Consumers shopping for medicine on the Internet often are getting convenience, a good price and the cloak of privacy, but they may not be getting the real thing.
A burgeoning multibillion-dollar industry of counterfeit drugs — ranging from AIDS and cancer medications to antidepressants and sexual enhancers — is keeping regulators busy and leaving the public vulnerable.
These medicines can deliver too little, too much or none of the active ingredient — or the wrong one — and sometimes are adulterated with dangerous chemicals or contaminated by unsanitary manufacturing or storage conditions.
The FDA in recent years has confiscated millions of dollars worth of counterfeit and other illegal medicine. The agency, in partnership with international regulatory, customs and law enforcement agencies from 100 countries, shut down thousands of Internet pharmacies selling illegal drugs and seized about $10.5 million worth of pharmaceuticals during a weeklong crackdown on counterfeit and unapproved medications that began in late September.
But such enforcement action isn't nearly enough to stop the proliferation of phony medicine, FDA officials concede.
"This is a drop in the bucket," said Ilisa Bernstein, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "We don't know how many websites are out there, but there are a lot more. We may have some impact on these 4,100 websites, but they can pop up days or weeks later using another URL and another way to deceive consumers."
It is illegal in the U.S. to sell medication without a valid prescription. All U.S. pharmacies, including those offering drugs online, must be licensed in the state where they are based or where they do business.
Foreign pharmacies can be licensed in the U.S. only if they follow all state and federal laws and distribute only FDA-approved products. No foreign pharmacy has met those requirements, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
Yet consumers can access tens of thousands of illegal online pharmacies, many of them based overseas. Buying drugs under those circumstances is illegal.
"It's as if they are going to the corner and buying drugs from a drug dealer," said Dr. Bryan Liang, director of the San Diego Center for Patient Safety at the University of California at San Diego School of Medicine.
Bernstein said it's impossible to know exactly how many people have died or been hurt by taking counterfeit drugs, although there have been highly publicized cases in the U.S. and overseas.
"A lot of people don't want to admit that they bought these drugs or were harmed by them," said Liang, who is on the board of the Partnership for Safe Medicines. Some people never realize that the drug they took was not the real thing.
Keavin Blount, the son of a St. Louis-area woman who died of cancer, said his mother suffered through her final months after she bought a counterfeit from her local pharmacist and was injected with it by a nurse at the hospital where she was getting treatment.
The drug, Procrit, was prescribed to treat Maxine Blount's anemia after chemotherapy, and for a time it helped her regain her energy so she could participate in family activities, her son said. After several months, though, it seemed to stop working. Authorities later determined that the drug was a highly diluted counterfeit, but they were unable to find out where it came from.
"I felt that there were some days with my mother that were taken from us," Blount said.
Experts say some of the illegal operations are based in the U.S., often with an elaborate cast of participants who make, sell and distribute the drugs. Many of the drug ingredients come from overseas.
Eli Lilly and Co. is one of the drugmakers battling the problem.
"Sometimes one criminal operation will make the packaging with our name brand on it," said Jeannie Salo, director of Lilly's global anti-counterfeiting operations. "Another operation may make the ingredient, which is not the (real) thing. Another person might operate an Internet site."
The appearance of fakes can be convincing, she said. "In some cases, you'd never know unless you tested it," Salo said.
Last year, 532 different medicines were identified as having been counterfeited, said Tom Kubic, president of the Pharmaceutical Security Institute, a global network of security directors for pharmaceutical manufacturers.