A Medical Device Daily

Bloomberg News reported late last week that a global search launched by Johnson & Johnson (J&J; New Brunswick, New Jersey) has resulted in counterfeit versions of a popular at-home diabetes test being tracked to China.

Potentially dangerous copies of the OneTouch Test Strip sold by J&J’s LifeScan unit (Milpitas, California) unit surfaced in American and Canadian pharmacies last fall, according to federal court documents unsealed earlier this summer. The OneTouch glucose meter and test strips are used by an estimated 10 million Americans to measure blood-sugar levels.

J&J officials first learned that corrupted strips were being sold “between Sept. 18 and Sept. 28, 2006, when LifeScan received complaints from 15 customers from various states, including Wisconsin, New Jersey and New York, concerning the same lot,” according to a company statement in court papers.

The Bloomberg report said investigators hired by LifeScan visited three pharmacies in Wisconsin in early October and found OneTouch packages with a lot number not created by the company’s plants in Inverness, Scotland and Cabo Rojo, Puerto Rico. Another investigator found a package with the same phony lot number in a Brooklyn drugstore.

The FDA issued a nationwide consumer alert in October without disclosing the link to China. 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 FDA reported running 54 counterfeit investigations in 2006, nearly double the figure for the prior year.

Peter Pitts, director of the Center for Medicines in the Public Interest (New York), told Bloomberg, “Growth in counterfeit medicines and devices is probably the biggest health threat besides infectious disease.” Pitts formerly was an FDA official whose responsibilities included investigating knockoff drugs.

The court filings disclosed, for the first time, that China is the source of about 1 million phony test strips that have turned up in at least 35 states and in Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia and Turkey.

“The source was from China, through Canada to the U.S.,” said Steven Gutman, director of the FDA’s Office of In Vitro Diagnostic Devices and Evaluation. “As far as we can tell, the counterfeiter has been put out of business in the U.S.”

The Bloomberg report said the federal court court documents reveal for the first time a worldwide distribution chain discovered in the past year by investigators hired by Johnson & Johnson. The trail, which J&J said was initiated by consumer complaints to a LifeScan hotline, initially led detectives to 700 pharmacies where the products were sold, then to eight U.S. wholesalers, and then to two importers, one in the U.S. and another in Canada.

Records seized from the importers showed that the counterfeit strips were bought from Halson Pharmaceutical (Shanghai), a company operated by Henry Fu. The Shanghai address listed on Halson’s web site doesn’t exist, Bloomberg said.

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

Geoffrey Potter, the lead lawyer for J&J, told U.S. District Court in Brooklyn: “When we started down this road, we had one box of product. The box looked like a counterfeit $100 bill looks, perfect. {But] they were made of parts we don’t have in our factory”

Bloomberg reported that Potter’s firm, Kramer Levin Naftalis & Frankel (New York), has brought an anti-counterfeiting and trademark action against more than a dozen companies on behalf of J&J.

David Detmers, a spokesman for LifeScan, said in a statement. “Our ongoing market surveillance hasn’t revealed any new cases of counterfeit products in the U.S. for several months.”

The report noted that a number of worldwide consumer scares this year — ranging from contaminated toothpaste to drug-tainted seafood – have been attributed to China. The country executed its former chief drug regulator last month for taking bribes and the government has said it will take five years to stamp out counterfeiting.

South Korea to deploy Velos systems

Velos (Fremont, California), a leading firm in U.S. clinical trial management information systems, and the nation of South Korea — through its National Cancer Center — have agreed to deploy Velos eResearch to support cancer research throughout that country.

The National Cancer Center of South Korea is a government research sponsor equivalent to the National Cancer Institute in the U.S.

“We are very pleased to launch the Velos relationship,” said Dr. Keun-Young Yoo, president of the Korean organization. “With Velos eResearch, we are ... establishing a state-of-the-art clinical trial collaboration and execution system infrastructure. Velos will support efficient, high quality multi-site collaboration and rapid deployment capabilities for cancer research throughout South Korea.”

Velos eResearch “fundamentally improves the way data is collected, organized and shared,” the company said. An Internet technology platform, it “harnesses advanced powers of the Internet to enable research sites, sponsors, and patients to collaborate in a secure, integrated system platform.”

Hyperbaric chamber sold in Indonesia

Environmental Tectonics’ (ETC; Southampton, Pennsylvania) BioMedical Systems Division said it has signed a contract for a Bara-Med monoplace hyperbaric chamber with Eakoh Enterprise (Singapore).

The chamber will be installed in Maltak, Indonesia, adding that country to a growing list of Bara-Med installations that includes Thailand, Vietnam, Singapore, India and Malaysia.

The chamber will be computer-controlled chamber includes ETC’s Smooth-Ride compression protocol.

Eric Sprague, director of Asia sales and marketing for the company, said, “The Indonesia hyperbaric chamber market is one of the emerging markets in the world and is very important to us. We are pleased that Eakoh has selected the Bara-Med and are looking forward to working with them as they continue to expand their presence in this market.”