An Advocate of Generic Drugs Reconsiders Their Risks
Author Joe Graedon has been urging people to buy generic drugs for more than 30 years, arguing that generics are chemically identical to brand-name drugs and come at as little as one fifth the cost. Now he's not so sure. In their most recent book, Best Choices From the People's Pharmacy (Rodale, 2006), Graedon and his wife and coauthor, Terry Graedon, say that the problems at the Food and Drug Administration, which approved prescription drugs like Vioxx only to discover safety problems once the drugs were on the market, raise larger questions about the safety of generic drugs. And in recent months, safety problems traced to Chinese manufacturers have underscored these concerns.
The Food and Drug Administration recently banned imports of shrimp and other seafood from China, because some of those imports were tainted with chemicals and drugs banned in the United States. That's raised concerns about drug safety, because a huge percentage of the drugs consumed in the United States—$675 million worth last year alone—are made in China. Should people be concerned?
Yes. If you dial back to 1976, when our first book, The People's Pharmacy, came out, doctors almost unanimously said: Stick with the brand names; they're safer than generics. [But my wife and I] bought the FDA line that they're 100 percent identical. We were very pro-consumer, we had no particular love for the industry, and we thought this was a fantastic way for people to save money. Then we started hearing from patients, and some doctors, that we have to look at [safety problems] more carefully.
What kinds of problems have you heard about?
People experienced either a therapeutic failure after success with the brand name or side effects they hadn't encountered with the brand name. These [problematic] drugs are getting shuffled into the pipeline unbeknownst to physicians and the FDA. Where are they coming from? One of the places to look is abroad. We began hearing from people in the business that more and more raw materials were coming from India and China and other countries where there were concerns about quality assurance. We heard that over-the-counter drug ingredients, such as ibuprofen and acetaminophen, are also coming from those countries. Nobody's testing these compounds.
Generic-drug manufacturers have to tell the FDA that they've tested their products for quality and that the active ingredient is the same as in the brand name. You're saying there's very little follow-up by the FDA to make sure that those tests are performed properly, or at all.
The FDA doesn't inspect what's on pharmacy shelves. What they do is pull 300 final dosage units of brand and generic drugs off the wholesaler's shelves each year, and they test those 300. So, of the 3-plus billion prescriptions dispensed each year in pharmacies, they test about 1 unit in 10 million. The FDA is supposed to inspect manufacturing plants every two years. But FDA officials tell us they don't have enough resources to do that, so some companies might get inspected only every three or four years. The Washington Post just reported that in the past seven years, the FDA conducted 200 quality-assurance inspections of plants in India and China, compared with 1,222 in the U.S. last year.
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.