With the H1N1 flu now on a run around the globe, traffickers in fake influenza medications are exploiting people's fears by marketing counterfeit Tamiflu, bogus vaccines and would-be cures that contain silver, playing off the belief the precious metal has antiviral powers.
Scam artists swung into action just as the first cases of swine flu emerged last spring, public health experts say, offering hundreds of products for sale online, many at Internet pharmacies based overseas.
"We have been identifying new [bogus] products weekly," said Alyson Saben, who heads the U.S. Food and Drug Administration's swine flu consumer fraud team, which works with the Federal Trade Commission to crack down on counterfeiters.
The fake flu treatments are part of a global drug-counterfeiting enterprise that the World Health Organization estimates nets $75 billion annually. The WHO also says that one in fourprescription drugs sold worldwide are fakes.
In the United States, an estimated 35 million fake drugs - 1 percent of all prescription medications - are taken by consumers, said Rep. Steve Israel (D-Huntington). He is hoping for passage before year's end of his proposed Counterfeit Drug Enforcement Act, which he first introduced in 2003. It would grant the FDA more power and money to penalize counterfeiters.
The drug industry, for its part, employs measures to protect consumers, such as adding holograms to packaging. But counterfeiters still lure buyers with cheap prices online. Katherine Eban, a Brooklyn author who has written about counterfeiters in her book, "Dangerous Doses," says they tend to target expensive genetically engineered drugs or big-volume sellers such as Tamiflu.
Some of the counterfeit drugs contain some of the active ingredient but not nearly enough to be effective. And many fake flu drugs have legitimate-sounding names. The FDA's online eavesdropping has uncovered CeraFlu; Flucinex; Defend-Rx; and Dr. Coldwell's.
Targeting online companies
Saben said FDA investigators have traced bogus flu products by buying them online. India, she said, was the source of a product advertised as Tamiflu. She said the round, white tablets took six weeks to arrive and looked nothing like the capsules containing the genuine drug.
The tablets turned out to be a simple blend of talc and the painkiller acetaminophen. The agency issues cease-and-desist warnings to sellers of bogus products but does not have power to arrest domestic counterfeiters or shut down foreign labs.
Penalties are usually light for makers of fake medications. Many face nothing more than fines and misdemeanor charges.
Israel's bill would create a paper trail that could be posted online revealing each point after manufacturing where medications change hands.
His bill is named for Tim Fagan, a Deer Park teenager who nearly died in 2002 after being injected with a counterfeit version of the immune booster Epogen following a liver transplant.
The genetically engineered Epogen was sold by a Florida counterfeiter who removed the labels of a lower-dose version of Epogen and placed his own labels on the bottles, claiming it as the higher dose. The medication, which then was never maintained at the proper temperature, was sold back into the supply chain at the higher price charged for higher doses.
Fagan's family purchased the medication at a CVS near their home.
"My son had terrible body spasms and when we talked to his doctor he said he never heard of that kind of reaction," said Kevin Fagan the father of Tim, who is doing well and is now in college. The Fagans' Manhattan attorney, Eric Turkewitz, said the family's lawsuit against multiple defendants, including CVS, was settled for an undisclosed sum.
Eban, who wrote about the Fagans in her book, said the counterfeiter who victimized Tim Fagan was indicted in 2003 on racketeering charges and sentenced to 12 years in prison.