DANGEROUS DRUGS
A New Book Argues That Generic Drugs Are Poisoning Us
If you take any medication, chances are one, if not all, are generic. Recently reports of a centipede, alive and well, incased in and elderly woman’s blood pressure medicine, glass shards in bottles of Lipitor, and growing concern that almost all of these drugs are made in India and China. Not such a good report, right?
Now there is a book by journalist Katherine Eban, who has been covering this topic for over 10 years. The book reveals documents that have been altered, equipment that does not function correctly and in fact, drops metallic shavings into the medicines it is packaging, and inspections by the FDA that are scheduled ahead of time, given these plants time to correct problems that might concern the FDA.
As the cost of prescription medication soars, consumers are increasingly taking generic drugs: low-cost alternatives to brand-name medicines. Often health insurance plans require patients to switch to generics as a way of controlling costs. But journalist Eban warns that some of these medications might not be as safe, or effective, as we think.
Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drug makers, but Eban’s new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results.
“These plants know that [the FDA inspectors are] coming,” Eban says. “I discovered [some overseas drug companies] would actually … alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old.”
What happened that our drugs started being made overseas? “There were a couple of reasons for this surge in globalization in the drug industry. One was environmental regulations. … How are you going to safely dispose of all the chemicals and solvents that you’re using? And … there was less environmental regulation overseas. But another one is: If you move your manufacturing plant to India, you’re going to save a huge amount on labor costs and supplies — ingredients — overnight.
And so what you saw was a huge migration, both of manufacturing to Indian-owned companies, Chinese-owned companies, but also Western- and U.S.-based companies, buying up manufacturing plants overseas and moving their manufacturing there.”
As for FDA Inspections, Eban says “In several instances I documented, the investigators were poisoned in the course of their inspections with tainted water from the tap, which you can’t drink in India. They felt sick during inspections. I mean, this was a way of running out the clock. They were followed. In one instance, an investigator had his hotel room bugged. In some cases that I had heard about, [the plants] were trying to scan passenger lists in airports to try to determine exactly who was coming when.” So there were elaborate measures that the plants took to try to protect against bad inspections resulting in inspections that did not reflect the true conditions of these plants.
“One drug investigator said to me that he thinks the concern is higher for people on maintenance medications who are taking these drugs day in and day out. Those drugs may have toxic impurities. Those can build up in your liver, you may not know it, or you may be having side effects that you didn’t think about before, and then you realize, “Wait a second I was switched to a different generic” or “I was switched from a brand to a generic.”
So I think that once consumers start thinking about this as a factor … I think they wake up to the fact that there may be consequences for them. … You can look on the dispensing label, you’ll have the name. Go into Google, put in the name of that company and “FDA warning letter.” What has the FDA found out about this company? Has this company had drug recalls? It is a bit of sleuthing, but if you’re taking this medication day in and day out, it’s worth it.”
Despite all the reassurance that generic drugs are just as save as the original, that statement does not actually indicate that the drugs are safe. If anything it is true because the original drugs may well be subject to the same careless and sometimes, criminal, behaviors that impact the safety of all drugs made overseas.
To look more carefully at this potential health risk, the book is available on Amazon and an interview with Eban, visit https://www.npr.org/sections/health-shots
