FDA deals with heparin scandal

Well, not exactly. This has been an issue that Hugh Hewitt brought to light last month, and he is rightly unhappy with the fact that we can find little in the media about this. Basically, there is heparin out in the market that has caused several allergic reactions; more than a few have been fatal. Today, the Chicago Tribune notes that the FDA has announced one firm that produces the drug has been found to have "unsuitable for it's intended use" and that they lack a way to locate the impurities:

The U.S. Food and Drug Administration today said a Wisconsin company's Chinese plant used to make the blood thinner heparin's active ingredient was "unsuitable for its intended use" and was not in a position to detect impurities in the product now linked to hundreds of potentially deadly allergic reactions.

The FDA is probing the China-based supply chain, where the active ingredient in heparin made by Baxter International Inc. originates. Health officials suspect it may have been intentionally contaminated with an animal-like substance similar to heparin that was put into the product to increase certain suppliers' profits.

In a stern warning letter to the general manager of Scientific Protein Laboratories (SPL's) Changzhou China plant manager that was released today, the FDA said its inspection two months ago of the plant revealed "significant deviations" from U.S. good manufacturing practices. In addition, the FDA said the plant's processing steps used to manufacturing heparin's active ingredient provided "no assurance" any impurities could have been effectively removed.

The plant was inspected in February for the first time despite several years of manufacturing heparin's active ingredient. FDA officials said the plant's inspection did not occur earlier because of a paperwork glitch. ...

"The contaminant found in certain lots of finished heparin product was not introduced in the manufacturing processes at Changzhou SPL or SPL," Scientific Protein said in a statement. "Based upon testing of crude heparin materials and reports from other manufacturers around the world, it is now clear that the suspect contaminant was introduced earlier in the supply chain in China and was widespread throughout the unrelated Chinese supply chains of many companies."

The FDA has said there are now 62 reports of deaths of patients who experienced one or more allergic reactions and who were infused with heparin from Jan. 1, 2007, through the end of last month, the agency said.

Let's be serious here. We're not talking about toys with lead in them, or some other garbage that comes from China, but we're talking about medicine. Now we could go to the conspiracy side of this and claim that china is doing this on purpose to kill us, but I don't think that's the case. I seriously believe this goes to their lax standards over in the People's Republic to have the same sort of oversight and safety regards for the goods and products they ship around the world.

I commend the FDA for stepping up and investigating this, and I hope that it continues. But I hope they don't take the UN route on how to address serious problems. Sternly-worded letters aren't the answer. I personally think they should have shut down the plant until they adopted more stringent methods of detecting impurities, and destroying those tainted batches.

If foreign companies want to come here to do business, or wish to carry on international trade, they need to abide by our laws and regulations. They don't get to pick and choose what they will and won't abide by. We have these regulations in place so that we don't have consumers dying or getting injured because of negligence. I think the FDA needs to check in to any Chinese-backed company that is currently producing medications for our consumption. And if they discover the same sort of lax procedures in those plants, again they should shut them down until those plants come up to compliance.

Publius II

ADDENDUM: I missed this WaPo story where Chinese and FDA investigators are pointing fingers at one another:

American and Chinese officials publicly disputed each other's conclusions today about what caused a deadly spike in severe reactions to the blood thinning drug heparin. Each side essentially said that the other was to blame.

Chinese officials today rejected the Food and Drug Administration's conclusion that a synthetic compound from China found in tainted supplies of the blood thinner heparin was the likely cause of the hundreds of injuries and deaths associated with the drug. Later, Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said that extensive research had convinced the agency that tainted heparin from China had indeed caused the reactions.

In addition, Woodcock said that the contaminated heparin had been found in 11 nations, and that at least 12 Chinese companies had some batches of the tainted drug ingredient.

In the Chinese government's first public statements on the controversy, Jin Shaohong, a top official with the Chinese National Institute for the Control of Pharmaceutical and Biological Products, said the compound -- oversulfated chondroitin -- could not be "the root cause" of the adverse reactions to heparin, as the FDA has suggested.

Speaking at the Chinese Embassy in Washington, Jin said some of the batches of heparin associated with severe allergic reactions and distributed by Baxter International did not have the synthetic chondroitin in them. He also said heparin with the contaminant has been found in more than 10 other nations, but none has reported a similar spike in harmful allergic reactions.

Jin said the Chinese government was conducting its own investigation of the heparin issue that would include a visit tomorrow to Baxter's New Jersey manufacturing plant. He said the allergic reactions could have been created by impurities introduced while the raw heparin from China was further refined by Scientific Protein Laboratories (SPL) of Wisconsin and then prepared for distribution in New Jersey.

Jin said he wanted to visit the Baxter plant and take back some samples of the company's heparin for "further in-depth analysis and investigation," because "when you see it, you believe it."

Yes, I'm sure he'd like to take some back; possibly an effort to destroy any sort of evidence we've found. Here's a compromise. If they're so sure that it didn't originate in China, then why not conduct the tests here. I'm sure the FDA would be willing to open up one of their labs and provide them with the instruments they'd need to conduct such an investigation. No need to fly the tainted samples back to China, and have them get "lost," shall we say?

I trust the FDA when they say they've done the tests and they say they've found the impurities in the drug; impurities that only could have come from it's initial creation phase in China. Like I said, we're not saying the Chinese are doing this deliberately, and until such information comes out that's contrary to that opinion, we'll stick by it. However, the practices in manufacturing over in China likely do not have the strict regulations that we do here. That's what has to change if China wants to continue doing business in the US.

Publius II