A closer look

The FDA, working to uncover fraud, encourages consumers to check carefully and note any changes in a drug’s label, taste or appearance. (Photo illustration by Ricardo DeAratanha / LAT)

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."

•  Last month, a 31-year-old Glendale man was indicted by a federal grand jury in Los Angeles on charges of trafficking in tens of thousands of counterfeit Viagra tablets. The fake Viagra was manufactured in China to look like the real thing.

Officials acknowledge that they don't know the full extent of the problem of counterfeit drugs. But many believe that it poses a growing danger. "There are two things that worry us," said William Hubbard, senior associate commissioner for policy and planning at the FDA. "The number of criminal cases has tripled in the past few years. That tells us that counterfeiters are more active. And we're seeing more organized elements getting involved."

The experience in Florida, where a grand jury report last year helped spotlight the issue, offers a case in point. From 1985 to 2001, only five counterfeit drug cases were investigated in the state, contrasted with 10 such cases in the last two years. The FDA also has seen a surge in investigations of counterfeit drugs, from an average of about five a year in the 1990s to 20 last year. And those numbers almost certainly underestimate the extent of drug counterfeiting.

"The business of selling counterfeited and adulterated drugs is booming," Robert Penezic, former assistant statewide prosecutor in Florida, told a congressional subcommittee in June. "In the case of buying and reselling adulterated prescription drugs, the money that can be made from illegal activity is staggering."

The U.S. pharmaceutical industry generates $180 billion a year. Some genetically engineered drugs now go for several thousand dollars for a single vial, making counterfeiting a potentially attractive business. Consider Serostim, a drug often taken by AIDS patients to prevent debilitating weight loss. A 12-week course of Serostim costs about $21,000, which explains why counterfeiters have targeted the drug.

What's more, counterfeiting pills, labels and packages is relatively simple. Most of the tools needed to produce authentic-looking but counterfeit drugs and packaging can be bought on the Internet. In December, federal officials in Florida charged Julio Cesar Cruz, 41, of Miami and others with selling more than $1 million worth of counterfeit Lipitor. The government's affidavit cites testimony from a material witness who confirmed a scheme "to manufacture counterfeit Lipitor, including the purchase of punches, dies, plates and other items they used to create and manufacture a tablet that appeared to be genuine Lipitor." A federal grand jury is expected to review the charges filed in the complaint and determine if the evidence warrants an indictment.

"With each new case we are shocked at the level of sophistication in the reproduction of labels, seals and containers," Gregg Jones, an expert with Florida's Bureau of Statewide Pharmaceutical Services, testified at a hearing in June before the oversight and investigations subcommittee of the House Energy and Commerce Committee in Washington, D.C.


Reaching the pharmacy