Linhardt hopes to be able to make a gram of synthetic heparin within a year, which would be enough to administer 100 doses in mice and allow the researchers to at least move forward with animal trials. He believes that one kilogram of synthetic heparin would provide the 10,000 doses needed to get through clinical testing on as many as 1,000 patients, although he says he is not able to give a timeline for when he would be able to make that much heparin. Success would mean that U.S. pharmaceutical companies could make the heparin they use in their blood-thinner products rather than importing it from China.
The heparin scare may prompt the U.S. National Institutes of Health to approve Linhardt's recent request for a $5-million federal grant over five years to complete his research. "Dr. Linhardt has a proof of concept," says Jawed Fareed, director the Special Coagulation Laboratory and the Hemostasis and Thrombosis Research Program at Loyola University Medical Center in Maywood, Ill. Fareed and Linhardt consulted during efforts to unravel the contamination mystery. Fareed became involved in the probe in March when doctors at the Medical Center's dialysis unit sought his advice on the FDA's heparin recall. "They wanted to know what they should do and asked if there was an alternative drug," he says. Fareed requested that the doctors send him all of the heparin in stock so he could determine whether they were contaminated in some way. Most of it was. "We were surprised by the results," he recalls, "and we were concerned about our patients."
A key factor in the success of synthetic heparin, at least initially: whether hospitals, clinics and insurance providers would be willing to pay a premium for it if it costs more than heparin coming from swine (which is about 20 cents per dose). Given how difficult it has been to produce small amounts today, it would take years and a "staggering" investment to make synthetic heparin a feasible business, says Erin Gardiner, a Baxter spokesperson, who adds that her company is not planning to get into the synthetic heparin business.
Still, Linhardt hopes that someone will take an interest in mass-producing the work he has begun. "The future is one that will be short continuously of heparin," he says. "Which means any adulterations of the heparin [imported by the U.S.], we're going to have to live with—or catch."
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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!!!!!!!
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