Tags: china | pharmaceuticals | valsartan

Tainted Generic Drugs From China Are a National Security Risk

Tainted Generic Drugs From China Are a National Security Risk
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Thursday, 15 August 2019 04:40 PM Current | Bio | Archive

Fentanyl, a deadly synthetic opioid painkiller 50 times stronger than heroin has flooded the U.S. market.

Made largely in China and smuggled into the United States over our southern border, the drug poses such a danger that President Trump has made the Chinese failure to curtail its manufacture a central issue in his ongoing trade negotiations with President Xi.

Yet fentanyl is just one element of dangerous Chinese drugs harming Americans.

Though barely registering a blip in the media, China also produces toxic ingredients found in generic drugs worldwide. Incredibly, those tainted drugs have found their way into the military health system through the Defense Logistics Agency (DLA) for consumption by both active duty and retired personnel. It’s the biggest national security risk that practically no one has ever even heard of.

Like so many products produced in China, quality control over substances used in generic drugs is virtually non-existent. For anyone familiar with how Chinese companies often operate, that’s not a big surprise.

Even if the average Joe or Jane hasn’t heard about it, the U.S. Food and Drug Administration (FDA) has issued recalls of generic valsartan, a blood pressure drug. That’s because China’s tainted valsartan contained a cancer-causing chemical called NDMA – a product used to make rocket fuel, as accurately described by the World Health Organization. In fact, NDMA is so dangerous that not only does it have no place in pharmaceuticals, it is actually not even used in making rocket fuel anymore, because it is considered too risky to work with.

According to The New York Times, “the tainted valsartan came from a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Company,” and was distributed in the U.S. by generic giant Teva Pharmaceutical Industries, among other companies.

The tainted Chinese valsartan was widely prescribed in North America beginning in September 2015 and used in some cases for years. The valsartan scandal is only the tip of the iceberg, however. Most Americans are not aware, but increasingly virtually all of the ingredients going into generic drugs are being manufactured outside of the United States in facilities where meaningful oversight is generally absent.

In fact, since last summer drug companies have had to announce a total of 45 recalls of generic lifesaving blood pressure medications. They include certain versions of valsartan and two other blood pressure drugs, losartan and irbesartan, as well as other blood pressure medications that contain the recalled drugs in their formulations. The raw ingredients were traced to overseas manufacturing sites.

Speaking publicly on the issue recently, Massoud Motamed, a former inspector with the U.S. Food and Drug Administration (FDA) had this to say: "Growing up, we had this saying, 'You get what you pay for,'" Motamed said. "We have that belief for everything except pharmaceuticals. If we want to drive competition and drive the price down, it comes at the cost of quality."

In fact, the FDA only inspects one in five foreign drug factories, and when they do inspect such facilities their authority is severely limited. The inspections are done only with advance notice and are of limited duration. In essence, in most cases, the FDA simply accepts the manufacturer’s word regarding conditions and procedures used in making ingredients, which then find their way directly into the bloodstreams of American patients.

The impact of this problem cannot be overstated. In 2016, for example 1.6 million people purchased valsartan and another 9.2 million purchased losartan. In the case of those medications, in fact, the FDA has been forced to publish a list of substitute blood pressure drugs that are known to be free of carcinogens, so patients and doctors can identify safe medications.

The U.S. government has rightly declared Chinese-manufactured ingredients in generic drugs to be such a problem that they constitute a “national security risk.”

As with so many aspects of our trade policy with China, the dire long term implications are now becoming clear. We are increasingly dependent upon Chinese factories to supply the medications that Americans need to treat serious, life-threatening illnesses.

Yet unfortunately, due to lack of quality control and China’s desire to make a fast buck… or billion, we’re also discovering that those medications come from a veritable poison factory.

It’s an urgent national security risk that we just can’t afford any longer.

Charles "Sam" Faddis is a Veteran, retired CIA operations officer, senior partner with Artemis, LLC and published author. With degrees from The Johns Hopkins University and the University of Maryland Law School, he is a contributor to sofrep.com, Newsmax, and The Hill among others. He regularly appears on many networks and radio programs as a national security and counter-terrorism expert. Sam is the author of "Beyond Repair: The Decline And Fall Of The CIA" and "Willful Neglect: The Dangerous Illusion Of Homeland Security." To read more of his reports, Click Here Now.

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CharlesFaddis
As with so many aspects of our trade policy with China, the dire long term implications are now becoming clear. We are increasingly dependent upon Chinese factories to supply the medications that Americans need to treat serious, life-threatening illnesses.
china, pharmaceuticals, valsartan
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2019-40-15
Thursday, 15 August 2019 04:40 PM
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