The Heparin Conundrum

December 9th, 2008

The heparin debacle is the only thing that’s going to be on my mind each time I pop pills or open a bottle of medicine, along with the question of how safe the drugs we use are. It’s an irony of sorts that the very drugs that are supposed to save lives end up taking them in a bizarre twist of events. The blame game has been going on for a while now with the Chinese government, the FDA, Baxter which was responsible for the manufacture of the drug and Scientific Protein Laboratories (SPL) which sourced the powder that heparin is made from, throwing the ball to the others’ courts even as they tried to wash their hands off the situation.

On one hand we hear stories of the FDA’s financial troubles, the reason being cited for the failure to inspect SPL’s Shanghai plant. And other the other we see statements from Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research that the FDA bungled badly and got the names of the factories mixed up when conducting inspections.

The SPL factory is guilty though, of deliberately adding over-sulfated chondroitin sulfate to the heparin pipeline because of a shortage of raw material from pigs (the main compound in heparin powder) following the blue ear virus and it’s destructive effect on the pig population of China. Considering that drug companies all over the world outsource their manufacturing operations to countries like China, not for the cheap man power but for its bountiful pig population, a situation like this is bound to happen each time a shortage occurs and the factory is not able to keep up with the demand for the drug.

No matter how stringent the rules are, the truth is that as long as there is room for error, both from the human fallibility factor and from the possibility of animal diseases, mix-ups like this are bound to happen. So what then is the alternative, one that’s safe and cost-effective? Rensselaer Polytechnic researcher Dr. Robert Linhart and his team have successfully demonstrated the value of the synthetic heparin that they’ve manufactured. While it has proved to be safe so far, it remains to be seen if it can be produced in large amounts in a cost-effective manner.

Till then, for the millions of people who depend on heparin and similar drugs to prevent heart disease, there’s no alternative but to cross their fingers each time they take their medication and hope that nothing untoward happens.