Families tell U.S. lawmakers of heparin deaths

Tue Apr 29, 2008 6:12pm EDT
 
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By Lisa Richwine and Susan Heavey

WASHINGTON (Reuters) - A man who said he lost his wife and a son to reactions from tainted heparin made with ingredients from China urged U.S. lawmakers on Tuesday to protect patients from other unsafe drugs.

Leroy Hubley said his wife, Bonnie, and son, Randy, had undergone kidney dialysis at an Ohio clinic and were given heparin that was later recalled by Baxter International Inc. Both had reactions to the blood thinner and died within one month of each other.

"Now I am left to deal not only with the pain of losing my wife and son, but anger that an unsafe drug was permitted to be sold in this country," Hubley, who frequently choked back tears and wiped his eyes, told a U.S. House of Representatives subcommittee hearing.

A U.S. Food and Drug Administration probe found a contaminant in some batches of Baxter's heparin. Officials said tests showed the chemical could have caused the reactions reported in 81 deaths of patients treated with some brand of heparin since January 2007.

Lawmakers questioned Baxter and its ingredient supplier, Scientific Protein Laboratories LLC (SPL), about why they failed to detect the heparin contamination. Both companies said it appeared the chemical was deliberately added before either company received the ingredients.

Baxter, which had supplied about half of the U.S. heparin market, recalled most of its heparin products in February.

The action followed a string of U.S. recalls linked to China last year, ranging from tainted pet food and toothpaste to excessive lead in paint that swept millions of toys from stores.

The heparin contaminant has been detected in 13 countries, FDA officials have said, but only the United States and Germany have seen reports of an increase in allergic reactions.

The FDA says all heparin imported into the United States is now tested for contamination and the current supply is safe.

NEW STEPS URGED

Hubley and other relatives of heparin victims urged new steps to keep medicines free of contamination.

"I want to know what is going to be done to rectify the matter. I want to know if my daughter, Dawn, and the millions of others who continue to receive dialysis are safe," Hubley said.

Baxter Chief Executive Robert Parkinson said the company was "alarmed that one of our products was used, in what appears to have been a deliberate scheme, to adulterate a life-saving medication, and that people have suffered as a result."

"We deeply regret that this has happened, and I feel a strong sense of personal responsibility for these circumstances," he said.

Heparin -- used in dialysis and some surgeries to prevent blood clots -- is derived from pig intestines and often collected from small, mostly unregulated farms in China.  Continued...

 
Dr. Qurrath U. Ain of the Elmhurst Pediatric Emergency Center examines a patient with flu-like symptoms at Elmhurst Hospital in New York in this December 12, 2003. file photo. REUTERS/Shannon Stapleton/Files
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