CHINA ESQUIRE

Despite all of the hubbub about Tibet (which is important news, don’t get me wrong), the headline that caught my eye fastest yesterday at China Digital Times was that the Heparin contaminant was actually identified.  Here is the article from the Los Angeles Times ( h/t to CDT):

A compound related to a common nutritional supplement has been identified as the contaminant in a blood-thinning drug imported from China that sickened hundreds of frail patients in the U.S. and is suspected in a number of deaths, federal officials said Wednesday.

The substance mimics the real drug — heparin — in standard safety tests and may have been deliberately substituted for the genuine compound somewhere along the line to boost middlemen’s profits. It could also have been added through a mishap or some kind of misguided experiment. Because of difficulties in back-checking, it’s unclear whether Food and Drug Administration officials will ever know for sure.

The recall inflamed public concerns about the safety of consumer goods from China; the heparin investigation may give a boost to legislation stalled in Congress that would set up a much more rigorous import inspection system.

“It is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering,” Sen. Edward M. Kennedy (D-Mass.), who chairs a panel that oversees the FDA, said in a statement. “Whether this contaminant was introduced intentionally or by accident, the full force of the law must be brought to bear to bring those responsible to justice.

“To guard against future abuses, every drug manufacturer needs to inform FDA of where it sources its ingredients and what it is doing to ensure that these ingredients are pure and potent.”

“This is not a new problem,” said England, who now advises foreign companies on how to comply with U.S. regulations. “This is a close cousin of problems that have presented themselves before.”

The FDA is chronically short of resources to meet its mandate to oversee a vast array of drugs, medical devices, and processed and natural foods. Inspections of foreign producers in particular are infrequent. And China has been difficult territory for U.S. regulators.

I have already been on the record many times about doing QC and due diligence with regards to the Heparin debacle, so I will refrain from overly beating a dead horse.  (see “ first pet food, then trader joe’s, now heparin…” and “ heparin update part 2: chinese fda lays responsibility on importers“)  Note that the FDA cannot catch all of the bad apples. It is short of resources–in fact, woefully short of resources.  So if you are counting on regulatory agencies to help solve your sourcing quality issues, the U.S. has no resources and the Chinese have disclaimed all responsibility.  In other words, the ball is in your court.  ‘Nuff said.

The other thing that I want to note is that Senator Kennedy is on the record saying “the full force of the law must be brought to bear to bring those responsible to justice.”  Well, if the LA City Attorney’s Office can do it, so can others.  We now have a Heparin contaminant identified.  As the article points out, we may never know where the problematic materials were introduced.  So who will take the fall?  The FDA won’t. I foresee yet another criminal case coming in the future.  Maybe not now, but if deadly toothpaste and pet food can warrant a criminal case, you can be sure this Heparin thing will too.  I don’t know if it will be Baxter or someone else, but just wait and see.  It may even be a different set of charges because this criminal liability thing for Chinese sourced products is so new that prosecutors have room to be creative in which causes of action to bring.

The storm is coming.  Do you feel it?

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