The NYTimes has a nice “summary” article on the heparin scare today.

They do a nice job, but they seem to assume that the episode is an accident, so the article it points to the FDA for failing to regulate the drug manufacturing process.

Dr. Roger L. Williams, chief executive of the United States Pharmacopeia, which sets quality standards for medicine and supplements.

“What you are seeing here is the tip of the iceberg,” Dr. Williams said. “How do we know what else has gone wrong?”

Ah yes. Passive verb: Gone wrong. Accident.

In American business, despite all those TV shows and movies about bad businessmen killing to make a profit, there is enough competition so that making shoddy items in the long run doesn’t work.

So you need honesty and trust to run a successful business. Lots of stuff goes on, but as a whole, business has to be honest to work.

Now, take Asia. Need a paper approved? Get your wife’s brother in law to fix it. Need a license, give a small gift to help.

I don’t know how it works in China, but here in the Philippines, what came out from the Broadband scandal was that the average bribe is 20% of the contract. (The rumor here about one broadband deal that gave the contract to China, was that China was willing to pay a higher bribe of 40%, but that amount was too much even for the usual honest Pinoy politicians) .

So if the heparin was (for example) accidentally contaminated with E.Coli from pig gut, or a small amount of chemical of any sort, that would be an accident.

But this was no accident.  As I pointed out elsewhere, this is not an accidental contamination. The contamination was done with a chemical that was altered chemically to mimic heparin in routine drug quality control testing. This required expertise both in knowing how testing was done, and in finding what cheap chemical could be used.

And the fact that some heparin batches contained up to 50% of the fake ingredient is the “smoking gun” that this was a deliberate act.

Let’s connect the dots.

The NYTimes article has a nice outline of the chain of ingredients. Let’s see where the deliberate “contamination” could have occured:

The way heparin is made and distributed illustrates the challenges they face. The drug’s raw material comes from mucous membranes in the intestines of slaughtered pigs.

I doubt contamination here, unless an outsider came in and supplied the chemical to put in at this point. Too many small slaughterhouses to work with, too many people would know about it and need to be bribed.

Those membranes are mixed together and cooked, a process that in China often takes place in unregulated family workshops.

Again, lack of expertise and too many people to bribe. Wouldn’t make sense from a profit angle.

It is then transported to middlemen, called consolidators, who direct the product to plants in China that manufacture heparin’s active ingredient for shipment to either another trader or the finished dose manufacturer.

Voila. The fake ingredient was probably added by the middlemen.

The clue is that not only was the heparin from one plant that supplied Baxter involved, but that some other supplies to Japan and Europe were involved. This suggests middlemen, who supplied the adulterated ingredients to several companies. Was it only one middleman, or did one tell another?

Knowing Asia, if I were a detective, I’d check their clan lines, native towns, and marriage lines. Then I’d check their bank accounts and see who is making a profit. But of course, they probably will have the money in another relative’s name, and maybe not even in China.

The real question is how far the corruption goes into the Chinese government inspectors who are supposed to regulate the industry.

Pressure the Chinese government, and they’ll clean up their act.

Once this is done, then start impressing on US businesses that they need to do a better job in checking their cheap Chinese goods. One suspects Baxter ordered the heparin products from China because it was cheap, and was watching it using routine testing for quality control. One doubts that Baxter was aware that criminals were substituting fake ingredients to make a profit.

As for the news reports: point the finger at the culprit, not the victim. Keep blaming the FDA, big business, and the Bush administration, and the real culprits will laugh themselves all the way to the bank.

Only by pressuring the Chinese government will such criminal practices be stopped.


Nancy Reyes is a retired physician living in the rural Philippines. Her website is Finest Kind Clinic and Fishmarket. 

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