Heparin May Have Been Contaminated Deliberately
While confirmation is still required, Dr.Janet Woodcock, director of the FDA's drug center testified in front of a House panel that they were working on the theory that the contamination was intentional.
A third of the material in some batches of the thinner heparin were contaminants, “and it does strain one’s credulity to suggest that might have been done accidentally,” Dr. Woodcock said.
This incident that caused 81 deaths brings back the bad memories of the 1982 Tylenol case that killed 8 people and led to the institution of tamper proof seals being placed on over the counter and prescription drug products.
Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, has been identified by the FDA as the source of the contaminated heparin. In what could be seen as the worst part of this story, it may have been done for profit!
A Congressional investigator said the contaminant, oversulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin.
Back in March, it was discussed that the FDA lacked the resources to conduct the required periodic inspections of the plants supplying manufactured Rx products. When the FDA finally did the inspection of this plant, they found numerous problems and blocked it from exporting products to the U.S. The identification of chondroitin sulfate as the contaminant and the plant resulted from Rensselaer Polytechnic Institute.
One of the things that this situation shows is that sourcing of ingredients or finished products overseas where there is less oversight and control and be risky. The other thing is that such "doctoring" of pharmaceutical products is as much an act of terrorism and the poisoning of a food or water supply. The issue of substitution of ingredients or the outright counterfeiting of products (as previously written here, the World Health Organization estimates that more than 10% of all pharmaceutical products are counterfeits and that the problem of counterfeits is a dangerous and pervasive problem.
When it comes to counterfeited medicines or, in the case of substituted ingredients for profit (as in this heparin case), the responsible parties are indeed bioterrorists.