Heparin: FDA says tainting may be deliberate

A third of the material in some batches of the thinner heparin were contaminants, “and it does strain one’s credulity to suggest that might have been done accidentally,” Woodcock said.

Two weeks ago, Food and Drug Commissioner Andrew C von Eschenbach told a Senate subcommittee that the contamination was done “by virtue of economic fraud”, but he quickly withdrew the remark, saying he had “probably gone too far”.

Woodcock’s statement on Tuesday was part of growing chorus that has labeled the heparin contamination as perhaps the most brazen poisoning incident since 1982, when seven people in the Chicago area died after taking Tylenol that had been laced with cyanide.

The Tylenol case led to substantial changes in product packaging, and the heparin contamination has led both Democratic and Republican committee members to call for major changes in the way the FDA functions and is financed.

Tuesday’s hearing was also the first in which family members of those who died were asked to testify.

LeRoy Hubley of Toledo, Ohio, described how both his 65-year-old wife and his 47-year-old son died within a few weeks of each other. Both suffered 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,” Hubley said, breaking down in tears. “Then my wife and love of 48 years drifted away.”

He did not know 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.