Baxter CEO Says Heparin Purposely Tainted
MELISSA BLOCK, host:
An alarming claim was made today about the recent contamination of the blood thinner, heparin. At a hearing on Capitol Hill, heparin's maker said the drug may have been tainted deliberately. That testimony came along with the voices of family members of people killed by heparin. They all spoke to a House subcommittee as part of its investigation into drug safety.
NPR's Debbie Elliott was following today's dramatic hearing.
Mr. LEROY HUBLEY (Resident, Toledo, Ohio): I'm going to try to get through this.
Representative BART STUPAK (Democrat, Michigan; Chairman, Subcommittee on Oversight and Investigations): Take your time.
Mr. HUBLEY: Mr. Chairman and members of the committee…
DEBBIE ELLIOTT: Leroy Hubley of Toledo struggled to tell the story of how a batch of counterfeit heparin devastated his family.
Mr. HUBLEY: My wife, Bonnie, died in December after receiving heparin that were later recalled by Baxter. My son, Randy, died a month later under the same circumstances.
ELLIOTT: He told the committee that his wife of 48 years had a genetic kidney disease requiring dialysis. His children have the same disease. At first, Hubley said, the family thought it was a cruel twist of fate that his 47-year-old son died so soon after his wife. Then, the local dialysis center told them both had received tainted heparin.
Mr. HUBLEY: Now, I am left to deal only with the pain of losing my wife and son. Yet the unsafe drug was permitted to be sold in this country. The FDA and Baxter have not done their jobs, somebody should be held - and I want to know where it is going to be done to testify this - to rectify this matter. I want to know if my daughter, Dawn, and the millions of others who continue to receive dialysis are safe.
ELLIOTT: His daughter-in-law, Colleen Hubley, is a dialysis nurse. She testified about her fruitless effort to save her husband with CPR when she awoke to him clutching his abdomen and chest and struggling to breathe.
Ms. COLLEEN HUBLEY (Dialysis Nurse, Randy Hubley's Wife): As a nurse, I thought that I would be there to save my husband from any errors. But I guess I was naive. I never thought the life-saving medication we're relying on might be contaminated. If citizens are truly going to ever feel safe in this country, going to the hospital, a doctor, taking your daily medication, we have a responsibility to make sure that everything that is given is free from contamination.
ELLIOTT: The Food and Drug Administration has linked at least 81 deaths and hundreds of severe allergic reactions to the contaminated blood thinner manufactured by Baxter International from ingredients imported from China.
Members of the House panel expressed growing frustration with the FDA for not having a better system to inspect foreign drug plants.
Washington Democrat, Jay Inslee.
Representative JAY INSLEE (Democrat, Washington): Can you imagine what we would do if al-Qaida had put some foreign substance in heparin? Can you imagine what the threat level would go to? Can you imagine how the FDA would respond then? Can you imagine how we would - could be in some (unintelligible) and actually do something to protect us from this nefarious stuff going on in China?
ELLIOTT: The contaminant discovered in the bad heparin is an altered form of chondroitin sulfate. It's been found in 11 countries. The contaminant in the U.S. has been traced to a Chinese plant owned by Scientific Protein Laboratories, or SPL, a Wisconsin-based firm.
SPL CEO David Strunce testified that the firm suspects foul play.
Mr. DAVID STRUNCE (CEO, Scientific Protein Laboratories): The recent worldwide contamination appears to be the result of a deliberate act upstream in the supply chain.
ELLIOTT: Heparin is made from slaughtered pigs. The supply chain begins with workshops - local Chinese family operations that render pig intestines unregulated. Brokers buy the product and sell it to consolidators. That's where SPL comes in and buys the raw material to process and ship to Baxter to make heparin.
Baxter Chairman Robert Parkinson also testified that the contamination appeared deliberate. He agreed that FDA needs to step up its inspections of foreign drug suppliers and suggested the company is willing to work with Congress on how to pay for that.
Debbie Elliott, NPR News, The Capitol.
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