According to Gardiner Harris and Wald Bogdanich of the Times,
- The FDA has received reports of 785 serious injuries and forty-six (46) deaths associated with Heparin;
- But the FDA has taken the position that only 19 of the 46 deaths are in fact, related to Heparin;
- Baxter International says it’s only four deaths.
Harris and Bogdanich also make it clear how difficult it can be to investigate these typpes of cases after the fact:
Federal drug regulators said Wednesday that a critical blood thinner that had been linked to at least 19 deaths and whose raw components were produced in China contained a possibly counterfeit ingredient that mimicked the real drug. (emphasis added)
Routine tests failed to distinguish the contaminant from the drug, heparin. Only sophisticated magnetic resonance imaging tests uncovered that as much as 20 percent of the product’s active ingredient was a heparin mimic blended in with the real thing. Federal officials said they did not know what the contaminant was.
In their piece the following day, Harris and Bogdanich reported that:
Food and Drug Administration officials announced that they were asking all companies in the United States that produce heparin to test it with two new procedures.
The complex tests, nuclear magnetic resonance spectroscopy and capillary electrophoresis, are the only ones that can uncover whether the drug contains a possibly counterfeit ingredient.
“German Authorities Report Problems With Blood Thinner,” March 7, 2008.
The Times has been on top of this story: a search for “blood thinner China” on the Times website yielded at least eight articles on the subject in the last five weeks.
Perhaps it’s time to think about making our drugs at home – rather than becoming dependent on a country without real regulation to produce medication, a commodity for which quality control is asolutely critical. One wonders what the those who are rosy-eyed about free-trade think about this. (We’ll keep an eye out to see if The Times’s Thomas Friedman weighs in on this).