It's interesting that there has been little or no followup in the news. This, in light of the recent exposure of melamine "contamination" .... (see: http://forum.prisonplanet.com/index.php?topic=74031.0
Page last updated at 11:32 GMT, Wednesday, 30 April 2008 12:32 UK
Heparin contaminated 'on purpose'
America's drugs watchdog believes that Chinese-made ingredients for a blood-thinning drug may have been deliberately contaminated.
The US Food and Drug Administration (FDA) said earlier that a chemical contaminant had been found in some batches of the drug heparin.
It has linked the contaminant to hundreds of severe allergic reactions and dozens of deaths across the US.
An FDA director said when and how the toxin had been introduced was unclear.
The contaminated stocks were made by Baxter International, using China-based suppliers.
According to the FDA, a chemical called oversulphated chondroitin sulphate has been found in supplies in 13 countries.
Baxter International Chief Executive Robert Parkinson said the company was "alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a life-saving medication".
The company has recalled the heparin and imports from the Chinese supplier have been blocked.
Chinese officials have acknowledged the presence of the contaminant.
But they say it is not to blame for the allergic reactions or deaths, citing a lack of incidents in more than 10 other countries which have received the same contaminated stocks. http://blog.worldvillage.com/business/heparin_contamination_deliberate_fda.html
Heparin Contamination Deliberate: FDA
For the first time since it was revealed that a contaminant in tainted heparin sourced from China may be linked to as many as 81 deaths, officials with the US Food and Drug Administration (FDA) have publicly put forth their belief that the addition of oversulfated chondroitin sulfate was a deliberate act.
Chinese officials are not only denying the charge, but a spokesperson with Scientific Protein Laboratories, the Wisconsin-based enterprise that has majority ownership in the vilified Changzhou SPL plant, suggested that when the company attempted to identify the original source of the tainted heparin, they were stopped dead in their tracks by the Chinese.
The heparin contamination issue is thought to be the most serious act of poisoning in decades. A spike in adverse reactions, and a suspected link to an increasing number of deaths led various companies, including Baxter International, to recall very nearly their entire inventory of heparin. The Changzhou SPL plant, as it turns out, supplied the majority of the raw heparin to Baxter and at least two other companies. The facility has since been isolated as the entry point of the contamination, although the source has yet to be identified.
Some argue that source may never be found, given the state of the Chinese heparin industry, which is best described as a cottage industry spread out over several provinces. Raw heparin is supplied to Changzhou SPL, through consolidators, from various suppliers, most of which are mom-and-pop shops fashioning the crude heparin from swine intestines. Most of these facilities are unregulated, and conditions are said to be deplorable.http://www.outsourcing-pharma.com/Contract-Manufacturing/FDA-suspects-heparin-contamination-due-to-fraud
FDA suspects heparin contamination due to fraud
By Gareth Macdonald, 17-Apr-2008
The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.
Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.
FDA Commissioner Andrew von Eschenbach told the US Senate on Tuesday that the agency suspected the ingredient switch had been made "by virtue of economic fraud," but added that it would leave further investigation of the matter to Chinese State Food and Drug Administration officials. http://chinaconfidential.blogspot.com/2008/04/ceo-heparin-contamination-deliberate.html
Tuesday, April 29, 2008
CEO Says Heparin Contamination Was Deliberate
The chief executive officer of the US pharmaceutical company, Baxter International, says its blood thinner, Heparin, which has been linked to dozens of deaths, appears to have been deliberately contaminated.
Robert Parkinson said Tuesday that a contaminant known as "oversulfated chondroitin sulfate" was found in certain lots of Baxter's Heparin product.
In prepared remarks before a US Congressional subcommittee, Parkinson also said it was difficult to detect the introduction of the contaminant because of how closely it mimicked heparin.
Eighty one deaths have been associated with allergic reactions to tainted doses of heparin.Then as of May 19 2008 - China declares Heperin "Safe" - end of story....http://www.outsourcing-pharma.com/Contract-Manufacturing/Heparin-declared-safe-China-remains-nonchalant
Heparin declared "safe", China remains nonchalant
By Kirsty Barnes, 19-May-2008
The US Food and Drug Administration has declared the country's previously-tainted heparin supply to be "safe" due to stronger testing and controls that are now in place. Meanwhile, China continues to distance itself from the matter.
While in Shanghai last week, FDA Health and Human Services (HHS) secretary Mike Leavitt told the media that these tighter controls "will ensure" that no more contaminated heparin products make their way into the US.
"The FDA is satisfied that that which is coming into the United States is safe," he reportedly told the Associated Press (AP).
"We have put in place processes that we believe can ensure the safety of the heparin supply within the United States."
France, Italy, and Denmark, the US, Germany, Switzerland and Japan are among the countries to recall heparin products after a heparin contamination scare over product materials linked to China.
Baxter's heparin was the first to be found to contain the contaminant in February after the FDA received hundreds of reports of serious injuries and/or deaths in patients who had been administered heparin made by the company. Baxter subsequently pulled its product from the market while an investigation ensued.
It has since been revealed by an FDA investigation that the drug lots in question were contaminated with a substance called oversulfated chondroitin sulphate, which is made from animal cartilage and is a cheaper alternative to raw heparin, which is normally derived from pig's intestines. It is not approved for use in medicine.
However, he did concede that the current system is only a short-term solution. "We believe the system that we have for ensuring safety is a good one but completely inadequate for the future," Leavitt told the AP.
"What you'll see from the US is a substantial change in our strategy," he said, eluding to the agency's plans to station officials in overseas posts such as China in order to keep a closer eye on the regulatory situation.
In February, FDA inspectors conducted an inspection of the Changzhou SPL plant in question and subsequently issued it with a warning lettter aftger its inspection uncovered "significant deviations" from current good manufacturing practice (GMP) within the facility. It also banned any imports from the company until further notice.
Despite this, it has been reported that in recent government testimony by an FDA inspector that the agency has been barred from investigating the matter further down the supply chain, having been denied complete access to two of Changzhou SPL's suppliers of crude heparin.
It is still "too early" to blame OSCS for the deaths of more than 80 people, he said.
He claimed that because Baxter destroyed the recalled drugs it was actually "impossible to determine" exactly what caused the deaths.
Blame is also being laid on the US company Scientific Protein Laboratories that actually owns Changzhou SPL, with China reasoning that the US parent company should "bear responsibility for the plant and its products".