Doctors couldn't explain why the medicine they were giving Tim Fagan wasn't working. The 16-year-old boy had been rushed to New York University Medical Center for an emergency liver transplant last February.
Fagan was given daily injections of a drug called Epogen to treat severe anemia. But his red blood cell count wasn't improving. And there was another mystery: Shortly after each injection, the young patient was getting severe and painful muscle cramps.
After two months of treatments, Fagan and his family received shocking news. The version of the drug he had received was counterfeit. The small vials contained only one-twentieth the amount of active ingredient the label indicated.
"This wasn't a drug someone bought on the street," but rather from a major national pharmacy chain, said Eric Turkewitz, a New York lawyer who is representing the Fagans in a pending lawsuit. "The family never thought for a moment that it was anything but real."
It wasn't. Somewhere between the drug's manufacture and its arrival at the pharmacy, counterfeiters had taken low-dose vials and relabeled them as high-dose versions. The weaker drug sells for $22 a bottle. The high-strength bottle fetches $445. An estimated 110,000 bogus bottles reached the market without raising suspicions. Investigators say the counterfeit scheme may have netted criminals a staggering $48 million.
The Food and Drug Administration insists that the country's pharmaceutical drug supply is the safest in the world. But a growing number of counterfeit drug seizures and arrests has raised new worries that consumers can't be so sure the pharmaceutical medicines they buy are safe or even genuine.
* In the spring of 2001, a pharmacist in Sunnyvale, Calif., noticed something amiss with bottles of the growth hormone Neupogen, which is prescribed to HIV and cancer patients. The bottles were fake, filled not with medicine but with salt water.
* In February 2002, Robert Courtney, a Kansas City, Mo., pharmacist pleaded guilty to diluting cancer drugs. He later admitted that he had diluted at least 98,000 prescriptions since 1992.
* In 2002, bottles of Zyprexa, a drug used to treat schizophrenia, were found to be bogus. The pills inside had been replaced with aspirin.
* In May 2003, the FDA issued an alert that nearly 200,000 counterfeit bottles of Lipitor, widely used to control cholesterol, had made their way onto the market, representing "a potentially significant risk to consumers."
