One New York man recovering from a liver transplant discovered the Epogen he purchased at a drugstore was a fake -- containing one-twentieth of the prescribed active ingredient. A California AIDS patient found that his human growth hormone prescription was counterfeit after reporting to his pharmacist that the injection left a burning sensation.
It's rare for consumers to detect fake medications. The public generally is unaware of the counterfeit pharmaceutical problem and the evidence often is ingested. But the risk to consumers is growing.
The Food and Drug Administration's counterfeit drug investigations have more than quadrupled since the late 1990s. The Pharmaceutical Security Institute, a not-for-profit public health group, estimates that $200 million in prescriptions in 2003 (latest statistics) were counterfeit or tainted -- a seven-fold increase over the previous year. And the World Health Organization estimates that counterfeit drugs are now a $32 billion-a-year business.
"It's significant. The estimates are that between 8 [percent] and 10 percent of all drugs around the world are fake or tainted," says Bryan Liang, executive director of the Institute of Health Law Studies at California Western School of Law and co-director of the San Diego Center for Patient Safety. "We write between 2 [billion] and 3 billion prescriptions here in the United States each year, so that's 200 [million] to 300 million prescriptions that could be affected."
According to a 2004 FDA report, the counterfeit pharmaceutical trade is largely operated by "well-organized criminal operations" producing look-alike products that contain only inactive ingredients, incorrect ingredients, improper or contaminated dosages. "Drug counterfeiting poses real public health and safety concerns today," concluded the report.
Demand for prescription drugs over the Internet and through the phone has spurred fake drug production -- though they have also been found in pharmacies.
"In the fake drug world, the product doesn't even need to work. It just needs to look like it's the drug," says Liang. "They're hard to detect and they make a lot of money."
And the public isn't aware of the problem. "When people think of counterfeits, they don't usually think pharmaceuticals," says Darren Pogoda, staff attorney of the International AntiCounterfeiting Coalition, a D.C.-based group fighting counterfeits. "An entire range of products are counterfeited and some of them produce obvious health and safety issues."
The trend in fake drugs five years ago was "lifestyle drugs" such as Viagra, or Third World malaria drugs, says Liang. "Now the scope is broadening to pretty much any expensive medicine," from cancer drugs and cholesterol-lowering drugs to flu vaccines and contraceptives.
To help consumers check their prescription drugs and avoid counterfeits, the Partnership for Safe Medicines -- a national coalition of patient, physician, industry and research groups -- recently released a checklist of safety tips. Among them:
Request manufacturer samples of your brand name medications from your physician so you can compare the appearance, taste, texture, reaction and packaging later when filling the prescription.
"Compare drugs and their containers with photos of the samples or pictures in 'The Physicians Desk Reference' " (available at public libraries), says Liang, who advised the Partnership for Safe Medicines in creating the checklist. "If they look even a little bit different, question it with your pharmacist or physician."
Note each drug's "taste and feel" in a drug diary. Does it go down smooth? Do you get stomach rumblings? Question any unusual reaction.
Is your condition improving over the course of the treatment? If not, contact your physician. Fake drugs can contain no active ingredient, not enough or too much, so one result is patients don't improve -- or get worse.
If you suspect or confirm that your medicine is fake, write down where and when you bought it, how long you've been taking it and anything else about it. Don't throw the drug out -- law enforcement and FDA officials will want the evidence. Remove it from your medicine cabinet, mark the packaging with a red pen and tape the container closed so nobody else takes it.
Then contact the pharmacy where you purchased them, the manufacturer and the FDA. "This will allow us to determine how these drugs ended up on the market and find a way to stop it," says Liang.
For FDA information on avoiding counterfeit medicine, visit www.fda.gov/cder/consumerinfo/counterfeit_text.htm.
For information on safe and affordable drugs, see the Partnership for Safe Medicine site at www.safemedicines.org.
For a list of certified Internet pharmacies, see National Association of Boards of Pharmacy's "VIPPS" site at www.nabp.net/vipps/consumer/listall.asp.
To report a possible counterfeit drug, contact the FDA at 800-FDA-1088 (800-332-1088), or online at www.fda.gov/medwatch.
Got questions? A consumer complaint? A helpful tip? E-mail details to firstname.lastname@example.org or write Don Oldenburg, The Washington Post, 1150 15th St. NW, Washington, D.C. 20071.