Joined: 19 Dec 2002
|Posted: Fri May 17, 2019 8:59 pm Post subject: The generic drugs - as you might think
|The Generic Drugs You're Taking May Not Be As Safe Or Effective As You Think
May 16, 20193:33 PM ET
A new book, Bottle of Lies, reveals serious safety and purity concerns about the global generic-drug supply.
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 Katherine 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. drugmakers, 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."
(In a statement to NPR, the FDA said that Americans "can be confident in the quality of the products the FDA approves" and notes it has "conducted a number of unannounced inspections" at foreign plants over the past several years.)
'Bottle Of Lies' Exposes The Dark Side Of The Generic-Drug Boom
'Bottle Of Lies' Exposes The Dark Side Of The Generic Drug Boom
As a result, Eban says, generic drugs sometimes go to market in the U.S. without proper vetting. She describes the FDA as "overwhelmed and underresourced" in its efforts to ensure the safety of overseas drug production.
Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives.
On why many drug companies moved production 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.
On how the 1984 Hatch-Waxman Act changed the generic-drug industry
What it created was a pathway at the FDA, a distinct application process for generics, because prior to Hatch-Waxman, basically the generic companies had to do the same set of tests [and] clinical studies that the brand did, and Hatch-Waxman said, you know what? We're gonna give you an abbreviated application. You can do the clinical studies on many fewer patients, because we've already proven safety and efficacy of this molecule in the human body.
But what Hatch-Waxman did that really ignited the generic-drug revolution is it gave the companies an incentive: The incentive was called "first to file," and it said if you are the first company to submit your application — and literally first by the minute or the second — and you get approved, you're going to get six months of exclusivity on the market to be the lead and only generic, and you're probably going to be able to sell your drugs at about 80 percent of the brand-name price. And that "first to file" really became the difference between making a fortune and making a living.
On how some plants that make generics prevent FDA inspectors from doing thorough inspections
Once you understand how vital these regulators are to safety and well-being, basically any sane American is not going to want to take a pill that's coming from a plant that's uninspected.
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.
On how the quality of generic drugs can vary depending on where the drugs are being sold
Generic-drug makers are adjusting the level of quality in their manufacturing depending on which market their drugs are going to, and depending upon the vigilance of the regulators in those markets. So they will take their biggest shortcuts, their biggest swaps of high-quality to low-quality ingredients, in markets with very poor regulation: sub-Saharan Africa, Southeast Asia, areas of South America.
On the Trump administration's efforts to ease corporate regulations
Once you understand how vital these regulators are to safety and well-being, basically any sane American is not going to want to take a pill that's coming from a plant that's uninspected. These regulators are doing absolutely vital work, and you can't go into this and come out thinking you want less regulation. I mean, it is too perilous and the costs of having, you know, nonsterile plants, non-bio-equivalent drugs — that cost is just too high.
But definitely, I think under the Trump administration you do see a more lenient attitude towards corporations generally, which, you know, has sort of trickled down to the FDA. But on the other hand, looking at the whole picture, I would have to call this a bipartisan failure that has not thought through in a systemic way how to respond to a drug supply in a globalized world.
On how much consumers should worry about the safety of generic drugs
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.
Sam Briger and Mooj Zadie produced and edited the audio of this interview. Bridget Bentz, Molly Seavy-Nesper and Carmel Wroth adapted it for the Web.