An update to my post on this subject (read it here to get the background on this) over a month ago:
Heparin Likely Cut With Cheap Counterfeit Ingredient (“A child could tell you it’s counterfeiting”)
Bloomberg reports that indeed, the contaminant in the widely-used “American-made” drug Heparin which caused at least 19 confirmed deaths and hundreds upon hundreds of confirmed adverse effects entered “the system” in China.
March 20 (Bloomberg) — Baxter International Inc.’s heparin was contaminated by a cheaper ingredient in China, that country said, confirming a finding from U.S. regulators probing deaths and allergic reactions linked to the blood-thinning medicine.
Tests showed traces of a substance known as over-sulfated chondroitin sulfate, the State Food and Drug Administration in Beijing said in a statement yesterday. The contaminant, a less expensive ingredient derived from animal cartilage, isn’t approved in the U.S. for medical use, said Janet Woodcock, head of the U.S. Food and Drug Administration’s drug division.
U.S. regulators are investigating whether the ingredient was intentionally added to raw heparin from China. Adding the contaminant to raw heparin, the active component in the finished product, would have been cheaper than using the pure ingredient, according to the FDA.
Baxter and U.S. regulators have said allergic reactions may have been caused by raw heparin that came from China. Baxter’s raw heparin was produced by Scientific Protein Laboratories, which has plants in China and Wisconsin.
The contamination was present in the powdered raw heparin purchased by Scientific Protein’s plant in China, said Robert Rhoades, a pharmaceutical consultant with Becker & Associates in Washington, speaking for Scientific Protein. The company wasn’t aware of the contamination at the time because it wasn’t detected in the tests Scientific Protein conducted on the powder provided by suppliers, he said.
Scientific Protein purchased raw heparin from consolidators and refined it further before sending it to Baxter, which uses the ingredient to make the finished drug, Rhoades said. The consolidators obtained the ingredients from workshops in China, he said.
And yes, this particular “workshop” in China is one of many which the FDA has never managed to inspect. As I noted in my earlier blog piece, China has an estimated 80,000 chemical companies, and the FDA doesn’t even know how many sell ingredients used in drugs consumed by Americans or on-sold to other countries. Meanwhile, pharma is increasingly moving production to China.
The FDA has now received permission from the State Department to put eight staffers in China, but the plan is said to be awaiting authorization from the Chinese government.
As Michael Santoro, author of ‘Ethics and the Pharmaceutical Industry’, states, “China is not ready to be a chemical manufacturing hub for the United States and the rest of the world. There’s far too great a safety danger. We’re getting too many safety signals in recent months. This isn’t a catastrophe waiting to happen. This is a catastrophe that is happening.”
(Update) The Wall Street Journal and the New York Times are also now reporting on this:
Citing interviews with researchers in the U.S. and China, the New York Times reports that the contaminant was likely made in China from animal cartilage, chemically altered to act like heparin, and added intentionally to batches of the drug’s active ingredient.
“A child could tell you it’s counterfeiting,” Jawed Fareed, a professor of pathology and pharmacology at Loyola University Chicago who is conducting his own investigation, told the Times. “This is a deliberate act of chemically manipulating a heparin-like substance and mixing it with heparin to increase the yield.” The chondroitin derivative is cheaper than heparin.
So once more I will repeat:
Message to big Pharmas: Forget this ‘lowest bidder’ shit. Get the f#&k out of China.
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For more on this see:
Memo to Big Pharmas: Get the FUCK out of China.
Contaminant in Baxter’s Heparin Was Added in China (Update2) (Bloomberg)
Heparin Likely Cut With Cheap Counterfeit Ingredient
Scientists Near Source of Altered Heparin
Baxter Halts Production of Heparin
Heparin Probe Finds U.S. Tie to Chinese Plant
Heparin Trail: Pig Intestines From China Via Wisconsin
F.D.A. Broke Its Rules by Not Inspecting Chinese Plant With Problem Drug (and over 40 other NYT articles here)
Pharmalot Blog (Excellent analysis of the China Pharma problem)
UPDATE: New post on this subject, “The FDA and foreign drug ingredients”
Theo Spark
The Tizona Group 