The Changzhou SPL facilityTHE CASE
The Australian Therapeutic Goods Administration (TGA) has just (20/03/2008) announced a safety warning on a heparinised saline. The pharmaceutical manufacturer Astra-Zeneca will ask the TGA for permission to recall all stocks of this drug. It is not yet certain if other heparin products, or even the low molecular weight heparins are involved.
The problem appears to stem from a Chinese heparin manufacturing plant, the Changzhou SPL facility. Apparently there is a significant amount, up to 20%, of an unexplained non-heparin contaminant, oversulfated chondroitin sulfate, in batches marketed by this facility.
Heparin is an anticoagulant, mainly used in hospitals to prevent and treat blood clots during surgery and dialysis. Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin. Although heparin will not dissolve clots that have already formed, it will prevent clots from enlarging. It is derived from cow and pig intestines. This problem is extremely serious as worldwide heparin supplies are threatened, and there are not any real alternatives.
Calcium Heparin crystals
What is truly ludicrous about this is that after nearly two months of inaction, the TGA has released its warning titled "Urgent safety advisory on use of Heparin products". Ummmm...... why wasn't it urgent six or so weeks ago?
If the TGA were an effective organisation, someone would have rung their counterpart in the FDA on the 18/01/2008, the day after the problem was first publicised. Then the TGA should telephone each of the Australian suppliers of heparin to determine the source of the product. The companies should be able to answer this very quickly, either straight away or at the most within 24 hours. If the Australian distributed product had the same source as the US product, then an advisory should have been issued straight away. I can't see how this process should take more than a week.
MY VERDICT
So the TGA is working at it's customary rate. I have previously illustrated TGA shortcomings with "Influenza treatments under scrutiny" "Maybe it really does send you blind (Viagra that is)" "Zolpidem (Stilnox or Ambien), infant cough preparations", "biphosphonates" and "varenicline (Chantix or Champix)". Please, Minister Roxon, give them a good kick in the bum.
Astra-Zeneca has not behaved very well either, they would have known where their product was sourced, and could have been pro-active. Perhaps they were hoping the problem would go away. Well it didn't.
The Australian Therapeutic Goods Administration (TGA) has just (20/03/2008) announced a safety warning on a heparinised saline. The pharmaceutical manufacturer Astra-Zeneca will ask the TGA for permission to recall all stocks of this drug. It is not yet certain if other heparin products, or even the low molecular weight heparins are involved.
The problem appears to stem from a Chinese heparin manufacturing plant, the Changzhou SPL facility. Apparently there is a significant amount, up to 20%, of an unexplained non-heparin contaminant, oversulfated chondroitin sulfate, in batches marketed by this facility.
Heparin is an anticoagulant, mainly used in hospitals to prevent and treat blood clots during surgery and dialysis. Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin. Although heparin will not dissolve clots that have already formed, it will prevent clots from enlarging. It is derived from cow and pig intestines. This problem is extremely serious as worldwide heparin supplies are threatened, and there are not any real alternatives.
Calcium Heparin crystals(nothing to do with the article - but beautiful!)
My concern is, that as the American drug company Baxter first announced there was a problem, and a recall on 17/01/2008, and the FDA issued a warning advisory on 11/02/2008, that it has taken another six weeks for knowledge of the problem to seep into the TGA. This is far too long, our supposed watchdog has put Australians health and lives at risk. All of this is on the public record, if I am aware there is a potential problem, so should the TGA.What is truly ludicrous about this is that after nearly two months of inaction, the TGA has released its warning titled "Urgent safety advisory on use of Heparin products". Ummmm...... why wasn't it urgent six or so weeks ago?
If the TGA were an effective organisation, someone would have rung their counterpart in the FDA on the 18/01/2008, the day after the problem was first publicised. Then the TGA should telephone each of the Australian suppliers of heparin to determine the source of the product. The companies should be able to answer this very quickly, either straight away or at the most within 24 hours. If the Australian distributed product had the same source as the US product, then an advisory should have been issued straight away. I can't see how this process should take more than a week.
MY VERDICT
So the TGA is working at it's customary rate. I have previously illustrated TGA shortcomings with "Influenza treatments under scrutiny" "Maybe it really does send you blind (Viagra that is)" "Zolpidem (Stilnox or Ambien), infant cough preparations", "biphosphonates" and "varenicline (Chantix or Champix)". Please, Minister Roxon, give them a good kick in the bum.
Astra-Zeneca has not behaved very well either, they would have known where their product was sourced, and could have been pro-active. Perhaps they were hoping the problem would go away. Well it didn't.
2 comments:
Diego...your facts are quite interesting. You either know nothing about what is going on or you choose to ignore facts. You post a picture of the SPL plant and you presume the Aussie recall from Astra Zeneca was heparin product from this plant. Where are your facts? In fact, since this site is supposed to be Evidence Based Only...it would help you to pay attention. Of all the multiple recalls in Europe and Australia, it has been clear that the products were from companies OTHER than SPL. Suggesting this is not a problem that originated in SPL but is pervasive throughout the entire Chinese heparin market and further back in the supply chain. Pay attention Diego...and post facts instead of half baked assumptions.
Dear Amonymous you write:
"Diego...your facts are quite interesting. You either know nothing about what is going on or you choose to ignore facts."
Which facts have I ignored? Everything in this blog is on the public record and unchallenged, if you have some new information, please let me know.
"You post a picture of the SPL plant and you presume the Aussie recall from Astra Zeneca was heparin product from this plant. Where are your facts? In fact, since this site is supposed to be Evidence Based Only...it would help you to pay attention. Of all the multiple recalls in Europe and Australia, it has been clear that the products were from companies OTHER than SPL. Suggesting this is not a problem that originated in SPL but is pervasive throughout the entire Chinese heparin market and further back in the supply chain. Pay attention Diego...and post facts instead of half baked assumptions."
If there are multiple recalls from around the world for the same product, Occam's Razor demands that we assume there is a connection until proven otherwise. But you are right the heparin could have been produced in another plant and marketed via Changzhou SPL, but you have to agree that the FDA intends to inspect this particular facility.
As an example of my evidence that Changzhou SPL is involved I invite you to read http://www.chinapost.com.tw "Another firm's heparin recall announced" on 23/03/2008. Moreover on 14/03/2008 the FDA put into effect a border alert for all heparin products manufactured by the Changzhou SPL facility in China. Contrary to what you say it certainly is NOT clear that the suspect heparin is from companies other than Changzhou SPL.
Now we will move to another matter. Why is it that you company BlogTrolls are never game to allow your comments to be attributed? Why are you always hiding? You would have more credibility if you were honourable enough announce who you were and who you represented.
Let me help you. You live in New York, you work for Pfizer Inc, your IP address is 204.114.19x.xx, your host name is ns13.pfizer.com, you use Windows XP running Internet Explorer 6.0. But what does Pfizer Inc have to do with this though? Hmm, let me think.
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