'Pharmaceutical Companies Must Take Responsibility'

Pharmaceutical executive says oversight process woefully lacking.

ByABC News
July 24, 2008, 10:11 AM

July 30, 2008— -- The blood thinner heparin is one of the most used drugs in America, employed daily in hospital surgeries and for kidney dialysis patients.

But a safe supply of this critical drug fell into jeopardy last winter in a catastrophe that illuminated severe problems caused by the fact that most ingredients for American drugs now come from foreign sources. These sources are not being adequately monitored by either the pharmaceutical industry or the Food and Drug Administration.

The FDA told "Nightline" that as many as 55, or perhaps considerably more, people may have died from the contaminated heparin. So far it's only been able to definitively link three deaths to specific lots of the tainted drug.

Although so far it's only been able to definitively link three deaths to specific lots of the tainted drug.Heparin used to be primarily produced by the pharmaceutical giant Baxter, but Baxter recalled its entire stock, nearly half the nation's supply, after the deaths from contaminated heparin. A number of smaller companies also recalled supplies. To date, Baxter says they have received 955 reports about contaminated heparin in 2008.

That's when billionaire pharmaceutical executive Dr. Patrick Soon-Shiong and his company American Pharmaceutical Partners (APP) stepped in with a large, safe supply of the drug. Without it, countless more Americans would have died.

"How would all these thousands of dialysis patients have dialysis? What would happen to all these surgeries?" Soon-Shiong said. "I have no idea; it's very scary to have thought."

Soon-Shiong has called for the reform of how the pharmaceutical industry polices its products. The companies must take a greater role, he argues, because the FDA is simply overwhelmed.

No one knows that better than Leroy Hubley. He says his wife of 48 years, Bonnie, died from a severe allergic reaction after taking contaminated heparin at a Toledo dialysis clinic.

"The doctors recommended we remove her breathing tube to end her suffering," Leroy recalled in congressional testimony. "Our entire family -- our son, daughter, in-laws and grandchildren -- were all there. Christmas music played in the background, and each one of us said our goodbyes. Then my wife of 48 years drifted away."

Hubley's nightmare didn't end there. Within weeks, he says his only son, Randy, also a dialysis patient, died after taking heparin from the same batch of the drug.

"He too developed nausea, low blood pressure, fatigue, abdominal pain and diarrhea," Hubley testified. "A week later, my 47-year-old son was dead, leaving behind three children and a grandchild." Randy also left behind his wife, Colleen Hubley, who testified before Congress.

Investigations into the deaths pointed to China, where the raw ingredient for heparin originates.  According to the FDA, someone there spiked the crude heparin with a counterfeit look-alike drug to increase profit.

"I see these foreign drugs as essentially a string of time bombs," said former FDA commissioner William Hubbard. "Heparin has gone off, and there will be more until we fix the problem."