Posted on 03/06/2008 2:19:12 AM PST by TigerLikesRooster
March 6, 2008
Drug Tied to China Had Contaminant, F.D.A. Says
By GARDINER HARRIS and WALT BOGDANICH
WASHINGTON — 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.
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.
“At this point, we do not know whether the introduction was accidental or whether it was deliberate,” said the Food and Drug Administration’s deputy commissioner, Dr. Janet Woodcock.
Heparin is made from pig intestines. Scientific Protein Laboratories, based in Waunakee, Wis., bought raw heparin produced in some cases in small, unregulated family workshops in China and processed it in plants in Wisconsin and China, according to heparin traders and producers in China. Baxter International purchased the active ingredient from Scientific Protein and sold the finished drug.
Wayne Pines, a spokesman for Scientific Protein Laboratories, said that nothing sinister about the contamination had been proved. “There is no evidence of counterfeiting or tampering or anything of that nature,” Mr. Pines said. “No one really knows what happened here.”
Beginning in November, public health officials received reports of patients experiencing severe allergic reactions after being given Baxter’s product. Baxter initiated a series of recalls that culminated last week in a withdrawal of nearly all of Baxter’s heparin production.
(Excerpt) Read more at nytimes.com ...
Ping!
This is simply the way the Chinese do business. They determine what the quality control procedure is, figure out how it can be defeated, and merrily adulturate the product with cheaper materials in order to increase short-term profit. It is a cultural thing that is a Chinese as Mom and Apple Pie.
We have seen it over and over again, with pet food, paint, drugs, dumplings, or any other product. There is simply no tendency to follow the rules like there is in the West. The rule is a barrier to be overcome.
As long as we treat the Chinese like short Westerners who talk funny, we will constantly be caught off-guard like this. Quality control procedures that work in the United States, which operate on the assumption that contaminants will be introduced accidentally, simply do not apply in China.
PING your lists. Wasn't that pig disease last year found to be a variant of the bird flu?
well it’s also because we have the FDA and its ability to enforce quality standards. I’m not a libertarian in this area...thanks Teddy R.
Post of the week Gridlock!
Lowest bidder with no regard to quality. ‘It’s a Global Economy’.
This was posted on FR about a month ago. I spoke with my doctor about it after I read the article because I received Heparin in Nov. after surgery and ended up with a hematoma in my hip that was very painful and debilitating. However, my doctor said that the heparin, with the ingredient mentioned had been taken off the market quite a while ago. At least that is what he told me.
“tests uncovered that as much as 20 percent of the product’s active ingredient was a heparin mimic blended in with the real thing”
“At this point, we do not know whether the introduction was accidental or whether it was deliberate,” said the Food and Drug Administration’s deputy commissioner, Dr. Janet Woodcock.
Uh, Dr. Woodcock, I’m sure it was just a mistake that a heparin analog got mixed in with a batch of real heparin.
Unf**kingbelievable!
Our FDA is useless when it comes to protecting us from Chinese imports. If they had an ounce of integrity they’d shut off ALL imports of Chinese medications until further notice.
“The F.D.A. admitted last month that it had violated its own policies by failing to inspect Scientific Protein’s China plant before approving the drug for sale. The agency sent inspectors to the plant last month who found that at least some heparin was made from “material from an unacceptable workshop vendor.”
Thanks FDA!
They are coming off as totally devoid of morals where there is a buck to be made.
Sorta like our American oil companies, our drug companies who get us addicted to "non addictive" brain chemicals (Xanax, Klonopin, Ativan, Valium and the other 18 or so look-alike drugs, (benzodiazapines), our doctors who lazily refuse to independently study these hideous chemicals and yet prescribe them.
Later they call their patients addicts! Yep, set a reeeely good example to the Chinese! (/rant)
Two things in this story:
I think the reporter recently had a MRI and confused it with NMR spectography.
What was the brand name and generic equivalents of the drug??? Sheesh.
Remember them "goats in trees" that were an issue during the football season? Well I suggest we start making some products with all that goat poop and send it their way.
China is NOT America. They do not appreciate life or anything that we do. People are disposable there, but yet we entrust them for nearly everything we eat or don’t eat, but can still kill (see baby toys laced with poison).
But it’s cheap. I guess that is all that matters to everyone.
You think oil companies are immoral?
Yep, that's the first thing that jumped out at me too. The FDA says, with a straight face, that it's entirely possible that out of the universe of hundreds of millions of potential contaminants, the one that "accidentally" tainted the product just happened to be the very one that mimics the real deal with such accuracy that normal screening tests do not discover it.
There's no way anyone could be stupid or gullible enough to really believe that. So the FDA's statement can only be taken as hard evidence that its mission is not to protect the food and drug supply, but to protect commerce and run interference for China.
“our drug companies who get us addicted to “non addictive” brain chemicals (Xanax, Klonopin, Ativan, Valium and the other 18 or so look-alike drugs, (benzodiazapines)”
Who ever said these things were “non-addictive”?
From the first time the benzodiazepines came out it was KNOWN that they caused dependency.
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