A Diagnostics & Imaging Week

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.

In other international news: TheraGenetics (London), an emerging personalized-medicine diagnostics company focused on central nervous system (CNS) disorders, reported the appointment of Heiner Dreismann, PhD, as chairman of the board.

Dreismann most recently served as president and CEO of Roche Molecular Systems, the division of Hoffmann-La Roche that pioneered clinical molecular diagnostics.

TheraGenetics CEO Richard Kivel said Dreismann “is counted among the earliest and most influential pioneers in the molecular diagnostics industry. His unparalleled expertise will be essential as we guide TheraGenetics through research, development and commercialization of new pharmacogenetic diagnostic tests for individual therapeutic response prediction in CNS disorders.”

Dreismann said TheraGenetics’ technology offers “a fundamental advance in the new era of personalized medicine. The days of trial and error-based prescribing are numbered as we continue to expand the use of pharmacogenetics to match the right patient to the right drug, prior to the initiation of therapy.”

He added that TheraGenetics has “a bright future and I am excited to be part of this team.”

Kivel said the company’s initial therapeutic focus is in schizophrenia, with several diagnostic tests designed to identify which patient is most likely to respond to a specific drug and experience the least amount of side effects.

“We are targeting late 2008 to launch these clinically important tests,” the company said. It also is developing a suite of personalized-medicine predictive tests for additional CNS conditions, including Alzheimer’s disease and mood disorders.

TheraGenetics was created as a spin-out of the Institute of Psychiatry at King’s College London. Current investors include Swarraton Partners, Tudor Ventures, IP Group and Kinetique Biomedical Seed Fund.