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Volume 3, Issue 15
September 16, 2004



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With all the chatter about potential terrorist strikes at the drug industry, a recent incident related to vaccine safety may strike a nerve with patients.

Late last month, Chiron Corp. (Emeryville, CA) announced that it had discovered tainted doses of Fluvirin, its flu vaccine. The company reported that eight of 60 batches it had tested—amounting to about 4 million doses—had failed to meet the company’s sterility specifications. The tainted vaccine was found in a small number of batches at its Liverpool, England, factory. About 1 million tainted doses had already been shipped, but none had reached the public. At press time, the unfortunate incident was still under investigation.

Chiron’s news came about the same time as did news about terrorist plots to attack the nation’s domestic drug supply. Speaking to a group of reporters at a press conference, acting FDA commissioner Lester M. Crawford revealed that cues from recent terrorist “chatter” suggest that attacks might already be planned on the drug supply, specifically illegally imported prescription drugs. During his talk, Crawford again voiced his concerns over the recent increase in the number of states looking to save money by importing drugs from Canada.

Both of these high-profile news stories illustrate the havoc that could be caused by contamination of the drug supply. Such incidents might not only put the general public’s health at risk, but also taint a company’s name and image, resulting in massive financial losses.

Chiron did not divulge the nature of the contamination, so we do not know whether it was a manufacturing or packaging error, or perhaps something sinister, such as intentional tampering. The good news is that the company did indeed locate the problem fairly quickly and report it to FDA immediately. The vaccine was never released to the public. “We are confident that we’ve identified the root cause,” said John Vavricka, Chiron’s vice president of commercial operations. He then announced that the company is initiating additional tests to ensure the vaccine’s safety. The shipment has also been delayed by two months.

Regardless of what caused the contamination, reports like this may make consumers wonder whether vaccines and other drugs in general are protected enough from potential threats. These news reports show once again how important packaging and testing are to the pharmaceutical industry. Companies should monitor their processes more than ever, and they should show patients and healthcare practitioners that they’re absolutely doing all they can to ship safe and effective products. Tamper-evident packaging may also be in order for a number of products, providing some proof that products are safe.


 

Ben Van Houten

 
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