Baxter tracked the contaminant to SPL, which has a facility in China that manufactures the heparin that companies such as Baxter bought and used in their blood-thinner products. The Chinese facility, known as Changzhou SPL, used a supply chain for the ingredients to make its heparin that the included unregulated labs and farms in rural China. The FDA ultimately traced the poisoned heparin back to 12 Chinese companies that had added OSCS to their products.
Chinese officials initially disputed charges that the contaminants came from their country but have since acquiesced to the FDA's demand that Chinese companies test all ingredients used in U.S. drugs for contamination. The FDA, which says it has developed improved tests for screening heparin for contamination, is also planning to participate in an international summit at an undetermined location next year where international scientists and regulators will discuss ways to improve and enforce drug safety rules. This case—like those involving melamine in baby formula and pet food—illustrates the danger of U.S. dependence on products, including drugs, from other countries where safety standards are lower than those enforced by the FDA.
Searching for a synthetic alternative
Nearly all of the $3-billion worth of heparin sold worldwide annually is derived from swine, but "there aren't enough pigs in this country to treat our own needs," Linhardt says.
Jian Liu, an assistant professor of medicinal chemistry at the University of North Carolina School of Pharmacy at Chapel Hill agrees. "We don't like the way we're getting heparin now," says Liu, who is working with Linhardt to create synthetic heparin. "The process of getting the raw materials for heparin from swine leaves the finished product open to viral contamination."
The threat has given a new sense of urgency to Linhardt's effort to develop a synthetic version of the heparin use in short-term blood thinners, but he still faces some major obstacles. Although it is possible to bioengineer heparin in the lab, the drug's complex structure makes it difficult to mass produce: It takes at least 100 metric tons of heparin to meet the world's needs for a single year. Through trial and error, it took Linhardt and his team a year to make just 100 milligrams of his synthetic version. "The challenge is there are multiple enzymatic steps involved," Liu says. "These enzymes are very sensitive to temperature and not very stable," which means the fermentation process is not always successful.
Even if the enzymes survive the fermentation process and produce heparin, making that much of the drug synthetically (without the use of swine) could require using a 264,172-gallon (one-million-liter) fermenter 100 times. The largest fermenter on RPI's campus has a capacity of 10.6 gallons (40 liters) and would be able to produce only one gram of synthetic heparin at a time with each successful fermentation.
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8 Comments
Add CommentNOT SURPRISING... when the U.S. continues to outsource vital industrial/medical processes. Yes, we "save a few bucks" on the front end with their cheap labor... then pay dearly when undetected toxins or unsafe products are disseminated in the marketplace among us.
Reply | Report Abuse | Link to thisLow molecular heparins (eg Lovenox) are preferred for their safety, ease of administration (do not require lab monitoring of clotting parameters) and the fact that over the long-term do not cause osteoporosis or a low-platelet count.
I really don't see a realistic market for completely synthetic "high molecular weight" heparin... but then again, if I were of the PORCINE persuasion, I would certainly hope for a breakthrough.
BTW, I quit eating pork (and lamb much earlier) due to the inhumane conditions of these massive, corporate hog farms... to say nothing of the incredible runoff of pollution to nearby streams. Furthermore, pigs are smarter than your pet dog.. and certainly more intelligent than a early toddler.
Cheers!
How far back does the Heparin recall go? My mom had heart surgery in August 2007, was given Heparin, never got off respirator, had hypotension, kidney failure, and died a week later.
Reply | Report Abuse | Link to thisI do not know how long the recall goes but I seen an add on T.V. about this subject. A lawyer was taking wrongful death suits. (This is why I am at this site right now). My brother-in-law is right now taking this drug and I was trying to find out as much as possible. I am sorry I do not recall the lawyer's name but I am sure if you put heparin lawsuit in any search engine I am sure you will find it. They probably could anawer your questions. I am sorry for your lose and may God be with you.
Reply | Report Abuse | Link to thisI had been given Heparin in November of 2008 because of blood clot in lower leg, was given it 3 times and had to be taken off because was causing more clots and had to have leg amputated just above knee and my whole life has changed to the point that I cannot do any of the things I use to do. Because of this it has caused many other problems in my families life. The TV adds telling about recall was on TV at the same time this was all going on, and my husband asked doctors about it and they told him not to worry about it.
Reply | Report Abuse | Link to thisIs anyone aware of birth defects in children, i.e., limb abnormalities, whose mothers took the Lovenox injections during pregnancy?
Reply | Report Abuse | Link to thisI was in the hospital for 20's days due to having a PE! They had me on HeParin for all that Time and then the Nurse hurried in my room and cut off the HeParin Machine and never tolod Me Why?! But Now I see Why?! Here it is 2 1/2 years Later and I been In And Out the Hospital Complaining about Pain, Pain, Pain And More Pain! Come to find out it did Heart and Muscle Damaged!!!!! But I Thank God I'm Still AliVe!!!! GOD IS GOOD!!!!!!!
Reply | Report Abuse | Link to thisI was in the hospital for 20's days due to having a PE! They had me on HeParin for all that Time and then the Nurse hurried in my room and cut off the HeParin Machine and never told Me Why?! But Now I see Why?! Here it is 2 1/2 years Later and I been In And Out the Hospital Complaining about Pain, Pain, Pain And More Pain! Come to find out it did Heart and Muscle Damaged!!!!! But I Thank God I'm Still AliVe!!!! GOD IS GOOD!!!!!!!
Reply | Report Abuse | Link to thisI was in the hospital for 20's days due to having a PE! They had me on HeParin for all that Time and then the Nurse hurried in my room and cut off the HeParin Machine and never tolod Me Why?! But Now I see Why?! Here it is 2 1/2 years Later and I been In And Out the Hospital Complaining about Pain, Pain, Pain And More Pain! Come to find out it did Heart and Muscle Damaged!!!!! But I Thank God I'm Still AliVe!!!! GOD IS GOOD!!!!!!!
Reply | Report Abuse | Link to this