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Volume 0, Issue 0
The real question in the Baxter heparin scandal is not who's guilty but whether pharma can get reliable results from a country in chaos
The folks in biotech have a saying, "The process is the product." In their world, drugs are so complex and difficult to characterize that you can't just run a set of simple chemical tests to ensure that what comes out of the bioreactor today is the same thing that came out a month ago. Instead, you have to develop a rigorous process and stick to it absolutely. There are chemical checks you can make, and they're getting better all the time, but in the end, the way you assure that you've got the right product is to stick to the process. They're thinking of process in the narrow sense—maintaining cell lines, monitoring temperatures, carrying out purification processes, things like that. But as the past few weeks have reminded us, process can mean a whole range of things—who you buy supplies from, who they buy their supplies from, how your raw ingredients are treated, and, of course, what you do to ensure that no one ekes out your active ingredient by loading it up with counterfeit APIs and contaminants.
That, of course, is what happened to Baxter. Somewhere along the chain of actions that leads from hog guts to heparin—an old and valuable anticoagulant—someone apparently mixed in a cheap chemical based on chondroitin sulfate, a commonly used dietary supplement made from animal cartilage. As we went to press with this issue, FDA and Chinese officials were still investigating, but it was impossible to doubt that the contamination was deliberate, the result either of an attempt to cut costs or of an unscrupulous vendor sneaking the chemical into the supply chain.
The heparin case is the subject of a story in this month's Pharm Exec, written by Senior Editor Walter Armstrong (see "Chinese Puzzle"). Walter makes the case that if the heparin contamination is in fact counterfeiting, as it seems to be, it represents counterfeiting on a whole new level. This is not a matter of substituting deadly but cheap ethylene glycol for glycerine (as one Chinese manufacturer did not so long ago). In this case, some clever chemist identified a cheap product that could be made to resemble heparin, then chemically modified it so the resulting product could pass all the standard tests of purity. It's fraud on a molecular level—an appalling waste of human skill, talent, and ingenuity in the service of greed and destruction.
It's essential for pharma to protect itself against this sort of crime—not least because FDA and others are making ominous rumblings about criminal prosecutions for executives whose products go bad, whether the defect was deliberate or not, and whether the executive knew about it or not.
But how? It's really not reasonable to expect that chemical testing will be adequate to thwart deliberate deception—in the heparin case, FDA and Baxter had to use state-of-the-art technologies to simply locate a contaminant it knew was there. Biologics are intrinsically complex and resistant to definitive analysis.
In the long run, the answer is probably going to be the classic biotech answer: If you want your product to be pure, control the process. But as Walter's story demonstrates, that won't be easy. In the heparin case, the Chinese government argued that it had no responsibility for supervising exports. And suppliers on the upstream side said they couldn't or wouldn't inspect their vendors. To get the Wild East under control will be the work of decades. But it has to happen. If you lose the process, you've lost the product.