Drug Counterfeiting, Adapt or Perish

"Adapt or perish, now as ever, is nature's inexorable imperative." H.G. Wells

The following is a re-posting of an opinion blog in Secure Pharma Chain blog from 2010:

By: Alan Clock, Senior Vice President, XStream Systems

For those of us knowledgeable about the issue of counterfeiting, we have long been aware of the huge growing menace that has seemingly lurked in the shadows of the collective consciousness of the public at large for some time now.

Even for those who have been at the forefront of this serious threat, which the FBI dubs “the crime of the 21st century”, currently there seems to be a heightened sense of concern about how quickly this criminal activity is proliferating. It would appear now that this threat is advancing well beyond even our own alarmist predictions.

To date, much of the death and destruction associated with counterfeiting activity has occurred off the radar screen from the populace of privileged, developed nations and instead in the isolated world of underdeveloped areas and their residents.

For some of us with the advantage of a prosperous free market system, we have been somewhat immune to the spectacle of the criminal poisoning of disadvantage populations, which happens routinely in Africa and Asia by the purveyors of this insidious transgression.

In 2010, the widely accepted World Health Organization’s estimate is that pharmaceutical counterfeits are a $75 billion industry with an annual growth percentage of 12-16%. The World Customs Institute estimates that food counterfeiting is a $49 billion annual enterprise.

According to the study of Counterfeiting Intelligence Bureau of the International Chamber of Commerce counterfeit goods make up conservatively 5 - 7% of World Trade which the International Anti-Counterfeiting Coalition calculates would make the current global counterfeit economy the world’s biggest single business.

We now find ourselves in a perfect storm that will expand counterfeit criminal activity well beyond our wildest estimates and make it far more deadly in scope and size. The primary elements feeding this calamity include:

· a worldwide economy in a downward spiral
· ineffective regulations and laws on the crime of counterfeiting
· spotty or careless enforcement of existing laws on counterfeiting
· disjointed supply chains that cross multiple governmental boundaries and jurisdictions
· huge taxes on critical commercial markets like healthcare that are squeezing both the business and the onsumer to look for cheaper goods
· a collective lack of knowledge and leadership by governments around the globe to protect their constituents
· industries that choose to ignore the threat to their businesses instead of protecting their brand and customers
· a collective lack awareness of the deadly nature of the threat of counterfeits by consumers worldwide, most consider this a harmless act

Until now, this criminal activity, although grand in its size has really been driven by single individuals or disparate organized entities that realize how lucrative and safe this nefarious criminal activity has become. Criminals understand that counterfeiting is the perfect crime:

· there are few ways to get caught
· if they do get caught their activity carries almost no significant ramifications
· most often their crime will not be discovered for some time giving them plenty of time to cover their tracks and escape
· they have a global marketplace where they can carry out transactions anonymously in cyberspace
· the profit margin derived from counterfeiting transcends what most businesses make in a legitimate activity

Even as this perfect crime expands to educated and developed nations, we now seem at the precipice of something far more dangerous and deadly as this menace seems likely to evolve into something much larger in size and scope and far more insidious as a whole.

Many experts now fear the inevitable, when terror organizations, who are not driven by greed but rather destruction, realize the relative ease and deadly effectiveness that a purposeful counterfeiting event could trigger in a region or nation. Be it in a consumer good, food stuff, electronics or medication, one single, simple adulteration could literally harm millions with relative impunity.

Adapt or Perish, the time is now for governments, industry and consumers to understand the need for solutions to protect themselves from the various nefarious sources that threaten their health and wellbeing.

Today there are many technologies and services available that can offer protection to industry and consumers from those who would seek to profit or cause destruction. Leaders in governments and industry around the globe need to act now to protect entire populations.

Although no one solution, to date provides a single, "iron clad" solution to this scourge, when appropriately layered, these existing solutions can and do create effective and efficient security to protect supply chains and consumers from fraudulent, adulterated and counterfeit products.

To learn more about, anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/

Chain of Custody Dilemma: Recovering Stolen Pharma Products

By: Alan Clock, Senior Vice President, XStream Systems

What happens to pharmaceutical products that are recovered intact, meaning in their original packaging or shipping containers, following a theft or high jacking?

According to most experts, the policy of Pharma companies is to destroy these recovered products because they have broken the chain of custody or transaction. The logic is that no one wants to assume the liability of the efficacy of the products because they are uncertain if the products were affected or somehow altered during their time spent outside of legitimate charge.

This is an obviously an expensive and wasteful expense especially if there is a technology available that would allow the supply chain to test these products, within their sealed, unit-of-sale container. A technology that will verify that the material inside is safe and has not been altered, tampered or somehow counterfeited without destroying or degrading the drug.

Recent statistics are showing a significant surge in criminal organizations targeting Pharma products within the pharmaceutical supply chain (manufacturer, distributor, dispenser and consumer). These groups are stealing large shipments; in transit to sell within gray or black markets for significant profits. Fortunately as the problem escalates, law enforcement and security often are recovering or interdicting these criminal acts quickly.

The following are some recent examples:

- Polish police have recovered eleven tons of human blood plasma that had been stolen at a truck rest stop in Germany while in transit to Austria. The owner of the plasma, BioLife Plasma Services, a subsidiary of Baxter International, valued the shipment at around $1.4m. All of the product had been recovered in its original boxes and packaging.

- Police recovered intact a shipment of Alcon Labs and Teva Pharmaceutical products, stolen on February 22. The value of the shipment has not been disclosed but included 70 pallets of assorted prescription, over-the-counter and personal healthcare products.

- A pharmaceutical shipment including products valued at over $500,000 belonging to Sanofi-Aventis was hijacked in Puerto Rico on January 29. A wide range of prescription medicines and vaccines was taken in the incident.

- AstraZeneca lost in transit, a FedEx shipment in late December/early January. The total value of the shipment, which included Casodex, Seroquel, Nexium, Toprol XL and Crestor and Zomig was in excess of $500,000.

As it stands today, even with the product recovered intact and within its original containers the product will be slated for destruction because of the lost chain of custody. However there is a readily available technology solution.

The most effective way to effectively know that the lost chain of custody has not impacted the quality, efficacy or somehow adulterated the stolen medications is to look inside the sealed container to screen, verify and authenticate the product inside the package.

An ideal solution, it allows packaged drugs to remain intact and is readily available to test products once they are retrieved. This technology provides a level of confidence that the temporary loss of chain of custody has not altered the product and that public safety is ensured.

XStream System’s technology solution is the ideal solution for the pharmaceutical industry's chain of custody challenge by using Energy Dispersive X-Ray Diffraction (EDXRD). This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product.

This solution transforms the process from looking at the chain of custody and/or transaction to looking inside the packaging with Molecular Screening. Ultimately, this truly provides all of the members of the supply chain, from manufacturer to consumer, the confidence to know that the medications in their inventories or supply chain are safe and efficacious.

EDXRD solutions function by matching the diffraction pattern obtained by the instrument with a library of patterns previously obtained for comparison. The EDXRD diffracted spectral patterns of crystalline substances are markedly different, even to an untrained eye. Much like a human fingerprint, although there may be a few features that are common to both patterns, they are nonetheless very different. In current iterations of the technology, which is fitted with a computer-based detection device, the system relies on a sophisticated mathematical algorithm to extract a unique feature set from the pattern and use them to identify the material giving rise to that pattern.

In general, the EDXRD methods are highly material specific, since the diffraction patterns of crystalline materials are unique. As it relates to pharmaceuticals, the signature of diffracted aspirin is very different from ibuprofen, acetaminophen, codeine, etc. Equally important is the fact that the diffracted patterns of the excipients specific to the unique recipe of the formulation are unique and one can determine differences in manufacturer, packaging, dosage, etc. For example, acetaminophen, 325mg from one vendor, will differ from acetaminophen 325mg from another vendor unless they follow the exact same recipe, density, pill configuration and utilize the exact same packaging.

This material sensitivity of EDXRD has two important ramifications - high detection/verification rates and low false alarm rates. Under ideal conditions (i.e. - low absorption and high test mass), the detection rate is close to 100% and the false alarm rate is 0.1% or lower. In addition because it uses X-Ray, EDXRD technology can penetrate through nearly all plastics, cardboard, wood and metals in order to screen the material.

XStream Systems has succeeded in establishing EDXRD as a robust Molecular Screening tool that can be used within the supply chain. XStream has conceptualized and architected the world’s first countertop EDXRD machine, the XT250 Material Identification System.

The XT250 has turned a complex technology into an easy to operate solution for the average end user. The XT250 system is now fully deployed in drug wholesalers, pharmaceutical manufacturers and pharmaceutical reverse logistics companies. The system is designed to be used either in a standalone or integrated capacity anywhere along the supply chain; the deployment can be in a warehouse setting and operated by a non-technical warehouse worker.

With the XT250, there no longer needs to be the very expensive and wasteful dilemma of product destruction because the product has lost its chain of custody. Because the XT250 can authenticate products non-destructively, will no longer be incumbent on the supply chain to absorb multi-million dollar losses as the threat of cargo theft proliferates.

To learn more about XStream Systems, material identification solutions, visit: http://www.xstreamsystems.net/.

Counterfeiting, Adapt or Perish

By: Alan Clock, Senior Vice President, XStream Systems

"Adapt or perish, now as ever, is nature's inexorable imperative." - H.G. Wells

For those of us knowledgeable about the issue of counterfeiting, we have long been aware of the huge growing menace that has seemingly lurked in the shadows of the collective consciousness of the public at large for some time now.

Even for those who have been at the forefront of this serious threat, which the FBI dubs “the crime of the 21st century”, currently there seems to be a heightened sense of concern about how quickly this criminal activity is proliferating. It would appear now that this threat is advancing well beyond even our own alarmist predictions.

To date, much of the death and destruction associated with counterfeiting activity has occurred off the radar screen from the populace of privileged, developed nations and instead in the isolated world of underdeveloped areas and their residents.

For some of us with the advantage of a prosperous free market system, we have been somewhat immune to the spectacle of the criminal poisoning of disadvantage populations, which happens routinely in Africa and Asia by the purveyors of this insidious transgression.

In 2010, the widely accepted World Health Organization’s estimate is that pharmaceutical counterfeits are a $75 billion industry with an annual growth percentage of 12-16%. The World Customs Institute estimates that food counterfeiting is a $49 billion annual enterprise.

According to the study of Counterfeiting Intelligence Bureau of the International Chamber of Commerce counterfeit goods make up conservatively 5 - 7% of World Trade which the International Anti-Counterfeiting Coalition calculates would make the current global counterfeit economy the world’s biggest single business.

We now find ourselves in a perfect storm that will expand counterfeit criminal activity well beyond our wildest estimates and make it far more deadly in scope and size. The primary elements feeding this calamity include:

· a worldwide economy in a downward spiral
· ineffective regulations and laws on the crime of counterfeiting
· spotty or careless enforcement of existing laws on counterfeiting
· disjointed supply chains that cross multiple governmental boundaries and jurisdictions
· huge taxes on critical commercial markets like healthcare that are squeezing both the business and the onsumer to look for cheaper goods
· a collective lack of knowledge and leadership by governments around the globe to protect their constituents
· industries that choose to ignore the threat to their businesses instead of protecting their brand and customers
· a collective lack awareness of the deadly nature of the threat of counterfeits by consumers worldwide, most consider this a harmless act

Until now, this criminal activity, although grand in its size has really been driven by single individuals or disparate organized entities that realize how lucrative and safe this nefarious criminal activity has become. Criminals understand that counterfeiting is the perfect crime:

· there are few ways to get caught
· if they do get caught their activity carries almost no significant ramifications
· most often their crime will not be discovered for some time giving them plenty of time to cover their tracks and escape
· they have a global marketplace where they can carry out transactions anonymously in cyberspace
· the profit margin derived from counterfeiting transcends what most businesses make in a legitimate activity

Even as this perfect crime expands to educated and developed nations, we now seem at the precipice of something far more dangerous and deadly as this menace seems likely to evolve into something much larger in size and scope and far more insidious as a whole.

Many experts now fear the inevitable, when terror organizations, who are not driven by greed but rather destruction, realize the relative ease and deadly effectiveness that a purposeful counterfeiting event could trigger in a region or nation. Be it in a consumer good, food stuff, electronics or medication, one single, simple adulteration could literally harm millions with relative impunity.

Adapt or Perish, the time is now for governments, industry and consumers to understand the need for solutions to protect themselves from the various nefarious sources that threaten their health and wellbeing.

Today there are many technologies and services available that can offer protection to industry and consumers from those who would seek to profit or cause destruction. Leaders in governments and industry around the globe need to act now to protect entire populations.

Although no one solution, to date provides a single, "iron clad" solution to this scourge, when appropriately layered, these existing solutions can and do create effective and efficient security to protect supply chains and consumers from fraudulent, adulterated and counterfeit products.

To learn more about, anti-counterfeiting solutions, visit: www.xstreamsystems.net.

The Decade of the Counterfeit-Part Two

The is the second and final installment of a two part opinion blog by Alan Clock, Senior Vice President at XStream Systems, Inc.

How do we as a society both domestically and globally solve this growing threat and eliminate the danger that looms as its deadly consequence to us all?

We now live in a worldwide, global economy. Trade and industry superpowers have emerged beyond the traditional European and North American developed nations. Comprehensively all industries have had enormous movement of production into underdeveloped nations, even those that have a tradition of trade riddled with fraud, counterfeiting and corruption. These countries with well know nefarious sources of supply, now find themselves as a primary producers of everyday consumer products that are in foodstuffs, household goods and medications on the retail shelves of Main Street USA.

The reality, unknown by many, is that this counterfeit phenomenon is growing and going well beyond the borders of the undeveloped world. Today, not one product, not one place, not one person is immune from the impact of counterfeit and fraudulent products. It is likely that we will continue to see this counterfeit boom continue unabated indefinitely.

How this phenomenon is happening is both complex and simple. This is a global event which adds to its complexity, but it is driven by easy money which is very straightforward to understand.

As such, some of the major factors driving the unprecedented proliferation of counterfeit products around the globe decade include:

• Global economies and worldwide supply chains. As companies become more global and procure raw materials and contract production overseas due to lower costs and expense, the supply chains become much more difficult to control and monitor. Companies lose control over their production, intellectual property and quality control. Regulatory processes and enforcement in third world countries lag behind the developed world and institutional control. Nefarious vendors can contaminate for quick profit a product by providing poor quality or adulterated raw materials prior to production. Without adequate controls manufacturers, distributors, retailers and consumers find themselves vulnerable to poor quality, contaminated or fraudulent materials. Often by the time an issue is discovered the product is well within distribution, its source difficult to pinpoint with the perpetrators long gone. Unfortunately by that time the impact of the bogus product has been borne by thousands.


• Ineffective laws and regulations. As a global economy expands, products move across multiple borders making them increasingly vulnerable and allowing for organizations to take advantage of legal loopholes, breaks in regulatory authority and the ability for law enforcement to adequately monitor movement of goods and services. Penalties for criminal activities also exacerbate the situation. A criminal organization can make more profit with less risk of being caught or with any significant legal ramifications by counterfeiting than almost any other criminal activity. Basically it is easier to counterfeit products, with much less risk and much more profit than in any other legitimate or illegitimate activity.


• Growth of the internet and unrestricted, instant access to millions of consumers. In the 21st century, counterfeit organizations can directly or indirectly market and sell their wares online, 24 hours a day in relative anonymity. These organizations can set up websites and fulfill transactions with only a few key strokes and completely camouflage their operation. By the time a regulatory body, law enforcement agency or consumer finds a fake product the marketing source or website and operation is long gone into a hazy cyber world.


• The global financial meltdown that occurred in the last half of the decade has caused many retailers and consumers to look at the price of materials, focusing less on quality and authenticity. As incomes and profits fall, so do the standards of the producer or consumer as they scramble to find the products and materials that they rely on. This is a dangerous environment where counterfeit organizations thrive. A perfect scenario for fraudulent activity occurs when members of the supply chain focus on price over cost and fraud. The criminals know that by the time their crime is discovered they have little chance of being held accountable.


• The lack of brand protection and security by members of the supply chain. Many manufacturers, distributors and retailers have been slow to realize the huge impact that counterfeit products have and could have to their businesses. Many have had and continue to show a lack of strategy in dealing with this issue, ostensibly because they have not educated themselves on the problem or they do not have the necessary solution to effectively deal with it. Regrettably until most of these organizations face the liability or brand erosion of a catastrophic event caused by fraudulent activity they simply ignore the issue altogether.


• The lack of implementation or acceptance of comprehensive solutions to combat counterfeiting. There have been scores of regulatory bodies, legislation and industry groups make attempts to implement comprehensive solutions to counterfeit activities. Most initiatives prove to be ineffective, based on their lack of acceptance, expense and their complicated approach. Functionally most of these solutions are based on a transactional approach. A transactional approach relies on the supply chain to continually interact and exchange data. This constant information exchange in real time is difficult at best and extraordinarily expensive at worst especially when you are dealing with a far reaching, global supply chain.
  
  Additionally transactional methods only deal with the product package and not the material or product itself. Some of the largest and most egregious fraud and counterfeit events of the past several years were products that had pristine transactional pedigrees but the product on the inside of the package was adulterated or fraudulent, causing harm to thousands of end use consumers and millions in losses to the brand.
  
  To date, most industries seem to have taken a wait-and-see approach driven by the cost of current solutions, which ultimately means that the initiatives die as the events which caused the activity loses momentum over time. The reality is that eventually business leaders within the supply chain have a “hear-no-evil, see-no-evil” attitude as it relates to this issue because they posses few answers and have little to no government or industry leadership to the mandate or guide them.

The dilemma of the next decade is how to marshal our resolve as a society globally and properly respond to the multiple factors which have driven this decade of fraudulent, adulterated and counterfeit products that have proliferated in the 21st century.

First and foremost, to win this battle, there needs to be a universal awareness of how prevalent and how dangerous this issue actually has become. Consumer’s awareness and their rejection of products that are not vetted and authenticated is critical.

Additionally, regulatory authorities across the globe need to be motivated, synchronized and resourced appropriately so as to eliminate the shadows and safe havens that allow counterfeiters to thrive.

Finally, industry and supply chains need to understand and realize the profit, loss and liability that exist if they do not deal with counterfeits head on. Each of the stakeholders of the consumer supply chain, from corporations to consumer, need to push for sophisticated solutions and eliminate this potentially deadly threat.

Vital to these three primary steps is the realization from all; manufacturer to consumer, is the understanding what this counterfeiting is currently, but what it can become if not properly addressed.

Most ominous is the potential for counterfeiting to evolve beyond the simple criminal act to becoming a massive terror threat is very real. As it stands today, millions die each year from individual criminal counterfeit acts, if done with a coordinated murderous intent; a terrorist element could comprehensively impact the health and mortality of an entire country or society.

Fortunately the solutions are at hand, today there are technologies that can be comprehensively layered to protect the various members of the supply chain, within individual channels to follow transactions, screen materials and authenticate the validity of products at each step of the sequence as it makes its way to the consumer.

One such solution is a technology known as EDXRD. This innovative technology allows the user to molecularly screen the product inside its original container without destroying or degrading the product, thus minimizing the need for Track and Trace or transactional solutions. Basically this solution adds functionality from the transactional and looking at the outside of the container to looking inside the container with Molecular Screening. Ultimately, this type of solution provides each member of the supply chain the confidence to know that their inventories safe and efficacious.

In the end, layered deployment of technology solutions, consumer awareness and a coordinated regulatory/law enforcement process will be the most effective strategy to lessen this very dangerous, criminal activity. When the criminal elements realize that there is little profit and a realistic chance that they will be held accountable for their actions, the deadly issue of counterfeit and fraudulent products will drastically decline and the Decade of the Counterfeit will become a brief historical story of how technology and public awareness save the day.

Alan Clock, Senior Vice-President of XStream Systems has over 20 years of pharmaceutical, healthcare and sales distribution experience. Mr. Clock has an impressive track record of promoting comprehensive solutions to healthcare providers, distributors, large corporate entities, group purchasing organizations, employer groups and managed care organizations. He has held senior sales executive and national account roles for major Fortune 100 healthcare industry leaders and has successfully negotiated and sold billions of dollars in multi-year pharmaceutical service, software, equipment, packaging and consulting agreements.

The Decade of the Counterfeit-Part One

This is the first installment of a two part opinion blog by Alan Clock, Senior Vice President at XStream Systems, Inc.

The first decade of the 21st century could carry many labels given the rise of global terrorism, a bursting housing bubble and a worldwide financial meltdown. However one very appropriate label, albeit lesser known by the masses, would be the Decade of the Counterfeit.

Although counterfeit materials and fraudulent supplies have been around for centuries, with the emergence of far reaching global supply chains and an expanding worldwide economy, the criminal activity of producing counterfeit goods have propagated and is impacting a greater number of consumers more than ever before.

In modern times counterfeit products go well beyond the conventional bogus purses and knock off apparel that we traditionally associate with this fraudulent activity. The scope and audacity of the contemporary counterfeiter goes well beyond what has traditionally been considered to be a victimless crime.

Today’s counterfeit products include every product that is used today. This runs the gamut from commercial aircraft parts to sophisticated electronics, and from consumer goods to food and life saving healthcare products. Counterfeited products include all of the goods that consumers rely upon for their safety and well being. At best, these bogus products fall short of their consumer’s expectation while at worst they threaten a population’s safety and overall health.

An insidious example of how counterfeit activity can create a deadly consequence and cause thousands to die is documented by the issue of counterfeit drugs causing drug resistant disease strains in underdeveloped countries in Africa and Asia.

With medical science producing drugs that can effectively cure or curb diseases such as tuberculosis, malaria and HIV/AIDS, unscrupulous counterfeiters are producing fake drugs with only a trace of the real drug’s active ingredient. The counterfeiters put only enough of the real ingredients in to fool rudimentary testing processes. The unfortunate side effect of these bogus treatments is that not only do they not provide any therapeutic cure, they actually create more dangerous strains of the disease that are impervious and resistant to the known drug regimens used to treat the illness.

The World Health Organization estimates that upwards of 2,000 children per day die as a result of taking counterfeits medications in Africa alone.

Well over 1 million children die in Africa and Asia die each year because of counterfeit drug medications.

A few global statistics from the World Health Organization regarding pharmaceuticals, even further energizes the debate regarding the label Decade of the Counterfeit:

• In 2010, the World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion industry worldwide.


• The WHO projects growth of counterfeit medications to be over 12-16% annually, worldwide.


• The WHO Reports that globally 10% of Pharmaceuticals are counterfeit, fraudulent or adulterated.

How do we as a society both domestically and globally solve this growing threat and eliminate the danger that looms as its deadly consequence to us all?

View Part Two of the opinion blog tomorrow on Secure Pharma Chain Blog.

Coming This Week a Two Part Blog Series: The Decade of the Counterfeit

Coming later this week, Secure Pharma Chain Blog will be presenting in a two part blog series a recent opinion paper written by Alan Clock, Senior Vice President at XStream Systems, Inc.

The paper, titled The Decade of the Counterfeit, discusses how the first decade of the 21st century has emerged due to the globalization of the world's economy as a time where counterfeit, fraudulent and adulterated products have proliferated and touch each and every product, brand and consumer around the globe.

The following is an exerpt from The Decade of the Counterfeit:

The first decade of the 21st century could carry many labels given the rise of global terrorism, housing bubble and a worldwide financial meltdown. However one very appropriate label, albeit lesser known by the masses, would be the Decade of the Counterfeit.

Although counterfeit materials and fraudulent supplies have been around for centuries, with the emergence of far reaching global supply chains and an expanding worldwide economy, the criminal activity of producing counterfeit goods have propagated and are impacting a greater number of consumers universally more than ever before.

In modern times counterfeit products go well beyond the conventional bogus purses and knock off apparel that we traditionally associate with this fraudulent activity. The scope and audacity of contemporary counterfeiters goes well beyond what has traditionally been considered to be a victimless crime.

Today’s counterfeit products include every product that is used today, running the gamut from commercial aircraft parts to sophisticated electronics, and from consumer goods to food and life saving healthcare products. These include all of the products that consumers rely upon for their safety and well being. At best, these bogus products fall short of their consumer’s expectation while at worst they threaten a population’s safety and overall health.

To learn more about XStream Systems, Inc. visit our website at: http://www.xstreamsystems.net/.

FDA Sets Up Shop in Mexico

The US Food and Drug Administration (FDA) has continued its expansion outside of the United States with the opening of an office in Mexico. This is now the third FDA office in Latin America after Costa Rica and Chile.

The move is the latest in an effort by the FDA to influence foreign markets, and in particular in areas which serve as important importation partners into the US supply chains including pharmaceuticals, medical devices and food.

The new office which is based in the capital, Mexico City, "represents an important step as we re-design our product safety strategy," commented FDA Commissioner Margaret Hamburg.

Mexico is the largest pharmaceutical market in Central America, with 2009 sales estimated to reach around $9bn and expected to grow to nearly $15bn over the next five years, according to Business Monitor International. It is the second-largest pharmaceutical market in Latin America as a whole.

XStream Systems encourages the continued expansion of the FDA into countries that are important trading partners but also suggest that regulatory bodies and supply chains, internationally and domestically, utilize technologies like EDXRD to protect itself from fraudulent, adulterated and counterfeit materials.

To learn more about supply chain protection technologies, visit: www.xstreamsystems.net.

Drug Resistant Diseases Fueled by Counterfeit Medications Impact Developed Nations

As has been repeatedly discussed on this blog, drug resistant strains of diseases have evolved in underdeveloped countries by counterfeit medications that contain just enough of the active ingredient of the drug used to treat the disease to fool rudimentary analytical testing used to verify the drugs authenticity. Unfortunately these fake medications, with minor amounts of the real drug add injury to insult by not only not treating the disease but in creating drug resistant strains of the disease itself.

Until lately this issue has largely impact underdeveloped nations in Africa and Asia but as you can see by recent media reports and this article which appears in the Minneapolis Star Tribune, this phenomenon is now hitting US shores with drug resistant strains of Tuberculosis.

This problem of drug resistant strains in Africa kills thousands every day.
Developed and underdeveloped nations need to take action and utilize a variety of solutions to put an end to this issue which makes deadly diseases more sophisticated and deadlier.

Solutions such as XStream System’s, XT250 are able to do on-site, molecular screening of pharmaceuticals that can verify active ingredients, excipients and packaging to authenticate and verify medications inside their sealed, unit-of-sale container would drastically curtail the ability of counterfeiters to sell and distribute substandard medications in developed and underdeveloped nations.

To read the Star Tribune story visit: http://www.startribune.com/lifestyle/health/80160622.html?elr=KArks7PYDiaK7DUvDE7aL_V_BD77:DiiUiacyKUnciaec8O7EyUr.

To learn more about XStream Systems and its XT250, visit: http://www.xstreamsystems.net/.

The National: Tighter Controls on Fake Drugs Sought

The Regional Conference on Fighting Counterfeit Medicines recently held in Dubai, examined the issue and solutions to fighting counterfeit medications. The conference, sponsored by Pfizer, attracted representatives from 15 countries.

XStream Systems President and Chief Technology Officer, Brian Mayo presented XStream’s revolutionary material screening technology at the conference.

Reported by Mitya Underwood and published by The National the following are some excerpts from the article:

• The UAE must tighten its border controls and increase co-operation between enforcement agencies if it hopes to turn back the rising tide of counterfeit drugs, officials said yesterday.


• The Ministry of Health said it would work with customs and free zone officials to stop fake medicines and medical equipment from entering the country or passing through its ports.


• Dr Amin al Amiri, the chief executive of medical practices and licensing, said the ministry would ask customs officials to stop clearance for medicines and equipment until it had approval for each consignment.


• Speaking at the Regional Conference on Fighting Counterfeit Medicines, Dr al Amari said the ministry hoped to reduce the UAE’s role in the global trafficking of illegal products. He declined to say how much counterfeit material was coming into or passing through the country.


• Figures from the European Commission’s Taxation and Customs Union recently showed that the UAE was the origin of almost nine per cent of all counterfeit medicines seized at European borders in 2008. The UAE was the third largest importer after India and Syria.


• Dr al Amiri said in addition to increased inspections and raids, a federal pharmaceutical law would be introduced to tighten penalties and introduce jail terms and larger fines.


• Dr Mohammed Abuelkhair, the head of drugs and medical products registration at the Health Authority-Abu Dhabi, said the law should deter pharmacies from knowingly stocking counterfeit drugs and stop importers from targeting the UAE market.

To read the entire article, visit: http://www.thenational.ae/apps/pbcs.dll/article?AID=/20091216/NATIONAL/712159821/1010

Are Counterfeit Products Contributing to Drug Resistant Strains of H1N1?

As reported in many media outlets, European physicians and the World Health Organization (WHO) are investigating drug resistant strains of the H1N1 virus.

To date, H1N1 has been effectively treated by anti-viral medication Tamiflu and Relenza.

As also reported in many media outlets and in SecurePharmChainBlog.com there is an emerging proliferation of organized crime organizations making hundreds of millions of dollars by counterfeiting and selling via the Internet the anti-viral drugs used to treat the H1N1 virus.

With the malaria and tuberculosis healthcare epidemics in Africa and Asia, counterfeit medications have been a significant contributor to the increase of drug resistant strains and are a considerable factor in the deaths of hundreds of thousands across the globe. In these incidents, unscrupulous counterfeiters manufacturer medications with just enough of the active ingredient to fool rudimentary testing devices. These counterfeit medications are more than just worthless, they actually facilitate drug resistant strains of the illness.

This begs the question of the correlation and impact on counterfeit drugs to the emergence of drug resistant strains of the H1N1 virus.

Are counterfeit medications contributing to drug resistant strains of the H1N1 virus?

XStream Systems encourages all drug regulatory agencies to utilize robust screening methods in the testing of all medications within the pharmaceutical supply chain. XStream's XT250 allows the end users to deploy as system within the supply chain and materially screen products for active ingredients, excepients and packaging, non-destructively, within its sealed unit-of-sale container.

To learn more about the XT250, visit XStream at: http://www.xstreamsystems.net/.

Freightwatch International: July 2009 Pharma Cargo Thefts

FreightWatch International (USA), an international logistics security company, whose expertise is in identifying threats and vulnerabilities to high-value supply and distribution chains, publishes a monthly Cargo Theft Report that contains some very interesting statistics and observations.

The July 2009 Cargo Theft Report is available on-line and outlines statistics and vulnerabilities of various supply chains, specifically reporting on pharmaceutical cargo theft incidents. In the July 2009 Report they list four Pharma cargo theft incidents worth tens of millions of dollars:

• July 4th in Breezewood, Pennsylvania a cargo theft of pharmaceutical healthcare products worth $262,000.


• July 9th in Forest Park, Georgia a cargo theft of pharmaceuticals worth in excess of $10,000,000.


• July 29th in Plainville, Connecticut a cargo theft of pharmaceutical products of an unreported value.


• July 30th in Effingham, Illinois a cargo theft of baby formula products of an unreported value.

XStream Systems encourages all within the pharmaceutical supply chain to verify and authenticate the products that they receive from all sources. XStream System’s solution of non-destructive screening of products within their sealed unit of sale containers protects inventories from nefarious sources of supply.

To view the entire July 2009 report visit Freightwatch’s website at: www.freightwatchusa.com

Using Scientific Tools in an International War on Fake Drugs

The July 20th edition of the New York Times published an excellent article written by Thomas Fuller about using mass spectrometers and other forensic laboratory technologies to identify and interdict fraudulent and counterfeit medications.

The article is an excellent source of information on counterfeit drugs and the efforts to use authentication technology as an effective tool in finding and securing international pharmaceutical supply chain.

Laboratory instruments are an excellent resource in gaining granular and exact information on suspect materials and fake medications.

XStream’s XT250 Material Identification solution like these laboratory technologies has proven to be an effective tool in identifying fake medication but has been developed to be deployed within the supply chain and used by a non-technical resource for instant and exact information on suspected product. The XT250 does not require the destruction of the material and allows the testing of the material inside its sealed unit-of-sale container so that material found to be good can remain in the supply chain and go onto the consumer. To find out more about XStream’s revolutionary technology visit our website at www.xstreamsystems.net.

XStream endorses all technologies used in the fight against counterfeit drugs because we realize that there is no one solution to protect the vital health care supply chain.
To read the Thomas Fuller’s article please follow the link:

http://www.nytimes.com/2009/07/21/science/21coun.htl?pagewanted=1&_r=1&emc=eta1

Why We Need A Suite of Solutions To Secure the Pharmaceutical Supply Chain — Now!

By: Alan Clock, Senior Vice President, XStream Systems

Gary Noon the CEO of Aegate, argues the case for mass serialization in an editorial titled “Why We Need Mass Serialization – Now!” which appeared in the June issue of Pharmacy Technology Europe. In this article, Noon explains why point of dispensing drug authentication is not only a guarantee of medicine integrity, but also a beneficial and cost-effective solution for the pharmaceutical industry.


Noon cites many compelling statistics in his piece, most of these are statistics are centered on the European medication supply chain but their points are global:

• Approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year — in other words; one pack in every 20,000 is counterfeit.
• Between now and 2020, the spread of counterfeit drugs is estimated to rise to either an 'optimistic' 19.5 million or a pessimistic 192 million packs in the legal supply chain.

Noon also correctly points out the danger of products that hit the legitimate market and the costs:

• In 2005, 2,500 packets of fake Lipitor, Pfizer's widely used anti-cholesterol medicine, were believed to have entered the UK market. Research by Frost & Sullivan estimates that fewer than 15% of the packs were recovered. Aside from the potential danger to patients this inability to effectively recall drugs poses, the damage to the reputations of individual manufacturers and to the industry as a whole is vast.
• According to the EU Commission consultation on combating counterfeiting medicines for human use, released in December 2008, the annual direct and indirect societal costs of counterfeiting are approximately €950 million. The overall costs of inaction will reach €9.5 billion–€116 billion by 2020, and this does not take into account the intangible yet significant damage to brand reputation and trust.

After Noon points out the compelling need for a solution, he leaps to the assumption that the only solution for this problem is via mass serialization of the supply chain. Basically he asserts that only a complex serialization solution from manufacturer to dispenser, which according to the an EU Commission consultant would result in staggering set up and annual costs across the supply chain, is the best and only way to secure the Pharmaceutical Supply Chain:

• An industry wide one- time cost of €11.5 billion to set up the proper systems within all members of the supply chain in Europe alone.
• Annual “running costs” for serialization with European companies to be €185.5 million for non-OTC companies. There were no estimates of costs associated to OTC companies.
• EU pharmacies would incur costs of installing the right IT and reading devices to support serialization estimated to be €157 million. Noon offered no estimates on the annual costs of running this the system.

We at XStream take a different view, frankly it doesn’t matter with what currency or market that you are serializing, Euros or Dollars, the costs are astronomical, very unrealistic given the current global economic malaise and the solution is so complex to implement it is very unlikely to impact the problem. Additionally it doesn't seem a stretch to make the point that the estimated costs are overly optimistic and and he is only referencing Europe.

What Noon does not factor in or discuss in this piece are the basic realities necessary to make serialization work:

• Mass serialization requires that each member of the supply chain be perfectly in synch, every link in the chain and each company has to be in a virtual daisy chain process to make it work.
• Each member's system and technology has to work seamlessly to process and communicate the serialization throughout the chain.
• Although Noon makes this serialization synchonization sound simple and seemingly downplays the costs, practically it would prove to be nearly as impossible to globally integrate and effective as herding cats.

In any industry there is little hope that an entire supply chain could be efficiently managed, globally integrated and synchronized across the spectrum without significant effort and coordination. Mass serialization would require massive regulatory mandates, huge cost overruns in the billions (Euros and Dollars) and many years of significant legal arm twisting across multiple borders.

Even if, by chance, the supply chain was all properly serialized, integrated, managed and set up, all it would take would be one link failing in this “daisy chain” even temporarily for the entire system to fall apart.

Bottom line one single failure and the multiple billions in Euros or Dollars becomes wasted and the security and efficacy of the product in doubt.

Although we see limited merit in serialization, where we differ from Noon is that we realize, as most who have studied the issue of global pharmaceutical counterfeiting, is that there is no one single technology or solution to the problem.

Even though there is no technology or singular solution that can offer comprehensive protection from raw materials to dispensing and ultimately consumption by the consumer; it is a battle that all within the pharmaceutical supply chain should join in to solve.

Serialization, like other Track and Trace solutions such as RFID, Pedigrees and Bar Codes has its place and uses and we believe can and should be a part of any sophisticated supply chain. But in order to properly protect the supply chain and the consumer comprehensively, a system and process of screening the actual product, not just the transaction or package, is necessary to eliminate fraudulent and counterfeit medications.

In recent memory there have been a variety of fraudulent and counterfeit medications that have passed through the global pharmaceutical supply chain, in most cases nearly all would have passed a pedigree, packaging tag or serial code but their contents impacted the health of those who consumed it.

Analytical screening throughout the process takes away the “daisy chain” effect which mandates and requires participation by all to be effective. By using technology like EDXRD, XStream’s XT250 can screen and validate the medication inside its sealed container, creating an instant pedigree while authenticating the medication inside the package is efficacious.

Screening and authentication technologies do not require complex integrations and can be deployed anywhere within the supply chain to validate the safety of the inventories on hand. Additionally screening solutions, at the point of dispense, can assist providers from averting medication and dispensing errors. The cost of implementing screening solutions would be a fraction of a mass serialization solution and could be deployed almost immediately.

Overall, we are not completely dismissing Mr. Noon’s point as it relates to the need for a solution; we do however take exception to his conclusion that Serialization is the only answer. XStream Systems believes that governments and industry need to deploy a variety of tactics and technology to defeat fraudulent and counterfeit medications and we do not believe that it will requires tens of billions of Euros or Dollars to begin the process. XStream suggests that each member of the supply chain needs to understand their place and responsibility within the chain and deploy the proper tools to secure it so that we can all have faith that the medications we supply and consume are safe.

XStream's XT250 System Verifies WHO Figure for Counterfeit Drugs in U.S.

Based on XStream Systems' usage data from end user XT250 systems, they can verify that the World Health Organization’s (WHO) estimate of 1% of the United States pharmaceutical supply chain being counterfeit, is accurate.

XStream System’s XT250 Materials Identification System verifies and authenticates materials within its sealed, unit of sale container. The standalone system is currently deployed in several pharmaceutical distribution companies that distribute pharmaceuticals throughout the United States.

“Based on our macro look at the data from the end user, we can confirm that the WHO estimates are reasonably accurate”, stated Alan Clock, Senior Vice President at XStream. “Our system is the only technology that can accurately authenticate pharmaceuticals within the supply chain without destroying the product or packaging so we have excellent visibility on what is going on literally inside the supply chain .”

“The XT250 is the only materials analysis technology that can keep up with the tremendous flow of drugs throughout the supply chain. We are seeing data that suggest between 0.67% and 1.4% of receivables and returns within these pharmaceutical distributor end users are likely counterfeit products or fraudulent medications,” explained Mr. Clock.

From the data, XStream is learning that authentication rejection/failure rates vary between pharmaceutical products, and even within a given pharmaceutical product the rejection rates can vary significantly over time. In some cases isolated bottles have been rejected, while in other cases entire lots have been rejected. “You can’t predict when the counterfeits will show up,” said Mr. Clock.

XStream’s data validates that the members of the pharmaceutical supply chain (manufacturers, distributors and dispensers) should be using authentication technology more and taking steps to screen as many pharmaceuticals as possible, as often as possible. Currently many regulatory officials have been advocating more frequent inspections at foreign manufacturing facilities as the primary solution to the problem of poor manufacturing and counterfeit medications in the supply chain. While inspections are needed, given the sheer quantity of places to inspect and global nature of these sites, inspectors have little chance of catching counterfeits. In addition, XStream’s data suggests that counterfeits are inserted at a multitude of sources all along the supply chain. The point of production is not the primary starting point for fake medications. Verification and authentication at each point along the supply chain is the most effective way to detect and interdict fraudulent and counterfeit pharmaceuticals.

“The good news is that the United States is one of the last of the developed countries to see an increase in counterfeit medications. The United Kingdom has already seen an increase in the last three years and it stands to reason it will not be long till we see significant increases domestically as well. Because of this impending proliferation, the XT250 is essential for the protection of the consumer since it is one of the only tools available which can act as a roadblock to counterfeiters.”, said Mr. Clock.

SecuringPharma – a New Counterfeit Drugs News Site Launched

Recently, SecuringPharma.com, a new free-to-access information service that covers the issues surrounding supply chain and brand security in the pharmaceutical industry went live. SecuringPharma.com provides practical advice and intelligence to help manufacturers define and pursue their own strategies for tackling the problem of counterfeit drugs and supply chain security.

XStream Systems, in an ongoing effort to provide our readers with the latest news regarding counterfeit drug issues, have included a link to this resource for your convenience under “Other Sites of Interest”.

Also included in this listing is another website, KnockoffReport.com. This site is dedicated to an overview of all counterfeiting and IP violation issues as well as counterfeit drugs.

We believe our readers will find these sites helpful and look forward to adding additional links in the future to help keep you informed on all the pharmaceutical security news.

When, Not If, a Major Pharmaceutical Counterfeit Incident Will Impact the US Supply Chain In 2009

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

As I have traveled around the country speaking with many pharmaceutical industry and supply chain thought leaders in 2008, it seems apparent to me that all those in the know realize that the United States will shortly be facing a major health care crisis caused by the introduction of large amounts of counterfeit pharmaceuticals into the supply chain.

The question among these leaders is not if, but when.

I am predicting something in 2009. And it won’t be something as subtle as the counterfeit heparin which officially wasn’t a counterfeit, but poor manufacturing process caused by counterfeit raw materials. The number of casualties will go well beyond the 250 or so officially considered killed by the bad heparin. I am guessing we in the United States will be dealing with something that will affect thousands of lives this time. Unfortunately this incident or number of incidents, will force many within the industry and regulatory agencies to finally act aggressively and begin doing things that will actually solve the problem.

Just for the record, I consider counterfeit raw materials a counterfeit and officially labeling it otherwise does not make the consequences any less deadly. I don’t believe officials will be able to pass the next incident off as bad manufacturing practices, because likely it will not be quite as subtle.

I don’t like to predict doom and gloom, but my outlook for this healthcare issue is based on some pretty significant evidence that points me to this ultimate conclusion.

• The continued rise in the estimated counterfeit percentage of the supply chain globally. Most experts believe that globally, in third world and developing countries that up to 50% of the medication within their supply chain is counterfeit or adulterated.

• The rise in percentage of counterfeit and adulterated medications in the supply chain in non-third world countries. Some European countries estimate averages above and beyond 10% of the medications within their supply chain are counterfeit or adulterated.

• The fact that over 90% of the raw materials and 60% of the production of medication globally (including Europe and the United States) is now done in countries with some of the highest rates of counterfeit medications within their supply chain.

• High death rates in Africa and Asia based on either the consumption of counterfeit or adulterated medications or diseases like malaria which were not properly treated because of counterfeit or adulterated drugs.

• The FDA hastily opening three major field offices in China and the deployment of thousands of inspectors overseas in an overt but questionable effort to somehow police hundreds of thousands manufacturers and suppliers importing billions of tons products into the United States into hundreds of ports of entry.

• The fact that nearly every major pharmaceutical manufacturer and pharmaceutical distributor in the United States has had to deal with significant liability because of a counterfeit or adulterated medication within their brand or distributed through their companies. The reality is though even after spending millions in attorneys, court cases and settlements there is still not a significant deterrent or protection of their inventories, in fact now given the increased globalization these same entities are in fact more vulnerable now than they were ten years ago.

• The global economy as it continues its slide will continue to fuel individuals and well financed organizations to continue their harmful but profitable enterprises of counterfeiting medications.

• Finally and of most significance to me is the fact that when XStream deployed an XT250 system within a small secondary distributor in the Southeast United States, our system discovered four individual counterfeit medications within the first sixty days of authenticating their inventory.

There are many more “signs” or evidence that I could point to but I think that I have made my point. This is one of those "perfect storm" issues where all of the elements of a significant disaster seem headed for a major collision and the United States consumer is the tiny boat hoping to stay afloat and above water.

I hope I am wrong, but unfortunately, I know I am right. Maybe not about the exact date but now it is a matter of when, not if.

About the author: Alan Clock is a veteran of over 20 years within the pharmaceutical industry. He has served in senior positions with pharmaceutical distribution companies and disease management organizations. He is currently the Senior Vice President of XStream Systems, a high tech start up focused on a revolutionary solution to the authentication of pharmaceutical products within their sealed unit of sale. He can be reached at aclock@xstreamsystems.net. For more information on XStream visit their website at www.xstreamsystem.net.

XStream Systems Stories and News for the Week of November 28, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the safety of our supply chain. Recent incidents such as the adulteration of heparin and the discovery of melamine in baby formula have heightened consumer’s awareness of safety risks to our food and drug supply.

U.S. pays millions for unapproved drugs
The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s.

Republican Lawmaker Asks GAO to Review FDA Handling of Heparin
The FDA may not have used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities, according to a Republican congressman. “Based on the available information … there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths,” Rep. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, says in a letter to the Government Accountability Office (GAO).

FDA Finds Melamine Traces In U.S. Infant Formula
Bloomberg News reported that the industrial chemical melamine was found in U.S. infant formula in trace amounts that pose no health concern, according to FDA. Since September, some 50,000 children in China were sickened by melamine-tainted milk and several died.

We at XStream Systems believe that molecular pharmaceutical authentication will play a major role in the coming years to protect us from contaminated, adulterated and counterfeit products. To learn more about how this can be done, please visit www.xstreamsytems.net.

Will the FDA’s China Office Protect US Consumers?

The Washington Post, New York Times, Bloomberg News and a variety of other media outlets all have stories today announcing the Food and Drug Administration (FDA) deploying staff and opening its first office in Beijing, China.

This is the FDA’s reaction to China’s increasing role as a major exporter to the United States in food, drug and consumer products. Unfortunately China is also the world leader in exporting counterfeit, adulterated and contaminated products and the FDA is attempting to slow down the dangerous impact to US consumers. Recent high profile examples of counterfeit, adulterated and contaminated products include the recent heparin contamination which resulted in over 250 deaths in the US, the pet food contamination with melamine and the huge issue over lead paint on children’s toys. Most experts agree that these examples of toxic products within our consumer supply chain represent only a fraction of the dangerous products that are reaching our shores on a daily basis.

Apparently the FDA has plans this year to open up other offices throughout China and certify third-party inspectors who can approve and qualify the safety of exports to the United States.

The question is when will the FDA deploy a materials analysis technology that can look inside product packaging to inspect and protect the US consumer instead of throwing bodies at a high expense to attempt to catch the problem before it gets into our supply chain?

Stay tuned, we at XStream Systems are trying our best to introduce our revolutionary technology as a solution to catching the problem before it impacts our nations health.

Weekend News Highlights International Epidemic of Counterfeit Medications

XStream Systems found an op-ed article in the New York Times regarding the health epidemic in the third world regarding poor quality and counterfeit medications and a story reported by Bloomberg News about the seizure of millions in counterfeit malaria, HIV and tuberculosis drugs in SE Asia.

The phenomenon of counterfeit, adulterated and contaminated pharmaceuticals continues to grow and flourish as our global economy declines.

Until technology solutions such as XStream’s XT250 become ubiquitous, this malady will continue to proliferate and impact those beyond the third world.

Op-ed: More needs to be done to ensure safety, quality of drugs in the developing world.

In an op-ed in the New York Times (11/15, A21), Roger Bate, author, director of the health advocacy group Africa Fighting Malaria, and resident fellow at the American Enterprise Institute, wrote that, "if aid organizations are serious about combating the spread of deadly diseases in the developing world, they must do more to ensure the safety and quality of drugs."

According to Bate, the importations of counterfeit medicines "are only part of the problem." Bate explained that in order "deal with the scarcity of drugs, many poor governments have turned to local production." Still, "local producers often make low-quality" medicines. "Many poor countries," he wrote, "lack the regulatory structure needed to monitor safety and effectiveness. Some do not even have laws against selling substandard drugs, and none have sophisticated agencies like the" Food and Drug Administration (FDA).

Bate concluded that aid organizations must first "give technical and financial support to governments' sincere efforts to maintain strict drug inspection standards." Second, they should "always refuse to subsidize any low-quality drugs." And finally, organizations need to "insist that only brand-name and generic products approved by stringent drug agencies like the FDA be distributed."


Interpol seizes more than $6.65 million of counterfeit medicines in Southeast Asia.

Bloomberg News (11/17, Bennett) reports, "Interpol seized more than $6.65 million of counterfeit medicines against malaria, HIV, and tuberculosis in Southeast Asia and made 27 arrests, disrupting the region's fake drug trade for the second time in three years."

According to Aline Plancon, an officer involved in the "five-month investigation called Operation Storm," officials "seized more than 16 million pills, including fake antibiotics for pneumonia and child-related illnesses." Operation Storm "involved almost 200 raids" conducted across "Cambodia, China, Laos, Myanmar, Singapore, Thailand, and Vietnam."

Health officials were particularly concerned by "copies of a class of malaria drugs called artemisinins." Fake "artemisinin-based treatments containing small amounts of the medicine are helping the parasite responsible for malaria to evade authentic drugs in patients near Cambodia's border with Thailand, a recent study showed."

Government Seizes Contaminated Heparin STILL in the US Supply Chain?

In a news report, the Federal Agents seized contaminated Heparin a full seven months following the recall. Read the full story.

It seems shocking that after confirmed deaths of over 250 people that this type of product would still be in the domestic supply chain. “I think that this is an illustration of how many gaps that remain in the process and the system that leaves the US consumer at risk,” stated Alan Clock, SVP of XStream Systems. “Those within the supply chain that believe that they are not vulnerable or that the burden of product safety lay elsewhere are in for a rude awakening when not if the next counterfeit or adulterated products hit their warehouse or store shelves.”

To learn more about XStream Systems revolutionary materials analysis solution to counterfeit, contaminated or adulterated products please visit us at www.xstreamsystems.net.