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/.

KV to Shut Down Ethex

According to published reports from Bloomberg News, the Associated Press and the St. Louis Post Dispatch, KV Pharmaceuticals has reached an agreement with the U.S. Department of Justice regarding an investigation into Ethex Corp, its generic pharmaceutical marketing and distribution subsidiary.

KV Pharmaceutical must pay $27.6 million in fines and an administrative forfeiture to cover costs of the investigation. Additionally KV plans on ceasing operation of its Ethex generic drug business.

This agreement comes after Ethex plead guilty to criminal charges for not disclosing issues with two to its drugs.

The agreement with the U.S. Attorney and the Department of Justice is subject to court approval and revolves around the 2008 investigation into Ethex which halted production and recalled drugs after making oversized tablets.

Specifically Ethex plans to plead guilty to two felony counts of failure in 2008 to file field alerts for the generic drugs Dextroamphetamine and Propafenone.

These incidents of substandard medications were significant and could have adversely affected the health of many consumers. Had material screening been in place within the supply chain, these substandard materials would have been intercepted prior to them reaching a dispenser and ultimately the consumer.

To learn more about material screening solutions within the pharmaceutical supply chain, 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.

RxPatrol Alert: Drug Cargo Theft in Puerto Rico

RxPatrol has reported about a recent pharmaceutical cargo theft that occurred on January 29th in Bayamon, Puerto Rico.

An unmarked truck and driver was high jacked at gun point near an industrial area and taken to a different town and put out of the vehicle. Ultimately the truck was left nearby and was recovered without the shipment.

The high jacked shipment was a delivery of drugs valued at $516,412 that was being shipped from Cesar Castillo to Borshow Drug. The items were the property of Sanofi Aventis

The stolen drugs included:
• 48 bottles of 100 ct. Ambien CR Tablets 6.25mg.
• 1,000 units of Lantus injection Vials

According to RxPatrol, for further information, law enforcement and other interested parties should contact the Puerto Rico Police, Detective Edward Rodriguez assigned, phone # 787-269-2030 or 787-269-4140. Incident # 2010-232-593.

Douglas Liptak is the security contact for Sanofi Aventis, phone # 908-981-4510

To learn more about RxPatrol and its various reports on pharmaceutical safety, visit: http://www.rxpatrol.com/

To learn more about pharmaceutical supply chain safety technology, visit: http://www.xstreamsystems.net/.

Interpol: Counterfeit Hotspots

The map above created by Interpol, shows by color code, the countries and continents and the severity of the issue of counterfeit activity within that area. Interpol labels this map as Global Counterfeiting Hotspots.

The color codes are red for severe, yellow for serious and green for significant.

This map shows counterfeiting activity in general but even with that clearly Asia and Middle East seem to dominate the areas that Interpol considers serious.

As it relates to drug counterfeiting, the World Health Organization estimates that the global market place for fake drugs will exceed $75 billion in 2010 and with a growth rate of 12-16%. If Interpol were to make a map exclusive to drug counterfeiting, it would be likely that there would be many more reds and yellows and less green..

To find out more about anti-counterfeiting solutions for the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

Newsweek: Food Fraud $49 Billion A Year Industry

Secure Pharma Chain Blog routinely reports on pharmaceutical counterfeits and product fraud. This blog post touches on another huge consumer issue, food counterfeiting. The following is an excerpt on a recent article in Newsweek.

Jeneen Interlandi writes an extremely pertinent and interesting article on the counterfeit food industry which appeared in the February 8th online edition of Newsweek.

This story chronicles the issue, its history and ongoing efforts to combat this $49 billion dollar a year crime. Interestingly, if you combine the food and pharmaceutical counterfeiting industries they represent overall a $124 billion annual threat to industry, supply chains and consumers around the globe.

Here are some interesting pieces from the Newsweek article:

· When the FBI dubbed counterfeiting “the crime of the 21st century” they weren't just talking about Prada handbags and Rolex watches. The counterfeit food industry is worth about $49 billion a year, according to the World Customs Institute, and it involves everything from fine food to boxed fruit juice. "Products are moving around the world so fast now that there is just ample opportunity," says John Spink, a food-fraud expert at Michigan State University. "And the demand for inexpensive food virtually guarantees that the problem will persist and grow."
· Food fraud, which typically means the intentional adulteration of food with cheaper ingredients for economic gain, has a long, fascinating history in both the U.S. and Europe, as documented in the excellent book Swindled: The Dark History of Food Fraud, from Poisoned Candy to Counterfeit Coffee. But because such fraud occupies an awkward gap between food safety (which deals with accidental food contamination) and food defense or bioterrorism (which deals with intentional corruption of the food supply by terrorist groups), it hasn't received much attention.
· In 2008, Chinese officials reported that milk adulterated with melamine—a chemical that makes the milk appear to have higher protein content—caused 900 infants to be hospitalized for kidney problems. When six of those babies died, a media firestorm shone a spotlight on food fraud in China and touched off a wave of panic in the United States.

As reported on repeatedly in Secure Pharma Chain Blog, adulterated, fraudulent and counterfeit products continue to proliferate and now constitute a significant threat to industry, commerce and the health and welfare of consumers everywhere. This threat demands solutions that require technologies, regulation and enforcement across the globe to protect us all. The greatest fear is that this threat will grow beyond a criminal act and evolve into an issue of national health and security.

To read the Newsweek article, visit: http://www.newsweek.com/id/233253.

To learn more about robust anti-counterfeit technologies, visit: http://www.xstreamsystems.net/.

Three Lebanese Pharmacies Closed for Selling Counterfeit Drugs

The following story is another example of the growth of the problem of fraudulent, adulterated and counterfeit drugs in the Middle East and the most recent efforts within the region by government authorities to protect their populations from this deadly issue.

This kind of action, as related in the story, is becoming all too commonplace within the Middle East and around the globe as government regulatory agencies are now beginning to respond to the issue of counterfeit medications which is impacting the health and welfare of consumers everywhere.

The February 17th edition of the Lebanese newspaper, Daily Star, report on three pharmacies being shut down in Lebanon for selling counterfeit drugs. The article was written by Carol Rizk.

The closing of the three pharmacies is in response to a Lebanese judicial decision to shut down all outlets selling counterfeit drugs.

In addition the overall issue of counterfeit drugs is prompting talks with Prime Minister Saad Hariri and the head of the Pharmacists Union Ziad Nassour.

According to the Daily Star:

• A security source told The Daily Star that it was yet to be determined whether the pharmacies were closed permanently or temporarily. The sources said the pharmacies would be reprimanded if they do not abide by the closure period mentioned in the judicial decision. “They form part of a whole network of pharmacies [which deal with counterfeit drugs],” the sources added.
• The Health Ministry had closed down in January nine pharmacies and four medical supplies warehouses for their alleged involvement in the smuggling and sale of counterfeit drugs.
• The medication mainly concerned is a counterfeit version of the drug Plavix, a type of heart medication designed to keep blood platelets from coagulating. It was discovered in one of the pharmacies and was believed to have been manufactured abroad and brought into the country illegally through China and Dubai.
• On Tuesday, the head of Pharmacists Union asked the prime minister to “relentlessly” pursue the matter and to forbid any politician from protecting those involved.
• He said that practical measures are to be taken on Wednesday and hoped that one day he would see a “Lebanon clean from counterfeit medicines.”
• He (Nassour) also stressed on applying the Health Ministry’s decision number 1/29 that mentioned the need to follow the course of any drug from warehouses to pharmacies and hospitals and finally to the patient or client.
• Sukarieh doubted that the entire stocks of the drug had been removed from the market and recalled a similar incident two years ago when 13 hospitals were involved in counterfeit drugs for cancer and AIDS. But he noted that the case was handled discretely and that the hospitals were still open.

Although many countries have laws and regulations in place, most have little resources to effectively police and punish individuals and entities from perpetrating this often life threatening crime.

Secure Pharma Chain Blog and XStream Systems encourages all public authorities and private members of the pharmaceutical supply chain to take aggressive actions in both pursuing perpetrators who deal in counterfeit medications and in securing the supply chain. As continuously reported in this blog the impact of fraudulent, adulterated and counterfeit medications to the health of consumers and to the bottom line of business can fatal to both if not properly secured.

A comprehensive, multi-layered approach is encouraged, to properly protect all of the members of the supply chain and consumers from the impact of bogus drugs. To learn more about these solutions, visit: http://www.xstreamsystems.net/.

To read the entire Daily Star article, visit:
http://www.dailystar.com.lb/article.asp?edition_id=1&categ_id=1&article_id=111840.

WSJ: No Cure for Fake Drugs

The Wall Street Journal reported on Tuesday on an effort within Syria to reduce the use of counterfeit drugs as the problem continues to grow and remain widespread in the Middle East.

The action within Syria resulted in the seizure in millions of dollars worth of breast cancer, leukemia and other medicines, along with tens of thousands of anticoagulant pills used in treating heart attacks and other diseases.

Included in the seizure was a large amount of equipment used to make and package fake drugs. This particular action is expected to stop at least one organization’s lucrative trade of counterfeits to Iraq, Turkey, Lebanon, Iran and Egypt.

The following are some of the highlights of the story:

• Smuggling of drugs remains a widespread and dangerous problem. Figures from the World Health Organization show it can reach 35% of all drugs in the Middle East, compared to less than 1% in the U.S. and Western Europe. One confiscated shipment by the Syrian ring to Egypt contained counterfeit copies of one brand of a leukemia drugs with a street value of over $4 million -- equivalent to 50% of the annual sales of the brand.


• Distributors not only sold the fake life-saving drugs to private pharmacies but also moved deep into the public health-care system, particularly in Iraq. A huge plastic bag seen amid the Damascus counterfeit haul contained hundreds of boxes of a treatment for mouth ulcers, all bearing the logo of the Iraqi health ministry, witnesses say.


• Authorities claim that the ring busted in Syria was the main one operating in that country. A pharmaceutical-company manager said it was the main network for Egypt as well, but others are still operating in other Middle-Eastern countries.


• One reason why drug counterfeiting has thrived in the Middle East is that authorities were unprepared for the sheer scale and sophistication of counterfeits and had neither the appropriate law enforcement framework nor the legislation to tackle them.


• "When we started the investigation, we had no idea of the scale of these counterfeit networks," the Syrian official said.


• A great proportion of the fake drugs smuggled by the network to Egypt and Syria came from China, according to Syrian Health Minister Reda Saed, sometime around 2007, the ring started making its own fake drugs, using technology mostly imported from China, the Syrian officials and the pharmaceutical-company managers said.

Secure Pharma Chain Blog, endorses a layered approach to pharmaceutical supply chain security to efficiently, economically and effectively secure the inventories of manufacturers, distributors and dispensers from fraudulent and counterfeit medications.

To read the Wall Street Journal story, visit: http://online.wsj.com/article/SB10001424052748704533204575047282075703998.html.html.

To learn more about an effective tool in combating counterfeit medications, visit: http://www.xstreamsystems.net/.

Western Europeans Spend $14.3B on Illicitly Sourced Meds

Ben Hirschler from Reuters reported on Monday that according to a Pfizer sponsored survey, Western Europeans spend an estimated $14.3 billion a year on illicitly sourced medicines, many of them counterfeit.

Some of the highlights from Hirschler’s report include:

• Germans and Italians buy the most prescription-only drugs without a prescription, either over the Internet or on overseas trips, in nightclubs, in shops and via friends.


• Counterfeit medicines often contain the wrong or even toxic ingredients and are a growing health threat worldwide, especially in poor countries, according to the World Health Organization.


• Outgoing European Union industry commissioner Guenter Verheugen said in December he was "extremely worried" about counterfeit medicines after 34 million fake tablets were seized at EU custom points in just two months.


• Jim Thomson, chairman of the European Alliance for Access to Safe Medicines, which receives funding from the drug industry, said tests by his group had shown that 62 percent of medicines purchased online were fake or substandard.


• Overall, 21 percent of 14,000 people surveyed in 14 states said they had bought medicines illicitly, with the rate ranging from 38 and 37 percent in Germany and Italy, respectively, to 12 and 10 percent in Britain and the Netherlands.


• Weight-loss medicines accounted for nearly half of all online purchases, followed by prescription treatments for flu, such as Roche's Tamiflu; pills for erectile dysfunction; quit-smoking drugs; and painkillers.

This issue of counterfeit, fraudulent and adulterated medications, which is causing a deadly healthcare crisis around the globe, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers everywhere.

To read the entire Reuters story, visit: http://www.reuters.com/article/idUSLDE61E16A20100216.

To learn more about medication counterfeit solutions, visit: http://www.xstreamsystems.net/.

Freightwatch International: January 2010 Cargo Theft Report

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released their monthly report on cargo theft for January 2010.

According to Freightwatch, following on the month of December 2009 where there were over 82 reported cargo thefts, the month of January recorded 64 reported cargo thefts.

By commodity FreightWatch recorded four thefts in the pharmaceutical sector.

The reported pharmaceutical thefts were a January 19th incident in Springfield, Michigan where over $500,000 of pharmaceuticals was stolen from a secured terminal lot. Two separate incidents in Colton, California that occurred on January 16th and the 19th involving an unknown value of pharmaceuticals. And a January 28th theft of pharmaceuticals in Newtown City, Illinois where an unknown amount of pharmaceutical products were stolen from a public access parking lot.

The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

To read the entire report from Freightwatch International, visit: http://www.freightwatchintl.com/.

To learn more about supply chain security solutions, visit: http://www.xstreamsystems.net/.

Medical High Jacking: Polish Police Recover 11 Tons of Stolen Plasma

Polish police announced that they have recovered 11 tons of human blood plasma that had been stolen from the U.S. Company BioLife Plasma Services, a collection facility owned by Baxter International. The plasma was on its way to Austria, officials said Thursday.

The stolen Blood Plasma was worth more than euro1 million ($1.4 million), and was taken while the driver made a rest stop in Germany.

The plasma was recovered in its original boxes originating from Harrisonburg, Virginia, where BioLife Plasma Services, has operations.

BioLife spokeswoman Laura Jacobs said the plasma had come from other facilities as well, but did not elaborate.

Jacobs said the company was working with local authorities to determine how the theft occurred. "Importantly, the plasma has been recovered and is currently in Baxter's Vienna facility," she said.

Plasma is a critical component used in the treatment of a wide range of medical procedures. Given that the product was stolen and has lost its official chain of custody it remains to be seen if all of the Blood Plasma would need to be destroyed due to potential issues of contamination and adulteration.

This particular incident, based on stolen but critical medical supplies, energizes the need for routine material screening of products within the supply chain, from manufacturing to dispensing, to properly protect consumers from fraud, adulteration, contamination and counterfeiting.

To learn more about supply chain material testing solutions, visit: http://www.xstreamsystems.net/.

Report Examines Adulteration, Counterfeiting of Products

The Grocery Manufacturers Association (GMA) and A.T. Kearny, very diligently lay out an excellent industry primer for the various members of the supply chain to learn about the impact and economics of adulteration and counterfeiting of products in a recently released study.


The report, Consumer Product Fraud: Deterrence and Detection, suggests that a shared library of ingredient data could reduce analytical costs and increase quality.

GMA and A.T. Kearny estimate the economic adulteration and counterfeiting of global food and consumer products is expected to cost their specific industry $10 to $15 billion a year.

Sales of counterfeit drugs world wide are estimated by the World Health Organization at reaching $75 billion in 2010.

According to the study, "the cost of one adulteration incident costs a company between 2% to 15% of its annual revenues depending upon the size of the company. This translates to $400 million to a $10 billion dollar company and $60 million to a smaller $500 million dollar a year company."

The GMA study obviously centers primarily on the food and consumer products industry but has relevance and great insight for nearly all industry supply chains as it relates to effective strategies and the economics on counterfeit products. Much can be taken by other consumer related industries, like Pharma, including relevant statistics.

Secure Pharma Chain Blog highly recommends that all members of the supply chain, manufacturers, distributors and dispensers read this report as an introduction into crafting tactics and policy towards dealing with fraudulent, adulterated and counterfeit products.

To read the report, visit: http://www.gmaonline.org/publications/consumerproductfraud.pdf.



To learn more about technologies and solutions that can effectively protect consumer product supply chains, visit: http://www.xstreamsystems.net/.

WHO: Poor Quality Drugs Used to Treat Malaria

Both the BBC and the Associated Press are reporting on a new World Health Organization study regarding the quality of drugs used to treat malaria in Africa.

The study goes into some depth regarding the findings that up to 40% of the artemisinin drugs used to treat malaria in poor African nations are of such poor quality they are ineffective in treating the disease. In addition because these poor quality drugs contain some of the active ingredient of the drugs, they are now causing drug resistant strains of malaria.

Here are some of the highlights from the BBC story:

• The group, conducting the study for the World Health Organization, said low-grade drugs were being used in both public and private health practices.



• Some 90% of malaria deaths in the world occur in Africa.



• They found 44% of the drugs from Senegal failed the testing, followed by 30% from Madagascar and 26% from Uganda.

To read the entire BBC story, visit: http://news.bbc.co.uk/2/hi/africa/8504137.stm

Some of the highlights of the Associate Press story which was published in the Chicago Tribune include:

• Between 16 percent and 40 percent of artemisinin-based drugs sold in Senegal, Madagascar and Uganda failed quality testing, including having impurities or not containing enough active ingredients, the survey found.


• Artemisinin-based drugs are the only affordable treatment for malaria left in the global medicine cabinet. Other drugs have already lost effectiveness due to resistance, which builds when not enough medicine is taken to kill all of the mosquito-transmitted parasites.



• If artemisinin-based drugs stop working, there is no good replacement and experts worry many people could die.


• "It is worrisome that almost all of the poor-quality data that was obtained was a result of inadequate amounts of active (ingredients) or the presence of impurities in the product," said Patrick Lukulay, director of a nongovernmental U.S. Pharmacopeia program funded by the U.S. government, which conducted the survey. "This is a disturbing trend that came to light."


• The study is the first part of a 10-country examination of anti-malarials in Africa by the U.S. and the World Health Organization. It follows evidence from the Thai-Cambodian border that artemisinin-based drugs there are taking longer to cure malaria patients, the first sign of drug resistance.


• The three-country report also found bad drugs in both the public and private health sectors, meaning governments — some buying medicines with donor funds — are not doing enough to keep poor-quality pills out. All of the drugs tested from the public sector in Uganda, however, passed the quality tests. But 40 percent of the artemisinin-based drugs in Senegal failed.


• "There are countries where donated medicines are not subjected to quality controls, they're just accepted," said Lukulay. "There are countries in Africa where Chinese products have been donated and found to be unacceptable later in the public sector."

To read the entire Associated Press story, visit: http://www.chicagotribune.com/health/sns-ap-med-africa-malaria-drugs,0,1354782.story.

This issue of counterfeit, fraudulent and adulterated medications, which is causing a deadly healthcare crisis around the globe, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers everywhere.

To learn more about material authentication solutions, visit: www.xstreamsystems.net.

FDA News: GSK Works With eBay to Stop Online Counterfeit Alli Sales

The following news release was posted online at FDANews.com:

GlaxoSmithKline (GSK) is working with eBay to remove online auctions of counterfeit Alli and inform consumers about potentially counterfeit product sold on similar websites.

eBay is removing auctions of the weight-loss drug Alli (orlistat) covered by the alert and asking sellers to review FDA communications to make sure they have legitimate Alli before relisting it for sale, Jack Christin Jr., eBay associate general counsel for government relations, said.

Pictures of counterfeit Alli samples of the packaging and product provided by GSK can be found at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm

To learn more about technologies that can verify drugs in their unit of sale container without degradation or destruction, visit: http://www.xstreamsystems.net/.

To read the entire FDANews news release, visit: http://www.fdanews.com/newsletter/article?articleId=124314&issueId=13409.

WSJ: U.S. Regulators Pressure Ranbaxy Over Factories

The Wall Street Journal in an article written by Rumman Ahmed and published in the February 8th edition, reports on the continued issues between the U.S. Food and Drug Administration and Ranbaxy Laboratories.

According to the story, the U.S. regulatory authority is accusing the drug maker of “an insufficient effort to meet manufacturing standards”.

U.S. sales, Ranbaxy’s biggest overseas markets have been depressed for more than a year because of manufacturing deficiencies at some of their plants.

This particular set of issues, based on substandard overseas manufacturing, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers from fraud, adulteration, contamination and counterfeit products.

To read the entire Wall Street Journal article, visit:
http://online.wsj.com/article/SB10001424052748704533204575046671948801274.html.html.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

The Counterfeiter

In an article that appeared in the February 1st edition of TheScientist.com online magazine, they highlight the stories and the overall themes and statistics of some of the more egregious examples of counterfeit fraud in recent years.

This excellent article highlights the necessity of supply chain solutions for the verification and authentication of pharmaceuticals in their unit of sale containers.

To read the article, visit: http://www.the-scientist.com/article/display/57108/

To learn more about supply chain counterfeit solutions, visit: http://www.xstreamsystems.net/.

Turkish Serialization Plan Delayed Yet Again

In a SecuringPharma.com online article written by Phil Taylor and Keribar Duman they document yet another delay in Turkey’s efforts to adopt a nationwide serialization coding system for pharmaceutical products.

According to the article, the further delay is a result of pharmacies still not having implemented the necessary technology for the process to begin.

Turkish authorities have pushed for the serialization due to widespread fraud in the reimbursement of medications, which is thought to cost the government over $150 million a year and as a deterrent to counterfeit and illegal drugs.

This is the third official delay of the ITS (Ilac Takip Sistemi) system. It was first set to launch on January 1, 2009, then July 1, 2009 and now the latest implementation date was at the start of 2010.

The ITS system was to employ a 2D datamatrix coding to medications that are either produced or imported into Turkey. According to the article the lack of implementation is the “ability and willingness in some cases-of pharmacies to implement and use the system for reading the codes”.

The Turkish Pharmacists Association has been instrumental in pushing authorities for extensions for the regulatory mandate and are on record as saying that issues with the ITS system make the process unworkable.

The inability of Turkey to implement this process in a timely and efficient manner exemplify the issue of a regulatory authority mandating a single approach to fraud, adulteration and counterfeit within a pharmaceutical supply chain. A serialized approach is totally dependent upon an entire system and process adopting an end to end “daisy chain” which is expensive and cumbersome to implement and maintain and relies on total compliance to become effective. Without 100% cooperation the process loses nearly its entire effectiveness and value.

Secure Pharma Chain Blog and XStream Systems; endorse a layered approach of material authentication, pedigree, overt and covert marker technology and ultimately serialization as the most effective way to efficiently, economically and effectively protect an entire supply chain. A multiple technology solution does not require absolute compliance to make it effective and valuable. In a layered technology approach, each solution provides specific protection which overlaps without creating added costs or onerous mandates.

To read Taylor and Duman’s article, visit: http://www.securingpharma.com/40/articles/366.php.

To learn more about efficient pharmaceutical supply chain technologies, visit: http://www.xstreamsystems.net/.

Counterfeit Medications: A Terrorist Threat

Officials fear toxic ingredient in Botox could become terrorist tool.

A recent Washington Post article chronicles a specific threat of counterfeit Botox being produced by organized criminal gangs and suspected ties to terrorist organizations.

The concern among many is that counterfeit medications could be used as a tool for terrorist organizations to have access to dangerous lethal material, have the ability to spread a toxic material to target consumers around the globe and be used as a profit making enterprise to fund their worldwide operations.

To view the Washington Post article, visit: http://www.washingtonpost.com/wp-dyn/content/article/2010/01/24/AR2010012403013.html?hpid=topnews

To learn more about pharmaceutical anti-counterfeiting technologies, visit:

www. xstreamsystems.net.

New York Times - Millions Disappear With Fake Technology

In probably one of the more creative and egregious examples of war profiteering in a war that has hundreds of examples of waste, corruption and excess, the New York Times writes about the now infamous ADE 651 "technology".

Basically the technology known as ADE 651, which is a hand-held wand, wielded by Iraq’s security teams at hundreds of checkpoints, is supposed to detect car bombs and weapons. However this technology which is a battery-free device — supposedly powered by the static electricity of a soldier’s body — turns out to be a very expensive hoax.

After widespread doubts, including warnings by American military officials who never used ADE 651's, Britain finally banned the devices’ export and arrested the manufacturer for fraud. But not before Iraq bought more than 800 wands, which cost $250 each to make but drew up to $60,000 each from the Baghdad government.

This boondoggle cost the Iraqi government $48 million, most of which probably came directly or indirectly from the US taxpayers.

The ridiculously obvious hoax is very frustrating to many within the technology sector who are developing very real and useful technologies that can be used in security, industrial and consumer applications.

The question is, how can such a crude and obviously fraudulent tool, fool an entire process, while very useful technologies, languish for years as they slog through a bureaucratic procurement process that seemingly rewards inaction over innovation?

Apparently greed and corruption in certain situations have little to impede their progress...

To read the New York Times Editorial, visit:

http://www.nytimes.com/2010/02/01/opinion/01mon4.html?th&emc=th


To learn more about a very real and effective technology that is being deployed around the globe that will protect millions, visit: http://www.xstreamsystems.net/.

WSJ: Cargo Theft Endangering Consumers

Heists Targeting Truckers On Rise-Robberies Are "Wreaking Havoc" on U.S. Highways, Endangering Consumers

The Wall Street Journal in an article written by Jennifer Levitz, explores in general the proliferation of cargo theft in general and its impact on supply chains and consumers.

You can access the article by visiting: http://online.wsj.com/article/SB10001424052748704722304575037241392821742.html

To view solutions that protect the supply chain from adulteration, contamination, fraud and counterfeiting, visit: www.xstreamsystems.net.

HealthDay: Fake Drugs Bought on the Web Pose Big Health Risks

2.5 million men in Europe alone may have taken counterfeit Viagra, study says.

Amanda Gardner from HealthDay makes another spin on the story about the International Journal of Clinical Practice report regarding the dangers of internet pharmacy purchases of prescription drugs which has been blogged on Secure Pharma Chain Blog earlier. This excellent story appears below:

FRIDAY, Jan. 29 (HealthDay News) -- People who buy prescription medications over the Internet, especially drugs purporting to treat erectile dysfunction, are playing Russian roulette with their lives, a new study contends.

At best the drugs won't help you and at worst they could kill you, the review article said.
"You may be wasting your money or you may actually be hurting yourself," said Dr. Margaret E. Wierman, professor of medicine at the University of Colorado at Denver and chief of endocrinology at the Denver VA Medical Center, who was not involved with the study.
Counterfeit Internet drugs are a mushrooming problem. Seizures of fake drugs in Europe quadrupled between 2005 and 2007. And the number of investigations undertaken by the U.S. Food and Drug Administration increased by a factor of eight between 2000 and 2006, according to the study, published in the International Journal of Clinical Practice.

The sale of counterfeit drugs has almost doubled in the last five years, and will hit $75 billion in 2010, according to one estimate, making it one of the more lucrative illicit drug markets.
As many as 2.5 million men in Europe may have taken counterfeit sildenafil (Viagra), the study authors stated.

"It's a very significant problem and I think there are people who are being injured," said Dr. Ira D. Sharlip, a spokesman for the American Urological Association and clinical professor of urology at the University of California, San Francisco. "The only way to avoid the problem is not to buy on the Internet."

Viagra-like tablets bought on the Internet aren't necessarily any cheaper than the real thing, but they do allow buyers to avoid the shame factor often associated with asking for this type of drug.
"The motivation is the anonymity of buying drugs on the Internet. It's embarrassing to some men to go to a pharmacy and pick up his Viagra prescription, and it's also embarrassing for some men to go to a doctor and say, 'I have erectile dysfunction. I need some Viagra,'" Sharlip said.
The problem of fake drugs isn't limited to impotence treatments.

According to the study, two pregnant women died after they were given injections of a counterfeit iron preparation for anemia, and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup that was contaminated with diethylene glycol, which is often used as antifreeze in cars.

So many things can go wrong with Internet purchases.

"The purity of the medication or the quality of the medication is under no sort of scrutiny or any type of oversight to determine if, first of all, it is the correct medication. And second, if it is correct is it in the correct dosage?" said Dr. Michael Chehval, chief of urology at St. Louis University.

Study author Dr. Graham Jackson, a cardiologist at London Bridge Hospital in the United Kingdom, said: "The first danger is people don't know what's in it. Some are just talcum powder or brick dust, while some have a bit of Viagra or Cialis and some chemicals that have nothing to do with it. One batch actually contained amphetamine, which is an addictive drug. Tablets are made shiny with road paint or shoe polish. The content of the medication could be anything."
In 2008, four men in Singapore died after ingesting counterfeit impotence drugs that had been contaminated with a blood-sugar-lowering agent, the study reported.

And bypassing the involvement of a competent doctor means red flags could be missed.
"Erection problems can be an early warning sign of heart disease or diabetes," Jackson said. "If you do have a problem and don't see a doctor, diagnosis of those important conditions can be missed. Men with no symptoms at all who get an erection problem usually are an average of three to five years away from a heart attack. Instead of going to the Internet, they should be going to their doctors to find out if they are at risk and to do something about it."

Problems also can occur when the impotence drugs actually do contain phosphodiesterase type 5 inhibitors (PDE5), the main ingredient in Viagra, as well as vardenafil (Levitra) and tadalafil (Cialis).

"People with underlying heart problems are at risk for cardiac events if they take this class of medication," Chehval said.

According to the review article, about one-third of men reported sidestepping a health-care professional when buying erectile dysfunction drugs.

"This is a really serious issue. We can fix the erectile dysfunction and we can also fix the chances of getting a heart attack," Jackson said.

Jackson is editor of the journal and reported multiple ties to pharmaceutical companies, including Pfizer, which makes Viagra. The review article covered more than fifty studies published between 1995 and 2009 and was conducted by British, Swedish and American researchers.

To read the story online, visit: http://healthday.com/Article.asp?AID=635386.

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

US Cargo Theft: A 2009 Review

A comprehensive report on Cargo Theft within the United States in 2009.

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, has published its 2009 review of cargo theft within the United States breaking it down by commodity type, date, locations, modus operandi and specific product.

This report, authored by Dan Burges summarizes the United States’ theft data base collected in 2009 and analyzes trends derived from database content, law enforcement information and industry personnel. It also examines observations by personnel in the field.

Here is some of the more interesting content from the report as it relates to pharmaceutical thefts, the complete report can be found at http://www.freightwatchusa.com/.

· In 2009, Freightwatch recorded an average of 72 cargo theft incidents per month, 859 theft incidents total, a 12% increase from 2008.

· By volume, pharmaceuticals represented 5% of the theft incidents in 2009 with 46 reported incidents. This was identical to the 2008 reported number.

· California, Florida and Texas topped the list of high-risk cargo theft states in 2009. Georgia, Illinois and Pennsylvania were in the second top tier of states for cargo theft.

· Even though pharmaceuticals only make up 5% of all cargo theft by volume, the average pharmaceutical theft was valued at $4 million. Even when eliminating the large $37 million theft in one incident in Pennsylvania in 2009, the average pharmaceuticals theft would value $2.5 million, easily surpassing the other commodity groups.

· According to Chuck Forsaith of the Pharma Cargo Security Coalition, his group recorded 16 cargo losses valued over $500,000 in 2008. Of those 16 losses, five were eventually recovered, representing 32% and $16 million. In 2009, his group recorded 15 losses valued at more than $500,000. Of those, there were 10 recoveries, representing 66% and $74.2 million.

To learn more about technologies that can be used by companies to authenticate and verify materials inside their unit of sale container without destruction or degradation visit http://www.xstreamsystems.net/.