People who lost relatives to deadly reactions from the
blood-thinner heparin recounted their loved ones in an emotional testimony
before a congressional panel Tuesday, expressing their anger at the same time
about the failure to ensure the drug’s safety.
LeRoy Hunley of Toledo,
Ohio, described how he lost both
his 65-year-old wife and his 47-year-old son within weeks of each other. Both
were suffering from a genetic kidney disease that required constant dialysis,
for which heparin is routinely used.
“As Christmas music softly played in the background, we each
said our goodbyes. Then my wife and love of 48 years drifted away,” Mr. Hubley
said, breaking down in tears, the Associated Press reports.
He had no idea for weeks after their deaths that his wife,
Bonnie and son, Randy, had been given contaminated heparin.
“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,” he said.
Colleen Hubley, a dialysis nurse, was also present at the
hearing on Tuesday. She recounted how her husband, Randy, came home from a
dialysis treatment experiencing diarrhea, abdominal pain and breathing problems.
He died the following night after she desperately tried to save his life with cardiopulmonary
resuscitation.
“We were certain that no matter what came our way we could handle it
together. Despite our hope, this man died while I did CPR on him, powerless to
save him. I watched my husband and my best friend slip away before my eyes. I
never thought the lifesaving medication we were relying on could be
contaminated,” she said.
Contaminated heparin has been connected to 81 deaths and 785
severe allergic reactions, according to Rep. Bart Stupak, D-Mich., chairman of
the House Energy and Commerce subcommittee on oversight and investigations.
The heparin, made from ingredients imported from China
and used in dialysis and other treatments, has been recalled by Baxter
International and the U.S. Food and Drug Administration has blocked imports
from the Chinese company.
It was further discovered that the heparin was contaminated
with oversulfated chondroitin sulfate, a chemical that mimics heparin but is
cheaper ($900 compared with $9). Moreover, it is believed that the
contamination was intentional.
“FDA’s working hypothesis is that this was intentional
contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the
FDA’s Center for Drug Evaluation and Research, told the panel in her prepared
testimony.
David G. Strunce, chief executive of Scientific Protein
Laboratories, the company that supplied contaminated heparin material to Baxter,
which manufactured and distributed the finished drug, believes the same thing,
saying the contamination “seems to us an intentional act upstream in the supply
chain.”
“We are 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
results,” Robert Parkinson, CEO of Baxter International testified Tuesday.
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. All heparin being
imported into the U.S.
is being tested for the contaminant and the FDA says heparin currently on the
market is safe.
