Officials Investigating Fake Avastin Production

Chinese health officials and police are investigating a pharmaceutical plant, Cancer Center, hospital employees and pharmaceutical dealers for the use and production of fake Avastin that harmed 61 patients last month.

Caj Wenjun in the October 23rd edition of the Shanghai Daily reports on the Chinese State Food and Drug Administration (SDFA) and the Shanghai Public Security Bureau investigating a Beijing pharmaceutical plant for allegedly producing a counterfeit version of the drug Avastin.

The fake Avastin caused eye infections in 61 patients at the Shanghai No. 1 People's Hospital last month according to officials from the Shanghai Health Bureau.

Shanghai No. 1 People’s Hospital illegally treated patients with Avastin on people with eye complaints, though its key component is believed to have a positive effect on some eye conditions, it is only officially approved for treatment of certain cancer conditions.

Roche, Avastin's producer, said the drug is only approved for colorectal cancer treatment in China. It is used in the treatment of five types of cancer in the United States, but is not permitted for use on eyes.

Avastin was not officially approved for use for colorectal cancer until October 22nd nearly a month after the incident at the hospital.

According to the Shanghai Daily story:

• Local police will also investigate the Avastin case.

• The Shanghai Ruijin-AmMed Cancer Center is under suspicion as it allegedly purchased the bogus Avastin and sold it on to hospitals.

• Several employees at the cancer center, along with some pharmaceutical dealers, have been detained. The relevant head of Shanghai No.1 People's Hospital will be charged with poor management and negligence, said health bureau officials.

• Only three patients from the case remain in the hospital. Many of those discharged have received compensation.

This incident features many culprits and plenty of criminal activity. The production of dangerous fake medications, dealing in counterfeit drugs and unofficial medical treatment to name just a few.

In this incident, each member of the supply chain perpetrated some level of criminal, fraudulent and unethical behavior with the consumers suffering serious injury.

It is critical for all members of the global pharmaceutical supply chain to protect their inventories by deploying best practices, solutions and technologies to authenticate and verify the efficacy of the products that flow through their operations.

To read the entire Shanghai Daily article, visit: http://www.shanghaidaily.com/article/?id=452464&type=Metro#ixzz13SEBnJZr

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

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/.

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/.