The news that our heparin supplies have been deliberately adulterated with a cut price and potentially lethal anticoagulant substitute from a Chinese supplier comes as no surprise to me. The only thing that surprises me is that much of the world’s supply of heparin has been quietly outsourced to shonky manufacturers.
The contaminant that causes anaphylactic reactions has been identified as over-sulphated chondroitin sulphate, added at an early stage in the supply chain by an unscrupulous operator because it has anticoagulant effects and is much cheaper than raw heparin derived from pig’s intestines.
In the US the contaminated heparin has been linked to hundreds of anaphylactic reactions and about 20 deaths. Now our own regulator, the TGA, has found the contaminant in Australian heparin supplies and products are being recalled.
So who exactly is responsible? One US doctor has traced back the production process and finds that everyone is passing the buck. The distributor blames the supplier, who blames the manufacturer, who blames the sub contractor who produced the raw material … etc etc. All this in spite of a supposedly “state-of-the-art, fully validated cGMP compliant Heparin API manufacturing facility” according to the manufacturer’s website.
One thing is clear – as a former FDA commissioner has already noted, we can have little confidence in the drug manufacturing standards of Chinese drug suppliers. The country is notorious for counterfeit products and its drug regulatory framework would be a joke if it weren’t dealing with matters of life and death. Totally unaccountable and lacking in transparency, the agency’s most recent director was taken out and shot last year after being caught taking backhanders to rubber stamp drug approvals. Neither the crime nor the punishment are likely to inspire confidence in a production system that is increasingly being used as a source of our pharmaceuticals.
We are constantly being told that generic medicines are just as good as their brand name equivalents. But these claims are based on infrequent and often one-off tests and inspections, and assume that manufacturers can be trusted to act in good faith. The tainted heparin scandal has shown that this is not the case for some raw material producers.
So if we are to increase the sourcing our medicines from developing countries we need to institute a more robust system of checks and quality assurance tests. This isn’t a Pan Pharmaceuticals situation where TGA inspectors were able to drop in unannounced to conduct spot checks. Therefore the onus should be on offshore manufacturers and suppliers to consistently prove that their medicinal products are exactly what they say they are.
Comments
Can you get heparin from human intestines, presuming all the usual safeguards? If the number of people involved seems to be as big as it might, then supplies could easily be rectified. New twist to " having someones guts for garters". At least its better than shooting them. Well, more useful then. Posted by H Bunton on Thursday, 27 March 2008
I agree with your comment re drugs supplies from countries with known problems with drugs manufacturing and quality (eg China). The issue is wider than that however. Widespread misuse of "critically important" antibiotics in food animals in China (and other countries) means that a large percentage of organism that are on foods (such as E.coli) are multi-resistant. This often can mean that no antibiotics are likely to be effective if invasive disease occurs with these bacteria. We thus need to have better testing of any uncooked foods that are brought into this country. If they contain resistant bacteria such as E.coli that are c very difficult or impossible to treat because of multi-resistance, then we should not allow those foods to be imported.
Many foods can also be contaminated with antibiotic and drug residues that also should not be there. Recent examples are of chloramphenicol in prawns and in honey from China. We need testing done much more frequently by our regulators than is occurring now. If any products fail on testing (as has been the case in past) we should insist that all future batches are tested and not just the minimal sampling and testing that occurs now even in products that have failed on testing before.
Peter Collignon Infectious Diseases Physician and Microbiologist Director Infectious Diseases Unit and Microbiology Department, The Canberra Hospital. Professor, School of Clinical Medicine, Australian National University.
Posted by Peter Collignon on Thursday, 27 March 2008
