Fake Medications Are a Growing Threat
There's lots of profit in counterfeit drugs, so consumers should be on guard
Counterfeit prescription drugs are a $35 billion-a-year business, and it's growing; by some estimates, 50 percent of prescription drugs in Africa, including those used to treat AIDS and malaria, are fake. Americans have long considered themselves immune, but a huge proportion of the prescription medications and devices used in the United States are now manufactured overseas, and the risks are escalating for Americans, too. It's no surprise; last year alone Americans spent $275 billion on their prescriptions. Consider:
• Last fall, counterfeit diabetes test strips from China flooded the U.S. market. The fake blood glucose monitoring strips first came to light in September, when 15 patients called the consumer hotline at LifeScan, sellers of the tests, and complained that they were getting faulty results. Surveillance by the company found fake OneTouch test strips on pharmacy shelves. More than 1 million fake test strips were distributed and were being sold in 700 pharmacies in 35 states. LifeScan and the Food and Drug Administration alerted patients and doctors in October, saying that relying on the bogus product could cause serious injury or death. Investigators for Johnson & Johnson, LifeScan's parent company, traced the counterfeit goods through importers in Florida and Canada to a company in Shanghai.
• In May, the FDA announced that patients who had bought Orlistat, a weight-loss drug, over the Internet received pills that looked identical to the Roche product but contained talc and starch.
• Fake Lipitor pills made in Costa Rica were mingled with genuine Lipitor illegally imported from Brazil, then distributed to pharmacies in at least 15 states. Last October, Julio Cesar Cruz, a Cuban living in Miami, was sentenced to 13 years in prison for his role in the $12.8 million-dollar drug ring. The problem first came to light in April 2003, after patients noticed that the pills had a bitter taste and dissolved quickly in their mouth. The FDA recalled more than 18 million fake and repackaged tablets. Lipitor, the biggest-selling drug in the world, is a statin used to treat high cholesterol.
Clearly the risks of counterfeit medications are no longer confined to drugs bought from Internet pharmacies—which do indeed pose a large risk. Last month, officials in Canada confirmed that Marsha Bergeron, a 58-year-old woman who lived on Vancouver Island, died of metal poisoning in December 2006 after taking tainted prescription medications purchased from an Internet pharmacy, including a sleeping pill. The drugs contained toxic amounts of aluminum.
Since 1999, the National Association of Boards of Pharmacy has certified online drugstores that meet national standards. That list is surprisingly short, with only 13 currently listed. A survey released this week by MarkMonitor, a San Francisco-based firm that keeps tabs on online sales and marketing abuses, found that just four of the 3,160 online pharmacies surveyed were certified by the National Association of Boards of Pharmacy as legitimate. Many offered pharmaceuticals at prices lower even than wholesalers, suggesting that the drugs being sold were, according to MarkMonitor's report, fake, stolen, alternate, expired, gray market, or diluted. "A relatively sophisticated person would be misled," says Fred Felsen, chief marketing officer for MarkMonitor. "Caveat emptor really doesn't work."
A few minutes' Web surfing turns up examples of surprisingly cheap online medications, including Zyprexa, an antipsychotic used to treat schizophrenia and bipolar disorder, for 43 cents a pill, compared with $10.77 at a certified pharmacy site. The pills are marketed as generics made in India; those generics aren't approved for sale in the United States.
Pharmaceutical companies are increasingly concerned about counterfeiting, not only because bogus drugs cut into sales but because patients could be harmed by drugs they think are legit. They increasingly deploy their own security teams and third-party investigators to detect bogus products in the marketplace. "Wherever a buck can be made, you're going to be seeing counterfeiting," says Bryant Haskins, a spokesman for Pfizer. Lipitor and Pfizer's other blockbuster drug, Viagra, are frequent targets of counterfeiters, but Haskins says that even drugs that sell for a few pennies a pill are counterfeited.
Tracking counterfeits to the source is difficult, because of the convoluted and little-monitored production and distribution systems. Pharmaceutical companies often purchase ingredients and assemble medications in different countries. Drugs then move through a variety of repackagers and distributors, some of which are little more than storefronts, before they reach pharmacy shelves.
The FDA is well aware of the problem; the agency's criminal investigations of counterfeiting have more than doubled in the past five years, from 21 in 2001 to 54 in 2006. Ilisa Bernstein, a pharmacist who is director of pharmacy affairs for the FDA, says the increase is due to more drugs being sold on the Internet and higher drug prices. "The counterfeiters have more incentives." Increasingly, drugs being counterfeited are not just "lifestyle" drugs like Viagra, which people often buy on the Internet, but widely used drugs like Lipitor, or high-ticket items, like some cancer and AIDS treatments. In June 2006, the FDA said it would require distributors to maintain documents attesting to the "pedigree" of their products. The agency had hoped to roll out an electronic system for tracking drugs through distribution, but such a system is nowhere near completion. Still, Bernstein says, "We are fairly confident that the domestic U.S. drug supply is safe."
Customers are at a disadvantage when it comes to figuring out if medications purchased at a pharmacy are fakes. In many cases, counterfeiters imitate packaging of the legitimate company (as in the case of the fake OneTouch test strips) or mix real pills with fake (as in the case of the counterfeit Lipitor). Pharmaceutical industry experts suggest taking a few steps to avoid using counterfeit medications:
Take note if pills look or taste different than they did before. Photographs of prescription drugs are available in the Physicians Desk Reference, at local libraries. Sometimes pills will look different because the pharmacist switched from one generic to another. When in doubt, ask the pharmacist.
Note any differences in reactions to medications compared with previous experiences, and report them to your doctor.
When purchasing drugs on the Internet, be sure the site is certified as a Verified Internet Pharmacy Practice Site (VIPPS) by the National Association of Boards of Pharmacy or by a state pharmacy board.
If you are suspicious about a medication or its packaging, contact the pharmacy that filled the prescription. The FDA's MedWatch program gathers consumer reports on medications at 800-332-1088, or fda.gov/medwatch.