Two years ago this month Baxter first recognized it had been selling contaminated heparin. We now know that this contamination was intentional, sophisticated, and deadly. Heparin is a sugar molecule, one of several glycosaminoglycans (GAGs) found naturally in the lining of the intestine of pigs. The contaminant also was a GAG. In fact, the contaminant may have been a combination of GAGs, all of which are found in crude heparin, the starting material for heparin.

Crude heparin consists of 4 GAGs, namely Dermatan Sulfate (DS), Chondroitin Sulfate (CS), Heparan Sulfate (HS) and Heparin. Responsible manufacturers have known of the requirement to test for the DS and CS to make sure their heparin is pure. If Baxter or its supplier, SPL, had been performing simple tests which were then in existence, they would have known and realized that their heparin was full of impurities.

These impurities, the contaminants, were easily distinguishable from heparin; yet Baxter failed to perform any testing to insure its heparin was free of common GAG impurities.

The contaminants included Chondroitin Sulfate which had been "sulfated", or chemically modified, to make it have anti coagulation properties. Heparin is an anticoagulant. So one of the purposes of adding the contaminant was to increase the anticoagulation properties.

The recipe for the contamination had been published by Robert Lindhardt in 1997 in a scientific journal, along with claims that this oversulfated chondroitin sulfated product had value as a heparin like compound:

It is possible that the anticoagulant activity can be
further increased by appropriate refinement of the
modification procedure for N-deacetylation–N-desulfonation
w26x of fully O-sulfonated chondroitin
sulfate. These possibilities point to new practically
feasible routes for the generation of heparin-like
compounds with various pharmacologically relevant
biological activities.

http://www-heparin.rpi.edu/

Unfortunately Baxter was too busy counting the profits from its cheap Chinese heparin to pay attention to what it was selling. Some one with a college education who was able to read scientific literature figured out that a cheap substitute for heparin could be made from the by product produced during the manufacture of heparin. All that had to be done was to follow the recipe published in 1997.

There are basically 2 classes of GAGs found in crude heparin. Heparin itself contains glucosamine. The contaminants included heparin byproducts that contain galactosamine. DS and CS both are galactosamines. Therefore the simple tests that had been used for decades to make sure the heparin had been properly purified to remove all of the galactosamine-containing GAGs would have also detected the contamination.

Recently published studies indicate that the contaminant was made from byproduct generated during the manufacture of heparin itself. http://ash.confex.com/ash/2009/webprogram/Paper17902.html

Neither the FDA nor the USP wants to admit that the contamination was a result of their inability to perform basic inspections and to require basic purity tests. However the failures of these organizations does not relieve Baxter or its supplier from responsibility.

The identity of the individuals and organizations responsible for intentionally contaminating Baxter's heparin remain a secret. But the list of suspects is actually pretty short. The FDA has still not finalized its investigation. Either the FDA has abandoned the hunt or they are closing in on the responsible party.

Meanwhile our civil justice system continues to grind ahead. Sooner or later Baxter and SPL will be held accountable. There are currently about 750 claims for death or permanent injury pending in federal and state courts. Hundreds more died without their survivors realizing they were victims of corporate greed.

The final chapter has yet to be written.

Labels: Baxter Heparin, Heparin, Heparin Class Action, heparin disaster, SPL