The heparin saga has taken a turn toward the strange. As we blogged about in the past, it was a heparin overdose that almost killed Dennis Quaid's twins. Most recently several contaminated batches that came from China had to be recalled. So far the drug has been responsible for 81 deaths and thousands of injuries.
Now the manufacturer of heparin, Baxter International, and the FDA are claiming that the blood thinning drug may have been contaminated on purpose. Yesterday Robert Parkinson, CEO of Baxter International, testified before Congress saying, "We are greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme." Whether deliberate or not, the makers of heparin need to be held accountable. I guess we'll see how this latest twist turns out.
Many congressional members agreed that the FDA is unable to do its job. The NY Times reported, "There is a growing bipartisan consensus on Capitol Hill that the F.D.A. needs a rapid increase in its budget to ensure the safety of the nation's drugs, medical devices and food." A major problem for consumers given that the FDA is supposedly the end all be all in deciding what is safe with little or no recourse for ordinary consumers (Just check out some of our past posts here, here, and here).
But just throwing money at the agency won't make the problems go away. The FDA seems to have a culture of not wanting to do it's job and waiting until someone catches them before revealing this to the public. In this case, the FDA admitted it violated its own policies approving heparin without first inspecting the plant where it was being manufactured.
If this story shows us anything it is that we need the civil justice system now more than ever to protect us from unsafe products, including those that receive approval from an overstretched and biased government agency.
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