Memo to Big Pharmas: Get the F#&K out of China.

Anyone who is familiar with me knows that I don’t drop the f-bomb very often — it takes a bit to provoke me to that point. As the saying goes, “it takes a long time for me to lose my temper, but once lost I could not find it with a dog.” Well put a picture of my temper on a milk carton and send out the scent-hounds, for it is well and truly lost.

It is one thing for manufacturers and consumers alike to take advantage of China’s ability to manufacture toys and electronic gadgets cheaply [if sometimes nastily]. It is another thing altogether to outsource manufacture of pharmaceuticals to a country which is fundamentally incapable of safeguarding the safety and efficacy of the products they make.

I remember an older rellie in the States who was involved in NASA in the late 50’s and 60’s telling me about Wally Shirra’s comment to a journo who asked him “How did you feel?” whilst sitting in a rocket on a launchpad which had recently seen an unseemly number of things go wrong. “How would you feel,” Wally is said to have replied, “if you were stuck here, on top of 20,000 parts each one supplied by the lowest bidder?”

Anyone dependent on pharmaceuticals to keep them alive today would be forgiven for feeling the same way. Decidedly nervous.

An unseemly number of things have recently gone wrong with pharmaceutical products sourced in part or in full from unregulated, unchecked Chinese manufacturers, and it’s time for regulators in first-world countries to stand up and say, as Michael Santoro, an associate professor of business ethics at Rutgers Business School, has said,

“China is not ready to be a chemical manufacturing hub for the United States and the rest of the world. There’s far too great a safety danger. We’re getting too many safety signals in recent months. This isn’t a catastrophe waiting to happen. This is a catastrophe that is happening.”

The particular disaster that has my ire up at the moment is a drug called Heparin, which has a wide range of uses from surgery to dialysis to treating clots to clearing IV lines & ports to procedures for blood disorders such as blood cancer and immune-system diseases. “It is a mainstay of our therapy,” says University of Chicago hematologist Joseph Baron. “It’s used extensively in virtually all medical services.” There have now been literally hundreds of adverse reactions to batches of heparin manufactured in part or in whole in China, and several confirmed deaths.

Originally, the finger was pointed at the US companies whose names were on the label, but just recently the problem was traced to a Chinese plant which has never been inspected by the FDA. (See Heparin Trail: Pig Intestines From China Via Wisconsin for more details.)

But as excerpts from Santoro’s paper to be presented next month, ‘Flight of the Toxic Dragon: The Global Threat to Safety Posed by China’s Underdeveloped Drug Regulation Regime,’ show, the Heparin debacle is almost certainly just the tip of the iceberg.

China has an estimated 80,000 chemical companies, and the FDA doesn’t know how many sell ingredients used in drugs consumed by Americans or on-sold to other countries. Meanwhile, pharma is increasingly moving production to China.

Just as news of toxic toys, toothpaste and dog food made headlines, an AstraZeneca exec acknowledged plans for outsourcing production of some of bestselling meds in the Far East, including China. And Pfizer wants to outsource as much as 30 percent of its manufacturing, mostly to Asia. Three years ago, Roche granted Shanghai Hua Lin a sublicense to make Tamiflu.

Other countries (such as India) who have large drugs manufacturers which source their ingredients from China must also start taking this threat seriously, as must all countries who import finished medications from such nations. China is currently the undisputed world leader in contaminated products and sourcing products for pharmaceuticals there is just stupid.

So here’s my message to our big Pharmas: Forget this ‘lowest bidder’ shit. Get the f#&k out of China.

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For more on this, see the following pieces (these are just the basics - there are many more out there):

Baxter Halts Production of Heparin

Heparin Probe Finds U.S. Tie to Chinese Plant

Heparin Trail: Pig Intestines From China Via Wisconsin

F.D.A. Broke Its Rules by Not Inspecting Chinese Plant With Problem Drug (and over 40 other NYT articles here)

Pharmalot Blog (Excellent analysis of the China Pharma problem)

UPDATE: 2 new posts on this subject. “China (again): It’s not just your pets they’re killing” and “The FDA and foreign drug ingredients”