WASHINGTON - 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.

Congressman John Dingell
©REUTERS/Kevin Lamarque
Congressman John Dingell (D-MI) holds up a newspaper story on the drug heparin on Capitol Hill in Washington April 22, 2008.

"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 type of reactions reported in 81 deaths of patients treated with some brand of heparin since January 2007.

Last year saw a string of U.S. recalls linked to China, ranging from contaminated pet food and toothpaste, to excessive lead in paint that saw millions of toys swept from stores.

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.

Colleen Hubley, the wife of Hubley's deceased son, said that as a nurse she had faith in the medicines given to her husband. "I never thought that the life-saving medication we were relying on might be contaminated," she said.

Baxter Chief Executive Robert Parkinson said it seemed the heparin contaminant, over-sulfated chondroitin sulfate, was deliberately added to the drug.

"We're 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," Parkinson said in written testimony prepared for the hearing.

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

Heparin is used in kidney dialysis and various surgeries to prevent blood clots. The drug is derived from pig intestines and often collected from small, mostly unregulated farms in China.

Baxter's Parkinson said it was "clear" the contaminant was added before crude heparin material reached Baxter's supplier in China, Scientific Protein Laboratories LLC (SPL).

SPL, in separate testimony, also said the contamination appeared deliberate.

Using the altered chondroitin sulfate is less expensive than real heparin, leading to concern that it was used as a cheaper substitute for the drug.

Rep. Bart Stupak, a Michigan Democrat, said it was still uncertain whether the contamination was intentional or accidental. He said both companies should have done more to assure their products were safe.

"Both Baxter and SPL have failed the American public," said Stupak, chairman of the U.S. House of Representatives Energy and Commerce Committee's oversight and investigations subcommittee.

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

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

All heparin being imported into the United States is now being tested for the contaminant and the current supply is safe, the FDA has said.