Wayne Pearl, like millions of people with high blood pressure, takes the widely prescribed generic drug valsartan.
So it was with more than a little concern that he recently learned the Chinese supplier of the drug’s active ingredient for years had been hiding the fact that its product was contaminated with a carcinogenic material once found in rocket fuel.
If that was the whole story, it would be sufficient to spark worry among all Americans about the safety and reliability of the pharmaceutical supply chain. But it gets even worse.
Pearl, 65, a Westlake Village resident, discovered that when the generic valsartan that cost him $8 a month was imperiled, his choice was to switch to a name-brand alternative costing — wait for it — nearly $300 monthly.
That led Pearl to forgo treatment for several weeks until his doctor could find a generic med that contained a different active ingredient.
There’s so much to be miffed about here, I hardly know where to begin.
Oh, I forgot to mention: Pearl isn’t exactly a bystander when it comes to the pharmaceutical business. He spent about 25 years with the Thousand Oaks biotech firm Amgen, including stints as vice president of manufacturing and vice president of operations. He currently works as an industry consultant.
“It’s all about money,” he told me. “It’s all about manufacturing for the cheapest amount possible.”
I asked Pearl if he was surprised to have been exposed to a potentially tainted med.
“No,” he replied. “I’m not surprised at all.”
The Food and Drug Administration announced in July and August the voluntary recall of a number of prescription drugs containing valsartan.
“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products,” the agency said with a breathtaking blandness.
According to the federal government’s Agency for Toxic Substances and Disease Registry, NDMA “is a yellow liquid which has no distinct odor.” It was “used to make rocket fuel, but this use was stopped after unusually high levels of this compound were found in air, water and soil samples collected near a rocket fuel manufacturing plant.”
“NDMA is very harmful to the liver of animals and humans,” it says. “People who were intentionally poisoned on one or several occasions with unknown levels of NDMA in beverage or food died of severe liver damage accompanied by internal bleeding.”
It adds that “when rats, mice, hamsters and other animals ate food, drank water or breathed air containing lower levels of NDMA for periods more than several weeks, liver cancer and lung cancer as well as non-cancerous liver damage occurred.”
So, yeah, not something you want in your medicine.
In its recall notice, the FDA said the tainted NDMA came from Zhejiang Huahai Pharmaceuticals in Linhai, China. European regulators say the company may have known about the contamination as early as 2012 and continued selling the ingredient worldwide to generic drug manufacturers.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The thing is, staying on top of drug safety is an increasingly challenging issue as medication supply chains traverse the globe, with many ingredients originating in far-flung plants throughout the developing world.
The FDA estimates that 80% of the active ingredients in drugs found in U.S. pharmacies originate abroad, with the main producers of these ingredients in China and India.
Joel Hay, a professor of pharmaceutical economics at USC, said the FDA just doesn’t have the funding or manpower to adequately monitor drug factories worldwide.
In the case of valsartan, the FDA didn’t act until 22 other countries announced their own recalls.
“Certainly it is the FDA’s responsibility to monitor the safety of these production facilities and the produced drugs,” Hay said. “There isn’t much we can do except get Congress to pass bigger FDA budgets.”
Ivo Abraham, a professor of pharmacy practice at the University of Arizona, agreed that it’s relatively easy for contaminated drugs to slip past regulators.
“It’s just not possible to enforce high standards to the extent we would like them enforced,” he said.
To a certain degree, patients have no recourse but to trust and hope for the best. It’s not like you should stop taking prescribed medications.
Still, I advise doing the occasional search for news regarding either the brand name of any regularly taken drug or its active ingredient (which will be on the label). That’s the best way to stay on top of any announcements.
“Patients have to be advocates for their own health and know that they must contact their providers for answers,” said Luba Ketsler, a healthcare economist at the University of Texas at Dallas. “That’s a big problem — people not asking or not understanding even what to ask.”
Switching from a generic to a name-brand drug may be safer — the big drug companies have more resources for quality control — but, as Pearl found, there’s a cost attached. Why an $8 generic would equate to a $300 name-brand version, however, is a mystery.
Moreover, many insurers may not cover the name-brand drug, leaving you on the hook for the entire cost. Make sure you speak with your doctor and insurance company before any change.
Here’s a thought: How about a requirement that drug companies provide full transparency if not on labels then online? Let people know the sourcing of all active ingredients, including both the manufacturer and country of origin.
This may be too much information for many patients. But for some, including myself, it would be a very helpful way to be an informed consumer, which is exactly what the drug industry says they want us to be.
Pearl told me you’ll never be able to prevent problems like this valsartan thing from cropping up, not the way the global drug business operates. Such issues are inevitable, he said.
So the more sunlight the better.