Chinese Counterfeit Cancer Drugs Impact Consumers and Pharmaceutical Firms

While counterfeit pharmaceuticals have been prevalent in China for many years, China’s food and drug regulatory system has once again drawn attention to itself with the recent discovery that large amounts of fake anti-cancer drugs are flooding the market.

In an article written by Michelle Yu of the Epoch Times from June 22nd, Ms. Yu outlines yet another counterfeit drug scandal involving bogus cancer drugs that seem to permeate within China.

According to Ms. Yu’s Epoch Times article:

· Chinese authorities announced on June 12 that a Chinese-American person with a surname of Ding, along with three accomplices, had been arrested for manufacturing and selling fake anti-cancer drugs valued at US$4.4 million.

· Ding, 47, became an American citizen in 2003 after completing his postdoctoral studies abroad. He started selling counterfeit drugs in 2008, while serving as a general manager of a Hangzhou-based biopharmaceutical company.

· The counterfeits were sold through the Internet at one-tenth the price of the genuine products, which average around US$3,000 per bottle. The bogus anti-cancer drugs had been sold throughout at least eight provinces.

· The major counterfeited brands included Norvatis' leukemia drug Gleevec, Bayer's kidney cancer drug Nexavar, Astrazeneca's lung cancer drug Iressa, and Genentech's lung cancer drug Tarceva.

· There is speculation that Ding’s counterfeits account for only a small portion of the fake cancer drugs manufactured and sold in China and abroad.

· A spokeswoman for the Shanghai branch of the U.S.-based SciClone Pharmaceutical International drug company said that more than 20 percent of the company’s anti-cancer drug Thymosin Alpha-1 is counterfeit in the Chinese market, according to a May 26 report by China’s Southern Weekly. She added that counterfeits were found in government-owned drug stores.

Ms. Yu humanizes the scandal by telling the story of some of the victims of this counterfeit drug scandal:

· Among those that have been victimized by the counterfeits is Nanjing resident Geng, who spent thousands of dollars on Thymosin before realizing that the medication was having no effect. Geng purchased his medication from a state-certified drug store, Xinte.

· Tests conducted on the medication concluded the lot was counterfeit. Two members of Geng’s family who also took the counterfeit drug have since passed away.

· The same store’s stock supply of Alimta was also proven to be counterfeit by tests conducted by the brand’s manufacturer, Lilly LLC.

· Although pharmaceutical companies have reported these issues to China’s State Food and Drug Administration (SFDA), the agency has a history of being lenient on distributors of the fake drug products.

The Epoch Times story includes the deep seeded issue of official corruption that continues to feed these deadly criminal acts:

· The SciClone Pharmaceutical spokeswoman said she traveled to Nanjing for the Xinte drugstore case. The company issued a written testimony against the distributor of the bogus medication, but the local SFDA witnesses claimed that the samples collected from the drugstore were, in fact, authentic.

· Shortly afterward, the drugstore’s license—which had been revoked—was reinstated, after the wife of the former store owner registered for a new license and subsequently reopened the store. Her husband has not been indicted or punished.

· Eight different pharmaceutical companies, including SciClone Pharmaceutical and Lilly, have consulted with Nanjing SFDA officials and also reported the case to higher authorities.

· Former head of the SFDA Zheng Xiaoyu was executed in 2007 after being accused by the state of taking bribes to license bogus drugs.

· Chinese citizens have been quick to point the finger at the corruption and inertia of the drug regulatory authorities.

With a country’s regulatory agency either unable or unwilling to combat the deadly crime of counterfeiting drugs it is incumbent upon the industry’s supply chain to protect their individual brands, the supply chain as a whole and their consumer from nefarious entities bent on destroying lives and businesses for profit alone.

Secure Pharma Chain Blog endorses that individual members of the supply chain utilize technology to combat the criminal act of fraudulent, adulterated and counterfeit drugs, specifically solutions that allow the user to authenticate that the material that they have within their inventories is safe and efficacious for the consumer.

To read the entire Epoch Times article, visit:

http://www.theepochtimes.com/n2/content/view/37824/

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

Chain of Custody Dilemma: Recovering Stolen Pharma Products

By: Alan Clock, Senior Vice President, XStream Systems

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

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

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

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

The following are some recent examples:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.