popular logistics

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).

Chinese government hasn’t been tracking drug manufacturers, much less regulating them, or ensuring drug safety. This arises out the investigation of (at least) four deaths linked to heparin sold in the United States by Baxter International, which contained ingredients made by a firm called Changzhou SPL, which is in China but whose majority ownership is held by the American company Scientific Protein Laboratories.

Excellent recent account (from which most of the details above were obtained can be found in Blood Thinner Might Be Tied to More Deaths,” by Walt Bogdanich, and “China Didn’t Check Drug Supplier, Files Show,” by Bogdanich and Jake Hooker, both of The New York Times.

Since getting drug companies to behave themselves responsibly is often so difficult - and setting up regulatory schemes is difficult even in the absence of an industry determined to resist regulation - we’d like to propose an interim solution: require that all pharmaceuticals which contain any ingredients, packaging, or in any other way have been produced in China, be explicitly and brightly labeled. The text might be only “Some components may have been made in the People’s Republic of China.” As an interim measure, this might allow the market to assist in reducing the risks associated with taking medication.

Liz Borkowski at The Pump Handle has an interesting discussion of sewage systems - she points out that

While most of sewage systems do a great job of making the water look clean and getting rid of bacteria and viruses, they often aren’t designed to remove synthetic chemicals. With so many of us dependent on daily doses of pharmaceuticals, we’re excreting lots of drugs (or their metabolites), and they’re sticking around in treated wastewater. Researchers are now starting to discover what that means for the environment.

What’s In Your Sewage? at The Pump Handle

And then, typically for The Pump Handle, follows up with well-sourced, calm discussion which will leave you better informed.

There may be long-term planning implications with respect to how we design sewage and filtration systems. We’re also reminded of the toxic soup post-Katrina - composed not only of sewage - but of every opened bottle of household cleanser, paint, insecticide, etc. which was on a floor low enough to have the water pass through. (I’ll try to update later with links to the post-Katrina water issues).

The Angry Toxicologist has a piece on the link between vaccines and autism.

AT’s verdict: this causal connection is likely - but

• we still shouldn’t  be using thimerosal (ethyl-mercury) in vaccines;
• the typical vaccine regimen makes sense.

After that, it’s over my head, so I’m sending interested readers over there.

Link to article.

The Angry Toxicologist.