollar that al-Qaeda was spending on insurgency in Iraq, the United States was spending $1 million there to combat the insurgency. This kind of economic calculus is a critical element of al-Qaeda’s strategy of asymmetric force and is likely to inform its future goals and activities.

1 The geographic footprint of the terrorist attacks of 9/11 are the most notable example of this globalization of terror  – the planning and recruitment for the attacks took place in at least 11 countries around the world, including Afghanistan, Czech Republic, Egypt, Germany, Lebanon, Malaysia, Pakistan, Saudi Arabia, Spain, United Arab Emirates, and the United States.
2 Al-Qaeda is referenced here rather than all terrorist groups, because the group’s millenarian intentions far surpass those of any other major terrorist  group today. But it is probable that future terrorist groups – ones which do not exist today – will emulate al- Qaeda’s intentions and match or surpass its capabilities.

Second, the terrorist  threat operates inside of the broader global economic system, and terrorists use its capabilities to move people, goods, conveyances, information, and money in support of their operations. The attacks of 9/11 were carried out within and through  the global economic system.

The terrorists  involved in planning and carrying out the attacks leveraged the global economic system to maximize their opportunity for success and multiply the effects of the attacks. They exploited gaps and flaws in visa and entry systems to get attackers and their support networks into a country. They understood  the operational imperatives of the aviation industry, and chose specific flights that would maximize their probability of success. They compartmentalized their operations, reducing the vulnerability that the capture or exposure of one person or one cell would expose the entire plot. They used the global financial system to acquire the funds necessary to carry out the attacks. Essentially, the terrorists were able to create their own “terrorist supply chain” and “terrorist travel system” within the broader system. Since 9/11, terrorist  groups have continued to develop their capabilities to exploit the system, using the Internet to disseminate information, raise funds, and conduct recruiting.

These two aspects contribute  to the need for a new framework to secure the global economic system: one that is aligned with the existing and complex realities of the system, but recognizes the paradigm shift in the nature of threat that it faces today. We call this framework Global Movement Management.

II.  Global Movement Management Defined

Global Movement Management (GMM) is a comprehensive and achievable framework for securing the key flows – people, goods, conveyances, money, and information – in the global economy against disruptive threats and for building resiliency into the system. It is a framework that sustains and protects  the core strengths of the current global system – its performance, speed, efficiency, interconnectedness, precision, and predictability – and adds two new system imperatives: security and resilience. It is a framework that recognizes and protects  core societal values such as privacy and civil liberties. Security means protecting the system from being disrupted or attacked, or exploited as a means of carrying out or planning an attack. Resilience means ensuring that the system can minimize the impacts of a disruption and recover easily from its direct or secondary effects.  

Efforts to secure and build resilience into the global economic system are not new, and have antecedents that are hundreds of years old, in the form of efforts to protect  nations and commerce against the threats of piracy, foreign infiltration, and commercial fraud. Since 9/11, many measures have been taken around the world to respond to these new imperatives and develop security for each of the five system flows, including:

#   People: Numerous efforts to improve security at national border checkpoints, including the Schengen Information System, US-VISIT, and the Australian Advanced Passenger Processing System. Remote border area security initiatives such as the planned America’s Shield Initiative (ASI). Passport, visa, and identification issuance systems in dozens of countries around the world, the supporting architecture for credentialing, checking backgrounds, and watch-listing people, and the International Civil Aviation Organization (ICAO) Machine Readable Travel Documents (MRTD) standards for these forms of identification. Passenger screening systems, both physical (e.g., explosive detection equipment, metal detectors  for the commercial aviation system and rail systems) and informational (e.g., Secure Flight in the United States, Project Semaphore in the United Kingdom).

#   Goods: Measures to certify cargo at the point of loading or embarkation (the Customs Trade Partnership against Terrorism  (C-TPAT)), screen it at points of departure  or other system chokepoints (the Container Security Initiative (CSI) and Megaports Initiative in the United States), track it across the supply chain, and certify it before its arrival into a country such as through the Advance Manifest Rules implemented by Canada, the European Union, and the United States.  

#   Conveyances: Efforts to track the conveyances, including planes, ships, trains, and trucks that move cargo around the world, whether at sea (Maritime Domain Awareness), or in the air (Air Traffic Control modernization), or on land (GPS-based truck-tracking systems).  

#   Money: Initiatives aimed at disrupting terrorism-related finances and money laundering, led by groups such as the international Financial Action Task Force (FATF) and agencies such as FINTRAC in Canada, the Terrorist Finance Unit in the United Kingdom, and FinCEN and OFAC in the United States.

#   Information: Measures aimed at monitoring and disrupting the communications of terrorist cells and related groups, through channels such as e-mail, chat room communications, telephony, and mail and courier services.  
There have also been a range of efforts undertaken to improve the physical and cybersecurity of the fixed assets of the global movement system, including airports, seaports, transportation centers and bottlenecks, border checkpoints, and major network hubs.
All of these initiatives and efforts contribute  to security and system resilience, and deter terrorists and other bad actors from carrying out attacks within it. But they are today a collection of tactics, not guided by a coherent  and overarching strategy. In the absence of such a strategy, the system is suboptimized in a number of ways. Governments lack the ability to make informed decisions about priorities among competing missions and needs. Private sector stakeholders are unable or unwilling to take the first move and invest their own resources. The risk of security gaps in the system is unnecessarily high. Potential system synergies and efficiencies cannot be easily created.  

To understand why a true strategy for securing the global economic system has not emerged, we need to look at four challenges within the system today.

III.  Challenges to a Strategic Approach

There are four key challenges to adopting a strategy that promotes security and resilience in the system today:

1.   Integration of security and resilience with the commercial imperatives of the system.
2.   Integration of security and resilience with societal imperatives such as privacy and civil liberties.
3.   International cooperation and harmonization.
4.   Cooperation between the public sector and the private sector.
A Global Movement Management framework enables the system to overcome these challenges through its two most important elements: a governance structure and a system architecture.

These are detailed in later sections of this report. Before that, it is necessary to look in detail at these systemic challenges.  
The first critical challenge is integrating security and resilience with the commercial imperatives of the system, including speed, performance, efficiency, interconnectedness, and predictability. Any new security-related activity will be more readily adopted if it enhances the performance and efficiency of the system, and will be resisted if it degrades that performance.

The key private sector stakeholders in the system are likely to fund security investments only if they deliver concrete benefits beyond the often intangible benefits of security and resilience. If a good security concept is flawed in execution and harms the stakeholders who are responsible for implementing it on a day-to-day basis, then it will not be used – a worse outcome than having no security at all. Ultimately, security and resilience need to become embedded into these broader system imperatives, creating a culture of “Total Security Management,” in a manner similar to the drive for “Total Quality Management” in manufacturing, or the growth of safety as a paramount engineering norm in the aviation system and in automotive design.
A second critical challenge derives from the existence of national laws and standards for privacy, data protection, and civil liberties. Privacy is a critically important civil and personal right around the world, and often leads to the creation of legal and regulatory constraints on the collection and use of personal and other sensitive information. There are good reasons why certain activity should be regulated and constrained, but it is often challenging to define where the line should be drawn, and for which activities the benefits of security outweigh the losses of privacy and personal freedom. Compounding this challenge is the fact that privacy means different things to different societies.

For example, in Europe, privacy is a fundamental right protected by cross-sectoral laws that apply to both the public and private sectors, and Europeans seem more comfortable sharing information with the government than with the private sector.  In the United States, the opposite is true, and people are generally more wary about use of personal information by the government.  Several existing frameworks and policies are applicable to cross-border transfers of personally-identifiable information,3 and need to be reconciled with the new security imperatives of the system. Civil liberties issues also sometimes pose a challenge to a strategic approach, in cases where societal norms such as non- discrimination and the right to due process might clash with the operational performance of some types of security activities, such as personal profiling in aviation screening or the detention
and removal of illegal aliens.

A third critical challenge is international cooperation, and finding ways to overcome and resolve the disparate interests among sovereign national governments in the GMM system. Governments are wary of sharing information about their citizens with other nations, especially in cases where safeguards are not in place or countries have different attitudes about where to strike the balance between privacy and security. Also, governments may have different perceptions of the terrorist threat, and thus may choose security investments that are optimal from a national perspective, but suboptimal from a global perspective. For example, a country in Europe that believes it is at low risk for terrorism could make only small investments in counter-terrorism, and create a permissive environment for groups that might carry out attacks on a broader international basis. The GMM system is intended to overcome the consequences of these disparate interests, and create a framework that aligns the interests of stakeholders and supports optimal participation by each country while allowing different policy choices.
3 Such as the OECD’s Guidelines on the Protection of Privacy and Transborder Flows of Personal Data

A fourth critical challenge is cooperation between public sector and private  sector stakeholders. The Global Movement Management system is largely a privately-owned and operated system, and private sector stakeholders understand the intricacies of the system better  than any bureaucracy. But national governments understand the threat of terrorism  much better  than any private company, and are in the best position to assess risk at the macro-level and establish priorities about how to secure the system.

This imbalance of information between private sector domain knowledge and public sector threat-related knowledge means that no single party has the ability to operate solely on its own, and it creates uncertainty about how to distribute and share the costs of upgrading security and resilience in the system, Taken together, these four challenges pose a formidable barrier to the implementation of a coherent  and effective security and resilience strategy for the global economic system. The complexity and heterogeneity of the system make it difficult to move forward strategically, which is why activity to date has been tactical and bite-sized. What is needed to overcome this barrier is a framework that distills the current system’s complexity and heterogeneity to its essential elements, and uses this understanding of the system to propose a governance structure and system architecture  that can enhance security and resilience in the entire system: a framework of Global Movement Management.

IV.  Building A GMM Framework

Given the scope and scale of the global economic system, establishing a GMM framework is a daunting task. But the system can be made comprehensible by breaking it down to its essential parts, and looking at it from a modular and decentralized perspective. This perspective makes it possible to proceed step-by-step, and use a spiral development approach to integrate new activities into the existing system – in a way that is coordinated in its design and delivers the level of security and resilience that the system needs, while at the same time maintaining or improving the commercial and privacy-related imperatives of the system.

The establishment of this framework is a four-step process:

1.   Analyze the current system to reveal its key building blocks.
2.   Use these building blocks to construct a clear picture of security- and resilience-relevant linkages and commonalities across the current system.
3.   Develop a governance structure on the basis of this system picture that can enable and manage GMM activities.
4.   Develop a common architecture for Global Movement Management that defines the basic requirements for human and technical capabilities needed to build the system of systems.
These four steps – moving from an analysis of the parts of the system, through a synthesis of common attributes, to the proposal of a governance structure  and system architecture – are discussed in detail in the remainder of Section IV as well as Sections V and VI.

A.   Analyzing the Global Economic System

The global economic system can be broken down along multiple dimensions. By analyzing the system and attempting to find patterns in its complexity, we can develop a strategy to manage security and resilience within it. Within a broader set of system dimensions and attributes (including efficiency, performance, cost, and identity), the five most relevant of these as they pertain to security and resilience are flow type, location, custody, mode of transportation and exchange, and time, as follows:

1.   Flow type: The first dimension of the system is what is moving through it. The five main flow types in the system, as identified earlier, are people, cargo, conveyances, information, and money.4  

2.   Location: The second dimension is the location where something is taking place. This can be looked at generically, such as internal to a country, at a border, or in a foreign country; or specifically, examining the critical differences among key countries (by things like national motivations, political frameworks, and resources) in the system.

3.   Custody:  The third dimension is who or what is in control and/or ownership of what is moving through the system. This includes both custody in a formal, legal sense (e.g., cargo moving through the supply chain) and in a less formal sense (e.g., passengers on an airplane or in a border queue).

4.   Mode of transport or exchange: The fourth dimension is the mode of transport and/or the mode of exchange. For people and goods, key modes of transport include air, sea (including ships and inland barges), and land (including cars, trucks, and rail).5 For money and information, important modes of exchange include telephony systems, the Internet, satellite- based communications systems, narrow-range communications technologies, including, for example, RFID and Bluetooth, and financial payment and settlement systems.

5.   Time: The fifth dimension of the system is the factor of time. Some transactions and interactions within the system are instantaneous; others are bound by the physical realities of the global transport system. In some parts of the system, it is possible today to have real- time situational awareness about the system state; in other parts, this awareness does not yet exist (and might be difficult to create).  

B.   System Commonalities and Linkages

Looking closely at the system along these five dimensions, a number of trends and commonalities start to emerge. System activities that had seemed unrelated reveal their linkages and commonalities. Patterns of human, physical, and informational interaction become self- evident. System activities that had no obvious connection to security or resilience reveal their potential utility for advancing these imperatives.  

Ultimately, four types of commonalities and linkages emerge:

1.   Common security and resilience-related business functions.
2.   Common control points, including national borders, movement chokepoints, and physical infrastructure.
3.   Existing data sources, transactions, and information flows that can provide inputs into the system.
4.   Relationships among key system stakeholders.
These four commonalities and linkages are the baseline building blocks of the GMM framework, and are discussed in the following four sections. They provide the leaders responsible for building security and resilience into the system with information on what they have to work with today, and what they need to create to plug gaps and weave together the system. The sections below describe each of these four types of commonalities and linkages in detail.

4 Some of these flows are both objects and agents of the global system; that is, as agents they also facilitate the movement of other flows within the system. For example, activities and transactions involving people, money, conveyances, and information are all necessary in order to move goods through the system.

5 These modes of transport are the same thing as the “conveyances” flow. But we treat it in this paper in two distinct places because conveyance-centric security is a security alternative distinct from the people or goods that conveyances carry.

1.  Security and Resilience-Related Business Functions in the GMM Framework
In terms of security and resilience activities in the global economic systems, there are six overarching business functions that cut across flow, location, mode, and time. These functions are: (1) risk management, (2) credentialing, (3) screening and inspections, (4) tracking, (5) enforcement and interdiction, and (6) command, control and integration (CCI). Chart I plots the business functions on the vertical axis against generic location types on the horizontal axis, with respect to multiple flows in the system.

Chart I: Security And Resilience Business Functions

Risk management is the collection and analysis of data about many different types of flows – such as people, cargo, and financial transactions – to identify the level of risk for a given entity. Risk management processes information in the aggregate, illuminating anomalies and identifying otherwise imperceptible threats. Most importantly, risk management programs facilitate efficient resource management and the expedited movement of low-risk people and cargo (the vast majority of the flow), focusing limited resources on the entities that pose the highest risk.

Credentialing is the business function that asserts that at a given point in time, people are who they claim to be and/or that the conditions of those types of flows (e.g., people, cargo, data sources, financial transactions) meet a certain standard. Generally, credentials are issued at points of surety, where a credentialing authority is convinced that certain standards have been met. These credentials are used at later points in time to help validate claims of identity, content, or other conditions.

In the event that the integrity of an identity or shipping credential is determined to be intact, any information related to the individual, cargo, or shipper can be used more effectively to manage risk and allocate inspection resources appropriately. Credentialing increasingly follows a model of registering trusted and authorized frequent users of a system and pre-clearing them, such as the piloted Registered Traveler programs in the United States; the Border Crossing Card programs involving Canada, Mexico, and the United States (FAST, SENTRI, NEXUS); and the Customs Trade Partnership against Terrorism within the physical supply chain. These are tied internationally to emerging standards for mutual recognition of credentials, such as the WCO Framework v2.0 or EU Customs 2007.

Screening and inspection includes business functions that conduct inspection and accounting activities to verify that flows that cross national borders or move through a chain of custody are properly identified and registered. Screening and inspection helps to validate that only lawful or low risk people or things enter intentional openings in perimeter boundaries such as ports of entry and that authorities are able to track the duration of their stay within those boundaries effectively. It is used throughout the supply chain to allocate additional inspection and/or enforcement and interdiction resources, and it informs compliance programs such as warnings, training, audits, and facilitation programs. Screening and inspection is highly dependent upon risk assessment to gauge the risk of the targets of inspection.

Tracking includes business functions that monitor and track people, cargo, conveyances, or transactions that have entered or intend to enter perimeter  boundaries lawfully. It includes processes and systems to track people, cargo, conveyances, and money to validate that their location and integrity is consistent with that authorized upon entry. It includes the process of attributing the ownership and control of items moving through the system. It includes traceability processes: tracking backward to find the source or origin of a system disruption (e.g., poultry infected with avian flu or WMD materials intercepted in a cargo container), isolating the problem and thus decreasing the need for a broad system shutdown.

Tracking is typically non-intrusive and the information from this business function can be aggregated to create a comprehensive real-time picture of the state of the system, which can be used both for security functions and business efficiency functions (e.g., inventory management, optimizing use of assets). Many of today’s legacy tracking systems are immature and unable to track flows moving across borders or chains of custody.  

Enforcement and interdiction facilitates the integrity of a country’s borders and interdicts illicit activity within countries. It includes enforcement of the law at and between lawful ports of entry, identifies breaches in the perimeter, and takes action to prevent entry of illegal immigrants or unauthorized cargo, including weapons of mass destruction. It includes the ability to respond effectively to changes in the at-entry conditions of people, cargo, and conveyances. Finally, it includes interior enforcement activities, including the detention and removal of illegal entrants and investigations into the smuggling of terror-related or other illicit substances.

Command, control and integration (CCI) includes net-centric command and control activities (involving both the public and private sectors) that monitor all available information about global movement, and fuse that information to create real-time intelligence about potential threats to the system, in a manner consistent with privacy and civil liberties standards.

It supports efforts across all of the business functions to share and analyze data more effectively, particularly from risk assessment, and it optimizes enforcement and interdiction response times and effectiveness.  

These six business processes in the global movement system interact with each other and with multiple other existing business processes that are not directly relevant to security, but are either affected by security or provide data inputs into the security business processes. These include:

1.   Regulatory compliance (legacy customs, immigration, border control, and financial oversight missions)
2.   Economic development (trade, travel, and investment facilitation)
3.   Border clearance (legacy customs and immigration missions)
4.   Revenue collection (duties, tariffs, and taxes)
Breaking down the strategic framework into these six business functions can help to reveal synergies and commonalities in the global economic system. For example, in the area of risk assessment, there are literally dozens of projects in governments around the world and in the private sector that are focused on some variant of the “needle in the haystack” problem – trying to find a potential terrorist  crossing a border checkpoint, or a cargo container containing a bomb, or an illicit financial transaction, amid the vast sea of people, goods, and data moving around the world. In each of these areas, it is possible to use subject-based queries or pattern- based predictive algorithms to focus inspection activities on high-risk people or things and associations of interest. System stakeholders can use this insight to find ways to create linkages between these diverse sets of activities.  

2.   Control Points in the GMM Framework
A second key building block of a GMM framework is an assessment of the existing control points in the system. There are three key types of control points in the system (represented in Chart II below):

1.   National borders
2.   Movement chokepoints
3.   Physical infrastructure
National borders exist as a means to enforce sovereignty. These are controlled both at formal checkpoints (either on the border  or at internal points-of-entry, such as airport immigration stations) and to a lesser extent, along remote  borders where attempts at smuggling or illegal immigration take place. Some countries, most notably the Schengen group within the European Union, have effectively removed their internal border  controls to promote international movement and exchange among a core set of countries.  

Chart II: GMM System Control Points

At the second level are chokepoints determined by the physical realities of movement and transport in the global economic system. These include key shipping bottlenecks such as the Panama and Suez Canals, the Straits of Bosporus, Gibraltar, Hormuz, and Malacca, and the mouths of the Mississippi and the Rhine rivers.  

They include non-redundant  transportation assets such as the Holland and Lincoln tunnels into Manhattan, the Ambassador Bridge and Detroit & Canada Tunnel connecting Detroit and Windsor, Ontario, the Jing Hu Freeway between Shanghai and Beijing, or the Channel Tunnel between England and France. Other chokepoints include major payments and clearance systems such as key communications switches, or hub or root servers in the global information grid. Each of these chokepoints is a place that unmanaged and disparate activity must “pass through” if it is to be anything above localized activity. Because of this, they are both places of criticality (impairing the entire system if shut down) and places where certain types of security activities (e.g., inspection) can be effectively organized and conducted.  

At the third level are a set of infrastructure-specific borders and control points such as fences and physical barriers to prevent entry into secure facilities. They also include passenger, baggage, and cargo screening systems for aviation and other modes of transportation as well as cybersecurity and information assurance activities for financial and communications systems.  
At each of these three control  point levels, there are existing security activities as well as new security activities that could be developed with minimal additional effort. It is also possible to integrate the three levels and prioritize security activities specific to certain flow types, locations, modes, and times.

3.   Data Sources, Transactions and Information Flows in the GMM Framework
A third key building block of the GMM framework is the availability of existing data sources, transactions, and information flows in the global economy – all of the moving bits, bytes, signals and sentences coursing through the global economy. The ability to carry out the security business functions in the first section above in conjunction with the control points in the last section is dependent upon information about what is moving through the system – in both physical and transactional terms.

It is unrealistic to expect a system that provides perfect real-time information about what is moving through the system.  Implementing such a vision for the system would be cost-prohibitive and likely to violate personal and commercial privacy norms. Instead, the framework should be built primarily upon data streams and information flows that exist today, many of which are imperfect and incomplete on their own, but collectively provide sufficient information about the near-real-time state of the system and its contents to facilitate and promote security.  

Examples of such data sources include: 6

People: Passenger name records (PNR) for commercial aviation. Visa and passport applications. Immigration declaration forms. Government and international watch lists. Pilot licenses. Commercial driver’s licenses. Border crossing cards. Registered traveler program enrollments. Lost or stolen passport information.

Goods: Shipping manifest data. Customs declarations and clearances. Known shipper program enrollments. Container or pallet tags. Credit service bureau databases. Other supply chain messages and transactions (e.g., orders, invoices, shipment status, freight booking confirmations).

Conveyances: Maritime vessel registrations. Airplane registrations. Container or pallet tags.

6 See also Markle Task Force Report, Protecting America’s Freedom in the Information Age, Appendix H, “The Landscape of Available Information” for a fuller list of security-relevant data sources. Available at

Money: Reporting requirements in many countries for large (ca. +$10,000) financial transactions. Counterfeiting monitoring systems.  
Information: Domain name registrations. Patent and trademark databases. Telephone directories. SIM Card purchases.

These data sources and information flows have security-relevant utility when used both on a stand-alone basis and (more importantly) in relation to one another. By mapping out the data sources that currently exist, it is possible to determine  the existing or potential linkages between the different types of data, develop new information by integrating existing data streams, and locate any gaps in the system where new data might be required. It is also likely that commercial benefits can emerge from this process: key public and private stakeholders can find new ways to increase their overall efficiency. Further, by having a completed and integrated picture of these information flows, it is possible to build privacy and data protection  into the system, and prevent misuse and unwarranted dissemination of personal information, by controlling access, using immutable audits, and anonymizing sensitive data as it moves through the system.

4.  Stakeholder Relationships in the GMM Framework
The fourth key building block of the GMM framework is the existing set of relationships among stakeholders in the system – governments (both national and sub-national), private sector companies of many types (e.g., shippers, manufacturers, banks, airlines, telecoms, retailers, service providers), international organizations (e.g., International Maritime Organization (IMO), International Civil Aviation Organization (ICAO), World Customs Organization (WCO), Interpol), public interest groups (including privacy and civil liberties advocates), and individuals.

These stakeholders interact with one another in a complex and disorderly framework, and many of their interactions are tacit rather than formal. Some stakeholders are primarily facilitators and intermediaries, whereas others have responsibility more operational in nature. By mapping out the relationships among these various stakeholders, and understanding where interests  converge and diverge, we can anticipate many of the obstacles that must be overcome to adopt an integrated strategy, and then use existing strong relationships to support the development of the framework. We can also start to envision a more orderly framework of stakeholder relationships, one in which relevant information is shared through standardized processes across the entire global economic system. Chart III on the next page provides a generic top-level map of these stakeholder relationships.

Chart III: GMM Stakeholder Relationships

These four building blocks – business functions, control points, data sources, and stakeholder relationships – provide the common template, the mesh canvas, upon which it is possible to build an integrated Global Movement Management framework. They make it possible to envision and develop a true “system-of-systems” for GMM. An overall understanding of these four building blocks and their interactions makes it possible to integrate dispersed security activities, and ensures that far-flung and unconnected activities can be potentially woven together and integrated as the system evolves. Chart IV below provides a representation of these last three building blocks and their interactions.[/size]
And  the King shall answer and say unto them, Verily I say unto you, 
Inasmuch as ye have done it unto one of the least of these my brethren,  ye have done it unto me.

Matthew 25:40