Baxter: under fire over contaminated heparin

-Pharmaceutical Business Review

05/08/2008 - In the latest development of the long drawn out heparin saga, Jin Shaohong, China's Deputy Director of the National Institute for the Control of Pharmaceutical and Biological Products, maintains that contamination, in the form of over-sulphated chondroitin sulphate (OSCS), cannot be irrefutably linked to up to 81 deaths and numerous cases of severe allergic reactions in the US.

These developments in the US led Baxter Pharmaceuticals to withdraw heparin in March of this year, with a subsequent slew of partial recalls and safety warnings in Europe. China is responsible for supplying up to 80% of the world's raw heparin stocks, and investigations have centered on the possibility of contamination entering the supply chain here. With the rising price of heparin, and raw material shortages, there are suspicions that contamination with OSCS, a cheap dietary supplement derived from animal cartilage, was deliberate.

Schaohong accused Baxter of not cooperating with the ongoing investigation by Chinese experts in the US, with the company failing to provide records and samples of the contaminated stocks. Baxter has also come under fire for not doing enough to secure its production line

The company, however, points to the FDA's failure to carry out a pre-approval check in 2004 for the Changzhou plant at the center of the controversy. The FDA maintains that it is unable to police the entire supply line for every product that enters the US, and that Baxter should have carried out more vigilant inspections.

The episode is likely to fuel distrust of imports from low cost manufacturing countries such as China, and will therefore have wider repercussions for all pharmaceutical companies which have, or are looking to set up bases overseas, due to the growing need to cuts costs. For example, both Pfizer and AstraZeneca have recently announced their intention to increase outsourcing to Asia, in a bid to stream-line manufacturing and production costs.

The controversy may also provide further momentum to the FDA's drive to set up operations overseas, with a base in China likely to act as a prototype for roll out in other countries. Such a move could shift the burden of ensuring drug safety toward the source country.

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