Wednesday, March 19, 2008

Toxic heparin: fraud is looking likely

Two weeks ago I wrote: Gordon's Notes: Toxic heparin was fraud, not accident. A comment rightly corrected me -- I'd jumped the gun.

Today, however, it's looking like fraud. Chondroitin sulfate was manufactured in place of heparin, contaminating up to 10% of the nation's supply of a heavily used medication. The Chinese government is denying investigators access to the suspected source of the counterfeited medications...
Heparin Discovery May Point to Chinese Counterfeiting

Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting...

...The contaminant, the regulators said, is a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain...

Federal officials stopped short of saying that the contaminant — constituting as much as 50 percent of the active ingredient in heparin — was counterfeit...

... the authorities left little doubt that they believed that the contaminant was not an unintended byproduct of some manufacturing process.

In its natural state, chondroitin sulfate does not have anticlotting properties. But it mimics heparin when altered to form what is called oversulfated chondroitin sulfate. That is what made it difficult for Baxter International, the manufacturer of the heparin associated with the allergic reactions, to detect the impurity...

...“The base compound, chondroitin sulfate, is very abundant and an inexpensive compound,” said Moheb Nasr, director of the agency’s office of new drug quality and assessment. Chemically modifying it, Mr. Nasr added, “will not be that expensive either.”

The F.D.A. said it had found the contaminated heparin at Changzhou SPL, the Chinese plant that supplies the active ingredient to Baxter...

... Erin Gardiner, a spokeswoman for Baxter, said Wednesday that tests found the supplies were contaminated before they arrived at the Changzhou plant. “The consolidators and workshops handle the crude material, so that is where our focus is turning,” Ms. Gardiner said.

So far, Ms. Gardiner said Baxter’s investigators had been denied access to the consolidators and workshops. “We will continue to seek access.”

Last week, the F.D.A. said it had not yet visited the workshops.

Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. Traders and producers say it is far cheaper than heparin, as little as one-twentieth the cost. That could be an enticement for counterfeiters, especially in the wake of a virulent pig virus that swept across China last year, substantially reducing the availability of the starting materials needed to make the active ingredient in heparin.

Contaminated heparin sourced from China has also turned up recently in Germany, where about 80 allergic reactions have been reported. But investigators there have yet to identify the contaminant. F.D.A. officials said their discovery of chemically modified chondroitin sulfate came exactly one year after the discovery that a pet food ingredient shipped from China contained toxic levels of melamine, which was added to make it appear higher in protein. Many pets became ill, and some died.

Around the same time, The Times reported that an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine in Panama, killing nearly 120 people and disabling hundreds more.

Diethylene glycol mimics its more expensive chemical cousin, glycerine, a safe ingredient used in medicine, food and toothpaste.

The F.D.A. said its search for answers in the heparin case had been made easier because of the cooperation it had received from China’s State Food and Drug Administration. That was not the case when United States officials inquired last year about the melamine and diethylene glycol.

The agency cited an accord signed in December by the governments of China and the United States as one reason for the cooperation they had received recently, which they said allowed American investigators to quickly begin their investigation of the additive...
So, does anyone really think that we happened to catch the very first instance of massive counterfeit in the American medication supply chain? If so, please contact me about a new financial instrument I've created just for you ...

People I love very much take medications every day. I suspect many of them are sourced from nations that have very weak regulatory and enforcement agencies, and a feeble justice system.*

Reading this article closely, I feel the journalists are quietly building a good case for panic. They are probably wondering what they need to do -- wander the streets banging drums?


PS. Bill Gates gets his medications from the same places we do. So does Warren Buffett. Maybe some people who own Senators will decide the turn up the heat a bit?

* The US now has weak regulation and enforcement, so we should all be very, very nice to our lawyers.

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