It is not a victimless crime. It isn't an offense against trademarks, or the balance sheets of deep-pocketed pharmaceutical companies. Counterfeit drugs hurt people. And the victims are most often people who need real, quality drugs the most: cancer patients, AIDS patients, and people being treated for heart disease.

Moreover, those who have ended up with counterfeit drugs didn't necessarily go shopping for cheap pills from questionable sources. Many bought them at their local pharmacy.

From 1997 to 2000, the FDA investigated an average of five counterfeit drug cases per year. In 2001, the number of investigations quadrupled and has remained as high since. Some cases involve hundreds of thousands of fake prescription drugs. This has federal regulators and the industry scrambling to plug leaks in the system before it's swamped by counterfeits.

Officials say counterfeit drugs in the U.S. still account for a small fraction of a percent of the more than 3 billion prescriptions filled each year. The problem is far worse in many other countries. But unless the weak points in our regulatory system are patched soon, our troubles could get much worse.

No one knows how many people have taken counterfeit prescription drugs in the U.S., although the number could be surprisingly high. In 2003, the FDA announced a recall of some 200,000 bottles of Lipitor (a popular cholesterol-lowering drug) that were believed to be fake. Over the previous two years, 110,000 bottles of counterfeit Epogen and Procrit, drugs used to boost red blood cell production in people with cancer, AIDS, and kidney disease, made their way into the marketplace. Law enforcement officials recovered only one-tenth of the counterfeit drugs.

In the latter case, the drugs patients got were highly diluted. In another instance, a man thought he was injecting himself daily with an AIDS medicine when he was actually taking a female pregnancy hormone. Others who have received counterfeit prescription drugs still have no idea what they really took.

Counterfeit Drugs More Lucrative Than Heroin

The main reason for the sudden rash of counterfeit drugs is, in a word, money. Criminals are getting wise to the fact that there are enormous profits to be made in fake pharmaceuticals. Americans spent $203 billion on prescription drugs in 2003, according to statistics from the National Association of Chain Drug Stores. Any counterfeiter who manages to nab a tiny sliver of the pie can make a fortune.

"Some of the experts are telling us it's more lucrative to sell a counterfeit drug than it is a narcotic such as heroin," William Hubbard, FDA's associate commissioner for policy and planning, tells WebMD. Nor is counterfeiting limited to small-time hustlers looking to turn a quick buck. "We're seeing organized criminal elements getting involved," Hubbard says, although he declined to provide details because investigations are ongoing.

Of the 30 medicines that the National Association of Boards of Pharmacy named in a list of drugs especially susceptible to counterfeiting, 23 are used in treating HIV/AIDS and cancer. Counterfeiters favor these drugs because of their cost. Sixty tablets of Combivir, an HIV drug, retails for around $600. Thirty-six tablets of Zofran, an anti-nausea medicine used by people undergoing cancer chemotherapy, retails for roughly $1,000. Epogen is counterfeiter's gold: A box of the most concentrated form retails for about $5,000.

Next: Leaks in the System