By Mata Press Service

Fake diabetic kits manufactured in China to take sensitive measurements of blood sugar levels were imported into Canada and used by millions of people in North America, according to recently unsealed court documents.

The potentially dangerous counterfeits of the OneTouch Test Strip sold by Johnson & Johnson (J & J) LifeScan unit surfaced in American and Canadian pharmacies last year, according to the U.S. court documents.

A global hunt by J & J – the world’s largest consumer- health products maker – tracked the production of the fakes to a company based in Shanghai, China. The company Halson Pharmaceutical, which has been shut down, also made pregnancy, HIU and Tuberculosis test kits.

Its owner Henry Fu has been arrested and jailed in China. The existence of the fakes came to light after 15 diabetic patients complained of faulty results last September.

Tipped off by J&J, the US Food and Drug Administration issued a nationwide consumer alert in October without disclosing the link to China, a news agency reported. The trail, initiated by consumer complaints, first led detectives to 700 pharmacies where the products were sold, then to eight US wholesalers and then to two importers, one in Las Vegas and another in Canada. While no injuries were reported, inaccurate test readings may lead a diabetic to inject the wrong amount of insulin, causing harm or death, the agency said. The at-home diabetes test is used by more than 10 million people in the U.S. and Canada.

The court filings disclose that China is the source of about one million phony test strips that have turned up in at least 35 US states as well as Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia and Turkey.

“The source was from China, through Canada, to the United States,” said Steven Gutman, director of the office of in-vitro diagnostic devices and evaluation at the FDA in Rockville, Maryland. “As far as we can tell, the counterfeiter has been put out of business in the United States.”

The court documents reveal, for the first time, a worldwide distribution chain discovered by investigators hired by J&J.

Records seized from the importers show the counterfeit strips were bought from Henry Fu’s company, Halson Pharmaceutical, which according to its internet site, is based in Shanghai.

Halson’s website says the company distributes and manufactures medical supplies, such as syringes, and is run by Fu who, according to a court order, is also known as Su Zhi Yong. Fu was arrested by mainland authorities and remains in prison, awaiting resolution of his case in the People’s Court of Shanghai.

The other importer from China, according to court documents, is a Montreal company known as Zoe Diagnostics, owned by Alexander Vega. J&J sued Vega in both Brooklyn and Quebec, where a raid seized counterfeit products from a storage locker.

Investigators linked Vega to Henry Fu from seized e-mails, purchase orders and wire transfers of money.

While the pharmaceutical sleuths were tracking Fu, LifeScan Canada issued warnings about the existence of the fakes.

“If you use, recommend, distribute, or sell OneTouch® Brand Test Strips, we want to make you aware that we have recently become aware of several incidents of counterfeit OneTouch® Ultra® and OneTouch® (Basic®/Profile®) Test Strips in the United States.

Although LifeScan has not received reports of counterfeit test strips being sold at Canadian retail stores, we are taking precautionary measures and warning Canadians in case these products are present in Canada. These counterfeit test strips being sold in the United States are labelled as being intended for use with various models of LifeScan’s OneTouch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose1.”

Fake medicines are a US$32 billion global business, says the World Health Organization, and the FDA says it ran 54 counterfeit investigations last year, almost double the year before.

An estimated two million Canadians have diabetes and the number is expected to hit three million by 2010.

Aboriginal people are three to five times more likely than the general population to develop diabetes while   77% of new Canadians come from populations that are at higher risk for diabetes. These include people of Hispanic, Asian, South Asian or African descent.

China, the biggest exporter of consumer products, has created a series of worldwide consumer scares this year ranging from contaminated toothpaste to drug-tainted seafood. The communist country executed its former chief drug regulator last month for taking bribes and the nation said it will take five years to stamp out counterfeiting.

More recently Mattel Inc, the world’s biggest toymaker, said it is recalling 18.2 million China-made Barbie dolls and other products with magnets children risk swallowing.

China reeling from the bad publicity stressed its cracking down on pharma-industry crime.

This month Chinese police said it arrested 15 members of a suspected counterfeit drug gang.

According to reports by China’s Xinhua News Agency, the gang allegedly either bought fake drugs and repackaged them, or manufactured them, using materials such as water and starch.

Police seized counterfeit versions of 67 types of drugs produced by 53 companies, including 10,000 doses of rabies vaccine, 20,250 bottles of an injectable cardiovascular drug and 211 bottles of blood protein.

As part of the effort to clean up its act, China has also finally withdrawn the business license of the notorious Taixing Glycerin Factory and shut down all its premises.

It is alleged that the firm exported a product consisting of 15 per cent diethylene glycol (DEG) - a poison used in anti-freeze and as a solvent which can cause kidney failure - among other substances, and fraudulently passing it off as 99.5 per cent pure glycerin.

Glycerin is used as a sweetener in some medicines and Taixing’s allegedly ‘fraudulent glycerin’ mixture ended up in medicines in Panama last year. Over 50 people were reported to have died as a result of taking cough syrup, antihistamine tablets, and calamine lotion contaminated with DEG.

Other facilities implicated in the production of unsafe consumable non-drug products were also shut down as part of the latest crackdown.