Our view on your safety: Businesses, regulators fail, and a tainted drug kills 81

[Woodmonkey]

Our view on your safety: Businesses, regulators fail, and a tainted drug kills 81

Leroy Hubley lost his wife, Bonnie, 65, last December and his son Randy, 47, a month later. "As Christmas music softly played in the background, we each said our goodbyes," Hubley recounted this week, fighting back tears. "Then my wife and love of 48 years drifted away. … The nightmare returned only weeks later when my son" died.

Both victims suffered from a genetic kidney disease, and both were being treated with heparin, a blood thinner used in the dialysis they needed to stay alive. They were among at least 81 people in the USA whose deaths from January 2007 to March 2008 have been linked to tainted heparin from China.

The heparin tragedy makes it horrifically clear that, much as with pet food fatally tainted with melamine and toys recalled because of lead or other harmful components, far more needs to be done to ensure that "made in China" meets U.S. health and safety standards. So far, the Food and Drug Administration has borne the brunt of criticism for failing to provide the necessary protection, but this is every bit as much the responsibility of companies that contract with low-cost Chinese suppliers.

In this case, a U.S. company, Baxter International, bought the heparin from a company in China. But it contained a contaminant, oversulfated chondroitin sulfate, that mimics heparin yet costs 99% less.

This week's congressional hearing, at which Hubley told his story, revealed a litany of failures.

Though the Chinese company, Changzhou SPL, a joint venture with Scientific Protein Laboratories, has manufactured heparin since 2004, it wasn't properly inspected. The FDA mistakenly identified a different plant because of a computer mix-up.

Baxter conducted its own inspection in a single day last September. Chinese authorities never bothered with an inspection because it was listed as a "chemical plant." When the FDA finally did a thorough inspection three months ago, it found so many problems it blocked exports to the USA.

If this contamination was intentional, as appears possible, those responsible must be criminally prosecuted. Beyond that, foreign governments and the understaffed FDA must work together to ensure that more people aren't harmed by tainted drugs or ingredients.

But no army of government inspectors can fully guarantee the safety of drugs, dog food or toys. The sellers of those products have to be the first line of defense. U.S. pharmaceutical companies have long fought drug reimportation from Canada and elsewhere, saying safety could be compromised. But many drugmakers have shifted to Chinese suppliers because of cost. Baxter's Wisconsin-based heparin supplier, for example, opened a plant in China.

Baxter says that even with a rigorous inspection, it could not have detected the fake ingredient. Perhaps not. It could, though, have discovered, as the FDA did, that the Chinese plant, among other things, did not have control over its raw-materials suppliers.

Presumably, this debacle and the inevitable litigation will prompt companies and suppliers to start cleaning up their act.

That's of little consolation to Leroy Hubley and relatives of other victims. Hubley's daughter, Dawn, is still on dialysis. He wants to know that she, and millions of others, will be safe. He deserves that assurance.

The Source

[Woodmonkey]

Before China, when we were doing our importing from Europe, S. Korea and Taiwan, we didn't have all these problems with tainted food and medicine.

[Snowden]

It's time to bring those things back here to be manufactured. We can hardly be expected to spend the rest of our lives checking every prescription or across-the-counter medical or hygienic product to be sure it's not made in China. But that seems the only way to remain safe from this sort of "accident."

Accident my foot; it's sloppy workmanship or it's intentional. Either way, it's not safe.

[Woodmonkey]

It has to do with standards and respect for human beings - plus the legal system we have here. China is lacking in all three.

Too bad we can't all take them to court for huge sums they have to pay - that might bring improvement. But ... we can't.

[leobold1]

Presumably, this debacle and the inevitable litigation will prompt companies and suppliers to start cleaning up their act.

You presume far too much.

I agree with Snow...we have to have control over these things.