Heparin Update: FDA Says Contamination May Be Intentional

While I am not surprised by this news, it still saddens me to report that the FDA and CEO of Baxter announced this week that the contamination of Heparin (which has been linked to 81 deaths and over 700 allergic reactions), may have been intentional. (The full story can be found on USA Today”s website.).

Ironically, that same report states that the Chinese plant accused of intentionally contaminating the Heparin supplies passed an audit by Baxter International just months before the recalls. The FDA then conducted an audit of its own after Baxter broke the news, only to find the facility lacked the appropriate equipment to remove impurities from the drug. And what was Baxter’s pathetic response? Apparently, Baxter CEO, Robert Parkinson, testified before a Congressional hearing that “the Baxter audit was ‘routine,’ while the FDA”s was an ‘inspection for cause.'”

So what exactly was the purpose of Baxter’s “routine” audit? An executive vacation to China? A networking event? Obviously it has nothing to do with patient safety or the contaminant would have been found before it made its way into 11 countries and killed 81 people so far. This is especially true when you look at the details surrounding the contamination. According to USA Today, an investigator for the House subcommittee found that:

…the chemical mimics the effect of manufactured heparin but costs one-hundredth as much. The heparin case has similarities to last year”s recalls of Chinese-made flour used in pet food. The ingredient was contaminated with the industrial chemical melamine, which makes the flour appear more protein-rich than it was. As with melamine, standard industry tests for heparin were not designed to find the contaminant.

Clearly, the goal in China is to use the cheapest materials possible and make the highest profit possible at the expense of consumers. And since the FDA essentially allows drug companies to police themselves until complaints begin to surface, this continues to be a successful plan for Chinese manufacturers and US pharmaceutical companies. Maybe when Baxter’s CEO is faced with the death of a loved one because of a dangerous drug product, then consumers might be afforded better protection than what they are receiving now.

Medical Malpractice and Serious Injury Page

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