WSJ: House Committee Investigation Faults FDA for Not Pursuing Heparin Contamination Leads

An April 30th Wall Street Journal article reports that the House Energy and Commerce Committee investigated and faulted the Food and Drug Administration for not pursuing “particular and plausible leads which could have fingered those responsible in China for playing a role in the contaminated heparin crisis two years ago.”

House members, Joe Barton (R-TX) and Mike Burgess (R-TX) sent a letter to the FDA in which they spelled out findings from the investigation, and said that the FDA has not pressed the government of China regarding Chinese companies involved.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703572504575214420823549694.html

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

RFID is Dead...

RFID is Dead…at Unit Level in Pharma or so says Dirk Rodgers, an industry veteran and active blogger.

Supported by excellent data, Mr. Rodgers in his opinion blog RxTrace.com posted a very good op/ed regarding RFID and its place within the pharmaceutical supply chain.

RFID technology originally developed as an inventory management tool was considered the panacea to the issue of fraudulent, adulterated and counterfeit medications by many industry insiders but their implementation and use as a solution has fallen short.

Bogus medications have now proliferated into a $75 billion annual worldwide criminal activity as the pharmaceutical supply chain has become more global.

In Mr. Rodgers' piece, he gives the historical perspective, graphs on costs, supply chain perspectives and insight into the reason that RFID has failed and will continue to fail as the ultimate solution within the supply chain.

Mr. Rodgers' concludes that RFID still has a place for use in bulk/case containers but feels that barcodes on individual units will ultimately become the norm because of costs.

Secure Pharma Chain Blog agrees in essence with Mr. Rodgers' case regarding RFID and barcodes. Ultimately we believe that tags, barcodes and other track and trace technologies are effective in what they do and that they are an import part but not the definitive solution to solving the issue of fraudulent, adulterated and counterfeit medications. Unfortunately these technologies only tell you information on the transaction and packaging.

What is most important in supply chain security is what is inside the box.

Secure Pharma Chain Blog believes in a multiple layered approach that includes transactional tracing but ultimately relies on material identification of the product to authenticate the product as it migrates throughout the supply chain.

To read Mr. Rodgers' entire blog, visit: http://www.rxtrace.com/2010/04/rfid-is-dead-at-unit-level-in-pharma.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+rxtrace%2Fvqly+%28RxTrace%29.

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

Canadian Gold Medal Paralympian Arrested for Counterfeit Drugs

The Globe and Mail are reporting on a story of the Gold Medal Skip or Captain of the 2010 Canadian Paralympics Curling Team being arrested in the United States on charges of trafficking in counterfeit drugs.

According to Washington State court records, Jim Armstrong of Richmond, BC was arrested in Blaine, Washington while trying to pick up a package of thousands of counterfeit Viagra and Cialis pills.

The court complaint, filed April 16, said Mr. Armstrong “caused the introduction into interstate commerce of a misbranded drug with intent to mislead or defraud.” It also alleges he was involved in the trafficking of these counterfeit drugs.

The issue of counterfeit drugs, its almost mainstream criminal activity and the threat to the healthcare of consumers worldwide encourages the need of all within the pharmaceutical supply chain to deploy solutions and technologies to combat this potentially deadly crime.

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

To read the entire Globe and Mail story, visit: http://www.theglobeandmail.com/news/national/british-columbia/paralympic-curling-skip-arrested-in-us-over-counterfeit-drugs/article1542641/

German Customs and the Economics of Pharmaceutical Counterfeiting

In an excellent piece by Phil Taylor in SecuringPharma.com he writes about an international operation headed by customs officers in Germany that is attempting to disrupt the trade in counterfeit medicines focusing primarily sales via the Internet.

According to the story this effort,” has notched up some notable successes in its first 18 months”.

The operation named Project Blue is specifically targeted at the illegal trade in pharmaceuticals and is being conducted by a 12-member team from German Customs, under the leadership of Sieghart Vosseler.

The highlights on Project Blue are:

· "The cooperation of the financial sector made this a unique operation, and was a major contributory factor towards the success of Project Blue," said Vosseler, who heads the Organized Crime Investigations unit at German Customs.
· Few people are aware of the hugely complicated network that is operating when they make a purchase using a credit card, and particularly the fact that the likes of Visa and MasterCard never actually touch the money that changes hands.
· "The credit card companies provide the network for payment, but the actual money is handled by independent companies known as acquirers," said Vosseler. He cited a case last May in which a German Internet pharmacy was raided and a large quantity of fake medicines were seized, including products mimicking Pfizer's erectile dysfunction product Viagra (sildenafil citrate). The ringleader of the operation was in fact a career criminal - a burglar - who had decided to swap over to counterfeit medicines as the risks were low and the rewards high. The Project Blue taskforce were able to follow the financial transactions of the ring - which involved shifting large quantities of money (around €3m) through seven separate countries, and freeze their bank accounts.
· A total of seven arrests were made in the operation, which resulted in the seizure of more than 172,000 medicine units and nearly €390,000 in cash, as well as the confiscation of around €700,000-worth of assets such as cars and property.

The most notable highlight of the story, aside from the specifics on Project Blue are the explanation from the German customs official, Mr. Vosseler, regarding the economics of pharmaceutical counterfeiting which is what makes it so financially attractive and driving its proliferation:

· "There is a lot of money in counterfeit medicines," commented Vosseler, at a recent IQPC conference in Amsterdam, the Netherlands.
· He cited a study carried out at the University of Bonn which looked at the profit which can be made when a criminal invests a €1,000 stake in counterfeit goods. For counterfeit money the return would be around €3,000 (on an investment of €1,000), rising to a little under €7,000 for a fake credit card (on an investment of €1,000). Counterfeiting software gives an even better return at around €100,000 profit (on an investment of €1,000), but all are eclipsed by fake pharmaceuticals with a whopping €500,000 return (on an investment of €1,000).

The story provides excellent insight into the international fight that pharmaceutical counterfeiting has become and the huge financial gains that is driving it.

Secure Pharma Chain Blog continues to highlight medication counterfeiting as one of the most dangerous forms of this criminal activity and encourages all within the pharmaceutical supply chains to deploy a variety of solutions and technologies in their efforts to protect the healthcare of the consumer.

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

To read the entire SecuringPharma.com story, visit: http://www.securingpharma.com/40/articles/455.php.

Taiwan’s Premier Stresses Determination to Fight Counterfeit Drugs

Focus Taiwan reported on statements from Taiwan’s Premier Wu Den-yih on April 15th regarding strengthening the crackdowns on counterfeit drugs and underground radio stations. Premier Wu stated that the recent actions were not meant to suppress freedom of speech or hurt the pharmaceutical industry, but to protect the public's health.

According to Focus Taiwan:

· Underground radio stations in Taiwan sometimes broadcast advertisements for fake or substandard medicine, and the premier issued a directive earlier this year asking authorities to report to him every week from April 1 on the progress of their crackdowns.
· From Jan. 1 to April 14, police discovered 65 cases involving the sale of unlicensed drugs and arrested eight suspects.
· Taiwan’s Department of Health (DOH) reported that from April 1 to April 13, local public health bureaus uncovered nine cases involving the possession of unlicensed medicine and handed out 13 fines. The bureaus also administered sanctions for 323 cases involving the illegal advertising of counterfeit medications and food products.
· Wu reiterated that it is the government's responsibility to eradicate the sale of unlicensed drugs and that every department should continue to work diligently toward that goal.

Secure Pharma Chain Blog continues to highlight medication counterfeiting as one of the most dangerous forms of this criminal activity and encourages all within the pharmaceutical supply chains to deploy a variety of solutions and technologies in their efforts to protect the healthcare of the consumer.

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

To read about the Focus Taiwan story, visit: http://focustaiwan.tw/ShowNews/WebNews_Detail.aspx?Type=aALL&ID=201004150019.

Smash and Grab Raid at Pharmaceutical Warehouse

Phil Taylor in a piece in SecuringPharma.com reports on a smash and grab raid of a pharmaceutical warehouse in British Columbia.

The Pharmaceutical Cargo Security Consortium has reported another pharmaceutical warehouse burglary at a wholesaler in Richmond, British Columbia, Canada.

The incident occurred on April 15 and resulted in the loss of around $40,000-worth of inventory, says the PCSC, which warned recently of an upsurge in suspicious activity around pharmaceutical facilities in the wake of the $76m raid on Eli Lilly's distribution facility in Enfield, Connecticut.

According to the report from PCSC, on April 15th, five individuals broke into the wholesaler’s warehouse lobby in a smash-and-grab raid in which they attacked the warehouse, cage and vault.

To read the SecuringPharma.com story online, visit: http://www.securingpharma.com/40/articles/451.php.

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.

As the value and prevalence increases, so too does the potential risk to consumers.

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

The Economist: The Spread of Counterfeiting, Knock-offs Catch On

Fake goods are proliferating, to the dismay of companies and governments, reports The Economist in a story that appeared in their March 4, 2010 edition.

The piece details the overall impact of counterfeiting in all marketplaces, its spread and impact to economies and consumers.

The impact of counterfeits hits everywhere, according to the article, “fake Porches and Ferraris zoom along the streets of China. A German bank has discovered an ersatz gold ingot made of tungsten in its reserves…NASA, America’s space agency, has even bought suspect materials.”

This story encapsulates how prevalent this criminal activity has become and that it not just a victimless crime of a bunch of knock-off purses or watches sold on the street corner.

Highlights of the article include:

· The OECD estimates that the international trade in counterfeit and pirated goods was worth around $250 billion in 2007. The International Anti-Counterfeiting Coalition (IACC), a lobby group, says the true figure is actually closer to $600 billion, because the OECD’s estimate does not include online piracy or counterfeits that are sold in the same country as they are made. Counterfeit goods make up 5-7% of world trade, according to the IACC.

· Several factors have contributed to the growth of counterfeiting in recent years. The shift of much of the world’s manufacturing to countries with poor protection of intellectual property has provided both the technology and the opportunity to make knock-offs. The internet in general and e-commerce sites like eBay in particular, have made it easier to distribute counterfeit goods. MarkMonitor, a firm that helps companies defend brands online, estimates that sales of counterfeit goods via the internet will reach $135 billion this year.

· The recession in the rich world may also have given a boost to counterfeit goods. Frederick Mostert of the Authentics Foundation, an anti-counterfeiting group, has noticed a “spike” in knock-offs this recession, as consumers short of money trade down from the real thing. Cost-cutting measures may also have made firms’ supply chains more vulnerable to counterfeit parts.

· Governments are also boosting their efforts to crack down on counterfeiting, which deprive them of tax revenue in addition to harming legitimate businesses. Counterfeiting and piracy cost G20 economies €62 billion ($85 billion) a year in lost taxes and higher spending on unemployment benefits, according to a study by Frontier Economics, a consultancy. For every dollar invested in the fight against counterfeiting in America, the government receives $5 in extra tax revenue, estimates the US Chamber of Commerce, a business lobby.

· In 2008 the value of fake goods seized at America’s borders increased by nearly 40% over the year before. It subsequently fell by 4% last year—far less than the 25% decline in imports overall. In Europe in 2008 customs services confiscated more than double the previous year’s haul of counterfeit goods.

· MarkMonitor raised the price of its online brand-protection service by 18% last year because demand was so high. America’s biggest firms spend $2m-4m a year to combat counterfeiting on average—a figure that is growing along with internet shopping.

· In China, where 80% of the world’s fake goods are thought to be produced, officials are loth to crack down on a thriving local business.

Secure Pharma Chain Blog continues to highlight medication counterfeiting as one of the most dangerous forms of this criminal activity and encourages all within the pharmaceutical supply chains to deploy a variety of solutions and technologies in their efforts to protect the healthcare of the consumer.

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

To read this excellent article which appeared in the March 4th edition of The Economist, visit: http://www.economist.com/.

WSJ: Ranbaxy Recalls Antibiotic in U.S.

The Wall Street Journal Thursday reported that Ranbaxy Laboratories, Ltd voluntarily recalled two lots of it oral antibiotic for ear, nose and throat infections.

The recall follows complaints by U.S. consumers that the antibiotic turned brown when reconstituted instead of its proper color, white. According to the FDA, this is a class II recall which indicates that the recalled antibiotic is not expected to cause health problems.

As stated in the previous blog, regarding an FDA warning letter to Apotex, Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

To view the Wall Street Journal story, visit: http://online.wsj.com/article/SB10001424052702303950104575185290784049982.html.html.

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

FDA Issues Second Warning Letter to Apotex

The Food and Drug Administration has posted on their website a March 29th warning letter to Apotex, Canada’s biggest drug company citing lapses that included charred particles in a diabetes drug, contamination of an antihistamine and a drug cross-contamination that resulted from inadequate cleaning of manufacturing equipment.

The FDA letter also claims that Apotex had failed to notify regulators in a timely fashion about such problems.

This is the second warning letter by the FDA to Apotex is less than a year which is highly unusual for the agency.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

The New York Times has an excellent article about this FDA letter, written by Natasha Singer and published on April 15th.

To view this article, visit: http://www.nytimes.com/2010/04/16/business/16generic.html.

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

FreightWatch International: March 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 March 2010.

FreightWatch recorded a 13% decrease in North American cargo theft from February to March.

Of the 65 recorded thefts in March, the highest frequencies were seen in California, Texas, Florida, and the York region of Ontario with 20, seven, six, and five reported theft incidents, respectively.

By commodity, pharmaceuticals experienced five incidents in March, matching their February numbers.

The five pharmaceutical thefts in the report include the huge $76,000,000 Eli Lilly warehouse theft in Connecticut making March’s approximate value of cargo theft to be in excess of $77,000,000. The thefts for March include:

• March 5th a theft of a trailer at a truck stop with undisclosed pharmaceuticals worth $400,000 in Dallas, Texas.
• March 13th a theft of a trailer at a truck stop with undisclosed pharmaceuticals worth $365,000 in Richwood, Kentucky.
• March 13th the warehouse theft of prescription drugs out of an Eli Lilly warehouse in Enfield, Connecticut worth valued at $76,000,000.
• March 27th theft of a trailer with undisclosed pharmaceuticals at a warehouse in Mississauga, Ontario worth $322,000.
• March 29th theft of a trailer at a public access parking lot in Avondale, Arizona with undisclosed value of pharmaceuticals.

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.

As the value and prevalence increases, so too does the potential risk to consumers.

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/.

AEI: Roger Bate's Speech to Drug Policy Group

Roger Bate, long considered one of the foremost authorities on counterfeit and fraudulent medications around the globe gave a speech to Harvard Medical School, Department of Population Medicine, Drug Policy Research Group on March 3, 2010.

The American Enterprise Institute for Public Policy Research recently published the text of the speech online.

In this excellent speech, Mr. Bate explores, as the cause, consequences and possible solutions for fighting this deadly global epidemic.

Here are some interesting highlights from the speech:

· Although it's easy to buy fake drugs over the Internet, focusing on the dangers is not helpful. We should be helping people know which sites sell good drugs.

· As we've seen above most counterfeiters are most interested in the packaging--the product must look the part (whether it's a Louis Vutton purse, a Rolex watch or an antibiotic).

· Some fake drugs are hardly fake in a quality sense at all, being made in very good conditions; often midnight runs in an otherwise legitimate organization. Indeed, some obviously try to make great copies since they want repeat business. But often they're really unhygienic, even if they're made with the correct ingredients.

· (Mr. Bate’s into three drug catagories) direct, indirect and long run impacts. Drugs can kill directly; if they have heavy metal, bacterial, fungal or other contamination (over-sulfated chondroitin sulfate contaminated heparin was the cause of a hundred US deaths two years ago). Drugs without active ingredients (such as the fake Cipro we saw before) allow people to die from otherwise treatable infections (this kills the most people, tens of thousands, even hundreds of thousands in poor nations). And drugs with some active ingredient may accelerate the process of natural selection of more robust microbes to previously effective drugs.

· The few counterfeiters I've spoken with, think nothing of making Rifampicin with 25% or 40% active ingredient to pass simple dye tests (they will quote prices to you based on API concentrations), and given Rifampicin's BCS classification and its problems of solubility--anything less than good manufacture will probably encourage resistance, possibly contributing to MDR-TB.

· The economics is quite simple, the demand for drugs runs into hundreds of billions of dollars globally, and the returns to fakery can be vast.

· So why is it that such traders can flourish? Take Viagra. It costs $60/kg to buy in China or India, and one kg on prescription in 25 mg tablets in US would sell for up to $200,000. That is a vast mark up and to some it's worth the risks.

· Counterfeiting immediate etymology comes from the French contrefait, to imitate, and it is largely a legal definition, not one derived for public health. Although there is no universally agreed upon definition, the WHO’s the most widely cited. And it is largely a matter of labeling, and the faking of a label (often but not always a trademark) that defines a product as counterfeit. Some countries, such as China, require demonstration of harm from the product for a charge of counterfeiting to stick.

· …going after criminals might be the best policy action for importers into the rich world, but may not address the major problems in mid-income and poorer nations.

· NAFDAC has done a great job. As the authority in charge of combating fakes in Nigeria it has probably overseen a reduction in fakes in the past few years from maybe 40% to far less than 20%. (My own sampling using visual identification, TLC and disintegration, showed failure rates of 32% in 2007, 16% in 2009 and just now I think about 8-10%--but the counterfeiters may be coming more sophisticated and adding enough API to fool simple tests, such as assays with thin layer chromatography--but there is little doubt quality improvements have occurred across Nigeria thanks to NAFDAC).

· Corporations do a good job to defend their brands and this does help in improving quality, but they are woeful at releasing that information and make it hard to know where faking is taking place. Company lawyers prevent PowerPoint presentations and other information from being used by others to improve knowledge and scholarship in this area. The Pharmaceutical Security Institute, comprised of big Pharma, almost certainly has the best data on fake drugs but unless you're a Pharma member you can't access it.

· Probably the single biggest problem in the developing world is the lack of State support for good federal laws in China and India. Drug manufacturing is regulated by the states in both countries and the federal agents can do nothing if state agents do not wish to enforce the laws properly.

Mr. Bate in this speech and its text is probably the most up-to-date global analysis of this growing epidemic. His statistics and updates are very relevant for those involved in the pharmaceutical global supply chain.

Secure Pharma Chain Blog endorses his conclusions and encourages the integration of technologies within the various pharmaceutical supply chain as one of the more robust ways in diluting and ultimately eradicating the issue of fraudulent, adulterated and counterfeit medications.

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

To read the entire text of the speech, visit: http://www.aei.org/speech/100125.

Breitbart: China Faces New Health Scare Over 'Bad Vaccines'

In a story posted on Breitbart.com, the various recent incidents of fraudulent, mis-handled, adulterated and counterfeit consumer products that have negatively impacted the healthcare of the Chinese consumer is chronicled.

Several of these deadly stories of corruption and greed have been previously reported in Secure Pharma Chain Blog.

This is an excellent read for the uninitiated as it relates to the dangers that exist when supply chains are not tightly controlled, regulated and enforced.

The stories of fraudulent vaccines, tainted Heparin, poisoned baby formula and various other deadly consumer products are all too commonplace in China. It would appear to the casual observer that instead of being isolated incidents these incidents of deadly consumer products seem to be on the rise.

Of concern to many is the fact that as the global economy expands, the reality is that a good many of the products that are consumed around the globe have raw materials and/or are manufactured in China. These products are now part of the various supply chains and can be found on the shelves of retailers everywhere.

Secure Pharma Chain Blog encourages industry leaders, governments and consumers require that the inventories of the supply chains that service their basic needs of food, medications and other goods are safe, secure, authenticated and fit for consumption.

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

To read the entire story, visit: http://www.breitbart.com/article.php?id=CNG.1b07d1be69ebdf895fab113ba26ecde7.321&show_article=1.

Egypt’s Bitter Pill

In the April 2010 issue of Business Today, Jessica Gray writes an excellent expose highlighting the booming healthcare issue of counterfeit drugs in Egypt.

The well written story moves from the unsophisticated manufacture, through troubling statistics from regulatory and industry experts and ultimately into Egypt’s efforts to fight this deadly problem.

While Egypt is experiencing a very significant influx of counterfeiting it seems clear that they are not alone in the Middle East or the world in how this deadly problem grows in size and scope.

The story that is told by Ms. Gray could be set in nearly any country on nearly any continent as this global epidemic proliferates. As with everywhere else on the globe there is a tremendous amount of money to be made illegally, there is little risk of getting caught because of inadequate enforcement, regulations and laws, legitimate dispensers and distributors have low profit margins, the criminals have inroads into the legitimate supply chain and consumers are taken in by the lower prices.

Here are some of the highlights from the Business Today article:

· Industry insiders say counterfeit drug-making operations like this one, discovered last year, are becoming an increasingly common find for law enforcement officials.
· According to government estimates, up to 10% of the medicine on pharmacy shelves is fake, though industry insiders believe the number could be much higher. At the same time, Egypt has become a major hub for the manufacture and export of counterfeit drugs posing as everything from Viagra to medicine used to treat Parkinson’s and potentially-fatal blood disorders.
· All told, the Ministry of Health estimates the counterfeit drug trade in Egypt is worth over LE 1 billion, a number that is expected to grow as the pharmaceutical industry and the government struggle to keep up with forgers. The counterfeit drug business has grown along with Egypt’s legitimate pharmaceutical industry, which is the biggest in the Middle East and North Africa.
· The country produced LE 3.5 billion worth of medicine and drugs last year, beating predictions by almost LE 1 billion, according to the Oxford Business Group, a consultancy.
· That has offered some cover to the counterfeiting industry, which has been propelled by high-profit margins and advances in counterfeiting technology, according to the International Narcotics Control Board, which released its annual report last month in Cairo.
· The most commonly counterfeited products include well-known brands like Viagra. But the health ministry says counterfeiters target any medication they think will make them money, including antibiotics, heart medication and diet pills.
· Mireille Mounir, who works at Zahran Pharmacy in Maadi, says that because medicine is priced according to state regulations, profit margins on most drugs are small. By buying from counterfeiters, whose prices are a fraction of those charged by legitimate distributors, pharmacists can pad their bottom line.
· Dr. Seif Allah Emam, assistant general secretary of the Egyptian Pharmacists Syndicate, says that in most cases the sales aren’t deliberate. About 90% the country’s 130,000 pharmacists do not have enough training to differentiate between brand names and counterfeits, he says.
· Omar Shoukry, public affairs manager for Pfizer Egypt, agrees some counterfeit medicine bears a striking resemblance to the genuine product. “As a Pfizer employee, when I see some of the counterfeits, sometimes I can’t tell if they are genuine or not. They are done so professionally.”
· Though one pharmacist, who asked to remain anonymous, says it’s easy to tell which drugs are counterfeit because they’re significantly cheaper than the originals, especially when bought in bulk from a distributor.
· Youssef says about 7% of the world’s counterfeit drugs were either made here, illegally imported for sale, or transported through the country be sold in Europe and North America. Youssef, who established Risk Free in July 2009, says the estimate comes partly from his extensive network of contacts in the local pharmaceutical industry, as well as intelligence gathering by his company.
· Last year, authorities seized approximately 2.1 million fake Pfizer tablets, according to the pharmaceutical giant’s global intelligence division. Almost all of the drugs were imitation Viagra, a popular prescription drug used to treat erectile dysfunction. The only country in the world where authorities seize more counterfeit Pfizer drugs is China.
· “Sometimes people buy the cheaper drug though they know it is counterfeit. They assume that if they take the genuine drug, they will recover in 10 days, let’s say. If they buy the counterfeited one, they believe they will recover as well, but in 20 days,” says Youssef. “Consumers don’t
understand how [fake drugs] could seriously affect their health.”

Secure Pharma Chain Blog endorses the authentication and verification of all inventories within specific pharmaceutical supply chains to eradicate fraudulent, adulterated and counterfeit drugs.

To read the entire Business Today article, visit: http://www.businesstodayegypt.com/article.aspx?ArticleID=8932

WSJ: US Authorities Investigating Alleged Sales Of Counterfeit Insulin Test Strips

Peter Loftus in the Wall Street Journal reports that the US government is currently investigating a Florida businessman who Johnson & Johnson says sold counterfeit versions of its OneTouch diabetes test strips.

J & J has aggressively conducted this investigation, which it says involves participants in China, Pakistan and the US, for the last four years.

According to the WSJ, if charges are filed against the US distributor, Jacques Duplessis, it would be the first instance resulting from J&J's four-year effort. Notably, a 2006 FDA alert about the counterfeit strips warned that they could give inaccurate readings, causing diabetes patients to take either too much, or too little, insulin.

This incident is very relevant in that it shows that the prevalence of counterfeit medications and devices that have been a major issue in the rest of the world outside of the United States has been impacting our consumers and will likely proliferate further.

Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain to use a variety of technology solutions to secure their inventories specifically material authentication which allows the user to verify the molecular fingerprint of the tested material inside its unit-of-sale container.

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

To read the WSJ article, visit: http://online.wsj.com/article/SB10001424052702303591204575169990446786552.html.

Canadian Charged In Online Cancer Drug Scam

Karen Kleiss in an article that appeared in the March 30th edition of the Edmonton Journal and Vancouver Sun writes a piece about a Canadian man who is accused by the U.S. Federal Bureau of Investigation of selling fake experimental cancer drug treatments via a website he operated.

The 21 year old Edmonton resident Hazim Gaber is charged with five counts of wire fraud for his role in operating www.DCAadvice .com that was reportedly selling a fake version of the experimental cancer drug dichloroacetate also know as DCA directly to patients.

According to authorities the international fraud duped dozens of desperate cancer patients around the world who came to the website after the patients discovered that in many cases they could no longer legitimately buy the experimental drug that they needed for their treatments. Court records indicate many of the victims had their cancer treatments interrupted or delayed because of Mr. Gaber’s fraudulent scheme.

The accused, Mr. Gaber, apparently operated his website and illegal operation in the home that he shared with his parents.

Highlights from Ms.Kliess’ story include:

· Edmonton police initiated an investigation on Nov. 14, 2007, after a local woman who purchased drugs from the site lodged a complaint.
· She told police she turned to the online store when she learned she could no longer buy the experimental tumor-shrinking drug from the United States. When her first shipment arrived in a spice bottle and looked nothing like the DCA she had been receiving from the United States, she went to police.
· Testing showed the white, coarse, sweet-smelling powder she had been sent was not DCA. Later analysis showed some of the shipments patients received were made up of milk sugar, artificial sweetener, starch and talcum powder.
· Investigators eventually discovered that the so-called drugs had been shipped to at least 67 customers in Canada, the U.S., Belgium, Netherlands and the United Kingdom. The website claimed to have served more than 1,000 patients and recorded tumor shrinkage in 80 to 90 per cent of them.
· On June 30, 2009, the FBI laid charges against Mr. Gaber in an Arizona court and arrested him at the airport in Frankfurt, Germany. He was later extradited to the U.S. and he is now in jail in Phoenix.
· On July 25, 2009, Edmonton police searched Mr. Gaber's home and found 58 drug orders and receipts for arrowroot powder, dextrose and bromelian powder. Last week, an Edmonton judge agreed to let the local police share their findings with the U.S. authorities.
· Mr. Gaber's trial is scheduled to begin June 1 in Arizona. In the United States, the maximum sentence for wire fraud is 20 years in prison.

This story appears to be a classic case of a relatively unsophisticated individual taking advantage of and preying on the frantic needs of sick with bogus drugs being peddled over the internet. His global scheme was aided by the relative anonymity and world wide access of the Internet which allowed him to market and sell his fakes to the desperately ill.

Unfortunately this tale is not an isolated occurrence but something that happens all over the world on a daily basis. This appalling crime is being perpetrated by far more sophisticated and nefarious criminals who take advantage of people’s frantic need for healthcare and kill millions each year.

To learn more about supply chain solutions that combat fake drugs, visit: http://www.xstreamsystems.net/.

Read Ms. Kliess’ entire story online at: http://www.vancouversun.com/news/Edmonton+behind+online+cancer+drug+scam/2744675/story.html.

17% of Drugs in Nigeria are Fake

In an article which appeared in the Nigerian Guardian newspaper, the National Agency for Food and Drugs Administration and Control (NAFDAC) has disclosed that about 16.7 per cent of drugs in Nigerian markets are counterfeit and are unfit for human consumption.

The announcement was made by the Director General of the Agency, Dr. Paul Orhii, during a meeting with Cross River State Deputy Governor, Efiok Cobham.

Many experts believe that this estimate is overly conservative and only includes products that are within the legitimate supply chain, factoring in gray or black markets in a country with a very loose pharmaceutical supply chain, the percentage is likely much higher.

According to the Guardian:

· Orhii declared that the major challenge facing the agency is the importation of fake drugs into the country by some unscrupulous people, adding that it has become so difficult to differentiate between genuine and counterfeit drugs in the market.
· Orhii, who decried the leniency of the law against the importers and marketers of fake drugs in Nigeria, said operatives of the agency in Lagos recently intercepted a container loaded with over 700,000 fake anti-malaria drugs that were labelled 'Made in India', whereas they were imported from China.
· Orhii said NAFDAC has signed a memorandum of understanding with the Indian government to impose life imprisonment as penalty for importers of fake drugs into the country.

Nigeria has been besieged by a variety of fake medication incidents that have directly killed hundreds each year and is thought to have killed thousands indirectly through drug resistant diseases caused by counterfeit drugs.

Secure Pharma Chain Blog endorses the authentication and verification of all inventories within the pharmaceutical supply chain to eradicate fraudulent, adulterated and counterfeit drugs.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

To read the entire article, visit: www.ngrguardiannews.com.

Chinese SFDA Official Arrested in Rabies Vaccine Scandal

In an online story, written by Phil Taylor in Securing Pharma, the Chinese newspaper 21st Century Business Herald is reporting that an official with the SDFA, the Chinese State Food and Drug Administration has been arrested in connection with an investigation into the adulteration of rabies vaccine.

Wei Liang an official with SFDA's Drug Registration Department has been charged with taking nearly $145,000 in bribes.

The arrest is related to the adulteration and substitution of raw materials used in the manufacturing of thousands of doses of rabies vaccines at a vaccine manufacturing plant operated by Jiangsu Ealong Biotech Co.

According to SFDA officials the adulterated vaccines will not provide the appropriate protection against the disease but are unlikely to cause adverse effects.

SDFA’s have investigated another rabies vaccine-producing company - Hebei Bioforwell Co - but have to find any evidence of criminal activity.

The entire investigation was precipitated by the December 2009 discovery by the SFDA that more than 215,000 doses of rabies vaccine supplied by the Jiangsu Ealong Biotech and Hebei Bioforwell had quality problems.

The SDFA is concerned that some of the adulterated and sub-potent vaccine may still be in the Chinese supply chain.

This particular healthcare scandal apparently contains the gamut of premeditated fraud, raw material adulteration, medication quality control issues, official bribery and official corruption all at the expense of the health of the Chinese population.

This incident, much like the Heparin scandal that cost thousands of lives several years ago, should encourage all members of the pharmaceutical supply chain to authenticate and verify medications within their control to avoid liability, protect their business brand and make certain that the healthcare consumer is protected from potentially deadly consequences of fraudulent, adulterated or counterfeit drugs.

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

To read the Securing Pharma online story, visit: http://www.securingpharma.com/.

Renal Failure Caused by Counterfeit Drugs

Taiwan’s Cabinet will intensify its crackdown on the sale of counterfeit and substandard drugs through Internet sites, adult stores and radio advertising, Radio Taiwan announced on March 26th.

According to the announcement, Premier Wu Den-yih told the legislature that the government would set up a task force to combat the sale of fake drugs and would begin giving the legislature weekly briefings in April. A Taiwanese Health Department official in charge of pharmaceutical affairs, Kan Jaw-jou is quoted as saying that many people in Taiwan suffer from renal failure caused by counterfeit drugs.

Taiwan’s National Health Insurance estimates that it costs the country about $1 billion USD in kidney dialysis treatments due to the impact of counterfeit drugs.

As governments and business entities begin to understand the financial and human cost of the criminal activity of counterfeit drugs they become more reactive and proactive in their efforts to curb this significant health crisis.

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

Washington Post: Large International Smuggling Ring Planned Expansion to Counterfeit Drugs

The Washington Post reported on a large international counterfeiting ring, operating out of the Port of Baltimore which was recently indicted by a Federal Grand Jury in Baltimore. Nine people were indicted in a scheme to bring bogus goods into the United States from Malaysia and China.

According to the story, this international counterfeiting ring smuggled tens of millions of dollars worth of fake Coach handbags, Nike sneakers, Gucci shoes and Cartier watches into the United States though the Port of Baltimore.

Authorities are reported as saying the ring had hoped to expand into the more lucrative counterfeit drug business and were seeking business partners in the Baltimore area in hopes of finding a market.

The indictments were the culmination of a two-year undercover investigation.

“This was not a mom-and-pop organization,” said John Morton, a U.S. Immigration and Customs assistant secretary, at a news conference announcing the indictments. “This was organized crime on a grand scale. Millions were made by crooks; millions were lost by legitimate U.S. companies.”

This is yet another example of the proliferation of counterfeit goods entering into legitimate supply chains that impact businesses and threatens the health and welfare of the consumer.

To read the Washington Post article, visit:
http://voices.washingtonpost.com/crime-scene/maryland/federal-authorities-bust-inter.html

New York Times Op/Ed: Are You Buying Illicit Drugs?

In a New York Times Op/Ed published on March 31st, author Katherine Eban and Aaron Graham, former DEA Agent write about the recent pharmaceutical thefts and how this trend is made possible by “our haphazardly regulated pharmaceutical supply chain and the dangerous gray market that intersects it.”

According to the Op/Ed, “As soon as medicines leave manufacturers' loading docks, they enter a market teeming with middlemen, many legitimate, but some not. The drugs may move through a dozen hands, through small secondary wholesalers and repackagers. With so many middlemen involved, thieves can easily unload stolen drugs, which may be resold to pharmacies and hospitals and dispensed."

Ms. Eban and Mr. Graham then go onto detail to describe some of the more egregious recent incidents of pharmaceutical theft, diversion and counterfeiting.

Ultimately Ms. Eban and Mr. Graham conclude that the most effective way to deal with this growing epidemic which threatens the healthcare of consumers everywhere is through technologies that Track and Trace drugs throughout the supply chain. While Track and Trace technologies are important, they are limited in their effectiveness in that they were initially designed and implemented as inventory management tools. Basically these tools tell the supply chain where the box has been.

We at Secure Pharma Chain Blog believe that while it is important to know where the drug has been, ultimately knowing what is inside the box properly protects both the supply chain and the consumer. Track and Trace technologies require a comprehensive and complex, daisy chain of data flow while Authentication Technologies like XStream Systems’ XT250 can tell you what is inside the box and if it is safe to consume without maintaining an elaborate transaction pedigree.

The best solution is a multi-layered approach of a variety of solutions that thwart the opportunity for criminal organizations to profit from their deadly activities.

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

To read the New York Times Op/Ed, visit: http://www.nytimes.com/2010/04/01/opinion/01eban.html?scp=1&sq=%2b%22Food+and+Drug+Administration%22&st=nyt.

Jordan FDA Seizes Smuggled Counterfeit Drugs

Khetam Malkawi in the Jordan Times reports that the Jordan Food and Drug Administration (JFDA) announced on Monday that they have seized a large consignment of counterfeit and unlicensed drugs that were smuggled into the Kingdom.

The following are some of the highlights of the story:

• JFDA Director General Mohammad Rawashdeh stated that this was one of the largest consignments of smuggled and counterfeit medicine confiscated by the administration over the past several years.
• Rawahdeh noted that some of the counterfeit drugs contain a substance with harmful side effects and cause death if used to excess.
• The JFDA is currently following up on complaints received from citizens about packages of blood pressure drugs sold in pharmacies that turned out to be empty, the Jordan News Agency, Petra, reported yesterday.
• Rawashdeh told Petra that the drugs are locally manufactured and that the JFDA has notified the manufacturing company, which attributed the empty packages to a problem in the production lines.
• According to JFDA figures, the JFDA seized about JD1 million worth of fake and smuggled medicine in 2008, compared to JD16 million in 2007. No figures are yet available for the year 2009.

XStream Systems endorses the necessity of adding material authentication within the pharmaceutical supply chain to interdict and protect healthcare consumers from fraudulent, adulterated and counterfeit drugs.

To read the Jordan Times article on line, visit: http://www.jordantimes.com/?news=25299&searchFor=jfda%20seizes%20smuggled%20drugs.