Previously, I had written about contamination that occurred in a batch of Heparin and caused the death of a number of patients undergoing dialysis. Free Yevgeniy: Heparin To review, Heparin is a natural anticoagulant found in the intestine (lumen) of pigs. Heparin is a variably-sulfated proteoglycan that consists of repeating disaccharide units (pictured to the right). The compound inhibits binding to the clotting factor ATIII and stops the blood clotting process.
Last year there were pediatric deaths that created a commotion in the community and led to the FDA issuing an investigation. One of the academic specialists on Heparin, called to assist in to identify the contaminant, was professor Robert J. Linhardt, at Rensselaer Polytechnic University.
Dr. Linhardt, working with a larger group, helped isolate the contaminant as persulfonated chondroitin, a compound that mimics heparin activity in vitro but causes extreme damage, even death, in vivo.
Heparin is used in dialysis and for invasive hospital tools. Therefore a contaminant was a disaster for the health care community
Dr. Linhardt discussed the need for laboratory made Heparin so that we could better monitor the drug making process and avoid Heparin shortages.
Interesting points made during the talk:
- Pigs in china made four doses of Heparin vs. one dose in America. Turned out Chinese farms are dirtier and cause an increase in mast cell Heparin production as Heparin levels are elevated during a parasitic response
- Heparin was first used in 1926 (prior to FDA existence) and as a compound can not be patented
- While the current process for Heparin production is gruesome (filthy slaughterhouses --> large unregulated factories --> US markets), the contaminant was purposely added to the mix sometime during the process. This is important as the FDA can not allow any inserted contaminant to be present (non process derived), therefore purification is not an option
- France continued to use contaminated Heparin, since the alternative was to stop dialysis
This meeting was targeted to chemists and business people. Yet, it is an essential concept for all medical doctors to understand. It seems amazing that doctors have so much faith in the prescription pad to provide the right drug. Often generics are recommended because similar efficacy has been shown in trials and cost is decreased. Is quality lost? Cheap sneakers are often of poorer quality then more expensive ones. As a society, we expect our medication to be treated with higher regard then sneakers. However, the FDA is underfunded. Less then 10% of imported drugs are checked when shipments arrive. Until this Heparin crisis occurred, there were no full time FDA officials in China reviewing the manufacturing process. Can physicians rely on the drug market to provide what is prescribed? This continues to be a pivotal issue.
A joke at every end:
Why is Cinderella bad at baseball?
She runs away from the ball and has a pumpkin for a coach.
