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Some call it the most perfect crime in medicine: Buy some empty gelatin capsules, fill them with worthless powder, print up a phony label and sell them to a drug wholesaler who has no scruples or just chooses to look the other way. The unsuspecting consumer who buys the drugs from his corner pharmacy will almost certainly never discover why he is getting sicker instead of better. This is called “drug counterfeiting,” a business that has expanded in the last five years. Phony drugs already have taken the lives of several Americans, and the perpetrators have walked off with nearly $35 billion in black-market profits.
Thankfully, the chances are fairly slim that your daily pills could be fakes, but the problem is worsening as counterfeiters become more savvy. The World Health Organization estimates that up to 10 percent of the medications sold globally are actually counterfeit. The number in the United States is much lower—experts peg it at 1 percent—but the practice is growing as dealers of illicit street drugs like cocaine and Ecstasy discover there are more profits and less risks in selling phony tablets of drugs like Ambien, Lipitor and Cipro.
“We’re seeing a lot more of this than ever before,” says John Theriault, vice president for global security at the pharmaceutical giant Pfizer. The problem has become serious enough for Pfizer to develop its own private team of 17 former law-enforcement agents to investigate counterfeit drugs. Theriault, an ex-FBI agent, says his team has come across drug labs in homes, hotel rooms and overseas warehouses.
Phony pills are put in conventional plastic bottles that sometimes have labels soaked off from legitimate shipments. One such case in 2003 involved as many as 18 million tablets of bogus Lipitor that had been manufactured in Costa Rica. The counterfeiters had purchased their ingredients from the Hong Kong office of a Swiss company and even embossed the fake product with a real-looking Pfizer logo. The “Lipitor” was then marketed through a drug wholesaler operating in the Midwest and sold through legitimate pharmacies. The pills reached Pfizer’s attention only after American customers began to complain about their bitter taste. It’s possible that more than 600,000 people could have received bottles containing the fake Lipitor tablets.
But not every counterfeit drug is cooked up in an illicit lab. Some unscrupulous suppliers have been known to boost their profits by “uplabeling”—for example, passing off a 10mg dose of a drug as 40mg. Expiration dates may be altered too. Experts say the vulnerabilities in the supply chain also can be traced to secondary drug wholesalers, who face pressure to keep costs low and may not be inclined to scrutinize the source of their purchase. Where the drug changes hands several times, that’s where you have the problem, says one industry expert. The bogus drugs go from a wholesaler’s warehouse to a retail pharmacy and into a consumer’s medicine cabinet.
Not surprisingly, the Internet is another common source of counterfeits. Direct-to-consumer Web sites offer great deals that are literally too good to be true. “You can find plenty of ‘Canadian’ sites that aren’t really Canadian,” says Pfizer spokesman Bryant Haskins. “They’re decorated with maple leaves, but we’ve tracked them to Belize, Russia, Vietnam—all over the place.”
The deception often goes further than that. “Overseas counterfeiters are also known for selling ‘ generic’ versions of drugs where no generics exist,” points out Joan Todd of Eli Lilly and Company. “The consumer assumes that somebody out there is regulating this. But anybody can set up a Web site and sell fake medicine.” In one notorious case, Lilly investigators found a machine used to create bogus drugs in which a toilet seat had been jerry-rigged into the device. “This obviously does not adhere to good manufacturing procedure,” remarks Todd dryly.
Last year, the U.S. Food and Drug Administration investigated 53 cases of drug counterfeiting—up from six just five years ago. Though it is difficult to chart how many people unwittingly ingest counterfeit drugs each year, the injuries and deaths likely number in the hundreds. Experts say that thousands of Americans doubtlessly have been affected without even knowing it.
Most ersatz-drug fatalities almost certainly have escaped notice, explains Haskins. Autopsies are not routine for the sick or elderly, and few doctors would ever suspect that the drugs they prescribed were nothing more than useless filler. What harms a patient is usually not toxic substances in the phony drug but a lack of the potentially lifesaving medication they are supposed to be receiving.
Besides, drug counterfeiters rarely set out to kill their customers—such a move would invite police attention and run contrary to their economic interests. The logic is similar to that of a parasite, which seeks not to kill the host but to feed off it for as long as possible. This is why expensive drugs that treat long-term conditions such as AIDS are the most likely to be counterfeited. Erectile-dysfunction drugs are also a prime target because of the big money involved—and the disinclination of many patients to complain about a lack of results.
Solving this problem will not be quick or easy. Rep. Mike Rogers (R., Mich.) has proposed raising the penalties for prescription drug counterfeiters from three years in prison to 20 years, putting the perpetrators on an equal plane with heroin dealers. The bill he proposed died in committee last session but was reintroduced earlier this month.
The Food and Drug Administration also has encouraged drug companies to track their pills after they leave the factory. GlaxoSmithKline, for example, now inscribes its pills and packages with invisible text symbols to authenticate its product. But these markings would be checked only after a counterfeit suspicion arises.
Tracking is becoming easier, however, with a technology known as Radio Frequency Identification (RFID), an advanced variety of bar code that is now used in the E-ZPass highway toll system, among other places. This technology would allow officials to scan entire pallets of drugs instead of checking individual barcodes. Such a system would make it hard to slip bogus products into the supply chain, because drugs could be tracked from factory to pharmacy counter. Progress with RFID has been slow due to the high costs involved. So far, only limited shipments of expensive drugs like the painkiller Oxycontin contain RFID tags on their labels.
One thing everyone agrees on: The problem is becoming widespread, and the supply chain is still vulnerable. Up to 40 million of the prescription bottles handed out in the U.S. today are filled with substances that aren’t what they claim to be, according to the National Association of Boards of Pharmacy.
“If the system becomes further compromised, it will get to the point where it’s very difficult to fix,” says Carmen Catizone, the association’s executive director. “Imagine someone going to the emergency room for a heart attack and being given counterfeit drugs by the hospital staff. This could cripple the whole health-care system.”
Don’t buy prescription drugs online unless it’s through the Web site of a legitimate pharmacy.
Look closely at your medicine. Note any signs of runny coloring or shoddy logos on the pills.
Watch for changes in appearance or taste in the prescriptions you regularly take.
Bring any reliable medication that suddenly begins to have no effect to your doctor right away.
•Learn more about the counterfeit drug problem in America
On its Web site, the U.S. Food and Drug Administration posts the latest warnings about counterfeit drugs and offers other important consumer information.
Click here to go to the FDA Web site
Report a suspicious drug
•The National Fraud Information Center/Internet Fraud Watch (NFIC/IFW) tells you step-by-step how to notify authorities if you think a drug you’ve bought is fake.
Click here to go to the NFIC/IFW Web site
Thankfully, the chances are fairly slim that your daily pills could be fakes, but the problem is worsening as counterfeiters become more savvy. The World Health Organization estimates that up to 10 percent of the medications sold globally are actually counterfeit. The number in the United States is much lower—experts peg it at 1 percent—but the practice is growing as dealers of illicit street drugs like cocaine and Ecstasy discover there are more profits and less risks in selling phony tablets of drugs like Ambien, Lipitor and Cipro.
“We’re seeing a lot more of this than ever before,” says John Theriault, vice president for global security at the pharmaceutical giant Pfizer. The problem has become serious enough for Pfizer to develop its own private team of 17 former law-enforcement agents to investigate counterfeit drugs. Theriault, an ex-FBI agent, says his team has come across drug labs in homes, hotel rooms and overseas warehouses.
Phony pills are put in conventional plastic bottles that sometimes have labels soaked off from legitimate shipments. One such case in 2003 involved as many as 18 million tablets of bogus Lipitor that had been manufactured in Costa Rica. The counterfeiters had purchased their ingredients from the Hong Kong office of a Swiss company and even embossed the fake product with a real-looking Pfizer logo. The “Lipitor” was then marketed through a drug wholesaler operating in the Midwest and sold through legitimate pharmacies. The pills reached Pfizer’s attention only after American customers began to complain about their bitter taste. It’s possible that more than 600,000 people could have received bottles containing the fake Lipitor tablets.
But not every counterfeit drug is cooked up in an illicit lab. Some unscrupulous suppliers have been known to boost their profits by “uplabeling”—for example, passing off a 10mg dose of a drug as 40mg. Expiration dates may be altered too. Experts say the vulnerabilities in the supply chain also can be traced to secondary drug wholesalers, who face pressure to keep costs low and may not be inclined to scrutinize the source of their purchase. Where the drug changes hands several times, that’s where you have the problem, says one industry expert. The bogus drugs go from a wholesaler’s warehouse to a retail pharmacy and into a consumer’s medicine cabinet.
Not surprisingly, the Internet is another common source of counterfeits. Direct-to-consumer Web sites offer great deals that are literally too good to be true. “You can find plenty of ‘Canadian’ sites that aren’t really Canadian,” says Pfizer spokesman Bryant Haskins. “They’re decorated with maple leaves, but we’ve tracked them to Belize, Russia, Vietnam—all over the place.”
The deception often goes further than that. “Overseas counterfeiters are also known for selling ‘ generic’ versions of drugs where no generics exist,” points out Joan Todd of Eli Lilly and Company. “The consumer assumes that somebody out there is regulating this. But anybody can set up a Web site and sell fake medicine.” In one notorious case, Lilly investigators found a machine used to create bogus drugs in which a toilet seat had been jerry-rigged into the device. “This obviously does not adhere to good manufacturing procedure,” remarks Todd dryly.
Last year, the U.S. Food and Drug Administration investigated 53 cases of drug counterfeiting—up from six just five years ago. Though it is difficult to chart how many people unwittingly ingest counterfeit drugs each year, the injuries and deaths likely number in the hundreds. Experts say that thousands of Americans doubtlessly have been affected without even knowing it.
Most ersatz-drug fatalities almost certainly have escaped notice, explains Haskins. Autopsies are not routine for the sick or elderly, and few doctors would ever suspect that the drugs they prescribed were nothing more than useless filler. What harms a patient is usually not toxic substances in the phony drug but a lack of the potentially lifesaving medication they are supposed to be receiving.
Besides, drug counterfeiters rarely set out to kill their customers—such a move would invite police attention and run contrary to their economic interests. The logic is similar to that of a parasite, which seeks not to kill the host but to feed off it for as long as possible. This is why expensive drugs that treat long-term conditions such as AIDS are the most likely to be counterfeited. Erectile-dysfunction drugs are also a prime target because of the big money involved—and the disinclination of many patients to complain about a lack of results.
Solving this problem will not be quick or easy. Rep. Mike Rogers (R., Mich.) has proposed raising the penalties for prescription drug counterfeiters from three years in prison to 20 years, putting the perpetrators on an equal plane with heroin dealers. The bill he proposed died in committee last session but was reintroduced earlier this month.
The Food and Drug Administration also has encouraged drug companies to track their pills after they leave the factory. GlaxoSmithKline, for example, now inscribes its pills and packages with invisible text symbols to authenticate its product. But these markings would be checked only after a counterfeit suspicion arises.
Tracking is becoming easier, however, with a technology known as Radio Frequency Identification (RFID), an advanced variety of bar code that is now used in the E-ZPass highway toll system, among other places. This technology would allow officials to scan entire pallets of drugs instead of checking individual barcodes. Such a system would make it hard to slip bogus products into the supply chain, because drugs could be tracked from factory to pharmacy counter. Progress with RFID has been slow due to the high costs involved. So far, only limited shipments of expensive drugs like the painkiller Oxycontin contain RFID tags on their labels.
One thing everyone agrees on: The problem is becoming widespread, and the supply chain is still vulnerable. Up to 40 million of the prescription bottles handed out in the U.S. today are filled with substances that aren’t what they claim to be, according to the National Association of Boards of Pharmacy.
“If the system becomes further compromised, it will get to the point where it’s very difficult to fix,” says Carmen Catizone, the association’s executive director. “Imagine someone going to the emergency room for a heart attack and being given counterfeit drugs by the hospital staff. This could cripple the whole health-care system.”
How to Protect Yourself
Here are a few precautions you can take to avoid counterfeit drugs:Don’t buy prescription drugs online unless it’s through the Web site of a legitimate pharmacy.
Look closely at your medicine. Note any signs of runny coloring or shoddy logos on the pills.
Watch for changes in appearance or taste in the prescriptions you regularly take.
Bring any reliable medication that suddenly begins to have no effect to your doctor right away.
•Learn more about the counterfeit drug problem in America
On its Web site, the U.S. Food and Drug Administration posts the latest warnings about counterfeit drugs and offers other important consumer information.
Click here to go to the FDA Web site
Report a suspicious drug
•The National Fraud Information Center/Internet Fraud Watch (NFIC/IFW) tells you step-by-step how to notify authorities if you think a drug you’ve bought is fake.
Click here to go to the NFIC/IFW Web site
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