It was revealed this morning, according to a report in the New York Times, that the FDA has now identified a clear link between the heparin contaminant oversulfated chondroitin sulfate??"found in various lots of heparin inbound from China??"and adverse reactions that have, according to the FDA, led to deaths.
And while Baxter International, one of many heparin suppliers that have undertaken massive recalls of heparin in recent weeks disputes that figure??"suggesting that the number is closer to 5??"there is little doubt that the heparin scare is the widest-ranging incident so far, pointing to the qualitative quotient of products imported into the United States and other nations, from China.
And worse, the drugs on which we rely to remain healthy, to avoid sickness, to stay alive.
In reality, they may be contributing to our demise.
In the very latest developments, the FDA sent a warning letter to Changzhou SPL on Monday. That's the American-owned plant located in China that appears to be at the center of the contaminated heparin crisis. The agency cited the plant for having used unclean tanks to make heparin, lacking adequate processes for removing impurities, and accepting raw materials from unacceptable vendors.
To that end the FDA has so far identified 12 companies in China that have supplied tainted heparin, although the agency concedes that it does not know the original source of all the contamination, or the points in the supply chain through which the contaminant was added.
The latter would take a Herculean effort to nail down, given the huge cottage industry in China of small, mom-and-pop heparin huts where workers in sweatshop conditions process raw heparin fashioned from the mucous membrane of pig intestines. There are literally thousands of such unregulated enterprises spread across several provinces in China.
So far, countries affected beyond the US include Canada, Germany, Denmark, France, Italy, Japan, New Zealand, the Netherlands, Australia and China itself.
It has since been determined that the heparin contaminant oversulfated chondroitin sulfate (OCS) had been showing up as early as 2006. However, with only a few deaths linked to adverse reaction to heparin, the alarm bells were mute until a spike of heparin deaths began in November of last year and continued until this past January.
Oversulfated chondroitin sulfate is a substance derived from shellfish that is used as an oral treatment for joint pain. However, it has remarkable similarities to heparin as to its chemical makeup??"hence its use as a counterfeit to bolster the content of real heparin. Why this was done, is anyone's guess but speculation abounds. OCS comes in at a fraction of the cost of real heparin, and escapes detection when standard testing procedures are used. An outbreak of blue ear pig disease last year in many of China's provinces depleted stocks, and is said to have driven prices up. The heparin counterfeiting also fits a previous profile with regard to past misdeeds, including adding melamine (plastics) to pet food to bolster protein readings, diethylene glycol (anti-freeze) to mimic pharmaceutical glycerin in toothpaste and cough syrup, and toxic leaded paint in children's toys.
In other words, to save a buck.
While the motive has yet to be established and the issue is still at play, Congress is in the midst of trying to figure out how to fix this problem, and deal with what's inevitably bound to keep coming down the Great Wall if procedures are not put in place now. Congressional hearings are scheduled for today in the House, and Thursday in the Senate.
The Government Accountability Office is set to release a report today suggesting that the FDA would need to spend $56 million more in 2009 to commence full inspection of foreign plants, and would need to spend $15 million annually to inspect all drug plants in China importing to the United States??"every other year.
The agency's own failure to inspect the Changzhou SPL plant prior to approving the facility for heparin production in 2004, is a telling example of the need for a drastic infusion of more money to hire inspectors. However so far the Bush Administration, while acknowledging the problem and claiming to have strategies in hand for improving the situation, has been reluctant to advance any new funding.
"Even the Bush administration seems to understand the potential peril that these foreign firms pose," said Representative John D. Dingell, a Michigan Democrat who leads the House Committee on Energy and Commerce, in comments published this morning in the New York Times. "But they offer only vague plans to address the problems and they refuse to spend more than a fraction of the money needed to protect the public."
The FDA has since unveiled plans to open inspection offices in three cities in China, but have yet to receive approval from the Chinese government. In fact, China is pushing back, suggesting, "we don't have strong evidence to show that it's heparin or its contaminate that caused the problem," according to comments attributed to Ning Chen, second secretary at the Chinese Embassy.
The Chinese have also suggest that inspections be reciprocal; in other words, for the US to be approved for inspection offices in China, the latter would wish for the same right in the United States.
Meanwhile, the FDA suggests there is little doubt that the contaminate found in tainted heparin, a blood thinner used commonly for dialysis and some surgical procedures, is the root for the adverse reactions which is thought to have contributed to 81 deaths now.
"Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events," said Dr. Janet Woodcock, director of the Food and Drug Administration's drug center. "We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions."
Baxter International concurs; noting that its own tests confirmed that the oversulfated chondroitin sulfate found in heparin could cause illness.
Meanwhile Scientific Protein Laboratories, based in Wisconsin, issued a statement suggesting that the company, and its satellite facility Changzhou SPL regretted the action taken by the FDA to issue a warning letter, and stressed that the allegations contained in the warning letter do not reflect the company's current safety practices.
The Chinese have since agreed to test heparin lots before they leave the country for export, although the fear is that testing may not be sophisticated enough to detect a counterfeit, as was the case with the current recalled lots of product. And while the FDA assures that all current supplies of heparin in the United States have been stringently tested and deemed free of contaminants, the fear of what is to come remains.
The recent Tibetan protests in tandem with the arrival of the Beijing Olympic games, and the fact that China admits to executing it's former chief drug official last July, is a telling snapshot of a country with which the US is doing increased business.
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Think about it. If you have experienced a heparin reaction, or have lost a loved one allegedly to tainted heparin, who lies at fault? The drug maker? China? Or an administration that has allowed manufacturers to shift production to foreign shores and away from American workers, without equipping its federal regulator with sufficient resources to properly police the process.
Your lawyer will help sort that one out.