Dennis Staples, a radio announcer in Toledo, Ohio, slipped into a coma the day before his 60th birthday. He had been on dialysis for more than two years because of kidney failure, but had fared well with treatment. Then one day, while on dialysis at the doctor's office, Staples went into cardiac arrest. Despite a quick medical response, he never recovered.
Today, his wife Johanna attributes his death to the blood-thinner drug heparin that he received to prevent clotting during treatment.
"My husband and many other ailing patients who received that drug suffered needlessly," Staples said.
Dennis Staples may be one of at least 81 patients who died from bad heparin between January 2007 and March 2008, in addition to hundreds of others who have experienced severe allergic reactions like low blood pressure, vomiting and shortness of breath.
The U.S. Food and Drug Administration is now investigating whether the drug's ingredients that came from China became contaminated on purpose or by accident, and where in the supply chain that contamination occurred.
Staples was among several people who provided emotional testimony Tuesday at a Capitol Hill hearing on how the medication became tainted and whether the FDA's inspection procedures for foreign drug plants fueled the problem.
Drug Makers Say Deliberate Contamination Happened Early in Supply Chain
Both the CEO of heparin manufacturer Baxter and the CEO of Scientific Protein Laboratories, the U.S. firm that operates the Chinese plant from which Baxter and others got their heparin, suggested the contamination was deliberate and happened before the drug's ingredient reached the lab.
"We are greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme," Robert L. Parkinson, Jr., chairman, CEO and president of Baxter International, Inc., said in a written statement to the House Energy and Commerce Committee's oversight and investigations panel.
David Strunce, CEO of Scientific Protein Laboratories, likewise said, "It seems to us that it's an intentional act upstream in the supply chain."
"This is thuggery," said Rep. Michael C. Burgess, R-Texas. "This is thievery. This is high crimes and a direct assault on the American public. I mean, this is not just testing for normal product manufacture, in my opinion, for what it's worth. Someone did this deliberately. They found a product much cheaper than the active ingredient."
Still subcommittee chairman Bart Stupak, D-Mich., pointed fingers at those companies for not ensuring the product that passed through their hands was safe.
"Make no mistake about it: Both Baxter and SPL have failed the American public," Stupak said.
Inspections Aim To Monitor Complex Supply Chain
Derived from pig intestines, often from farms in rural China, heparin is processed and manufactured in various plants in China, the United States and abroad before it is finally administered to patients.
Experts have since created a new test to detect the previously undetectable contaminant in that complex supply chain. The FDA has also ramped up efforts to test heparin shipments coming from overseas to find out whether they're safe.