Counterfeit medicine looks like the real thing but is made with cheaper, sometimes dangerous ingredients. In 1995, tainted cough medicine killed 89 Haitians. Now there's mounting evidence that counterfeit drugs have permeated the United States.
The House Commerce Committee Thursday accused the Food and Drug Administration of disregarding its own evidence of the growing public health risk, even after one FDA investigator warned in a 1996 internal memo that, "We literally have no control over bulk drugs that enter the U.S. These drugs can reach anyone including the president."
Chairman Tom Bliley, R.-Va., said his committee's investigation had revealed, "the FDA's regulatory system used to protect Americans from counterfeit or substandard drug ingredients has significant holes."
Bliley said the FDA allows the import of drugs based "merely on the representations of an international broker, who could in fact be the counterfeiter."
"The FDA admits it has information on only 18 percent of the foreign drug manufacturers shipping to the U.S," Bliley added. He reports that since 1997, some 4,600 foreign drug makers have shipped medication into the U.S. without getting inspected.
One possible victim of counterfeit drugs is Lynn Brown, whose doctor gave her a common antibiotic, gentamicin, for a toenail infection. She was stricken by an imbalance disorder so profound, she literally had to re-train herself to walk.
While counterfeit drugs are suspected to be connected to her case, it's not been proven. It's possible she could have been harmed by regular gentamicin.
Whatever the cause, the effect on Brown has been devastating.
"My balance mechanism has been destroyed," said Brown. "This is permanent damage. It is irreversible."
Experts believe counterfeit gentamicin may be to blame for hundreds of severe reactions and at least 66 deaths in the U.S.
In 1996, a company called Flavine International admitted it imported nine counterfeit drugs into the U.S. for years undetected, including gentamicin. Those drugs were associated with "deaths," an FDA memo noted after-the-fact.
According to an FDA document, the investigation of Flavine began in 1990. In 1995, a grand jury indicted Flavine on counts of conspiracy for bringing gentamicin and a veterinary antibiotic from an unapproved source in ChinaLong March Pharmaceuticalsand selling it in the U.S. at inflated prices.
Owner Gerd Weithase was arrested in Paris and later pleaded guilty to the charges. He was sentenced in 1997 to two years in prison and fined $75,000. Flavine was fined $925,000.
In September 1999, the FDA sent Long March a letter complaining of "significant deviations from current good manufacturing practices."
However, it wasn't until June 5 of this year that the FDA finally stopped the gentamicin shipments from Long March Pharmaceuticals, and then only after hospitals in California and Colorado noticed unusual reactions in patients.
Even after the gentamicin episode, the FDA allowed Flavine International to bring other medicine into the U.S., made by the same counterfeit drug maker in China.
FDA officials have now vowed to put a stop to that and devote more attention to the problem.
"We certainly have investigated a number of deaths and injuries associated with counterfeit drugs," said Dennis Baker, FDA associate commissioner for regulatory affairs.
Indeed, one Chinese maker of gentamicin, China Fuzhou Antibiotic Group, located in Fuzhou, China, displays on its Web site a picture of FDA team inspecting its plant.
However, Bliley charges that the FDA told him it has no open investigations of counterfeit drug makers.
Last month, the World Health Organization issued an alarm on the growing threat from counterfeit drugs.
Dr Yasuhiro Suzuki, WHO Executive Director in charge of Health Technology and Pharmaceuticals, said "No country is immune from the threat of counterfeit drugs."
Gentamicin Sulfate is used to treat infections of the eye or ear.