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/.

Two Minnesota Men Accused of Distributing Counterfeit Drugs

Two Minnesota men, Nicholas Lundsten, 26, of Spring Lake Park, and Patrick Barron, 29, of Fridley were charged Wednesday for distributing misbranded medication. The pair sent 10,419 pills labeled as Viagra; 3,600 pills labeled as Cialis; 1,582 pills labeled as Propecia; and 340 pills labeled as Levitra.

Viagra is manufactured by Pfizer; Cialis by Eli Lilly; and Levitra by Bayer; all treat erectile dysfunction. Propecia, manufactured by Merck, treats male pattern hair loss.

Lundsten and Barron are also accused of illegally importing about 40,000 pills of alprazolam — used to control anxiety disorders — and about 27,000 pills of sibutramine — an appetite suppressant used to treat obesity — into the United States. Both are classified as "Schedule IV" controlled substances.

The indictments are the result of an investigation by the FDA, U.S. Immigration and Customs Enforcement and the U.S. Postal Inspection Service, with assistance from U.S. Customs and Border Protection.

If convicted, Lundsten and Barron face up to six years in prison.

To view entire article, visit: www.startribune.com.

Where, Oh Where Did My Medicine Come From?

You may think you know where your medicine originated. It came from Pfizer, or Merck, or Bayer, or some other big name pharmaceutical manufacturer. The question is where did they get it?

Many of our modern day medications are complex. They might be synthesized from chemicals or use biological agents and all have some kind of filler, bulking agent, or suspension liquid. So where do all those ingredients come from and why can’t you tell where your medication was made?

Almost 80% of the active ingredients come from overseas and many of the companies that supply the fillers or chemicals are not inspected by the FDA because the product is not considered pharmaceutical. Even to inspect only the active ingredients, the FDA has stated it would take them over 13 years to inspect each plant.

What’s more – pharmaceutical companies are only required to list active ingredients not the raw material or fillers that make up the medicine.

It’s like a giant puzzle; but what if you could zoom out and see the whole picture, match it against the picture on the box and know if something didn’t fit? That might be just around the corner with EDXRD technology. A new product, the XT250 System, uses this technology to build an industry standard of a compound and then use it when comparing a sample. The software will even do the thinking for you to determine if it is or is not a match – no scientific knowledge required. It’s like a pharmaceutical lie detector to stand guard at our gates.

It would give consumers the peace of mind to know “what they see is what they get” because after all, isn’t that what really counts?