Heparin deaths detailed to Congress
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 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 Deerfield-based 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 House subcommittee.
Contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions, said Rep. Bart Stupak, a Michigan Democrat and chairman of the House Energy and Commerce subcommittee on oversight and investigations.
At Tuesday's hearing, executives from Baxter and its supplier, Scientific Protein Laboratories, testified that the contaminant was added before the ingredient reached SPL's Chinese factory.
The Food and Drug Administration suspects the contamination was a deliberate effort to make money, through the use of a cheaper ingredient, though there isn't proof, according to the agency.
Baxter recalled heparin, used to prevent blood clots, in January of this year after reports of harmful side effects. Tainted heparin made by other drugmakers has been found in more than a dozen countries since Baxter's recall, and regulators have said they don't know how it was introduced.
"We're alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a lifesaving medication," Baxter Chief Executive Officer Robert Parkinson told the House investigative subcommittee.
Some samples of Baxter's heparin were found contaminated with a cheaper substance known as over-sulfated chondroitin sulfate, according to the company and the FDA. U.S. and Chinese officials have argued publicly whether the contaminant was to blame for the allergic reactions and deaths.
"It seems to us that it's an intentional act upstream in the supply chain," said David Strunce, the chief executive officer of Waunakee, Wis.-based SPL, during the hearing. "We don't know specifically where."
Baxter sold about half of the U.S. supply of injectable heparin before the recall. APP Pharmaceuticals Inc. of Schaumburg, whose products remain on the market, produced the other half. The FDA says heparin currently on the market is safe.
People who said they lost family members to tainted heparin described their emotional pain to committee members.
The widow of a man who died said "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 an evening 60th birthday party at a steakhouse with friends after receiving his dialysis treatment.
But during the treatment he become unresponsive, stopped breathing and went into cardiac arrest, she said. Paramedics rushed him to a nearby hospital but he never regained consciousness, she said.
Hubley, dabbing his eyes with a handkerchief, told of losing both wife and son. His wife Bonnie suffered diarrhea, pain and trouble breathing after being rushed to a hospital where doctors recommended removal of her breathing tube to end her suffering.
"Christmas music played in the background as each one of us said our goodbyes," said a shaking Leroy Hubley. "And the nightmare returned only weeks later when my son, Randy, started dialysis at the same clinic."
Baxter's Parkinson, in written testimony prepared for the hearing, expressed grief for the families.
"We deeply regret that this has happened, and I feel a strong sense of personal responsibility for these circumstances," he said.