Thursday, June 20, 2019

More Contaminated Blood pressure medicine discovered

CNBC notes another batch of Valsartan, a medicine used for high blood pressure and heart failure, has been found to be contaminated with small amounts of a cancer causing chemicals.

But missing from the story: Where was it manufactured?

From Sciencemagazine.

In this case, the valsartan recall was originally traced back to a problem with the material from Zhejiang Huahai Pharmaceuticals. 
Remember that name: ZHP.
That’s the Chinese manufacturer of the first recalled batch.
however, it wasn't just ZHP: the newest batch recalled? That was made in India.

the article goes into details about manufacturing, but if you continue reading you find (TADA!) the source of the problem:


But how do you get N-nitroso compounds from the amines, and why was the solvent switched?....
ZHP themselves appear to have introduced a cheaper, higher-yielding route using just sodium azide and zinc chloride in an aprotic solvent like DMF...

italics mine. 

In other words, it was done to make a higher profit, and they didn't care if people die. 

The Science magazine link goes into the chemical details of the problem. 

But then the author blames the drug companies for not figuring out that someone was corrupt enough to do such a thing and trying to catch them at it.
The Science magazine article naively wonders what is behind the problem.
 So we’re going to have to think about the way that synthetic routes in the generic API business are monitored, it would seem. People seem to have missed that changing the chemistry for the sartans could lead to this problem, so what else are we missing?
again, italics mine.


Anyone here in Asia could tell you what you are missing: corruption.




Just like what happened in dozens of other fake medicine /fake dog food additives/fake heparinfake baby formula or the Panama cough medicine deaths: scandals from deliberate actions by those in charge of the factories: it was deliberate, not accidental, and it was done to make money.

But it isn't just China: after ZHP got away with it, apparently other manufacturers found they could do it too, and decided they could get away with it too.


The problem for my US readers? The dirty little secret is a lot of the world's medicines are outsourced to third world factories who can manufacture it cheaper. True, if it has a brand name company supervising the third world factory, you are safe from simple carelessness and shoddy manufacturing problems, but if the one who owns the factory is smart and corrupt, he will figure a way to get around the quality control inspections.

something to remember when Trumpieboy threatens tariffs on Chinese goods.


World Health Organization article on this problem estimates one out of ten medicines sold in third world countries are fake, counterfeit, substandard or have toxic additives.:

No countries remain untouched by this issue — from North America and Europe through to sub-Saharan Africa, South East Asia, and Latin America. What was once considered a problem limited to developing and low-income countries has now become an issue for all.
With the exponential increase in internet connectivity those engaged in the manufacture, distribution and supply of substandard and falsified medical products have gained access to a global market place. This extends both to consumers and business forums. ...
However, it is in low- and middle-income countries and those in areas of conflict, or civil unrest, where health systems are weak or non-existent that bear the greatest burden of substandard and falsified medical products.

a slightly longer version of this article is posted to my medical blog. 

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