The Contaminant and Baxter- a Deliberate Act

On March 19, the chemical responsible for contaminating heparin products was identified as over sulfated chondroitin sulfate.  This chemically synthesized compound, normally used to treat arthritis, has not been approved for use in prescription medication sold in the US, and according to officials, has no business showing up in the production of Heparin. 

Tainted heparin has been found in more than a dozen countries since Baxter's recall.  Regulators have said they still don't know how it was introduced, but they now suspect it to have been a deliberate act.

The chemical eluded discovery for so long because it mirrored the main ingredient found in heparin, even sharing some of the same blood-thinning properties.  By mimicking the appearance and properties of the rightful ingredient, the contaminant was able to pass routine quality tests.  It is unclear how the chondroitin sulfate found its way into the blood thinner.
                                                                                                           
Following the discovery of the contaminant, the FDA launched an investigation into its origin which led some officials to question whether or not it was put there on purpose.  Andrew von Eschenbach, the commissioner of the FDA, spoke about the agency’s suspicions during an early Senate hearing held on March 15 saying, “It was apparently, we suspect, done by virtue of economic fraud.”

In a house meeting held Tuesday, April 29, both the FDA and Baxter told the House Subcommittee on Oversight and Investigations that the drug appeared to have been deliberately contaminated.

Robert L. Parkinson Jr., Baxter’s chief executive officer, said in a prepared testimony that Baxter is "greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme."

In a prepared statement, director of the FDA’s drug center Dr. Janet Woodcock told the panel, "FDA's working hypothesis is that this was intentional contamination, but this is not yet proven."

The Chinese company Changzhou SPL, a subsidiary of Scientific Protein Laboratories, was named by the FDA as the source of the contaminated heparin.

David G. Strunce, president of Scientific Protein Laboratories, also gave a prepared testimony.  In his statement, Strunce speculated that since the contaminant was added before the ingredient reached the Changzhou plant in China, the contaminated heparin could only be traced back to the Chinese crude heparin supply, where there seems to be a deliberate and widespread contamination.

Even though the agency has no evidence of actual fraud, officials believe that since the chemical could not have occurred during any normal processing, the contamination had to be by design.

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