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Heparin Recall Expanded Yet Again

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Bethlehem, PAWhile yesterday was Good Friday, there was no rest for those caught up in, and trying to manage the heparin scare—and it certainly was not a good Friday at all, after B. Braun Medical recalled 23 lots of heparin infusion bags linked to a plant that is, in turn linked to tainted heparin originating in China.

Previously, Baxter International had recalled virtually all of its heparin products after several deaths and hundreds of adverse reactions have been reported. The Braun Medical product was manufactured with crude heparin originating with Changzhuo SPL, the American-owned plant in China that has been at the center, if not the origin of the heparin issue.

Hospital SettingInfusion bags are used mostly in a hospital setting. There is no concern that even with this recall, there would be a shortage of heparin.

Meantime, Scientific Protein Laboratories, the Wisconsin-based firm that holds the majority ownership in Changzhuo SPL, said yesterday that their investigation has concluded that the tainted raw heparin did not originate with its facility. In other words, it is assumed that while the plant served as a conduit to get the tainted raw heparin into what would eventually become refined heparin, the source of the tainted heparin does not originate at its facility.

Thus, it believes that the tainted heparin originated earlier in the supply chain.

Changzhuo SPL, which supplied to both Baxter International and Braun Medical, bought its raw heparin from two primary suppliers or consolidators, which source the crude heparin from smaller producers.

However, the majority of the crude heparin industry in China is based on a largely un-regulated cottage industry of small houses numbering into the thousands, where workers and sometimes entire families process crude heparin from the intestines of pigs in less-than-ideal conditions. An outbreak of blue ear pig disease last year may have contributed to the problem.

Meantime, scientists have pretty much narrowed down the identity of the counterfeit mimic found to represent as much as 20 per cent of the tainted heparin, although it is unknown where the contaminant originated, and why it showed up. Speculation runs from the need to flesh out the heparin due to short supply, or to mitigate higher prices supposedly stemming from increased demand, and decreased supply.

Or, it could be a simple case of profiteering, seen in the same light as past spiking of toothpaste and pet food.

It is not known if the counterfeit heparin mimic—oversulfated chondroitin sulfate—is what is making people sick.

For its part, the State Food and Drug Administration for the Peoples Republic of China announced yesterday that it is stepping up supervision with regard to the production of heparin, and is now requiring producers of the active ingredient to obtain raw materials only from registered suppliers. Those suppliers, in turn, have been ordered to increase surveillance, and the various checks and balances to verify the quality, and efficacy of the raw material.

Whether that will indeed happen, is anyone's guess. However, given the number of unregulated heparin houses and sweat shops—which number into the thousands over several provinces—the potential to regulate, and ride herd over all of them is a dubious goal.

To shut them down would wipe out an entire industry that could easily migrate to avoid detection. In the meantime, simply requiring plants and consolidators to purchase their raw materials from only regulated producers, without addressing the existence of the hordes of heparin huts already running at full capacity, simply means that proprietors would be forced to find new markets for their crude heparin, and new ways to circumvent the law.

There is also a crimp in China's regulatory law, given that many legitimate suppliers and producers of heparin are above regulatory authority given that they are regarded as chemical plants, and not drug manufacturers.

For its part the US Food and Drug Administration (FDA) has ordered all American imports of heparin to be inspected after confirming that the contaminated heparin linked to the Baxter heparin recall originated with a contaminated active ingredient from the Changzhuo SPL plant.

While we now know what the contaminant in the Chinese heparin is, we have yet to learn how it got in there, and what role that contaminant has in the scores of adverse patient reactions. So far, 19 deaths and hundreds of adverse reactions have been associated with tainted heparin products.

Regardless of who is at fault—the FDA for not inspecting the Changzhou SPL plant in the first place, the Bush Administration for not properly funding the FDA, the Chinese for being lax or greedy or both, or the various producers with links to the supply chain, the fact remains a large number of innocent lives have been compromised due to this lack of due diligence. Given previous alleged, and substantiated concerns over recent imports from China, it is unconscionable that government regulators did not take a closer look at any and every product, raw or finished, coming into the country to be consumed by innocent and well-meaning Americans.

The fact that more and more consumable products are coming into the country from offshore, contributing to a manufacturer's profit margin, does not excuse government or industry from implementing safeguards to protect innocent lives.

Perhaps, as the court cases mount, they'll start listening now.

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