Families describe deaths from contaminated heparin

FDA cites need for increased vigilance

Johanna Marie Staples weeps as she testifies to Congress about her husband's death following a reaction to heparin. (Win McNamee/getty images)

WASHINGTON - The widow of a man who died after receiving contaminated heparin told a congressional subcommittee yesterday "we have a false sense of security" in a land where people expect to be protected and safe.

Brushing away tears, Johanna Marie Staples of Toledo, Ohio, said her husband, Dennis, was looking forward to his 60th birthday party on the last day of his life.

Contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions, said Representative Bart Stupak, Democrat of Michigan and chairman of the House Energy and Commerce subcommittee on oversight and investigations.

The heparin, made from ingredients imported from China, has been recalled by Baxter International and the Food and Drug Administration has blocked imports from the Chinese company.

The FDA found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing, Stupak noted.

When it was introduced into the product has not yet been determined.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told the subcommittee that in recent years major changes have occurred in where drugs are made.

For example, in 2007 the agency received only about 150 applications for approval to make generic drugs in the United States compared to nearly 500 from China and more than 400 from India, she said.

"Great vigilance is required to maintain" drug safety, she said.

Baxter president Robert L. Parkinson Jr., said in testimony prepared for the subcommittee that his company is "greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme."

"The complexity of the global drug supply chain creates new and emerging risks," Parkinson said.