Carcinogens Have Infiltrated The Generic Drug Supply In The U.S

[Mito]

“Carcinogens have infiltrated the generic drug supply in the U.S.
An FDA quality-control nightmare reveals how impurities end up in America’s blood pressure pills.
The chemical N-Nitrosodimethylamine, or NDMA, is a yellow liquid that dissolves in water. It doesn’t have an odor or much of a taste. It’s known to cause cancer in animals and is classified as a probable carcinogen in humans—it’s most toxic to the liver. A single dose of less than a milligram can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days. An Oklahoma man poisoned the family of an ex-girlfriend in 1978 by pouring a small vial of NDMA into a pitcher of lemonade. In 2018 a graduate student in Canada sickened a colleague by injecting the chemical into his apple pie.”

Carcinogens have infiltrated the generic drug supply in the U.S. — Bloomberg Businessweek

 

['peataphysique]

Some of the contaminated valsartan contains as much as 17 micrograms of NDMA in a single pill. That’s equivalent to eating 48 pounds of bacon. The FDA estimates that for every 8,000 people who took the highest dose of contaminated valsartan daily for four years, there would be one additional occurrence of cancer.

You’d find nitrosamine—a category of carcinogen that includes NDMA—but you wouldn’t find 17 micrograms of it. European health regulators put the cancer risk from contaminated blood pressure medicines higher: They estimate that one out of every 3,390 people could become sick.

Motamed found black metallic and yellow rust particles in some of the machinery. In his report, he wrote that gaskets were discolored, warped, fraying, and missing pieces. Through a translator, Du told him the equipment was old and needed to be replaced.

Motamed identified worse problems. During regular quality testing, the company had found impurities in its drugs, which appeared as spikes or peaks in graphs that resemble the readout of an echocardiogram. Huahai didn’t try to identify them. Instead, it omitted those tests from its official reports, retested the drugs, and recorded passing grades.

Du called those spikes “ghost peaks” and said they appeared from time to time for undetermined reasons. Motamed was incredulous. “I indicated that I am not familiar with this concept,” he wrote. He concluded in his report that Huahai’s decision not to investigate or identify the impurities “casts a cloud of uncertainty over the accuracy of test results used in approval and release of the firm’s finished API products.” He recommended the FDA send a warning letter, the strongest of the agency’s rebukes. That likely would have meant the factory couldn’t manufacture any new drugs until it passed another inspection.


The FDA didn’t send the letter.

 

[yerrag]

Just goes to show anyone in the world can get away as long as they have the financial means to influence US regulatory agencies through lobbyists and their kind. The FDA, in this case, protects errant business while throwing consumers to the dogs.

It's good to practice defensive living (as you would when you practice defensive driving). If I could avoid having to taking bp medication like Valsartan, I won't be exposed to the cancer. In theory, it should not happen. In reality, it can happen, and it will happen. Murphy's Law. On the other hand, thinking wrongly that the FDA has you covered and will protect you, is being naive and as trusting as a beagle.