Heparin Contamination Deliberate: FDA

Washington, DCLeRoy Hubley not only lost his son, but also his wife to tainted heparin. He told stunned observers at a hearing of the House Subcommittee on Oversight and Investigations in Washington Tuesday that "as Christmas music played softly in the background, we each said our goodbyes," the distraught man said, breaking down in tears to a hushed room. "Then my wife and love of 48 years drifted away."

For the first time since it was revealed that a contaminant in tainted heparin sourced from China may be linked to as many as 81 deaths, officials with the US Food and Drug Administration (FDA) have publicly put forth their belief that the addition of oversulfated chondroitin sulfate was a deliberate act.

That accusation was leveled at the Chinese two weeks ago by FDA head Andrew C. von Eschenbach, who testified at a Senate subcommittee that the contamination was carried out "by virtue of economic fraud." However, he quickly backtracked on that statement, remarking that he had "probably gone too far."

Tuesday's admission to the House Subcommittee on Oversight and Investigations by the FDA, in written testimony, puts forth the view that while the accusation is still not yet proven, "FDA's working hypothesis is that this was intentional contamination," on the part of the Chinese, according to Dr. Janet Woodcock, director of the FDA drug center.

Little wonder, when one considers that over sulfated chondroitin sulfate prices out at about $9 per pound, compared to $900 per pound for heparin.

Chinese officials are not only denying the charge, but a spokesperson with Scientific Protein Laboratories, the Wisconsin-based enterprise that has majority ownership in the vilified Changzhou SPL plant, suggested that when the company attempted to identify the original source of the tainted heparin, they were stopped dead in their tracks by the Chinese.

The heparin contamination issue is thought to be the most serious act of poisoning in decades. A spike in adverse reactions, and a suspected link to an increasing number of deaths led various companies, including Baxter International, to recall very nearly their entire inventory of heparin. The Changzhou SPL plant, as it turns out, supplied the majority of the raw heparin to Baxter and at least two other companies. The facility has since been isolated as the entry point of the contamination, although the source has yet to be identified.

Some argue that source may never be found, given the state of the Chinese heparin industry, which is best described as a cottage industry spread out over several provinces. Raw heparin is supplied to Changzhou SPL, through consolidators, from various suppliers, most of which are mom-and-pop shops fashioning the crude heparin from swine intestines. Most of these facilities are unregulated, and conditions are said to be deplorable.

Both the FDA, and Baxter International, were grilled hard at the hearing Tuesday. Congressional investigator David Nelson noted that Baxter had purchased crude heparin from Changzhou SPL over a four-year period beginning in 2004, but failed to insect the facility until September of 2007. At that time, it has been reported, Baxter sent one individual, who spent a single day at the plant.

When the FDA inspected the plant five months later, in February of this year, they found so many violations that the agency barred the facility from exporting to the United States. Nelson suggested to hearing participants that a plant couldn't go downhill that fast in just five months: thus, the supposition that problems existed well before September of last year.

The FDA did not escape the grilling, which was described as 'withering.' The point was made that the FDA also failed to inspect the plant in a timely fashion, a violation of its own mandate. The FDA countered that the oversight was done in error, but made the point—agreed to by nearly everyone—that the agency needs a serious infusion of new funding in order to support its mandate in an ever-increasing globalized marketplace. It was estimated that the FDA would require $225 million in additional funding annually, in order to inspect every foreign drug plant every other year.

So far, the Bush Administration has only proposed an increase of three per cent, which is said to not even meet expected cost increases due to inflation.

Meantime, the feds are spending trillions on the war...

Tell that to LeRoy Hubley, who lost his wife and son within weeks of each other. Both were suffering from genetic kidney defects requiring constant dialysis. Heparin is routinely used for the procedure.

"Now I am left to deal not only with the pain of losing my wife and son," he said tearfully in Washington on Tuesday, "but anger that an unsafe drug was permitted to be sold in this country."

The heparin watch continues.