FDA Thinks FDA Contamination May Have Been Deliberate

Since early February the FDA has been dealing with contaminated Heparin that was causing patients to have allergic reactions including problems breathing, nausea, vomiting, and rapid drop in blood pressure which can lead to life threatening shock. The type of Heparin at issue is typically given to dialysis patients during the dialysis procedure. At this point, the FDA is aware of approximately 131 reports of death related to being given heparin between January 07 and April 08. The significant jumps in death reports started in Nov 07 through end of February 08 when 81 of those 131 deaths occurred, prompting the FDA to call for ending the use of Heparin. As fate would have it, the problematic doses of heparin were manufactured by a company in, yup, good ‘ole China.
Congress has been having hearings for several weeks now trying to get to the bottom of this problem, specifically addressing the failure of the FDA to properly and timely inspect the facilities in China who were manufacturing this product. In order to avoid this happening in the future, Congress has been trying to get the FDA to tell it how much money it needs to properly and timely inspect these foreign manufacturers and have been stonewalled by the FDA officials regarding its needs to properly undertake these inspections.
Just this past Tuesday, Jane Woodcock, director of the FDA’s drug center, indicated that the FDA is now working on the hypothesis that this contamination of heparin was INTENTIONAL!!! They believe that someone(s) purposely contaminated this drug to cause people to get ill. Some are saying this is the most significant case of poisoning since the contamination of Tylenol back in 1982 when someone laced Tylenol with cyanide.
One of the Congressional investigators told Congress that this all could have been avoided if there was some oversight of this plant. Apparently, the distributor of the drug, Baxter, has purchased ingredients for heparin from the Chines plant in question between 2004 and 2008, but only visited the plant once, in September 2007. It is reported Baxter sent one person for one day to look at the plant at that time. However, 5 months later when the FDA went to the same plant after this problem came to the surface they found tons of problems. The congressional investigator, David Nelson’s thoughts on this apparent 5 month “change” in the plant from fine when Baxter looked at it to horribly out of compliance when the FDA looked at: “It really is impossible for a plant to have fallen that far out of compliance in five months.” So what was the Baxter official doing during that inspection…enjoying some good Chinese food????
This continues to be an interesting story as it develops. Another drug company caught with egg on its face and not spending the money to properly address safety of its products. I am in the process of evaluating several cases where patients appeared to be injured as a result of being given heparin during dialysis treatment. If you or someone you know may have been a victim of this tragic situation, you are welcome to call me to discuss.