An Advocate of Generic Drugs Reconsiders Their Risks
When did you first start to suspect that there may be problems with generic drug quality?
It was in about 1998 or 2000. Our readers started communicating to us that they were having therapeutic failures with drugs when they switched from brand names to generics. Then we talked with pharmacists, who said they heard the same thing from patients.
That's intriguing. But if it's really a problem, wouldn't the FDA have more convincing data?
When a patient's antidepressant or pain reliever doesn't work, it's very hard to know whether defective or counterfeit manufacturing is to blame. So, the FDA basically ignores therapeutic failures. What they have a harder time ignoring are adverse events like kidney failure, which are reported [to the agency through a system called] MedWatch. Kidney failure caused by a drug is hard enough for them to catch.
You're also concerned about counterfeit drugs, which have been a problem for consumers in China and elsewhere. Last year, hundreds of people died in Panama after taking cold medicine that was contaminated with antifreeze that had been falsely labeled by manufacturers in China.
No one knows whether counterfeits have penetrated the generic-drug market. As far as we know, investigators haven't bothered to look. But the market is huge, and it is cutthroat. [Sellers] get a drug into retailers based on price, not quality. Everyone is relying on the manufacturer to supply a quality product, but the manufacturer might have bought the raw materials in China.
As a longtime champion of generic drugs, how do you feel about these new concerns?
I feel betrayed. I want generic drugs to be safe and effective, so people can save on their prescription medicines. The FDA does a great job of approving drugs, but once they're approved, it's like, Katy bar the door.
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