The Saturday, May 31, 2008 edition of the Wisconsin State Journal ran a story on Scientific Protein Labs, the supplier of the contaminated heparin to Baxter. (SPL was formerly a division of Oscar Mayer, the hot dog company.) The story is worth reading for several reasons.

First, it describes the process involved in processing pig intestines into the raw sugar powder used to make heparin. This powder is called the api, or active pharmaceutical ingredient. Here in the United States, SPL controls its supply by actually processing the pig intestines. One 22 ton semi load of pig guts is processed down into just six pounds of heparin powder.

In China, SPL - Changzhou (SPL-CZL), an SPL joint venture, bought processed pig guts, rather than act as the parent company and purchase the raw pig guts. SPL-CZL purchased the material after some processing had been done. SPL - CZL then shipped the heparin powder in bags from China to Wisconsin. SPL did not even open the bags in Wisconsin, but simply forwarded them to Baxter's Cherry Hill, New Jersey plant. These bags contained material that had been "cut" with a counterfeit product that mimicked heparin. Up to 30% or more of the material was actually oversulfated chondroitin sulfate (OSCS).

What is new in this article is the admission that Baxter bought all of its raw heparin only from the China operation. The raw heparin that is made by SPL from domestic pigs is all sold to Sanofi Aventis, another drug company.

All of SPL's heparin was made in the United States until 2004, when it acquired the China operations. In China SPL purchases its raw materials from two different companies, and each of them obtain the processed raw material from 10 other workshops, which do the initial processing of the pig intestines. So the supply chain of SPL is much different than that here in the United States, a fact which should have been known by Baxter.

The most critical admission in the latest article is the admission by SPL that it feared suppliers would try to sell it counterfeit products because of the blue ear pig disease that was ravaging the pig supply in China. It started testing its incoming supplies to make sure that sheep intestines weren't being substituted. But amazingly it never utilized the common test of NMR until after it was too late.

It didn't even own an NMR machine.

CEO Strunce stated that he has learned a lesson. "The lesson is that you have to be constantly vigilant."

Mr. Strunce, that lesson was taught in drug manufacturing 101. You must have missed that class.

Labels: Baxter, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, MDL, MDL; Multi-District Litigation, nightline, NMR, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, Scientific Protein Labs, SPL