The prescription drug industry is a $190 billion-a-year business. With that much money to be made, and with the price of drugs in the United States skyrocketing, an increasing number of criminals are turning to a lucrative trade — counterfeit medications.
"The counterfeiters are getting more sophisticated," said Dr. Mark McClellan, commissioner of the Food and Drug Administration. "We're seeing increasingly well-organized criminal operations coming into the drug distribution system and trying to make a fast buck at the expense of the public health."
The FDA currently has 22 counterfeit drug investigations under way, according to McClellan. That has increased fourfold from the late 1990s, when the agency averaged only five such investigations a year. It is scheduled to address drug wholesalers, manufacturers and other industry officials Wednesday in an effort to raise awareness of counterfeit drugs.
Aaron Graham, who is in charge of security for the drug company Perdue Pharma, said producing bogus prescriptions is easy, "because all you have to do is mimic the color and shape and you have a pill that looks like the authentic good."
Counterfeit drugs often get into the system through crooked wholesalers who act as middlemen.
"We do not have a protocol in place that mandates tracking of the product throughout the supply chain from the manufacturer through to the retail pharmacy," Graham said, "and that is in fact the loophole that is being exploited today."
The loophole allows counterfeit drugs to find their way to pharmacies and ultimately to consumers.
That's how Rick Roberts of San Francisco believes he got his counterfeit medication. Roberts was taking Serostim, a drug prescribed to AIDS patients to help keep weight on.
He noticed some subtle differences from previous prescriptions, like stinging at the injection site and soreness the next day. Both were side effects he had not experienced before.
"I didn't get the medicine I was supposed to get," Roberts said. "Somehow I'd gotten something else that looked close enough to the real thing that it passed the pharmacist's inspection and I injected it. I didn't know what I was up against."
Ultimately, the prescription proved to be counterfeit. It was linked to an illegal wholesaler in Florida, despite the fact that Roberts obtained the prescription from a national pharmacy chain.
Roberts said the drug he received was actually fertility medication. Luckily, he suffered no ill effects from it.
Computers make it easy to print realistic-looking labels, and drugs are widely available at the click of a mouse on the Internet.
Earlier this year, the FDA warned about contraceptives offered online that were fakes. Wholesalers have been sued for allegedly passing along counterfeit versions of medicines like Epogen, a drug to treat anemia. And last year, in the biggest case, more than 200,000 bottles of Lipitor, a cholesterol medicine, were recalled after it was discovered that fakes from overseas were mixed into the actual drug.
The FDA recently released a report saying that "drug counterfeiting poses real public and health safety concerns today, and may pose an even greater threat in the future if we fail to take preventative measures now."
To prevent the growing problem, the FDA wants drug manufacturers to put a tracking system in place voluntarily by 2007. The makers of tracking devices have been testing tiny radio frequency computer chips that would be attached to drug labels or the prescription packaging.
"FDA will not rest until we have strong protections in each link of the drug supply chain, and we intend to work with all of those involved in getting medicines to Americans legally and safely to make sure that Americans are protected," McClellan said.
Roberts, however, has a bleaker view of the picture. "FDA, I think, is working really hard to catch up to the bad guys," he said, "but right now the bad guys are in the lead."