Some prescription drugs are tampered with as they pass through several middlemen on their way to the local pharmacy, reports 60 Minutes correspondent Bob Simon. What's more, if the drugs' manufacturers find out, they are not required to tell patients or the FDA that the drugs could be dangerous.
"A drug comes from the manufacturer. It goes to the national distributors. From there it goes to the pharmaceutical wholesalers," says Special Agent Michael Mann of Florida's Department of Law Enforcement. "We've seen drugs take as many as 10 stops," he tells Simon. That's because the price charged by the maker varies by several factors, including where the buyer does business and how much they are buying.
Such differences in price create profit opportunities for re-sellers, extending the length of the distribution system, which is largely unregulated and vulnerable. "Criminals…found a niche that we hadn't envisioned," says Mann.
Those criminals are emboldened by the fact that a paper trail tracking the drugs' movements is rarely required. As drugs wend their way through the system, they can be harmed simply by the failure to keep them refrigerated. Or, in the case of some extremely expensive drugs, especially those for cancer and AIDS, they can be diluted to multiply profits. There can be terrible consequences for those who take such drugs, called "counterfeit" by the industry.
"I'm sleeping and I'd wake up and cramp my whole body and I'd be crying and screaming," says a 17-year-old liver transplant recipient, whose weekly injections of a drug to raise his red blood cell count turned out to be counterfeits. A second batch was also found to be counterfeit by the boy and his parents, who appear on camera in the report but do not wish their names to be used.
Even if drug manufacturers know their drugs are being counterfeited, they may not want to scare patients into the arms of a competitor by revealing the problem.
"Manufacturers are not required to tell a drug store," FDA Commissioner Dr. Mark McClellan tells Simon. Nor do they have to tell patients, he says. The FDA, which is responsible for the safe manufacture of a drug, is not responsible for safe distribution. That responsibility lies with the individual states.
Some states are beginning to crack down, but what's really needed, say prosecutors and health officials, is a law requiring paperwork tracing the movements of drugs that would make it more difficult for criminals to get away with drug tampering.